{"version":"1.0.0","segments":[{"startTime":0.72,"endTime":3.393,"body":"- [Announcer] Welcome to"},{"startTime":0.72,"endTime":3.393,"body":"this Mtech Access webinar."},{"startTime":4.35,"endTime":6.57,"body":"At Mtech Access, we provide"},{"startTime":6.57,"endTime":8.76,"body":"health economics and outcomes research"},{"startTime":8.76,"endTime":10.68,"body":"and market access services"},{"startTime":10.68,"endTime":13.263,"body":"from strategy through to implementation."},{"startTime":14.64,"endTime":18.75,"body":"Get in touch today to discuss"},{"startTime":14.64,"endTime":18.75,"body":"your market access goals."},{"startTime":18.75,"endTime":21.72,"body":"First, though, I hope"},{"startTime":18.75,"endTime":21.72,"body":"you enjoy the webinar."},{"startTime":21.72,"endTime":22.553,"body":"- Hello."},{"startTime":22.553,"endTime":25.71,"body":"Welcome, everyone, to our"},{"startTime":22.553,"endTime":25.71,"body":"latest Global Whispers webinar."},{"startTime":25.71,"endTime":28.32,"body":"Please see our YouTube"},{"startTime":25.71,"endTime":28.32,"body":"channel for past webinars"},{"startTime":28.32,"endTime":31.8,"body":"and look out for more content"},{"startTime":28.32,"endTime":31.8,"body":"from us in the future."},{"startTime":31.8,"endTime":35.58,"body":"The topic today is navigating"},{"startTime":31.8,"endTime":35.58,"body":"US payer evidence needs"},{"startTime":35.58,"endTime":38.04,"body":"to optimise market access."},{"startTime":38.04,"endTime":41.49,"body":"I'm Clare Foy, director"},{"startTime":38.04,"endTime":41.49,"body":"of Global Market Access"},{"startTime":41.49,"endTime":43.62,"body":"at Mtech Access."},{"startTime":43.62,"endTime":45.84,"body":"We have a great mix of audience today"},{"startTime":45.84,"endTime":48.72,"body":"across industry and healthcare systems."},{"startTime":48.72,"endTime":50.4,"body":"I'd like to particularly welcome"},{"startTime":50.4,"endTime":52.08,"body":"our global affiliate partners"},{"startTime":52.08,"endTime":54.483,"body":"who play a key role in"},{"startTime":52.08,"endTime":54.483,"body":"the work that we do."},{"startTime":55.53,"endTime":57.93,"body":"For anyone that doesn't know us very well,"},{"startTime":57.93,"endTime":61.26,"body":"Mtech Access is a global"},{"startTime":57.93,"endTime":61.26,"body":"specialist health economics"},{"startTime":61.26,"endTime":64.44,"body":"outcomes and market access consultancy."},{"startTime":64.44,"endTime":66.66,"body":"With a track record and expert delivery,"},{"startTime":66.66,"endTime":68.28,"body":"we provide specialist support"},{"startTime":68.28,"endTime":70.95,"body":"to pharmaceutical and MedTech clients"},{"startTime":70.95,"endTime":72.54,"body":"and work as a collaborative partner"},{"startTime":72.54,"endTime":75.36,"body":"to healthcare systems worldwide."},{"startTime":75.36,"endTime":79.23,"body":"Today we're focusing on"},{"startTime":75.36,"endTime":79.23,"body":"navigating US payer evidence needs"},{"startTime":79.23,"endTime":81.36,"body":"to optimise market access,"},{"startTime":81.36,"endTime":83.55,"body":"and I'm delighted to"},{"startTime":81.36,"endTime":83.55,"body":"welcome my colleagues,"},{"startTime":83.55,"endTime":85.2,"body":"Nicole and Bob."},{"startTime":85.2,"endTime":86.37,"body":"Welcome, both of you."},{"startTime":86.37,"endTime":89.64,"body":"Could you please take a moment"},{"startTime":86.37,"endTime":89.64,"body":"to introduce yourselves,"},{"startTime":89.64,"endTime":91.74,"body":"your backgrounds, and your current roles?"},{"startTime":91.74,"endTime":93.36,"body":"Start with Nicole."},{"startTime":93.36,"endTime":95.88,"body":"- Sure. Happy to, Clare."},{"startTime":95.88,"endTime":97.35,"body":"Good morning and good afternoon"},{"startTime":97.35,"endTime":100.23,"body":"to those across the pond"},{"startTime":97.35,"endTime":100.23,"body":"or even good evening."},{"startTime":100.23,"endTime":103.62,"body":"I'm managing director"},{"startTime":100.23,"endTime":103.62,"body":"within our US Evidence Team"},{"startTime":103.62,"endTime":106.95,"body":"of Petauri based in the US."},{"startTime":106.95,"endTime":110.01,"body":"I've been in the pharmaceutical"},{"startTime":106.95,"endTime":110.01,"body":"and consultancy world"},{"startTime":110.01,"endTime":111.9,"body":"for over 15 years,"},{"startTime":111.9,"endTime":115.38,"body":"with roles spanning global and US,"},{"startTime":115.38,"endTime":116.7,"body":"obviously based in the US,"},{"startTime":116.7,"endTime":118.32,"body":"with a heavy focus in the US,"},{"startTime":118.32,"endTime":120.72,"body":"but a lot of the work"},{"startTime":118.32,"endTime":120.72,"body":"I've done has spanned"},{"startTime":120.72,"endTime":122.88,"body":"global roles as well,"},{"startTime":122.88,"endTime":124.68,"body":"and really have diverse experience"},{"startTime":124.68,"endTime":127.23,"body":"working in the HEOR space,"},{"startTime":127.23,"endTime":129.48,"body":"as well as strategic market access,"},{"startTime":129.48,"endTime":132.72,"body":"US payer marketing and medical affairs."},{"startTime":132.72,"endTime":135.57,"body":"And throughout my roles,"},{"startTime":132.72,"endTime":135.57,"body":"I've had a deep focus"},{"startTime":135.57,"endTime":138.87,"body":"on planning, developing,"},{"startTime":135.57,"endTime":138.87,"body":"communicating evidence,"},{"startTime":138.87,"endTime":140.97,"body":"hence the role at Petauri"},{"startTime":140.97,"endTime":144.45,"body":"to really support the value"},{"startTime":140.97,"endTime":144.45,"body":"of innovative therapeutics,"},{"startTime":144.45,"endTime":146.58,"body":"both globally and in the US."},{"startTime":146.58,"endTime":148.98,"body":"And just to note again,"},{"startTime":148.98,"endTime":152.67,"body":"really myself and Bob both"},{"startTime":148.98,"endTime":152.67,"body":"focus heavily on the US,"},{"startTime":152.67,"endTime":154.92,"body":"but we really partner closely with Clare"},{"startTime":154.92,"endTime":158.25,"body":"and the broader Mtech team and Petauri"},{"startTime":158.25,"endTime":159.48,"body":"to work with global clients"},{"startTime":159.48,"endTime":162.48,"body":"to distil some of that"},{"startTime":159.48,"endTime":162.48,"body":"critical information for the US"},{"startTime":162.48,"endTime":166.26,"body":"which will really touch the"},{"startTime":162.48,"endTime":166.26,"body":"tip of the iceberg today,"},{"startTime":166.26,"endTime":168.72,"body":"but look forward to"},{"startTime":166.26,"endTime":168.72,"body":"discussing more detail."},{"startTime":168.72,"endTime":170.28,"body":"Bob?"},{"startTime":170.28,"endTime":171.113,"body":"- Hey there."},{"startTime":171.113,"endTime":173.76,"body":"Bob Nordyke, senior advisor at Petauri."},{"startTime":173.76,"endTime":176.94,"body":"I too got several years of experience,"},{"startTime":176.94,"endTime":180.39,"body":"coming up on 25 in the"},{"startTime":176.94,"endTime":180.39,"body":"pharmaceutical industry,"},{"startTime":180.39,"endTime":183.0,"body":"both on the manufacturer"},{"startTime":180.39,"endTime":183.0,"body":"side, large and small,"},{"startTime":183.0,"endTime":186.39,"body":"and consultancies in health economics"},{"startTime":186.39,"endTime":188.88,"body":"and market access roles,"},{"startTime":188.88,"endTime":191.97,"body":"have also spent some time working"},{"startTime":191.97,"endTime":195.18,"body":"at a US-focused trade association"},{"startTime":195.18,"endTime":197.55,"body":"where I was responsible for"},{"startTime":197.55,"endTime":202.55,"body":"their pricing, value assessment,"},{"startTime":197.55,"endTime":202.55,"body":"and research on innovation."},{"startTime":203.04,"endTime":204.363,"body":"Glad to be joining today."},{"startTime":206.34,"endTime":209.43,"body":"- Thank you, both, really"},{"startTime":206.34,"endTime":209.43,"body":"happy to have you with us."},{"startTime":209.43,"endTime":211.35,"body":"Could we start by talking about"},{"startTime":211.35,"endTime":214.53,"body":"the US payer landscape in general?"},{"startTime":214.53,"endTime":216.24,"body":"It's probably a hard question,"},{"startTime":216.24,"endTime":218.49,"body":"but if you could outline what we mean"},{"startTime":218.49,"endTime":221.37,"body":"when we talk about payers in the US?"},{"startTime":221.37,"endTime":223.323,"body":"- Oh, sure. Where do we start, Clare?"},{"startTime":224.37,"endTime":228.21,"body":"So as you're aware, US is one of the most"},{"startTime":228.21,"endTime":230.58,"body":"complex health systems in the world"},{"startTime":230.58,"endTime":233.94,"body":"and don't necessarily say"},{"startTime":230.58,"endTime":233.94,"body":"that in a full positive light."},{"startTime":233.94,"endTime":236.07,"body":"We'll go into a lot of topics today"},{"startTime":236.07,"endTime":238.65,"body":"to try to scratch the surface"},{"startTime":236.07,"endTime":238.65,"body":"of some of these things,"},{"startTime":238.65,"endTime":241.89,"body":"but let's just cover some"},{"startTime":238.65,"endTime":241.89,"body":"of the top things to know"},{"startTime":241.89,"endTime":245.7,"body":"and we'll sprinkle some other"},{"startTime":241.89,"endTime":245.7,"body":"tidbits throughout today."},{"startTime":245.7,"endTime":247.62,"body":"So we do have..."},{"startTime":247.62,"endTime":250.53,"body":"Right, we start with a"},{"startTime":247.62,"endTime":250.53,"body":"central regulatory approval"},{"startTime":250.53,"endTime":253.83,"body":"with the Food and Drug"},{"startTime":250.53,"endTime":253.83,"body":"Administration, the FDA,"},{"startTime":253.83,"endTime":258.21,"body":"similar to EMA, reviewing the"},{"startTime":253.83,"endTime":258.21,"body":"efficacy and safety of a drug."},{"startTime":258.21,"endTime":261.903,"body":"And that's where it all"},{"startTime":258.21,"endTime":261.903,"body":"kind of goes awry in the US."},{"startTime":262.77,"endTime":263.94,"body":"We have a complex..."},{"startTime":263.94,"endTime":267.42,"body":"Drugs then go to individual payers."},{"startTime":267.42,"endTime":269.46,"body":"So we have a complex mixture of"},{"startTime":269.46,"endTime":272.61,"body":"both private and public payers in the US."},{"startTime":272.61,"endTime":275.31,"body":"Over a third of the US population"},{"startTime":275.31,"endTime":278.94,"body":"has some sort of public"},{"startTime":275.31,"endTime":278.94,"body":"insurance, including Medicare,"},{"startTime":278.94,"endTime":280.89,"body":"which is mainly for elderly patients"},{"startTime":280.89,"endTime":282.84,"body":"as well as some chronic conditions."},{"startTime":282.84,"endTime":285.63,"body":"Medicaid, mainly for"},{"startTime":282.84,"endTime":285.63,"body":"patients of low income,"},{"startTime":285.63,"endTime":288.18,"body":"but again some additional kind of"},{"startTime":288.18,"endTime":291.27,"body":"subgroups in there that are covered."},{"startTime":291.27,"endTime":293.49,"body":"And then there's sub archetypes"},{"startTime":293.49,"endTime":296.01,"body":"of kind of all of these"},{"startTime":293.49,"endTime":296.01,"body":"with managed Medicaid,"},{"startTime":296.01,"endTime":299.04,"body":"Medicaid fee-for-service,"},{"startTime":296.01,"endTime":299.04,"body":"Medicare advantage."},{"startTime":299.04,"endTime":302.31,"body":"There's so many different arms and models,"},{"startTime":302.31,"endTime":304.35,"body":"and then there's additional public payers"},{"startTime":304.35,"endTime":307.47,"body":"when you get into Veterans"},{"startTime":304.35,"endTime":307.47,"body":"Affairs, for example."},{"startTime":307.47,"endTime":310.56,"body":"So there's a lot of different"},{"startTime":307.47,"endTime":310.56,"body":"stakeholders at play,"},{"startTime":310.56,"endTime":312.6,"body":"and that's just on the public side."},{"startTime":312.6,"endTime":315.72,"body":"And then there's the"},{"startTime":312.6,"endTime":315.72,"body":"private side of insurance."},{"startTime":315.72,"endTime":318.93,"body":"Over half of Americans"},{"startTime":315.72,"endTime":318.93,"body":"receive some form of"},{"startTime":318.93,"endTime":320.79,"body":"private health insurance."},{"startTime":320.79,"endTime":323.97,"body":"Most of them receiving this"},{"startTime":320.79,"endTime":323.97,"body":"through their employer,"},{"startTime":323.97,"endTime":325.773,"body":"at least partially funded."},{"startTime":326.88,"endTime":329.07,"body":"It really varies by individual employer."},{"startTime":329.07,"endTime":331.59,"body":"We'll get into some of"},{"startTime":329.07,"endTime":331.59,"body":"those nuances a bit."},{"startTime":331.59,"endTime":334.77,"body":"And then when you look into"},{"startTime":331.59,"endTime":334.77,"body":"commercial payer archetypes,"},{"startTime":334.77,"endTime":338.753,"body":"you might hear things like MCO, IDN, PBM."},{"startTime":338.753,"endTime":341.07,"body":"So MCOs are managed care organisations,"},{"startTime":341.07,"endTime":343.86,"body":"really your traditional"},{"startTime":341.07,"endTime":343.86,"body":"commercial healthcare plans"},{"startTime":343.86,"endTime":348.86,"body":"that focus on managing care to limit cost."},{"startTime":349.02,"endTime":352.41,"body":"Things like PBMs,"},{"startTime":349.02,"endTime":352.41,"body":"pharmacy benefit managers,"},{"startTime":352.41,"endTime":354.48,"body":"provide the drug or pharmacy benefit"},{"startTime":354.48,"endTime":357.48,"body":"and really coordinate"},{"startTime":354.48,"endTime":357.48,"body":"with healthcare plans"},{"startTime":357.48,"endTime":360.24,"body":"to manage that drug cost"},{"startTime":360.24,"endTime":362.79,"body":"and that integrated delivery networks,"},{"startTime":362.79,"endTime":364.35,"body":"almost a one stop shop,"},{"startTime":364.35,"endTime":366.81,"body":"with a payer and"},{"startTime":364.35,"endTime":366.81,"body":"integrated healthcare plan"},{"startTime":366.81,"endTime":369.24,"body":"and health system within,"},{"startTime":369.24,"endTime":372.27,"body":"and a more popular model that's coming"},{"startTime":372.27,"endTime":376.14,"body":"with more vertical horizontal"},{"startTime":372.27,"endTime":376.14,"body":"integration in this US web"},{"startTime":376.14,"endTime":379.47,"body":"that keeps getting bigger"},{"startTime":376.14,"endTime":379.47,"body":"and smaller at the same time."},{"startTime":379.47,"endTime":383.25,"body":"And this leaves an important"},{"startTime":379.47,"endTime":383.25,"body":"subset of the population out"},{"startTime":383.25,"endTime":386.973,"body":"which different than some"},{"startTime":383.25,"endTime":386.973,"body":"other countries in the world."},{"startTime":387.9,"endTime":391.86,"body":"The US has quite a large"},{"startTime":387.9,"endTime":391.86,"body":"uninsured population."},{"startTime":391.86,"endTime":393.9,"body":"The latest CDC report, I think,"},{"startTime":393.9,"endTime":397.2,"body":"about 8% of the US population"},{"startTime":397.2,"endTime":399.54,"body":"having no insurance whatsoever."},{"startTime":399.54,"endTime":401.733,"body":"And this is not just"},{"startTime":399.54,"endTime":401.733,"body":"adults, it's children."},{"startTime":402.6,"endTime":404.01,"body":"Although, again, there are subsets"},{"startTime":404.01,"endTime":405.86,"body":"that are covered under certain plans."},{"startTime":407.28,"endTime":410.46,"body":"So about 25 million individuals in the US"},{"startTime":410.46,"endTime":412.2,"body":"don't have any healthcare."},{"startTime":412.2,"endTime":415.62,"body":"There's also an underinsured population"},{"startTime":415.62,"endTime":417.18,"body":"that might not have full coverage,"},{"startTime":417.18,"endTime":419.83,"body":"and that's a large portion"},{"startTime":417.18,"endTime":419.83,"body":"of the population as well."},{"startTime":421.35,"endTime":424.23,"body":"And beyond this, we look at drugs."},{"startTime":424.23,"endTime":425.28,"body":"There's medical benefits."},{"startTime":425.28,"endTime":426.6,"body":"There's pharmacy benefits."},{"startTime":426.6,"endTime":428.31,"body":"And again, we'll get into"},{"startTime":426.6,"endTime":428.31,"body":"some of those nuances,"},{"startTime":428.31,"endTime":431.343,"body":"especially when we talk about"},{"startTime":428.31,"endTime":431.343,"body":"things like IRA a bit more."},{"startTime":432.66,"endTime":435.6,"body":"And then payers, kind of as mentioned,"},{"startTime":435.6,"endTime":438.33,"body":"with the complexity of the US."},{"startTime":438.33,"endTime":441.18,"body":"We don't have an HTA,"},{"startTime":438.33,"endTime":441.18,"body":"and we'll get into that."},{"startTime":441.18,"endTime":442.92,"body":"We don't have a centralised"},{"startTime":442.92,"endTime":444.54,"body":"health technology assessment body"},{"startTime":444.54,"endTime":446.52,"body":"like other markets in the world."},{"startTime":446.52,"endTime":449.25,"body":"We try with some of our independent bodies"},{"startTime":449.25,"endTime":451.29,"body":"and some models that"},{"startTime":449.25,"endTime":451.29,"body":"we're shifting towards,"},{"startTime":451.29,"endTime":455.13,"body":"but these negotiation"},{"startTime":451.29,"endTime":455.13,"body":"reimbursement discussions"},{"startTime":455.13,"endTime":459.24,"body":"are happening on an individual"},{"startTime":455.13,"endTime":459.24,"body":"payer basis right now largely"},{"startTime":459.24,"endTime":461.82,"body":"and going on behind closed doors with"},{"startTime":461.82,"endTime":463.62,"body":"really a lack of transparency,"},{"startTime":463.62,"endTime":468.093,"body":"which, again, makes the"},{"startTime":463.62,"endTime":468.093,"body":"US a fun place to play in."},{"startTime":469.11,"endTime":472.98,"body":"Bob, I'll turn over to you for"},{"startTime":469.11,"endTime":472.98,"body":"any additional perspectives."},{"startTime":472.98,"endTime":474.15,"body":"I'm sure I missed a lot,"},{"startTime":474.15,"endTime":477.273,"body":"but just trying to give"},{"startTime":474.15,"endTime":477.273,"body":"a small snip of this."},{"startTime":478.71,"endTime":480.06,"body":"- Thanks."},{"startTime":480.06,"endTime":485.06,"body":"Yeah, I will add I guess even"},{"startTime":480.06,"endTime":485.06,"body":"a little bit more complexity."},{"startTime":486.69,"endTime":490.56,"body":"Nicole mentioned that a"},{"startTime":486.69,"endTime":490.56,"body":"third of the US population"},{"startTime":490.56,"endTime":493.17,"body":"has public health insurance."},{"startTime":493.17,"endTime":495.93,"body":"So two thirds have commercial insurance,"},{"startTime":495.93,"endTime":499.92,"body":"dominant player in the US."},{"startTime":499.92,"endTime":502.41,"body":"And most of that commercial insurance"},{"startTime":502.41,"endTime":504.45,"body":"is actually sponsored by employers."},{"startTime":504.45,"endTime":507.3,"body":"So employers are yet another stakeholder"},{"startTime":507.3,"endTime":511.53,"body":"that anybody launching, managing"},{"startTime":511.53,"endTime":515.4,"body":"a product in the US"},{"startTime":511.53,"endTime":515.4,"body":"market needs to consider,"},{"startTime":515.4,"endTime":518.97,"body":"and they're pretty critical stakeholder"},{"startTime":518.97,"endTime":521.94,"body":"and importantly have"},{"startTime":518.97,"endTime":521.94,"body":"different perspectives"},{"startTime":521.94,"endTime":526.68,"body":"on some endpoints, some measures of value"},{"startTime":526.68,"endTime":529.47,"body":"than would a health plan."},{"startTime":529.47,"endTime":532.41,"body":"Productivity obviously is going to be"},{"startTime":532.41,"endTime":534.783,"body":"pretty important to employers."},{"startTime":535.68,"endTime":537.21,"body":"Hospitals too."},{"startTime":537.21,"endTime":539.59,"body":"If you have a hospital-based product"},{"startTime":540.6,"endTime":544.26,"body":"and the hospital purchase"},{"startTime":540.6,"endTime":544.26,"body":"decision is important,"},{"startTime":544.26,"endTime":547.53,"body":"you need to be thinking"},{"startTime":544.26,"endTime":547.53,"body":"about the hospital,"},{"startTime":547.53,"endTime":549.99,"body":"P\u0026T committees as as as well."},{"startTime":549.99,"endTime":552.87,"body":"So it's pretty complex market"},{"startTime":552.87,"endTime":556.56,"body":"obviously for every product,"},{"startTime":552.87,"endTime":556.56,"body":"every disease state."},{"startTime":556.56,"endTime":560.97,"body":"Each stakeholder isn't going"},{"startTime":556.56,"endTime":560.97,"body":"to be as relevant as another,"},{"startTime":560.97,"endTime":563.34,"body":"so you need to take"},{"startTime":560.97,"endTime":563.34,"body":"that into consideration"},{"startTime":563.34,"endTime":566.67,"body":"in your early stage"},{"startTime":563.34,"endTime":566.67,"body":"evidence generation planning"},{"startTime":566.67,"endTime":569.19,"body":"as you prioritise which stakeholders,"},{"startTime":569.19,"endTime":571.39,"body":"which evidence you're"},{"startTime":569.19,"endTime":571.39,"body":"going to generate for."},{"startTime":573.93,"endTime":574.763,"body":"- Right. Thank you."},{"startTime":574.763,"endTime":577.08,"body":"And we can explore all of the needs"},{"startTime":577.08,"endTime":578.34,"body":"of all of those stakeholders"},{"startTime":578.34,"endTime":581.16,"body":"as we go through today's webinar."},{"startTime":581.16,"endTime":585.15,"body":"So, Nicole, you mentioned"},{"startTime":581.16,"endTime":585.15,"body":"HTA, some of our listeners"},{"startTime":585.15,"endTime":587.67,"body":"may indeed be more familiar"},{"startTime":585.15,"endTime":587.67,"body":"with the payer landscape"},{"startTime":587.67,"endTime":591.39,"body":"in countries that have health"},{"startTime":587.67,"endTime":591.39,"body":"technology assessment bodies"},{"startTime":591.39,"endTime":594.063,"body":"such as NICE, G-BA, CADTH in Canada."},{"startTime":595.59,"endTime":598.233,"body":"That's now changed as well of course."},{"startTime":599.16,"endTime":602.4,"body":"So HTA is often considered"},{"startTime":599.16,"endTime":602.4,"body":"an additional hurdle"},{"startTime":602.4,"endTime":604.593,"body":"after regulatory submission."},{"startTime":605.79,"endTime":608.25,"body":"I just wondered if you"},{"startTime":605.79,"endTime":608.25,"body":"could tell us a bit more"},{"startTime":608.25,"endTime":609.96,"body":"about the situation in the US."},{"startTime":609.96,"endTime":612.21,"body":"Can we make a similar comparison?"},{"startTime":612.21,"endTime":614.34,"body":"Do payers conduct similar assessments"},{"startTime":614.34,"endTime":615.75,"body":"of clinical effectiveness"},{"startTime":615.75,"endTime":619.623,"body":"and economic considerations"},{"startTime":615.75,"endTime":619.623,"body":"after the FDA decision?"},{"startTime":621.12,"endTime":622.53,"body":"- certainly they do."},{"startTime":622.53,"endTime":626.25,"body":"And with all of the headlines"},{"startTime":626.25,"endTime":630.3,"body":"about the IRA and CMS being able to"},{"startTime":630.3,"endTime":633.0,"body":"negotiate prices for the first time"},{"startTime":633.0,"endTime":636.21,"body":"kind of obscures the fact that"},{"startTime":636.21,"endTime":638.76,"body":"we do negotiate prices in the US."},{"startTime":638.76,"endTime":641.64,"body":"Commercial insurers, PBMs, to an extent,"},{"startTime":641.64,"endTime":644.43,"body":"do negotiate with manufacturers,"},{"startTime":644.43,"endTime":649.14,"body":"and these are private organisations"},{"startTime":649.14,"endTime":650.67,"body":"making private decisions,"},{"startTime":650.67,"endTime":653.34,"body":"so we don't have a lot of information"},{"startTime":653.34,"endTime":656.7,"body":"on decisions made on individual products,"},{"startTime":656.7,"endTime":659.76,"body":"but there are formal evaluations."},{"startTime":659.76,"endTime":664.02,"body":"Large and small plans have"},{"startTime":659.76,"endTime":664.02,"body":"their own P\u0026T committees,"},{"startTime":664.02,"endTime":668.76,"body":"and the evaluations tend to be more on"},{"startTime":668.76,"endTime":670.74,"body":"the clinical value of the drug"},{"startTime":670.74,"endTime":673.05,"body":"and comparative effectiveness."},{"startTime":673.05,"endTime":674.94,"body":"We'll talk a bit about what is"},{"startTime":674.94,"endTime":679.94,"body":"the best evidence to support"},{"startTime":674.94,"endTime":679.94,"body":"that pre an post-launch."},{"startTime":681.96,"endTime":685.469,"body":"The AMCP format dossier is,"},{"startTime":685.469,"endTime":688.5,"body":"if you're not familiar"},{"startTime":685.469,"endTime":688.5,"body":"with that, becomes so,"},{"startTime":688.5,"endTime":691.32,"body":"because that is a really nice format"},{"startTime":691.32,"endTime":694.29,"body":"that is designed for manufacturers"},{"startTime":694.29,"endTime":699.29,"body":"to communicate clinical and"},{"startTime":694.29,"endTime":699.29,"body":"economic value to payers."},{"startTime":699.3,"endTime":704.3,"body":"Another set of evaluations,"},{"startTime":699.3,"endTime":704.3,"body":"obviously under the DPMP,"},{"startTime":704.67,"endTime":707.82,"body":"we just had a start"},{"startTime":704.67,"endTime":707.82,"body":"with the first 10 drugs"},{"startTime":707.82,"endTime":712.05,"body":"that were negotiated in Part D only."},{"startTime":712.05,"endTime":714.96,"body":"That will expand over time."},{"startTime":714.96,"endTime":719.96,"body":"We don't know yet about the"},{"startTime":714.96,"endTime":719.96,"body":"actual negotiation process."},{"startTime":722.07,"endTime":726.303,"body":"Congress has laid out a number"},{"startTime":722.07,"endTime":726.303,"body":"of negotiation elements,"},{"startTime":727.32,"endTime":731.79,"body":"evidence elements that"},{"startTime":727.32,"endTime":731.79,"body":"manufacturers have to submit."},{"startTime":731.79,"endTime":732.99,"body":"How those are weighed"},{"startTime":732.99,"endTime":736.77,"body":"and exactly how CMS is making decisions,"},{"startTime":736.77,"endTime":739.95,"body":"we're going to have to"},{"startTime":736.77,"endTime":739.95,"body":"wait until early 2025,"},{"startTime":739.95,"endTime":741.93,"body":"until the initial rational"},{"startTime":741.93,"endTime":744.093,"body":"for that first 10 drugs are issued."},{"startTime":745.2,"endTime":749.19,"body":"And then thirdly, finally,"},{"startTime":745.2,"endTime":749.19,"body":"and certainly not not least,"},{"startTime":749.19,"endTime":752.64,"body":"is the Institute for"},{"startTime":749.19,"endTime":752.64,"body":"Clinical and Economic Review."},{"startTime":752.64,"endTime":755.85,"body":"Independent, private, non-profit"},{"startTime":755.85,"endTime":759.78,"body":"that has a bit of an"},{"startTime":755.85,"endTime":759.78,"body":"out outsize in influence"},{"startTime":759.78,"endTime":764.1,"body":"in that they can only conduct about"},{"startTime":764.1,"endTime":766.77,"body":"six to eight assessments per year,"},{"startTime":766.77,"endTime":770.61,"body":"but US commercial payers do"},{"startTime":766.77,"endTime":770.61,"body":"look to those evaluations"},{"startTime":770.61,"endTime":774.09,"body":"for information on comparative"},{"startTime":770.61,"endTime":774.09,"body":"clinical effectiveness,"},{"startTime":774.09,"endTime":779.09,"body":"and they also do use the"},{"startTime":774.09,"endTime":779.09,"body":"health benefit price benchmarks"},{"startTime":779.28,"endTime":783.57,"body":"that ICER issues as part"},{"startTime":779.28,"endTime":783.57,"body":"of the price negotiations"},{"startTime":783.57,"endTime":784.833,"body":"with manufacturers."},{"startTime":787.2,"endTime":789.06,"body":"- Yeah, that's interesting, Bob."},{"startTime":789.06,"endTime":794.04,"body":"We sometimes consider ICER"},{"startTime":789.06,"endTime":794.04,"body":"as almost a proxy HTA body."},{"startTime":794.04,"endTime":796.05,"body":"Could you just tell us"},{"startTime":794.04,"endTime":796.05,"body":"a little bit more about"},{"startTime":796.05,"endTime":798.783,"body":"how impactful their evaluations are?"},{"startTime":800.1,"endTime":800.933,"body":"- Well,"},{"startTime":802.29,"endTime":806.77,"body":"they do centre cost"},{"startTime":802.29,"endTime":806.77,"body":"effectiveness and analyses"},{"startTime":807.67,"endTime":808.92,"body":"in their assessments."},{"startTime":808.92,"endTime":812.01,"body":"They are significantly expanding"},{"startTime":812.01,"endTime":816.96,"body":"the methods and the scope"},{"startTime":812.01,"endTime":816.96,"body":"of their patient engagement"},{"startTime":816.96,"endTime":820.923,"body":"to gain patient input on the value."},{"startTime":822.66,"endTime":824.37,"body":"My sense, my opinion only"},{"startTime":824.37,"endTime":826.95,"body":"is that since these these are"},{"startTime":826.95,"endTime":831.72,"body":"cost effectiveness analysis"},{"startTime":826.95,"endTime":831.72,"body":"centred value assessments"},{"startTime":831.72,"endTime":835.33,"body":"and US commercial health plans"},{"startTime":836.31,"endTime":839.37,"body":"don't really understand, don't fully use"},{"startTime":839.37,"endTime":842.79,"body":"cost effectiveness"},{"startTime":839.37,"endTime":842.79,"body":"analysis to a large extent,"},{"startTime":842.79,"endTime":845.22,"body":"that may limit the uptake,"},{"startTime":845.22,"endTime":849.21,"body":"the impact of the ICER assessments"},{"startTime":849.21,"endTime":852.03,"body":"on coverage and reimbursement"},{"startTime":849.21,"endTime":852.03,"body":"decision-making."},{"startTime":852.03,"endTime":853.56,"body":"But like I mentioned,"},{"startTime":853.56,"endTime":856.863,"body":"where those value"},{"startTime":853.56,"endTime":856.863,"body":"assessments are available,"},{"startTime":857.82,"endTime":860.13,"body":"payers will pay attention to them."},{"startTime":860.13,"endTime":863.13,"body":"They will use them throughout"},{"startTime":860.13,"endTime":863.13,"body":"their decision-making"},{"startTime":863.13,"endTime":865.563,"body":"and negotiation process."},{"startTime":867.06,"endTime":870.81,"body":"So while the impact might be limited"},{"startTime":870.81,"endTime":872.61,"body":"in terms of the number"},{"startTime":870.81,"endTime":872.61,"body":"of value assessments,"},{"startTime":872.61,"endTime":876.524,"body":"the number of drugs that"},{"startTime":872.61,"endTime":876.524,"body":"are evaluated each year,"},{"startTime":876.524,"endTime":879.54,"body":"ICER does tend to be very selective."},{"startTime":879.54,"endTime":880.473,"body":"They have to be."},{"startTime":881.67,"endTime":885.15,"body":"And they tend to, and"},{"startTime":881.67,"endTime":885.15,"body":"quite understandably,"},{"startTime":885.15,"endTime":888.69,"body":"tend to focus on products where there is"},{"startTime":888.69,"endTime":891.75,"body":"high unmet need, high potential,"},{"startTime":891.75,"endTime":894.12,"body":"and perhaps some uncertainties,"},{"startTime":894.12,"endTime":899.12,"body":"particularly in long-term"},{"startTime":894.12,"endTime":899.12,"body":"impact, long-term outcomes."},{"startTime":899.73,"endTime":904.11,"body":"So if you're planning on"},{"startTime":899.73,"endTime":904.11,"body":"launching in the United States,"},{"startTime":904.11,"endTime":906.54,"body":"paying attention to an ICER evaluation"},{"startTime":906.54,"endTime":909.543,"body":"and preparing for that would"},{"startTime":906.54,"endTime":909.543,"body":"be a very good thing to do."},{"startTime":910.53,"endTime":913.237,"body":"- And I think Bob, just to add,"},{"startTime":914.55,"endTime":916.77,"body":"we use them as a proxy, quite frankly."},{"startTime":916.77,"endTime":918.21,"body":"It's the best thing available,"},{"startTime":918.21,"endTime":921.813,"body":"the most transparent thing"},{"startTime":918.21,"endTime":921.813,"body":"we have available in the US."},{"startTime":922.77,"endTime":925.436,"body":"The other way we get at"},{"startTime":922.77,"endTime":925.436,"body":"this information in the US"},{"startTime":925.436,"endTime":927.69,"body":"is more so..."},{"startTime":927.69,"endTime":930.21,"body":"I know primary research is"},{"startTime":927.69,"endTime":930.21,"body":"critical in every market,"},{"startTime":930.21,"endTime":932.97,"body":"but that allows us in the US"},{"startTime":930.21,"endTime":932.97,"body":"to actually get under the hood."},{"startTime":932.97,"endTime":934.92,"body":"We might see some of the prices."},{"startTime":934.92,"endTime":937.23,"body":"We might see how drugs are covered"},{"startTime":937.23,"endTime":940.14,"body":"and what prior authorizations"},{"startTime":937.23,"endTime":940.14,"body":"are put in place"},{"startTime":940.14,"endTime":941.61,"body":"or what steps are put in place."},{"startTime":941.61,"endTime":942.78,"body":"We don't know the why."},{"startTime":942.78,"endTime":943.92,"body":"It doesn't give us the why."},{"startTime":943.92,"endTime":946.26,"body":"So that's where we have to dive into"},{"startTime":946.26,"endTime":948.75,"body":"kind of our relationships with US payers"},{"startTime":948.75,"endTime":950.67,"body":"to get under the hood and understand"},{"startTime":950.67,"endTime":952.05,"body":"why did they make this decision,"},{"startTime":952.05,"endTime":953.487,"body":"what were the factors in play,"},{"startTime":953.487,"endTime":955.62,"body":"and a lot of times it comes down to price"},{"startTime":955.62,"endTime":957.96,"body":"and what various manufacturers are willing"},{"startTime":957.96,"endTime":960.603,"body":"to put on the table from"},{"startTime":957.96,"endTime":960.603,"body":"a negotiation standpoint."},{"startTime":963.24,"endTime":964.83,"body":"- That's really interesting."},{"startTime":964.83,"endTime":968.07,"body":"And yeah, together, I"},{"startTime":964.83,"endTime":968.07,"body":"suppose that builds a picture"},{"startTime":968.07,"endTime":971.19,"body":"of how decisions are made"},{"startTime":968.07,"endTime":971.19,"body":"and what's important."},{"startTime":971.19,"endTime":972.78,"body":"Okay, you touched on price there."},{"startTime":972.78,"endTime":977.22,"body":"So, we know the US is often"},{"startTime":972.78,"endTime":977.22,"body":"the first launch market"},{"startTime":977.22,"endTime":979.59,"body":"for pharma and MedTech companies."},{"startTime":979.59,"endTime":982.14,"body":"Could you tell us a bit"},{"startTime":979.59,"endTime":982.14,"body":"more about why this might be"},{"startTime":982.14,"endTime":987.14,"body":"and what the attractiveness of"},{"startTime":982.14,"endTime":987.14,"body":"the US is as a launch market?"},{"startTime":987.84,"endTime":990.6,"body":"- Yeah, so some of it"},{"startTime":987.84,"endTime":990.6,"body":"probably bubbles back"},{"startTime":990.6,"endTime":992.16,"body":"to things we've already mentioned,"},{"startTime":992.16,"endTime":995.55,"body":"but it's no surprise"},{"startTime":992.16,"endTime":995.55,"body":"that US is attractive."},{"startTime":995.55,"endTime":997.053,"body":"It's large,"},{"startTime":997.904,"endTime":1000.35,"body":"not the largest market,"},{"startTime":997.904,"endTime":1000.35,"body":"obviously, in the world,"},{"startTime":1000.35,"endTime":1001.7,"body":"but the large..."},{"startTime":1001.7,"endTime":1004.1,"body":"Population-wise, it's a large market,"},{"startTime":1004.1,"endTime":1005.99,"body":"but even more so the high price potential"},{"startTime":1005.99,"endTime":1008.66,"body":"as we've kind of touched upon a bit."},{"startTime":1008.66,"endTime":1010.4,"body":"The US has a population of..."},{"startTime":1010.4,"endTime":1014.45,"body":"I think the latest was 335, 337 million,"},{"startTime":1014.45,"endTime":1017.03,"body":"about 5% of the global population,"},{"startTime":1017.03,"endTime":1020.27,"body":"which big but not the biggest as we know,"},{"startTime":1020.27,"endTime":1022.01,"body":"but that alone accounts for,"},{"startTime":1022.01,"endTime":1023.93,"body":"and again these numbers change"},{"startTime":1023.93,"endTime":1025.91,"body":"between what report and"},{"startTime":1023.93,"endTime":1025.91,"body":"what source you're reading,"},{"startTime":1025.91,"endTime":1029.45,"body":"but about 50% of global"},{"startTime":1025.91,"endTime":1029.45,"body":"pharma sales come from the US"},{"startTime":1029.45,"endTime":1032.36,"body":"or revenue comes from the US,"},{"startTime":1032.36,"endTime":1034.46,"body":"so that is immense."},{"startTime":1034.46,"endTime":1037.49,"body":"Just 5% of the population in the world"},{"startTime":1037.49,"endTime":1040.85,"body":"is accounting for 50%"},{"startTime":1037.49,"endTime":1040.85,"body":"of global pharma sales."},{"startTime":1040.85,"endTime":1043.37,"body":"And there's a number of"},{"startTime":1040.85,"endTime":1043.37,"body":"things that go into that,"},{"startTime":1043.37,"endTime":1047.63,"body":"and we won't go into some"},{"startTime":1043.37,"endTime":1047.63,"body":"of the political components"},{"startTime":1047.63,"endTime":1049.37,"body":"as much about US pricing,"},{"startTime":1049.37,"endTime":1051.26,"body":"but I know there's strong perspectives,"},{"startTime":1051.26,"endTime":1052.94,"body":"obviously, on both sides about that."},{"startTime":1052.94,"endTime":1055.94,"body":"But one of the things"},{"startTime":1052.94,"endTime":1055.94,"body":"being there is a low level"},{"startTime":1055.94,"endTime":1057.74,"body":"of price regulation in the US."},{"startTime":1057.74,"endTime":1059.18,"body":"They're set by the manufacturers,"},{"startTime":1059.18,"endTime":1061.28,"body":"negotiations happen behind closed doors"},{"startTime":1061.28,"endTime":1063.32,"body":"with rebates and discounts,"},{"startTime":1063.32,"endTime":1065.69,"body":"but there's no HTA that's saying"},{"startTime":1065.69,"endTime":1069.2,"body":"really negotiating on a large"},{"startTime":1065.69,"endTime":1069.2,"body":"scale to say this is the bulk"},{"startTime":1069.2,"endTime":1072.02,"body":"kind of overall price"},{"startTime":1069.2,"endTime":1072.02,"body":"that we're going to pay"},{"startTime":1072.02,"endTime":1076.373,"body":"with this kind of volume"},{"startTime":1072.02,"endTime":1076.373,"body":"discount that we're working with."},{"startTime":1077.75,"endTime":1080.693,"body":"And then with that,"},{"startTime":1077.75,"endTime":1080.693,"body":"timelines are also quicker."},{"startTime":1082.04,"endTime":1084.44,"body":"You get FDA approval,"},{"startTime":1084.44,"endTime":1087.29,"body":"you could technically be"},{"startTime":1084.44,"endTime":1087.29,"body":"on a formulary right away,"},{"startTime":1087.29,"endTime":1088.16,"body":"especially if you're having"},{"startTime":1088.16,"endTime":1090.263,"body":"some of those pre-approval discussions."},{"startTime":1091.13,"endTime":1092.91,"body":"Companies can go in"},{"startTime":1094.16,"endTime":1097.07,"body":"often six to zero months,"},{"startTime":1094.16,"endTime":1097.07,"body":"sometimes 6 to 12 months."},{"startTime":1097.07,"endTime":1098.84,"body":"They're going in having discussions,"},{"startTime":1098.84,"endTime":1101.27,"body":"especially with some of"},{"startTime":1098.84,"endTime":1101.27,"body":"these large cost drugs"},{"startTime":1101.27,"endTime":1103.37,"body":"or big populations,"},{"startTime":1103.37,"endTime":1104.96,"body":"and payers are preparing"},{"startTime":1104.96,"endTime":1107.3,"body":"especially if it's a high need area that"},{"startTime":1107.3,"endTime":1108.74,"body":"maybe it's the first to market"},{"startTime":1108.74,"endTime":1111.29,"body":"or maybe it's a really innovative therapy"},{"startTime":1111.29,"endTime":1114.5,"body":"or going to have a huge"},{"startTime":1111.29,"endTime":1114.5,"body":"game-changing impact"},{"startTime":1114.5,"endTime":1116.63,"body":"from an efficacy of safety perspective."},{"startTime":1116.63,"endTime":1118.94,"body":"They're having these discussions"},{"startTime":1116.63,"endTime":1118.94,"body":"a lot of times in advance"},{"startTime":1118.94,"endTime":1121.61,"body":"to allow them to proactively"},{"startTime":1118.94,"endTime":1121.61,"body":"plan their formularies"},{"startTime":1121.61,"endTime":1124.61,"body":"and kind of have a heads"},{"startTime":1121.61,"endTime":1124.61,"body":"up that these are coming"},{"startTime":1124.61,"endTime":1126.89,"body":"and allow them to look at that in advance."},{"startTime":1126.89,"endTime":1130.49,"body":"So we don't have to go"},{"startTime":1126.89,"endTime":1130.49,"body":"through EMA and then NICE,"},{"startTime":1130.49,"endTime":1135.23,"body":"for example, as other"},{"startTime":1130.49,"endTime":1135.23,"body":"you might be used to,"},{"startTime":1135.23,"endTime":1136.52,"body":"or even additional bodies"},{"startTime":1136.52,"endTime":1138.473,"body":"that come into play with some of those."},{"startTime":1139.64,"endTime":1141.92,"body":"We go FDA, you go to individual payers,"},{"startTime":1141.92,"endTime":1143.75,"body":"and you can be on formulary quite quick."},{"startTime":1143.75,"endTime":1145.58,"body":"It takes longer with"},{"startTime":1143.75,"endTime":1145.58,"body":"some of them, obviously,"},{"startTime":1145.58,"endTime":1147.23,"body":"but again, some of that proactive planning"},{"startTime":1147.23,"endTime":1150.533,"body":"allows them to be the"},{"startTime":1147.23,"endTime":1150.533,"body":"market really quickly."},{"startTime":1153.17,"endTime":1155.21,"body":"Yeah, and I think, yeah, just with..."},{"startTime":1155.21,"endTime":1158.147,"body":"Right, I think US tends to..."},{"startTime":1158.147,"endTime":1159.8,"body":"And Bob, I don't know if"},{"startTime":1158.147,"endTime":1159.8,"body":"you've heard differently,"},{"startTime":1159.8,"endTime":1163.29,"body":"I think about a year before"},{"startTime":1159.8,"endTime":1163.29,"body":"a lot of these other global"},{"startTime":1164.45,"endTime":1168.8,"body":"high, kind of developed"},{"startTime":1164.45,"endTime":1168.8,"body":"markets, the US is often,"},{"startTime":1168.8,"endTime":1171.53,"body":"drugs are available as"},{"startTime":1168.8,"endTime":1171.53,"body":"soon as a year before"},{"startTime":1171.53,"endTime":1173.3,"body":"some of these other markets due to"},{"startTime":1173.3,"endTime":1175.91,"body":"the lengthy HTA timelines"},{"startTime":1173.3,"endTime":1175.91,"body":"that can take place"},{"startTime":1175.91,"endTime":1177.98,"body":"and all of the other"},{"startTime":1175.91,"endTime":1177.98,"body":"processes that need to happen"},{"startTime":1177.98,"endTime":1180.833,"body":"before full availability"},{"startTime":1177.98,"endTime":1180.833,"body":"in some other markets."},{"startTime":1183.95,"endTime":1188.95,"body":"- And I think that tho"},{"startTime":1183.95,"endTime":1188.95,"body":"those social preferences,"},{"startTime":1189.02,"endTime":1194.02,"body":"if you will, for high"},{"startTime":1189.02,"endTime":1194.02,"body":"value placed on innovation"},{"startTime":1195.02,"endTime":1200.02,"body":"and rapid and relatively broad"},{"startTime":1195.02,"endTime":1200.02,"body":"access to those new drugs"},{"startTime":1201.56,"endTime":1205.91,"body":"are essential values"},{"startTime":1201.56,"endTime":1205.91,"body":"reflected in the US market."},{"startTime":1205.91,"endTime":1209.57,"body":"We often struggle with those,"},{"startTime":1205.91,"endTime":1209.57,"body":"and we argue about those,"},{"startTime":1209.57,"endTime":1213.74,"body":"and sometimes you see"},{"startTime":1209.57,"endTime":1213.74,"body":"results like the IRA,"},{"startTime":1213.74,"endTime":1216.38,"body":"but we still remain that market"},{"startTime":1216.38,"endTime":1218.78,"body":"that places a relatively high value"},{"startTime":1218.78,"endTime":1222.203,"body":"on new innovation and"},{"startTime":1218.78,"endTime":1222.203,"body":"access to that innovation."},{"startTime":1225.92,"endTime":1226.753,"body":"- Okay."},{"startTime":1227.63,"endTime":1229.55,"body":"Let's think a bit about evidence now."},{"startTime":1229.55,"endTime":1231.98,"body":"So it'd be helpful if you"},{"startTime":1229.55,"endTime":1231.98,"body":"could give an overview"},{"startTime":1231.98,"endTime":1236.06,"body":"of the type of evidence required"},{"startTime":1231.98,"endTime":1236.06,"body":"by key payers in the US."},{"startTime":1236.06,"endTime":1239.42,"body":"For example, how does the"},{"startTime":1236.06,"endTime":1239.42,"body":"evidentiary standard compare"},{"startTime":1239.42,"endTime":1241.58,"body":"with what's needed by the FDA,"},{"startTime":1241.58,"endTime":1244.19,"body":"what clinical and"},{"startTime":1241.58,"endTime":1244.19,"body":"economic evidence, if any,"},{"startTime":1244.19,"endTime":1247.01,"body":"economic US payers like to see"},{"startTime":1247.01,"endTime":1249.47,"body":"from companies to optimise market access?"},{"startTime":1249.47,"endTime":1252.71,"body":"And how should evidence be"},{"startTime":1249.47,"endTime":1252.71,"body":"generated, and synthesised,"},{"startTime":1252.71,"endTime":1254.603,"body":"and presented for the US market?"},{"startTime":1256.16,"endTime":1257.03,"body":"- Sure."},{"startTime":1257.03,"endTime":1258.41,"body":"I'll take this one and start, Bob,"},{"startTime":1258.41,"endTime":1259.82,"body":"and then turn it over to you."},{"startTime":1259.82,"endTime":1260.9,"body":"I'm sure I'll miss things,"},{"startTime":1260.9,"endTime":1264.59,"body":"but really I think the first point to say,"},{"startTime":1264.59,"endTime":1266.57,"body":"and hearing that word, Clare,"},{"startTime":1266.57,"endTime":1269.57,"body":"and it's such a common"},{"startTime":1266.57,"endTime":1269.57,"body":"kind of term that's used"},{"startTime":1269.57,"endTime":1271.52,"body":"when you talk about the US is required."},{"startTime":1272.45,"endTime":1274.07,"body":"There are formal..."},{"startTime":1274.07,"endTime":1278.66,"body":"FDA will require things"},{"startTime":1274.07,"endTime":1278.66,"body":"for regulatory approval."},{"startTime":1278.66,"endTime":1281.57,"body":"Payers don't have a you must do."},{"startTime":1281.57,"endTime":1284.15,"body":"There's no government guidance"},{"startTime":1284.15,"endTime":1286.76,"body":"similar to an HTA body"},{"startTime":1284.15,"endTime":1286.76,"body":"of, \"You have to have this"},{"startTime":1286.76,"endTime":1288.56,"body":"to reach this level of approval"},{"startTime":1288.56,"endTime":1291.65,"body":"or this level of reimbursement"},{"startTime":1288.56,"endTime":1291.65,"body":"or acceptability.\""},{"startTime":1291.65,"endTime":1292.483,"body":"We don't have that."},{"startTime":1292.483,"endTime":1296.36,"body":"It really comes down to"},{"startTime":1292.483,"endTime":1296.36,"body":"individual payer preference"},{"startTime":1296.36,"endTime":1299.36,"body":"and kind of the way they work"},{"startTime":1296.36,"endTime":1299.36,"body":"and what they want to see."},{"startTime":1299.36,"endTime":1301.64,"body":"This changes year to"},{"startTime":1299.36,"endTime":1301.64,"body":"year, and month to month,"},{"startTime":1301.64,"endTime":1303.83,"body":"and day to day as things evolve,"},{"startTime":1303.83,"endTime":1306.71,"body":"which again makes it"},{"startTime":1303.83,"endTime":1306.71,"body":"another level of complexity"},{"startTime":1306.71,"endTime":1308.99,"body":"that different payers"},{"startTime":1306.71,"endTime":1308.99,"body":"have different evidence"},{"startTime":1308.99,"endTime":1312.44,"body":"needs and preferences, but"},{"startTime":1308.99,"endTime":1312.44,"body":"no formal requirements."},{"startTime":1312.44,"endTime":1315.563,"body":"It's not all laid out on a"},{"startTime":1312.44,"endTime":1315.563,"body":"silver platter, unfortunately,"},{"startTime":1316.61,"endTime":1319.01,"body":"but some of this"},{"startTime":1316.61,"endTime":1319.01,"body":"transparency is increasing,"},{"startTime":1319.01,"endTime":1322.04,"body":"hopefully, as we get there."},{"startTime":1322.04,"endTime":1323.36,"body":"They can vary, as mentioned,"},{"startTime":1323.36,"endTime":1325.97,"body":"kind of widely between"},{"startTime":1323.36,"endTime":1325.97,"body":"archetypes organisations,"},{"startTime":1325.97,"endTime":1327.23,"body":"even individual payers"},{"startTime":1327.23,"endTime":1329.93,"body":"if you talk to two different"},{"startTime":1327.23,"endTime":1329.93,"body":"payers at the same organisation"},{"startTime":1329.93,"endTime":1331.7,"body":"and do in-depth interviews with them."},{"startTime":1331.7,"endTime":1334.49,"body":"I've heard complete opposite"},{"startTime":1331.7,"endTime":1334.49,"body":"ends of the spectrum"},{"startTime":1334.49,"endTime":1336.056,"body":"talking about the same exact drug and"},{"startTime":1336.056,"endTime":1337.7,"body":"what they'd want to see."},{"startTime":1337.7,"endTime":1339.713,"body":"So there are so many layers here,"},{"startTime":1340.64,"endTime":1343.4,"body":"and it also varies widely"},{"startTime":1340.64,"endTime":1343.4,"body":"between disease states."},{"startTime":1343.4,"endTime":1346.64,"body":"There might be more flexibility"},{"startTime":1343.4,"endTime":1346.64,"body":"in what they're open to"},{"startTime":1346.64,"endTime":1349.1,"body":"in seeing with rare disease states"},{"startTime":1349.1,"endTime":1351.92,"body":"where surrogate endpoints might be okay."},{"startTime":1351.92,"endTime":1353.15,"body":"They just want to see something"},{"startTime":1353.15,"endTime":1355.46,"body":"and have some kind of patient improvement,"},{"startTime":1355.46,"endTime":1357.32,"body":"really establish disease areas."},{"startTime":1357.32,"endTime":1359.45,"body":"Those surrogate endpoints,"},{"startTime":1357.32,"endTime":1359.45,"body":"they're not going to fly,"},{"startTime":1359.45,"endTime":1360.77,"body":"or things like oncology."},{"startTime":1360.77,"endTime":1361.603,"body":"They might be okay"},{"startTime":1361.603,"endTime":1365.273,"body":"with some of the surrogate"},{"startTime":1361.603,"endTime":1365.273,"body":"endpoints to start with."},{"startTime":1366.41,"endTime":1367.82,"body":"They they might be okay"},{"startTime":1367.82,"endTime":1370.34,"body":"with progression-free survival to start,"},{"startTime":1370.34,"endTime":1371.9,"body":"but they'll want to see overall survival"},{"startTime":1371.9,"endTime":1373.7,"body":"if you continue to come back for access"},{"startTime":1373.7,"endTime":1376.82,"body":"and look at as the landscape"},{"startTime":1373.7,"endTime":1376.82,"body":"gets more competitive"},{"startTime":1376.82,"endTime":1378.26,"body":"and more therapies come to market,"},{"startTime":1378.26,"endTime":1382.1,"body":"and you've been on commercially"},{"startTime":1378.26,"endTime":1382.1,"body":"available for three years."},{"startTime":1382.1,"endTime":1384.17,"body":"They're not going to want"},{"startTime":1382.1,"endTime":1384.17,"body":"to continue to see PFS,"},{"startTime":1384.17,"endTime":1385.37,"body":"and that's where things like"},{"startTime":1385.37,"endTime":1387.62,"body":"real world evidence really comes into play"},{"startTime":1387.62,"endTime":1391.883,"body":"and continuing to generate"},{"startTime":1387.62,"endTime":1391.883,"body":"evidence and value for a product."},{"startTime":1392.84,"endTime":1395.45,"body":"Same thing with kind"},{"startTime":1392.84,"endTime":1395.45,"body":"of head to head launch."},{"startTime":1395.45,"endTime":1397.05,"body":"Obviously, they'd want to see"},{"startTime":1398.69,"endTime":1401.66,"body":"comparative evidence at launch."},{"startTime":1401.66,"endTime":1402.8,"body":"If they're the first to market,"},{"startTime":1402.8,"endTime":1405.02,"body":"obviously, that's not an option."},{"startTime":1405.02,"endTime":1407.0,"body":"If the other drugs,"},{"startTime":1407.0,"endTime":1408.62,"body":"when they started their"},{"startTime":1407.0,"endTime":1408.62,"body":"clinical trial programme,"},{"startTime":1408.62,"endTime":1410.123,"body":"maybe they come after."},{"startTime":1411.29,"endTime":1412.79,"body":"It might not be possible."},{"startTime":1412.79,"endTime":1416.66,"body":"But again, some of that real"},{"startTime":1412.79,"endTime":1416.66,"body":"world comparative evidence"},{"startTime":1416.66,"endTime":1420.98,"body":"or the indirect kind of"},{"startTime":1416.66,"endTime":1420.98,"body":"comparisons do come into play,"},{"startTime":1420.98,"endTime":1422.96,"body":"but not the preference in the US"},{"startTime":1422.96,"endTime":1427.96,"body":"to have some of that indirect,"},{"startTime":1422.96,"endTime":1427.96,"body":"of course, economic impact."},{"startTime":1430.22,"endTime":1432.98,"body":"While they appreciate,"},{"startTime":1432.98,"endTime":1435.08,"body":"appreciate might be a strong word,"},{"startTime":1435.08,"endTime":1437.12,"body":"the type of economic evidence"},{"startTime":1437.12,"endTime":1439.49,"body":"that manufacturers are putting forward,"},{"startTime":1439.49,"endTime":1441.21,"body":"we know that there are"},{"startTime":1442.31,"endTime":1444.95,"body":"concerns about the transparency"},{"startTime":1444.95,"endTime":1448.49,"body":"and the information that's"},{"startTime":1444.95,"endTime":1448.49,"body":"included in those models often."},{"startTime":1448.49,"endTime":1451.43,"body":"So I think an important"},{"startTime":1448.49,"endTime":1451.43,"body":"thing to note is that"},{"startTime":1451.43,"endTime":1454.85,"body":"US payers do have a hesitancy towards"},{"startTime":1454.85,"endTime":1456.8,"body":"manufacturer-provided economic data."},{"startTime":1456.8,"endTime":1458.9,"body":"So wherever there are opportunities"},{"startTime":1458.9,"endTime":1463.67,"body":"to provide clarity, transparency,"},{"startTime":1463.67,"endTime":1466.43,"body":"our latest, and we'll talk"},{"startTime":1463.67,"endTime":1466.43,"body":"about this a little later,"},{"startTime":1466.43,"endTime":1470.72,"body":"but we did a recent payer survey"},{"startTime":1466.43,"endTime":1470.72,"body":"in the US, not surprising,"},{"startTime":1470.72,"endTime":1473.45,"body":"but over half of payers said that they had"},{"startTime":1473.45,"endTime":1476.36,"body":"a low or no level of trust"},{"startTime":1476.36,"endTime":1480.86,"body":"of manufacturer-provided"},{"startTime":1476.36,"endTime":1480.86,"body":"health economic models"},{"startTime":1480.86,"endTime":1485.0,"body":"with issues being transparency,"},{"startTime":1480.86,"endTime":1485.0,"body":"uncertainty, and rationale."},{"startTime":1485.0,"endTime":1489.35,"body":"Again, not news and nothing"},{"startTime":1485.0,"endTime":1489.35,"body":"that's earth-shattering."},{"startTime":1489.35,"endTime":1491.39,"body":"We've heard this for many years and years."},{"startTime":1491.39,"endTime":1493.64,"body":"But I think just as we move the needle"},{"startTime":1493.64,"endTime":1497.81,"body":"and really go to these"},{"startTime":1493.64,"endTime":1497.81,"body":"more price-focused models"},{"startTime":1497.81,"endTime":1501.47,"body":"and a world where we are"},{"startTime":1497.81,"endTime":1501.47,"body":"sharing more evidence,"},{"startTime":1501.47,"endTime":1502.97,"body":"and more evidence is available,"},{"startTime":1502.97,"endTime":1504.86,"body":"and more tools and resources are available"},{"startTime":1504.86,"endTime":1507.23,"body":"with things like real world evidence,"},{"startTime":1507.23,"endTime":1509.0,"body":"how do we continue to move that needle"},{"startTime":1509.0,"endTime":1511.55,"body":"to have more of this"},{"startTime":1509.0,"endTime":1511.55,"body":"collaboration with payers"},{"startTime":1511.55,"endTime":1513.8,"body":"versus us versus them kind of nature?"},{"startTime":1513.8,"endTime":1517.46,"body":"And some payers are more accepted of it."},{"startTime":1517.46,"endTime":1519.68,"body":"And building those relationships though"},{"startTime":1519.68,"endTime":1521.3,"body":"I think are really important to"},{"startTime":1521.3,"endTime":1523.13,"body":"continue to build upon that trust"},{"startTime":1523.13,"endTime":1526.613,"body":"and get to this kind of next"},{"startTime":1523.13,"endTime":1526.613,"body":"era of information sharing."},{"startTime":1528.44,"endTime":1530.36,"body":"Bob, what else?"},{"startTime":1530.36,"endTime":1534.563,"body":"- Well, just a couple of"},{"startTime":1530.36,"endTime":1534.563,"body":"things to highlight and,"},{"startTime":1535.85,"endTime":1538.97,"body":"what, caution against."},{"startTime":1538.97,"endTime":1541.553,"body":"Just because we don't have a central HTA"},{"startTime":1541.553,"endTime":1544.43,"body":"that is expecting or demanding"},{"startTime":1544.43,"endTime":1546.683,"body":"head-to-head clinical trial data."},{"startTime":1548.0,"endTime":1550.73,"body":"If your product profile supports it,"},{"startTime":1550.73,"endTime":1553.313,"body":"I would encourage you"},{"startTime":1550.73,"endTime":1553.313,"body":"to strongly consider,"},{"startTime":1554.39,"endTime":1558.2,"body":"at the very least, an economic substudy"},{"startTime":1558.2,"endTime":1563.2,"body":"as a part of, alongside, as"},{"startTime":1558.2,"endTime":1563.2,"body":"an adjunct to a clinical trial"},{"startTime":1563.78,"endTime":1568.46,"body":"if you can't get to the commitment"},{"startTime":1563.78,"endTime":1568.46,"body":"of a head-to-head study,"},{"startTime":1568.46,"endTime":1571.46,"body":"because while they're"},{"startTime":1568.46,"endTime":1571.46,"body":"not required in the US,"},{"startTime":1571.46,"endTime":1573.62,"body":"they are typically rewarded."},{"startTime":1573.62,"endTime":1578.243,"body":"That will change your market"},{"startTime":1573.62,"endTime":1578.243,"body":"access approach and uptake."},{"startTime":1580.306,"endTime":1583.88,"body":"Another caution I guess and encouragement"},{"startTime":1583.88,"endTime":1588.02,"body":"is around the value of"},{"startTime":1583.88,"endTime":1588.02,"body":"patient-reported outcomes"},{"startTime":1588.02,"endTime":1592.373,"body":"and patient preference"},{"startTime":1588.02,"endTime":1592.373,"body":"information among US payers."},{"startTime":1593.21,"endTime":1597.933,"body":"Yes, it does not have the"},{"startTime":1593.21,"endTime":1597.933,"body":"same impact in HTA markets,"},{"startTime":1599.75,"endTime":1603.35,"body":"but payers repeatedly say"},{"startTime":1603.35,"endTime":1607.37,"body":"it's a reason to believe"},{"startTime":1603.35,"endTime":1607.37,"body":"the clinical evidence."},{"startTime":1607.37,"endTime":1610.04,"body":"And certainly, depending"},{"startTime":1607.37,"endTime":1610.04,"body":"on the patient population,"},{"startTime":1610.04,"endTime":1612.59,"body":"the disease state, the product type,"},{"startTime":1612.59,"endTime":1615.68,"body":"patient reported outcomes"},{"startTime":1612.59,"endTime":1615.68,"body":"are very important"},{"startTime":1615.68,"endTime":1617.87,"body":"and payers are beginning to catch on"},{"startTime":1617.87,"endTime":1621.35,"body":"to patient preference information"},{"startTime":1621.35,"endTime":1625.05,"body":"as providing them some insight into both"},{"startTime":1626.66,"endTime":1629.69,"body":"whether patients might"},{"startTime":1626.66,"endTime":1629.69,"body":"be more or less adherent"},{"startTime":1629.69,"endTime":1631.94,"body":"to a particular product."},{"startTime":1631.94,"endTime":1633.32,"body":"And importantly,"},{"startTime":1633.32,"endTime":1636.02,"body":"as they're thinking about"},{"startTime":1633.32,"endTime":1636.02,"body":"utilisation management"},{"startTime":1636.02,"endTime":1638.51,"body":"across a portfolio,"},{"startTime":1638.51,"endTime":1640.85,"body":"using patient preferences information"},{"startTime":1640.85,"endTime":1644.21,"body":"and provider preference information"},{"startTime":1644.21,"endTime":1646.82,"body":"to better understand how physicians,"},{"startTime":1646.82,"endTime":1650.753,"body":"how prescribers might"},{"startTime":1646.82,"endTime":1650.753,"body":"switch between drugs."},{"startTime":1651.62,"endTime":1652.46,"body":"- Yeah."},{"startTime":1652.46,"endTime":1654.21,"body":"And Bob, just to build off of that,"},{"startTime":1655.26,"endTime":1657.32,"body":"doing ad boards, and in-depth interviews,"},{"startTime":1657.32,"endTime":1659.72,"body":"and different research with payers,"},{"startTime":1659.72,"endTime":1661.67,"body":"I feel like I always, more recently,"},{"startTime":1661.67,"endTime":1664.85,"body":"but I'm hearing this,"},{"startTime":1661.67,"endTime":1664.85,"body":"let's tell the whole story."},{"startTime":1664.85,"endTime":1666.32,"body":"Adherence alone, great."},{"startTime":1666.32,"endTime":1668.48,"body":"Put that on a slide, go to payers,"},{"startTime":1668.48,"endTime":1669.68,"body":"it's okay, this is nice."},{"startTime":1669.68,"endTime":1671.03,"body":"But what does it mean to me?"},{"startTime":1671.03,"endTime":1673.22,"body":"So does this better adherence,"},{"startTime":1673.22,"endTime":1675.2,"body":"can we link this to improved outcomes"},{"startTime":1675.2,"endTime":1676.7,"body":"and ultimately cost savings"},{"startTime":1676.7,"endTime":1678.68,"body":"where the payers really are focused?"},{"startTime":1678.68,"endTime":1681.8,"body":"Are we able to tell that"},{"startTime":1678.68,"endTime":1681.8,"body":"story and connect the dots?"},{"startTime":1681.8,"endTime":1685.79,"body":"Patient preference alone,"},{"startTime":1681.8,"endTime":1685.79,"body":"again, great in isolation,"},{"startTime":1685.79,"endTime":1687.77,"body":"but what does this mean for the payer?"},{"startTime":1687.77,"endTime":1690.05,"body":"So does that patient preference"},{"startTime":1690.05,"endTime":1693.23,"body":"towards an oral versus injectable,"},{"startTime":1693.23,"endTime":1694.76,"body":"does that lead to better adherence"},{"startTime":1694.76,"endTime":1696.11,"body":"and therefore better outcomes?"},{"startTime":1696.11,"endTime":1699.35,"body":"And then kind of tying"},{"startTime":1696.11,"endTime":1699.35,"body":"that value story together"},{"startTime":1699.35,"endTime":1701.0,"body":"for payers in the US,"},{"startTime":1701.0,"endTime":1703.67,"body":"'cause, again, those standalone facts,"},{"startTime":1703.67,"endTime":1706.16,"body":"nice, okay, cool, glad you did that study,"},{"startTime":1706.16,"endTime":1707.54,"body":"but what does this mean for me?"},{"startTime":1707.54,"endTime":1709.7,"body":"So I think that's really the important"},{"startTime":1709.7,"endTime":1711.113,"body":"takeaway that we're hearing."},{"startTime":1713.57,"endTime":1715.13,"body":"- Great point."},{"startTime":1715.13,"endTime":1718.73,"body":"Okay, I think we've"},{"startTime":1715.13,"endTime":1718.73,"body":"probably considered pharma"},{"startTime":1718.73,"endTime":1721.58,"body":"a bit more than MedTech"},{"startTime":1718.73,"endTime":1721.58,"body":"so far in our discussion."},{"startTime":1721.58,"endTime":1724.16,"body":"So what are the"},{"startTime":1721.58,"endTime":1724.16,"body":"similarities and differences"},{"startTime":1724.16,"endTime":1727.49,"body":"when preparing for a MedTech"},{"startTime":1724.16,"endTime":1727.49,"body":"or medical device launch"},{"startTime":1727.49,"endTime":1729.47,"body":"versus a pharma product?"},{"startTime":1729.47,"endTime":1731.44,"body":"Who are the key stakeholders there"},{"startTime":1731.44,"endTime":1735.2,"body":"and how should MedTech companies prepare?"},{"startTime":1735.2,"endTime":1738.74,"body":"- Well, the evidence expectations"},{"startTime":1738.74,"endTime":1742.49,"body":"among payers and hospital purchasers"},{"startTime":1742.49,"endTime":1744.38,"body":"have certainly been strengthening"},{"startTime":1744.38,"endTime":1746.9,"body":"over the last say 10 years."},{"startTime":1746.9,"endTime":1751.9,"body":"And on a path towards evidence generation"},{"startTime":1752.36,"endTime":1755.0,"body":"needs for pharmaceuticals,"},{"startTime":1755.0,"endTime":1757.64,"body":"whether it ever gets there is a question"},{"startTime":1757.64,"endTime":1759.86,"body":"because anybody in the space knows"},{"startTime":1759.86,"endTime":1762.83,"body":"that the development"},{"startTime":1759.86,"endTime":1762.83,"body":"cycles, if nothing else,"},{"startTime":1762.83,"endTime":1766.13,"body":"are so much shorter in the MedTech space,"},{"startTime":1766.13,"endTime":1768.77,"body":"that your ability to generate the evidence"},{"startTime":1768.77,"endTime":1770.483,"body":"is much more limited."},{"startTime":1772.041,"endTime":1776.12,"body":"One thing that I've seen,"},{"startTime":1772.041,"endTime":1776.12,"body":"just my limited experience,"},{"startTime":1776.12,"endTime":1780.2,"body":"is the value, the importance of"},{"startTime":1780.2,"endTime":1782.93,"body":"relatively small clinical trials."},{"startTime":1782.93,"endTime":1785.84,"body":"They don't have to be fully randomised,"},{"startTime":1785.84,"endTime":1789.44,"body":"but some prospective evidence generation,"},{"startTime":1789.44,"endTime":1792.44,"body":"which typically has not been done,"},{"startTime":1792.44,"endTime":1796.64,"body":"not all that prevalent"},{"startTime":1792.44,"endTime":1796.64,"body":"in MedTech and devices,"},{"startTime":1796.64,"endTime":1800.72,"body":"but perhaps working with"},{"startTime":1796.64,"endTime":1800.72,"body":"individual health plans,"},{"startTime":1800.72,"endTime":1805.43,"body":"large health plans that may"},{"startTime":1800.72,"endTime":1805.43,"body":"have a technology champion"},{"startTime":1805.43,"endTime":1806.84,"body":"within their organisation,"},{"startTime":1806.84,"endTime":1810.98,"body":"and then establishing a relatively small,"},{"startTime":1810.98,"endTime":1813.77,"body":"observational even, prospective study"},{"startTime":1813.77,"endTime":1818.77,"body":"can really be a beachhead to"},{"startTime":1813.77,"endTime":1818.77,"body":"market access for MedTech."},{"startTime":1822.68,"endTime":1824.84,"body":"- So how can companies ensure"},{"startTime":1824.84,"endTime":1826.7,"body":"they have the right evidence and tools"},{"startTime":1826.7,"endTime":1829.103,"body":"to engage with payer bodies in the US?"},{"startTime":1830.75,"endTime":1833.93,"body":"Is there any mechanism"},{"startTime":1830.75,"endTime":1833.93,"body":"for submitting evidence?"},{"startTime":1833.93,"endTime":1836.72,"body":"What level of interaction is possible?"},{"startTime":1836.72,"endTime":1837.68,"body":"And how does it differ"},{"startTime":1837.68,"endTime":1839.81,"body":"across all the different"},{"startTime":1837.68,"endTime":1839.81,"body":"payer organisations"},{"startTime":1839.81,"endTime":1840.91,"body":"that you've mentioned?"},{"startTime":1842.87,"endTime":1847.87,"body":"- Yeah, I mean, to get into"},{"startTime":1842.87,"endTime":1847.87,"body":"technical nuance again,"},{"startTime":1848.96,"endTime":1851.81,"body":"there's no formal submission."},{"startTime":1851.81,"endTime":1854.42,"body":"There's no formal submission process"},{"startTime":1854.42,"endTime":1857.093,"body":"in the way that HTA"},{"startTime":1854.42,"endTime":1857.093,"body":"bodies have a submission,"},{"startTime":1858.05,"endTime":1859.823,"body":"clearly specified document."},{"startTime":1860.96,"endTime":1864.17,"body":"As Bob noted before, there"},{"startTime":1860.96,"endTime":1864.17,"body":"are various templates"},{"startTime":1864.17,"endTime":1868.25,"body":"and organisations that"},{"startTime":1864.17,"endTime":1868.25,"body":"have put together guidance,"},{"startTime":1868.25,"endTime":1870.98,"body":"one of them being the FDA"},{"startTime":1870.98,"endTime":1874.43,"body":"with pre-approval information"},{"startTime":1870.98,"endTime":1874.43,"body":"exchange, and this is..."},{"startTime":1874.43,"endTime":1877.01,"body":"Bob I think will mention it a bit later,"},{"startTime":1877.01,"endTime":1877.89,"body":"but as we look in,"},{"startTime":1877.89,"endTime":1880.91,"body":"FDAMA 114 was obviously put in place"},{"startTime":1880.91,"endTime":1884.69,"body":"to allow for communication of healthcare,"},{"startTime":1884.69,"endTime":1886.55,"body":"economic information."},{"startTime":1886.55,"endTime":1889.13,"body":"With this, there are opportunities,"},{"startTime":1889.13,"endTime":1890.99,"body":"and this has been loosened with PIE"},{"startTime":1890.99,"endTime":1892.67,"body":"and some PIE approval and guidance"},{"startTime":1892.67,"endTime":1896.54,"body":"that has been revised and"},{"startTime":1892.67,"endTime":1896.54,"body":"reformed over the years,"},{"startTime":1896.54,"endTime":1899.15,"body":"but manufacturers can go out in the US"},{"startTime":1899.15,"endTime":1903.35,"body":"to have those prior to launch"},{"startTime":1899.15,"endTime":1903.35,"body":"pre-approval discussions,"},{"startTime":1903.35,"endTime":1906.35,"body":"whether that's through an"},{"startTime":1903.35,"endTime":1906.35,"body":"pre-approval AMCP dossier"},{"startTime":1906.35,"endTime":1908.87,"body":"and there is a format for that"},{"startTime":1908.87,"endTime":1911.54,"body":"or pre-approval information exchange"},{"startTime":1911.54,"endTime":1915.02,"body":"where manufacturer field teams can go out"},{"startTime":1915.02,"endTime":1916.88,"body":"and the right individuals can go out"},{"startTime":1916.88,"endTime":1920.45,"body":"and have those discussions with payers."},{"startTime":1920.45,"endTime":1922.52,"body":"Again, the right"},{"startTime":1920.45,"endTime":1922.52,"body":"stakeholders within payers,"},{"startTime":1922.52,"endTime":1924.44,"body":"and there's nuances around"},{"startTime":1924.44,"endTime":1926.51,"body":"who can engage in those discussions,"},{"startTime":1926.51,"endTime":1928.46,"body":"and what type of information can be shared"},{"startTime":1928.46,"endTime":1930.53,"body":"in what nature, et cetera."},{"startTime":1930.53,"endTime":1932.33,"body":"But those are really important,"},{"startTime":1932.33,"endTime":1935.12,"body":"especially when there's a"},{"startTime":1932.33,"endTime":1935.12,"body":"large population as mentioned"},{"startTime":1935.12,"endTime":1937.16,"body":"or a large financial impact."},{"startTime":1937.16,"endTime":1940.19,"body":"So kind of looking"},{"startTime":1937.16,"endTime":1940.19,"body":"ahead, if it's another..."},{"startTime":1940.19,"endTime":1944.03,"body":"If it's the 17th drug to market"},{"startTime":1940.19,"endTime":1944.03,"body":"in a very crowded landscape"},{"startTime":1944.03,"endTime":1946.37,"body":"and it's kind of a me too asset,"},{"startTime":1946.37,"endTime":1947.63,"body":"that might not be as important."},{"startTime":1947.63,"endTime":1948.92,"body":"They know the area."},{"startTime":1948.92,"endTime":1950.3,"body":"They know the population"},{"startTime":1950.3,"endTime":1952.19,"body":"is just potentially another modality,"},{"startTime":1952.19,"endTime":1957.19,"body":"or inpatients that are relapsing,"},{"startTime":1952.19,"endTime":1957.19,"body":"or refractory, et cetera."},{"startTime":1958.22,"endTime":1960.92,"body":"In a new area that maybe they haven't had,"},{"startTime":1960.92,"endTime":1962.69,"body":"what is my patient population?"},{"startTime":1962.69,"endTime":1963.92,"body":"I haven't had a drug for this,"},{"startTime":1963.92,"endTime":1965.36,"body":"so I'm not sure how many patients"},{"startTime":1965.36,"endTime":1967.49,"body":"potentially have this condition"},{"startTime":1967.49,"endTime":1970.91,"body":"or would be potentially on this drug."},{"startTime":1970.91,"endTime":1972.11,"body":"That would be an important area."},{"startTime":1972.11,"endTime":1977.11,"body":"Or a drug that's coming to"},{"startTime":1972.11,"endTime":1977.11,"body":"market at a large price,"},{"startTime":1977.15,"endTime":1978.59,"body":"they're going to care about that."},{"startTime":1978.59,"endTime":1983.59,"body":"Or a huge population, that's"},{"startTime":1978.59,"endTime":1983.59,"body":"another big thing to consider."},{"startTime":1985.1,"endTime":1986.21,"body":"So that's leading up to launch."},{"startTime":1986.21,"endTime":1988.16,"body":"And kind of as mentioned before,"},{"startTime":1988.16,"endTime":1992.42,"body":"this allows them to plan"},{"startTime":1988.16,"endTime":1992.42,"body":"for their formularies plan,"},{"startTime":1992.42,"endTime":1993.5,"body":"look at their data,"},{"startTime":1993.5,"endTime":1995.18,"body":"look at how they think they'll cover this"},{"startTime":1995.18,"endTime":1997.1,"body":"to prepare for those."},{"startTime":1997.1,"endTime":1998.39,"body":"Okay, we have this drug."},{"startTime":1998.39,"endTime":2000.19,"body":"It gives them that advanced notification."},{"startTime":2000.19,"endTime":2001.66,"body":"Really the important things there"},{"startTime":2001.66,"endTime":2003.25,"body":"that we hear time and time again,"},{"startTime":2003.25,"endTime":2006.4,"body":"they want to see efficacy,"},{"startTime":2003.25,"endTime":2006.4,"body":"safety, they want to see price."},{"startTime":2006.4,"endTime":2008.74,"body":"Obviously, some manufacturers"},{"startTime":2008.74,"endTime":2010.6,"body":"don't want to share full"},{"startTime":2008.74,"endTime":2010.6,"body":"pricing information."},{"startTime":2010.6,"endTime":2011.92,"body":"They might not be aware of it."},{"startTime":2011.92,"endTime":2013.06,"body":"Where are they going to land"},{"startTime":2013.06,"endTime":2014.14,"body":"and where are they going to fall"},{"startTime":2014.14,"endTime":2016.54,"body":"as they continue to play"},{"startTime":2014.14,"endTime":2016.54,"body":"with various pricing models"},{"startTime":2016.54,"endTime":2019.24,"body":"and pricing methodologies,"},{"startTime":2019.24,"endTime":2021.22,"body":"but they want to see"},{"startTime":2021.22,"endTime":2023.62,"body":"at least some type of economic information"},{"startTime":2023.62,"endTime":2025.27,"body":"and not an economic model per se,"},{"startTime":2025.27,"endTime":2026.92,"body":"but just what is this going to cost me"},{"startTime":2026.92,"endTime":2029.47,"body":"and what will this mean for my population?"},{"startTime":2029.47,"endTime":2030.97,"body":"And then after launch,"},{"startTime":2030.97,"endTime":2033.82,"body":"going out and having"},{"startTime":2030.97,"endTime":2033.82,"body":"those meetings further,"},{"startTime":2033.82,"endTime":2038.26,"body":"providing a full AMCP dossier"},{"startTime":2033.82,"endTime":2038.26,"body":"that we hear payers will use."},{"startTime":2038.26,"endTime":2040.75,"body":"They always like to look to them"},{"startTime":2040.75,"endTime":2043.96,"body":"'cause it is a comprehensive"},{"startTime":2040.75,"endTime":2043.96,"body":"placement of their information"},{"startTime":2043.96,"endTime":2046.57,"body":"as long as it's done scientifically,"},{"startTime":2046.57,"endTime":2049.81,"body":"properly referenced,"},{"startTime":2046.57,"endTime":2049.81,"body":"transparent, et cetera."},{"startTime":2049.81,"endTime":2052.27,"body":"Ideally substantiated by things like"},{"startTime":2052.27,"endTime":2053.89,"body":"systematic literature reviews"},{"startTime":2053.89,"endTime":2055.84,"body":"and clinical trial populations,"},{"startTime":2055.84,"endTime":2059.23,"body":"economic models that can be"},{"startTime":2055.84,"endTime":2059.23,"body":"included in those dossiers."},{"startTime":2059.23,"endTime":2063.133,"body":"Really it's similar to an"},{"startTime":2059.23,"endTime":2063.133,"body":"HTA submission in a sense,"},{"startTime":2064.18,"endTime":2066.22,"body":"but it's a guidance on"},{"startTime":2066.22,"endTime":2068.2,"body":"what information to submit to a payer."},{"startTime":2068.2,"endTime":2071.2,"body":"There are also things like"},{"startTime":2068.2,"endTime":2071.2,"body":"payer value propositions"},{"startTime":2071.2,"endTime":2073.45,"body":"that might be on the"},{"startTime":2071.2,"endTime":2073.45,"body":"more commercial sense."},{"startTime":2073.45,"endTime":2076.87,"body":"There's often health economic"},{"startTime":2073.45,"endTime":2076.87,"body":"field team presentations"},{"startTime":2076.87,"endTime":2078.34,"body":"that might have different stakeholders."},{"startTime":2078.34,"endTime":2080.11,"body":"So there's lots of ways to engage."},{"startTime":2080.11,"endTime":2082.93,"body":"And, obviously, again,"},{"startTime":2080.11,"endTime":2082.93,"body":"there's guidance around this"},{"startTime":2082.93,"endTime":2085.3,"body":"and a lot of specific nuances,"},{"startTime":2085.3,"endTime":2089.113,"body":"but the most important thing"},{"startTime":2085.3,"endTime":2089.113,"body":"we continually hear is,"},{"startTime":2089.95,"endTime":2090.91,"body":"we've alluded to this,"},{"startTime":2090.91,"endTime":2093.61,"body":"but let's be transparent and"},{"startTime":2090.91,"endTime":2093.61,"body":"scientific wherever possible."},{"startTime":2093.61,"endTime":2095.38,"body":"Obviously, there are commercial nuances."},{"startTime":2095.38,"endTime":2097.9,"body":"We want to have some commercial messaging"},{"startTime":2097.9,"endTime":2099.553,"body":"and try to paint that picture,"},{"startTime":2100.39,"endTime":2102.67,"body":"but the more that we can get payers"},{"startTime":2102.67,"endTime":2104.47,"body":"to really trust that communication,"},{"startTime":2104.47,"endTime":2105.76,"body":"the more that they'll take that"},{"startTime":2105.76,"endTime":2109.933,"body":"and really start to collaborate"},{"startTime":2105.76,"endTime":2109.933,"body":"more with manufacturers."},{"startTime":2110.86,"endTime":2112.63,"body":"And I mentioned this again before,"},{"startTime":2112.63,"endTime":2114.79,"body":"but it's important to"},{"startTime":2112.63,"endTime":2114.79,"body":"collaborate with payers"},{"startTime":2114.79,"endTime":2116.32,"body":"to kind of seek their perspectives"},{"startTime":2116.32,"endTime":2120.1,"body":"around what they will want"},{"startTime":2116.32,"endTime":2120.1,"body":"to see wherever possible."},{"startTime":2120.1,"endTime":2121.54,"body":"Start to engage early."},{"startTime":2121.54,"endTime":2123.49,"body":"If you know that you're in phase two,"},{"startTime":2123.49,"endTime":2125.35,"body":"okay, we're planning"},{"startTime":2123.49,"endTime":2125.35,"body":"our phase three trial,"},{"startTime":2125.35,"endTime":2126.88,"body":"what should we include?"},{"startTime":2126.88,"endTime":2128.17,"body":"If you include the right endpoint,"},{"startTime":2128.17,"endTime":2129.52,"body":"you have to wait until post-launch"},{"startTime":2129.52,"endTime":2131.35,"body":"to do a long-term extension."},{"startTime":2131.35,"endTime":2133.69,"body":"You have to wait until that"},{"startTime":2131.35,"endTime":2133.69,"body":"real world evidence is available"},{"startTime":2133.69,"endTime":2134.56,"body":"to get that endpoint"},{"startTime":2134.56,"endTime":2138.55,"body":"or try to do some fancy"},{"startTime":2134.56,"endTime":2138.55,"body":"analytics in the background"},{"startTime":2138.55,"endTime":2140.62,"body":"to try to make sense of it."},{"startTime":2140.62,"endTime":2142.03,"body":"But if you don't have the right endpoint"},{"startTime":2142.03,"endTime":2144.7,"body":"that payers and other stakeholders"},{"startTime":2142.03,"endTime":2144.7,"body":"are going to care about,"},{"startTime":2144.7,"endTime":2146.92,"body":"it's really too late by the time you"},{"startTime":2146.92,"endTime":2148.9,"body":"start recruiting for that phase three."},{"startTime":2148.9,"endTime":2151.63,"body":"So, as early as possible, understand,"},{"startTime":2151.63,"endTime":2154.93,"body":"especially, again, if it's"},{"startTime":2151.63,"endTime":2154.93,"body":"a new therapeutic area."},{"startTime":2154.93,"endTime":2157.96,"body":"What type of surrogate"},{"startTime":2154.93,"endTime":2157.96,"body":"endpoints might be accepted?"},{"startTime":2157.96,"endTime":2159.55,"body":"Do we have to do surrogate endpoint"},{"startTime":2159.55,"endTime":2162.103,"body":"kind of testing and"},{"startTime":2159.55,"endTime":2162.103,"body":"validation around this?"},{"startTime":2163.39,"endTime":2166.09,"body":"So really the earlier the better,"},{"startTime":2166.09,"endTime":2169.21,"body":"and that's kind of getting"},{"startTime":2166.09,"endTime":2169.21,"body":"into evidence again but..."},{"startTime":2169.21,"endTime":2171.733,"body":"And the last point I'll make is just,"},{"startTime":2173.11,"endTime":2176.17,"body":"obviously, the engagement"},{"startTime":2173.11,"endTime":2176.17,"body":"with payers has changed"},{"startTime":2176.17,"endTime":2177.94,"body":"kind of in this post COVID area,"},{"startTime":2177.94,"endTime":2180.19,"body":"live in person engagement with payers,"},{"startTime":2180.19,"endTime":2184.06,"body":"but obviously medical doctors"},{"startTime":2184.06,"endTime":2186.55,"body":"and healthcare providers as well."},{"startTime":2186.55,"endTime":2189.7,"body":"It's become different and"},{"startTime":2186.55,"endTime":2189.7,"body":"it's become more infrequent,"},{"startTime":2189.7,"endTime":2191.2,"body":"so you do need to optimise"},{"startTime":2191.2,"endTime":2193.03,"body":"that time that you have with key accounts"},{"startTime":2193.03,"endTime":2195.79,"body":"and really make that engagement"},{"startTime":2195.79,"endTime":2198.76,"body":"in whatever time you do have,"},{"startTime":2195.79,"endTime":2198.76,"body":"especially before launch,"},{"startTime":2198.76,"endTime":2201.13,"body":"as productive and mutually beneficial"},{"startTime":2201.13,"endTime":2202.963,"body":"and collaborative as possible."},{"startTime":2205.03,"endTime":2208.66,"body":"Bob, I think you had some points to add"},{"startTime":2208.66,"endTime":2210.97,"body":"about PIE and all of that,"},{"startTime":2210.97,"endTime":2212.52,"body":"so if I could turn over to you."},{"startTime":2213.43,"endTime":2217.51,"body":"- Yeah, and just a little"},{"startTime":2213.43,"endTime":2217.51,"body":"bit of additional background"},{"startTime":2217.51,"endTime":2220.69,"body":"so you understand what you're getting into"},{"startTime":2220.69,"endTime":2223.633,"body":"with pre-approval information exchange."},{"startTime":2224.62,"endTime":2228.31,"body":"It's still fairly early"},{"startTime":2224.62,"endTime":2228.31,"body":"days, it feels like to us."},{"startTime":2228.31,"endTime":2230.63,"body":"It's a pretty standardised"},{"startTime":2231.49,"endTime":2236.04,"body":"approach to share information"},{"startTime":2231.49,"endTime":2236.04,"body":"with payers but the..."},{"startTime":2238.356,"endTime":2241.81,"body":"FDAMA 114 was so vague"},{"startTime":2241.81,"endTime":2245.83,"body":"that how it was interpreted"},{"startTime":2245.83,"endTime":2248.95,"body":"by different manufacturers"},{"startTime":2245.83,"endTime":2248.95,"body":"varied substantially."},{"startTime":2248.95,"endTime":2252.1,"body":"So the information that"},{"startTime":2248.95,"endTime":2252.1,"body":"payers were getting"},{"startTime":2252.1,"endTime":2254.2,"body":"for relatively comparable products"},{"startTime":2254.2,"endTime":2255.34,"body":"may be in the same class"},{"startTime":2255.34,"endTime":2257.71,"body":"from different manufacturers"},{"startTime":2255.34,"endTime":2257.71,"body":"were very different."},{"startTime":2257.71,"endTime":2261.04,"body":"That was not a happy"},{"startTime":2257.71,"endTime":2261.04,"body":"situation for anybody."},{"startTime":2261.04,"endTime":2265.15,"body":"It was actual act of Congress in late 2022"},{"startTime":2265.15,"endTime":2267.37,"body":"that passed the PIE Act."},{"startTime":2267.37,"endTime":2271.215,"body":"So while it feels comfortable"},{"startTime":2271.215,"endTime":2274.96,"body":"for us on the supply side of the market,"},{"startTime":2274.96,"endTime":2277.9,"body":"payers are still really"},{"startTime":2274.96,"endTime":2277.9,"body":"just getting used to"},{"startTime":2277.9,"endTime":2282.41,"body":"receiving this newer, better,"},{"startTime":2277.9,"endTime":2282.41,"body":"more complete information"},{"startTime":2283.57,"endTime":2286.3,"body":"maybe eight 18 months or so."},{"startTime":2286.3,"endTime":2289.48,"body":"So be serious about that."},{"startTime":2289.48,"endTime":2292.96,"body":"I think test it with payers,"},{"startTime":2292.96,"endTime":2295.54,"body":"and get your PIE decks,"},{"startTime":2295.54,"endTime":2297.55,"body":"get your information out pretty early"},{"startTime":2297.55,"endTime":2301.73,"body":"because payers are now getting"},{"startTime":2297.55,"endTime":2301.73,"body":"accustomed to seeing that"},{"startTime":2302.92,"endTime":2306.52,"body":"nine months, 12 months prior to launch."},{"startTime":2306.52,"endTime":2309.16,"body":"Doing so will help your initial uptake"},{"startTime":2309.16,"endTime":2310.453,"body":"in commercial success."},{"startTime":2312.88,"endTime":2314.68,"body":"- Great advice on collaboration."},{"startTime":2314.68,"endTime":2318.48,"body":"I think that's really so key, isn't it?"},{"startTime":2318.48,"endTime":2320.05,"body":"So let's think about the future."},{"startTime":2320.05,"endTime":2321.7,"body":"What changes are happening"},{"startTime":2321.7,"endTime":2324.01,"body":"that our audience should be aware of?"},{"startTime":2324.01,"endTime":2325.96,"body":"I know we're planning a future webinar"},{"startTime":2325.96,"endTime":2327.7,"body":"specifically on the IRA,"},{"startTime":2327.7,"endTime":2330.643,"body":"but maybe that's something"},{"startTime":2327.7,"endTime":2330.643,"body":"you could start with."},{"startTime":2332.14,"endTime":2332.973,"body":"- Sure, yeah."},{"startTime":2332.973,"endTime":2334.63,"body":"We would need at least an hour"},{"startTime":2334.63,"endTime":2338.05,"body":"to talk about the potential,"},{"startTime":2338.05,"endTime":2342.82,"body":"well, the design and the"},{"startTime":2338.05,"endTime":2342.82,"body":"potential implications of the IRA."},{"startTime":2342.82,"endTime":2345.25,"body":"But at a very high level,"},{"startTime":2345.25,"endTime":2349.303,"body":"to introduce it to those who"},{"startTime":2345.25,"endTime":2349.303,"body":"aren't fully familiar with it."},{"startTime":2350.2,"endTime":2355.2,"body":"This is new legislation,"},{"startTime":2350.2,"endTime":2355.2,"body":"again, couple of years ago,"},{"startTime":2355.27,"endTime":2357.55,"body":"that allows CMS for the first time"},{"startTime":2357.55,"endTime":2360.88,"body":"to negotiate prices with manufacturers"},{"startTime":2360.88,"endTime":2364.87,"body":"for a fairly limited"},{"startTime":2360.88,"endTime":2364.87,"body":"number of drugs each year,"},{"startTime":2364.87,"endTime":2367.93,"body":"but that's accumulative"},{"startTime":2364.87,"endTime":2367.93,"body":"and it will build up."},{"startTime":2367.93,"endTime":2372.28,"body":"And the drugs that are eligible"},{"startTime":2367.93,"endTime":2372.28,"body":"are high expenditure drugs"},{"startTime":2372.28,"endTime":2377.28,"body":"for Medicare in both Part D"},{"startTime":2372.28,"endTime":2377.28,"body":"and ultimately in three years,"},{"startTime":2377.95,"endTime":2381.88,"body":"I think Part B, hospital drugs, as well,"},{"startTime":2381.88,"endTime":2384.493,"body":"that have been on the"},{"startTime":2381.88,"endTime":2384.493,"body":"market for several years."},{"startTime":2385.63,"endTime":2389.05,"body":"Nine years post-approval"},{"startTime":2385.63,"endTime":2389.05,"body":"for small molecules"},{"startTime":2389.05,"endTime":2393.697,"body":"and 13 years post"},{"startTime":2389.05,"endTime":2393.697,"body":"post-approval for biologics."},{"startTime":2397.36,"endTime":2398.77,"body":"I mentioned this earlier,"},{"startTime":2398.77,"endTime":2401.38,"body":"the actual process by which CMS"},{"startTime":2401.38,"endTime":2404.29,"body":"is conducting these evaluations,"},{"startTime":2404.29,"endTime":2408.4,"body":"the elements that go into"},{"startTime":2404.29,"endTime":2408.4,"body":"the negotiation process"},{"startTime":2408.4,"endTime":2411.163,"body":"is still a bit unknown."},{"startTime":2412.87,"endTime":2414.64,"body":"There are..."},{"startTime":2414.64,"endTime":2415.543,"body":"Let's see."},{"startTime":2418.21,"endTime":2421.42,"body":"Out of the negotiation process then come"},{"startTime":2421.42,"endTime":2425.5,"body":"maximum fair prices for"},{"startTime":2421.42,"endTime":2425.5,"body":"the negotiated drugs."},{"startTime":2425.5,"endTime":2430.5,"body":"And those drugs are"},{"startTime":2425.5,"endTime":2430.5,"body":"going to be existing in"},{"startTime":2432.073,"endTime":2433.483,"body":"large drug classes."},{"startTime":2434.59,"endTime":2438.46,"body":"And the dynamics of pricing and rebates"},{"startTime":2438.46,"endTime":2442.18,"body":"both in the Medicare Advantage market,"},{"startTime":2442.18,"endTime":2445.9,"body":"but also in the commercial"},{"startTime":2442.18,"endTime":2445.9,"body":"market, are unknown."},{"startTime":2445.9,"endTime":2450.73,"body":"Imagine price goes down on a leading drug."},{"startTime":2450.73,"endTime":2454.03,"body":"What are the knock on effects for pricing"},{"startTime":2454.03,"endTime":2456.55,"body":"and access for the other drugs?"},{"startTime":2456.55,"endTime":2458.623,"body":"Those were all TBD."},{"startTime":2460.03,"endTime":2462.19,"body":"There are also concerns regarding"},{"startTime":2462.19,"endTime":2465.88,"body":"the impact of the drug"},{"startTime":2462.19,"endTime":2465.88,"body":"price negotiation programme"},{"startTime":2465.88,"endTime":2469.54,"body":"on the incentives to conduct R\u0026D"},{"startTime":2469.54,"endTime":2472.12,"body":"for drugs that might be selected"},{"startTime":2472.12,"endTime":2475.72,"body":"for the DPNP say in five years, 10 years."},{"startTime":2475.72,"endTime":2479.21,"body":"So I think there's going to be"},{"startTime":2475.72,"endTime":2479.21,"body":"a pretty significant shift in"},{"startTime":2480.43,"endTime":2483.13,"body":"incentives to invest in a particular"},{"startTime":2483.13,"endTime":2487.54,"body":"drug class disease state versus another."},{"startTime":2487.54,"endTime":2489.34,"body":"So there's a lot to say"},{"startTime":2489.34,"endTime":2491.41,"body":"about the drug price"},{"startTime":2489.34,"endTime":2491.41,"body":"negotiation programme."},{"startTime":2491.41,"endTime":2493.39,"body":"We can hold that for a bit."},{"startTime":2493.39,"endTime":2494.86,"body":"And I should also mention"},{"startTime":2494.86,"endTime":2498.1,"body":"a couple of the other"},{"startTime":2494.86,"endTime":2498.1,"body":"main elements of the IRA."},{"startTime":2498.1,"endTime":2501.34,"body":"One are inflation rebates."},{"startTime":2501.34,"endTime":2506.17,"body":"This is where drugs that have"},{"startTime":2501.34,"endTime":2506.17,"body":"been approved on the market"},{"startTime":2506.17,"endTime":2508.37,"body":"would be required to"},{"startTime":2509.53,"endTime":2513.34,"body":"provide a pretty substantial"},{"startTime":2509.53,"endTime":2513.34,"body":"rebate back to CMS"},{"startTime":2513.34,"endTime":2517.75,"body":"if the list prices for those drugs go up"},{"startTime":2517.75,"endTime":2521.923,"body":"greater than the rate of"},{"startTime":2517.75,"endTime":2521.923,"body":"inflation in any given year."},{"startTime":2523.66,"endTime":2526.69,"body":"That'll play out largely"},{"startTime":2523.66,"endTime":2526.69,"body":"in upward pressure"},{"startTime":2526.69,"endTime":2529.003,"body":"on launch prices over time."},{"startTime":2530.14,"endTime":2535.14,"body":"Third large element of the"},{"startTime":2530.14,"endTime":2535.14,"body":"IRA is the Part D redesign,"},{"startTime":2536.26,"endTime":2538.34,"body":"really substantial effort to"},{"startTime":2539.47,"endTime":2543.58,"body":"rationalise the patient participation,"},{"startTime":2543.58,"endTime":2545.86,"body":"the patient cost sharing,"},{"startTime":2545.86,"endTime":2548.59,"body":"the donut hole if you're familiar"},{"startTime":2548.59,"endTime":2552.55,"body":"with the catastrophic"},{"startTime":2548.59,"endTime":2552.55,"body":"phase that has been closed."},{"startTime":2552.55,"endTime":2557.11,"body":"Out-of-pocket maximum for CMS"},{"startTime":2557.11,"endTime":2559.72,"body":"beneficiaries receiving prescription drugs"},{"startTime":2559.72,"endTime":2562.75,"body":"has been capped at $2,000,"},{"startTime":2562.75,"endTime":2566.29,"body":"and all of this is shifting"},{"startTime":2566.29,"endTime":2571.24,"body":"somewhere around $40 billion of costs"},{"startTime":2571.24,"endTime":2575.35,"body":"from patients and from CMS to an extent"},{"startTime":2575.35,"endTime":2580.35,"body":"to largely payers to the"},{"startTime":2575.35,"endTime":2580.35,"body":"plan, the Part D plan sponsors"},{"startTime":2582.04,"endTime":2584.95,"body":"smaller extent to manufacturers."},{"startTime":2584.95,"endTime":2589.95,"body":"That shift of cost burden to payers"},{"startTime":2590.32,"endTime":2594.13,"body":"is clearly going to impact access."},{"startTime":2594.13,"endTime":2597.1,"body":"We're already seeing"},{"startTime":2594.13,"endTime":2597.1,"body":"proposals for deductibles"},{"startTime":2597.1,"endTime":2599.23,"body":"to increase pretty substantially."},{"startTime":2599.23,"endTime":2604.23,"body":"For PDP, the Part D"},{"startTime":2599.23,"endTime":2604.23,"body":"prescription drug plans"},{"startTime":2605.59,"endTime":2609.31,"body":"have premium increases that"},{"startTime":2605.59,"endTime":2609.31,"body":"are pretty substantial."},{"startTime":2609.31,"endTime":2611.53,"body":"This is going to play out"},{"startTime":2609.31,"endTime":2611.53,"body":"over the next couple of years,"},{"startTime":2611.53,"endTime":2615.55,"body":"but there certainly seems"},{"startTime":2611.53,"endTime":2615.55,"body":"to be pretty substantial"},{"startTime":2615.55,"endTime":2619.31,"body":"unintended consequences of the IRA."},{"startTime":2619.31,"endTime":2621.88,"body":"- Yeah, and, Bob, just to add"},{"startTime":2621.88,"endTime":2625.45,"body":"some quantification in some of that."},{"startTime":2625.45,"endTime":2628.33,"body":"Experts, when they laid out this plan,"},{"startTime":2628.33,"endTime":2630.37,"body":"we've heard things like,"},{"startTime":2628.33,"endTime":2630.37,"body":"\"Oh, over 10 years,"},{"startTime":2630.37,"endTime":2632.29,"body":"it'll save 100 billion dollars.\""},{"startTime":2632.29,"endTime":2634.0,"body":"And again, we don't know"},{"startTime":2632.29,"endTime":2634.0,"body":"what that looks like."},{"startTime":2634.0,"endTime":2635.77,"body":"I don't think anyone knows exactly."},{"startTime":2635.77,"endTime":2639.82,"body":"And as Bob mentioned, I"},{"startTime":2635.77,"endTime":2639.82,"body":"think it's not just like,"},{"startTime":2639.82,"endTime":2642.55,"body":"okay, that 100 billion will"},{"startTime":2639.82,"endTime":2642.55,"body":"come from manufacturers."},{"startTime":2642.55,"endTime":2645.91,"body":"Those costs will be shared."},{"startTime":2645.91,"endTime":2647.74,"body":"Pharma's still here too."},{"startTime":2647.74,"endTime":2649.45,"body":"It's a for-profit business."},{"startTime":2649.45,"endTime":2651.55,"body":"Some of those costs will"},{"startTime":2649.45,"endTime":2651.55,"body":"be pushed to patients"},{"startTime":2651.55,"endTime":2655.15,"body":"and other wherein have some"},{"startTime":2651.55,"endTime":2655.15,"body":"unintended consequences that"},{"startTime":2655.15,"endTime":2657.37,"body":"people are starting to"},{"startTime":2655.15,"endTime":2657.37,"body":"estimate and model out,"},{"startTime":2657.37,"endTime":2659.773,"body":"but we don't know the full effect of it."},{"startTime":2661.9,"endTime":2663.343,"body":"The drug prices, again,"},{"startTime":2664.69,"endTime":2669.13,"body":"we've seen the negotiated"},{"startTime":2664.69,"endTime":2669.13,"body":"prices in August of this year."},{"startTime":2669.13,"endTime":2671.2,"body":"We saw the first negotiated prices,"},{"startTime":2671.2,"endTime":2673.24,"body":"and those came largely in line"},{"startTime":2673.24,"endTime":2674.62,"body":"with what people were modelling,"},{"startTime":2674.62,"endTime":2676.27,"body":"but it's anywhere from,"},{"startTime":2676.27,"endTime":2678.91,"body":"I think 38%, Bob, was the lowest"},{"startTime":2678.91,"endTime":2682.91,"body":"up to 79% of the drug price"},{"startTime":2684.52,"endTime":2686.2,"body":"kind of discount was put in place."},{"startTime":2686.2,"endTime":2688.96,"body":"So again, and this will vary year to year,"},{"startTime":2688.96,"endTime":2690.81,"body":"and as these compound..."},{"startTime":2692.259,"endTime":2694.24,"body":"And it will have spill"},{"startTime":2692.259,"endTime":2694.24,"body":"over to other markets too."},{"startTime":2694.24,"endTime":2696.13,"body":"Again, we've talked"},{"startTime":2694.24,"endTime":2696.13,"body":"about this at the start,"},{"startTime":2696.13,"endTime":2700.12,"body":"but US is that leading"},{"startTime":2696.13,"endTime":2700.12,"body":"market, and that's where"},{"startTime":2700.12,"endTime":2703.09,"body":"50% of the world's pharmaceutical"},{"startTime":2700.12,"endTime":2703.09,"body":"revenues coming from."},{"startTime":2703.09,"endTime":2705.58,"body":"Will that change as more of these drugs"},{"startTime":2705.58,"endTime":2708.13,"body":"are added to the DPNP?"},{"startTime":2708.13,"endTime":2709.3,"body":"Yet to be seen."},{"startTime":2709.3,"endTime":2712.69,"body":"So again, meant to have a positive impact,"},{"startTime":2712.69,"endTime":2715.63,"body":"but I think some of the"},{"startTime":2712.69,"endTime":2715.63,"body":"unintended consequences"},{"startTime":2715.63,"endTime":2718.24,"body":"will have downstream"},{"startTime":2715.63,"endTime":2718.24,"body":"and will have to kind of"},{"startTime":2718.24,"endTime":2719.89,"body":"figure out how to work around those."},{"startTime":2719.89,"endTime":2722.14,"body":"So patient access and patient outcomes"},{"startTime":2722.14,"endTime":2724.46,"body":"ultimately aren't impacted and negatively"},{"startTime":2725.35,"endTime":2728.14,"body":"kind of impacted based on this"},{"startTime":2728.14,"endTime":2731.62,"body":"thing that was put in place"},{"startTime":2728.14,"endTime":2731.62,"body":"to positively increase,"},{"startTime":2731.62,"endTime":2734.74,"body":"improve patient access via pricing"},{"startTime":2734.74,"endTime":2737.323,"body":"and overall pricing and spend in the US."},{"startTime":2742.27,"endTime":2743.89,"body":"And then, Bob, I know there's some"},{"startTime":2743.89,"endTime":2745.99,"body":"other large things in the US."},{"startTime":2745.99,"endTime":2748.963,"body":"I don't know if we want to"},{"startTime":2745.99,"endTime":2748.963,"body":"cover those off now, Clare."},{"startTime":2750.25,"endTime":2752.11,"body":"Obviously, IRA is at the forefront."},{"startTime":2752.11,"endTime":2756.88,"body":"Other things like"},{"startTime":2752.11,"endTime":2756.88,"body":"biosimilars, still emerging."},{"startTime":2756.88,"endTime":2761.41,"body":"US is so much lower than"},{"startTime":2756.88,"endTime":2761.41,"body":"especially Europe to uptake these,"},{"startTime":2761.41,"endTime":2766.41,"body":"but they are starting to"},{"startTime":2761.41,"endTime":2766.41,"body":"get momentum, finally."},{"startTime":2766.78,"endTime":2767.98,"body":"It's taken a long time."},{"startTime":2767.98,"endTime":2769.937,"body":"I remember, 10 years, ago"},{"startTime":2767.98,"endTime":2769.937,"body":"we were talking about,"},{"startTime":2769.937,"endTime":2771.64,"body":"\"Ooh, biosimilars are coming."},{"startTime":2771.64,"endTime":2773.38,"body":"What do we do about them in the US"},{"startTime":2773.38,"endTime":2775.15,"body":"and how do we plan for them?\""},{"startTime":2775.15,"endTime":2776.83,"body":"It's taken a lot longer, I think,"},{"startTime":2776.83,"endTime":2779.32,"body":"than most people"},{"startTime":2776.83,"endTime":2779.32,"body":"anticipated to really hit,"},{"startTime":2779.32,"endTime":2781.69,"body":"and now it's quite"},{"startTime":2779.32,"endTime":2781.69,"body":"frankly being overshadowed"},{"startTime":2781.69,"endTime":2784.48,"body":"by some other things but not to be missed."},{"startTime":2784.48,"endTime":2785.68,"body":"It's kind of something that's happening,"},{"startTime":2785.68,"endTime":2788.02,"body":"but no one's talking"},{"startTime":2785.68,"endTime":2788.02,"body":"about it quite as much."},{"startTime":2788.02,"endTime":2790.69,"body":"And then GLP-1s, Bob,"},{"startTime":2790.69,"endTime":2793.51,"body":"I know you have quite a lot"},{"startTime":2790.69,"endTime":2793.51,"body":"of perspectives about that,"},{"startTime":2793.51,"endTime":2796.54,"body":"but just the markets exploded"},{"startTime":2796.54,"endTime":2800.5,"body":"and taken the spotlight"},{"startTime":2796.54,"endTime":2800.5,"body":"from some other areas"},{"startTime":2800.5,"endTime":2803.53,"body":"and things like rare disease."},{"startTime":2803.53,"endTime":2805.57,"body":"Three or four years ago,"},{"startTime":2803.53,"endTime":2805.57,"body":"everyone was talking about"},{"startTime":2805.57,"endTime":2807.91,"body":"rare disease and gene and cell therapy."},{"startTime":2807.91,"endTime":2809.47,"body":"Obviously still a huge cost"},{"startTime":2809.47,"endTime":2811.3,"body":"and a huge concern for US payers,"},{"startTime":2811.3,"endTime":2815.68,"body":"but GLP-1, you can't turn on the radio"},{"startTime":2815.68,"endTime":2819.22,"body":"without hearing about GLP-1s in the US."},{"startTime":2819.22,"endTime":2821.32,"body":"You can't open the"},{"startTime":2819.22,"endTime":2821.32,"body":"newspaper. It's everywhere."},{"startTime":2821.32,"endTime":2823.54,"body":"It's one of those drugs"},{"startTime":2821.32,"endTime":2823.54,"body":"that's really exploded"},{"startTime":2823.54,"endTime":2826.93,"body":"and you can't go on social"},{"startTime":2823.54,"endTime":2826.93,"body":"media without seeing ads for it."},{"startTime":2826.93,"endTime":2828.67,"body":"They're everywhere right now in the US"},{"startTime":2828.67,"endTime":2830.29,"body":"and I know the rest of the world as well."},{"startTime":2830.29,"endTime":2834.08,"body":"But, Bob, any perspectives"},{"startTime":2830.29,"endTime":2834.08,"body":"around how those will"},{"startTime":2835.03,"endTime":2838.0,"body":"continue to change and"},{"startTime":2835.03,"endTime":2838.0,"body":"impact the market as well?"},{"startTime":2838.0,"endTime":2841.75,"body":"- I think payers are going"},{"startTime":2838.0,"endTime":2841.75,"body":"to have GLP-1s on the brain"},{"startTime":2841.75,"endTime":2845.11,"body":"for the next few years"},{"startTime":2845.11,"endTime":2847.96,"body":"in part because"},{"startTime":2847.96,"endTime":2852.91,"body":"about a third or less of"},{"startTime":2847.96,"endTime":2852.91,"body":"employer-sponsored plans"},{"startTime":2852.91,"endTime":2857.32,"body":"provide coverage for"},{"startTime":2852.91,"endTime":2857.32,"body":"GLP-1s for weight loss,"},{"startTime":2857.32,"endTime":2861.973,"body":"pretty broad coverage for type 2 diabetes."},{"startTime":2862.84,"endTime":2867.28,"body":"But coverage access for"},{"startTime":2862.84,"endTime":2867.28,"body":"GLP-1s is pretty limited"},{"startTime":2867.28,"endTime":2869.62,"body":"among commercial plans"},{"startTime":2869.62,"endTime":2873.853,"body":"for the Affordable Care"},{"startTime":2869.62,"endTime":2873.853,"body":"Act exchange plans."},{"startTime":2875.71,"endTime":2877.363,"body":"As of about six months ago,"},{"startTime":2878.23,"endTime":2883.033,"body":"none of the exchange plans"},{"startTime":2878.23,"endTime":2883.033,"body":"provided coverage for GLP-1s."},{"startTime":2884.35,"endTime":2887.12,"body":"There are movements to"},{"startTime":2888.46,"endTime":2891.79,"body":"allow to force CMS to provide coverage"},{"startTime":2891.79,"endTime":2895.57,"body":"for GLP-1s for weight loss."},{"startTime":2895.57,"endTime":2898.63,"body":"And I think if that ever comes to pass,"},{"startTime":2898.63,"endTime":2902.263,"body":"then the commercial market will certainly"},{"startTime":2902.263,"endTime":2904.48,"body":"follow CMS coverage."},{"startTime":2904.48,"endTime":2909.48,"body":"But that is going to have a"},{"startTime":2904.48,"endTime":2909.48,"body":"huge impact on payers' budgets."},{"startTime":2909.85,"endTime":2911.08,"body":"And like Nicole said,"},{"startTime":2911.08,"endTime":2913.21,"body":"that is going to replace concerns"},{"startTime":2913.21,"endTime":2917.2,"body":"about the cost of cell and"},{"startTime":2913.21,"endTime":2917.2,"body":"gene therapy in payers' minds."},{"startTime":2917.2,"endTime":2919.073,"body":"They're all over GLP-1s."},{"startTime":2921.198,"endTime":2922.69,"body":"- That's a great point."},{"startTime":2922.69,"endTime":2925.06,"body":"Okay, that's really helpful to think about"},{"startTime":2925.06,"endTime":2926.38,"body":"what's coming in the future"},{"startTime":2926.38,"endTime":2928.573,"body":"and some of those trends"},{"startTime":2926.38,"endTime":2928.573,"body":"that are emerging."},{"startTime":2929.41,"endTime":2931.6,"body":"Let's think now about opportunities"},{"startTime":2931.6,"endTime":2933.4,"body":"for pharma and MedTech companies"},{"startTime":2933.4,"endTime":2935.17,"body":"launching new products in the US."},{"startTime":2935.17,"endTime":2937.753,"body":"What would you say about that topic?"},{"startTime":2939.46,"endTime":2943.96,"body":"- Yeah, well, I think I"},{"startTime":2939.46,"endTime":2943.96,"body":"touched on this before,"},{"startTime":2943.96,"endTime":2948.653,"body":"but the opportunities I think in the US,"},{"startTime":2949.69,"endTime":2954.1,"body":"despite the craziness with the IRA"},{"startTime":2954.1,"endTime":2955.87,"body":"and how much bandwidth that's taken"},{"startTime":2955.87,"endTime":2959.23,"body":"out of everybody in the US,"},{"startTime":2959.23,"endTime":2963.667,"body":"still a very attractive market for"},{"startTime":2965.02,"endTime":2966.76,"body":"pharmaceutical innovation,"},{"startTime":2966.76,"endTime":2969.07,"body":"again, because we do place high value"},{"startTime":2969.07,"endTime":2971.29,"body":"in the US on innovation."},{"startTime":2971.29,"endTime":2972.94,"body":"And we,"},{"startTime":2972.94,"endTime":2976.99,"body":"within the restrictions"},{"startTime":2972.94,"endTime":2976.99,"body":"of our insurance system,"},{"startTime":2976.99,"endTime":2981.99,"body":"do provide pretty rapid"},{"startTime":2976.99,"endTime":2981.99,"body":"access to that information."},{"startTime":2983.2,"endTime":2987.37,"body":"And by drug class, by disease"},{"startTime":2983.2,"endTime":2987.37,"body":"state, this all varies,"},{"startTime":2987.37,"endTime":2991.51,"body":"but thinking very loosely,"},{"startTime":2991.51,"endTime":2993.79,"body":"say if you're in phase two"},{"startTime":2993.79,"endTime":2995.94,"body":"and beginning to think"},{"startTime":2993.79,"endTime":2995.94,"body":"about the US market,"},{"startTime":2997.21,"endTime":3000.21,"body":"there are clear hierarchies."},{"startTime":3000.21,"endTime":3005.21,"body":"Gaining coverage through CMS"},{"startTime":3000.21,"endTime":3005.21,"body":"can be pretty straightforward."},{"startTime":3006.21,"endTime":3009.84,"body":"They typically are required to"},{"startTime":3009.84,"endTime":3012.39,"body":"cover drugs that are FDA-approved."},{"startTime":3012.39,"endTime":3017.39,"body":"But if a national coverage"},{"startTime":3012.39,"endTime":3017.39,"body":"decision is issued,"},{"startTime":3017.58,"endTime":3022.2,"body":"NCD, that's an acronym"},{"startTime":3017.58,"endTime":3022.2,"body":"to keep on your checklist"},{"startTime":3022.2,"endTime":3025.08,"body":"on your pre-launch checklists."},{"startTime":3025.08,"endTime":3030.08,"body":"If you have an NCD that's"},{"startTime":3025.08,"endTime":3030.08,"body":"either positive or negative,"},{"startTime":3030.6,"endTime":3034.113,"body":"commercial plans will follow NCDs."},{"startTime":3035.1,"endTime":3039.07,"body":"And it's a bit of a"},{"startTime":3040.35,"endTime":3042.76,"body":"gross generalisation that"},{"startTime":3040.35,"endTime":3042.76,"body":"there are going to be"},{"startTime":3043.702,"endTime":3046.59,"body":"priority payers, priority stakeholders."},{"startTime":3046.59,"endTime":3050.37,"body":"Everyone is clearly important"},{"startTime":3046.59,"endTime":3050.37,"body":"over the entire lifecycle."},{"startTime":3050.37,"endTime":3055.05,"body":"Bu at launch, preparing for launch,"},{"startTime":3055.05,"endTime":3060.05,"body":"a very deliberate,"},{"startTime":3055.05,"endTime":3060.05,"body":"focus-prioritised access plan"},{"startTime":3060.3,"endTime":3064.74,"body":"that focuses on the two or"},{"startTime":3060.3,"endTime":3064.74,"body":"three payer purchaser types"},{"startTime":3064.74,"endTime":3068.82,"body":"that are going to be pretty"},{"startTime":3064.74,"endTime":3068.82,"body":"critical for your initial launch"},{"startTime":3068.82,"endTime":3071.55,"body":"and market access should be the centre"},{"startTime":3071.55,"endTime":3073.863,"body":"of your evidence generation planning."},{"startTime":3076.32,"endTime":3078.09,"body":"- Okay. All right."},{"startTime":3078.09,"endTime":3080.16,"body":"So what recommendations would you make"},{"startTime":3080.16,"endTime":3081.81,"body":"to a company launching a product"},{"startTime":3081.81,"endTime":3083.613,"body":"in the US for the first time?"},{"startTime":3085.17,"endTime":3088.35,"body":"- Yeah, I mean, I think we've"},{"startTime":3085.17,"endTime":3088.35,"body":"mentioned most of these,"},{"startTime":3088.35,"endTime":3091.22,"body":"but putting a US spin in..."},{"startTime":3092.58,"endTime":3094.35,"body":"Land early, which is no different"},{"startTime":3094.35,"endTime":3095.88,"body":"than the rest of the world,"},{"startTime":3095.88,"endTime":3099.51,"body":"but really there's no"},{"startTime":3099.51,"endTime":3102.06,"body":"cookie cutter approach"},{"startTime":3099.51,"endTime":3102.06,"body":"to any product launch."},{"startTime":3102.06,"endTime":3104.64,"body":"There's different competitive dynamics,"},{"startTime":3104.64,"endTime":3106.14,"body":"there's different stakeholders,"},{"startTime":3106.14,"endTime":3108.38,"body":"and that's where it starts"},{"startTime":3106.14,"endTime":3108.38,"body":"to get complex in the US,"},{"startTime":3108.38,"endTime":3109.56,"body":"is this medical benefit."},{"startTime":3109.56,"endTime":3110.64,"body":"Is it pharmacy benefit?"},{"startTime":3110.64,"endTime":3112.38,"body":"Is it a mix?"},{"startTime":3112.38,"endTime":3114.54,"body":"What's the patient population?"},{"startTime":3114.54,"endTime":3116.04,"body":"Do we have those subgroups?"},{"startTime":3116.04,"endTime":3118.5,"body":"If it's a primarily elderly population"},{"startTime":3118.5,"endTime":3122.49,"body":"or it heavily impacts"},{"startTime":3118.5,"endTime":3122.49,"body":"African-American population,"},{"startTime":3122.49,"endTime":3123.81,"body":"do we have that population"},{"startTime":3123.81,"endTime":3126.0,"body":"represented in the clinical trial?"},{"startTime":3126.0,"endTime":3127.59,"body":"I've seen this time and time again."},{"startTime":3127.59,"endTime":3129.54,"body":"The clinical trial was done in"},{"startTime":3129.54,"endTime":3131.85,"body":"a different market for example."},{"startTime":3131.85,"endTime":3132.683,"body":"You need to make sure"},{"startTime":3132.683,"endTime":3135.72,"body":"you have that right evidence for the US"},{"startTime":3135.72,"endTime":3138.21,"body":"because US payers do want to see,"},{"startTime":3138.21,"endTime":3140.07,"body":"Does this clinical trial population"},{"startTime":3140.07,"endTime":3141.207,"body":"look like my population?"},{"startTime":3141.207,"endTime":3143.703,"body":"And the US is so heterogeneous."},{"startTime":3144.75,"endTime":3147.69,"body":"We know that things will..."},{"startTime":3147.69,"endTime":3149.73,"body":"You need to really"},{"startTime":3147.69,"endTime":3149.73,"body":"represent that in the US,"},{"startTime":3149.73,"endTime":3151.2,"body":"so you do need to plan early"},{"startTime":3151.2,"endTime":3152.73,"body":"and make sure that that's reflected,"},{"startTime":3152.73,"endTime":3154.95,"body":"especially if it will be"},{"startTime":3154.95,"endTime":3157.47,"body":"50% of your pharmaceutical revenue"},{"startTime":3157.47,"endTime":3159.27,"body":"for that asset, for example."},{"startTime":3159.27,"endTime":3160.89,"body":"You need to make sure that you have that"},{"startTime":3160.89,"endTime":3162.96,"body":"and continue to refine as well."},{"startTime":3162.96,"endTime":3165.81,"body":"Things change, and again"},{"startTime":3162.96,"endTime":3165.81,"body":"this isn't unique to the US,"},{"startTime":3165.81,"endTime":3167.46,"body":"but refine that evidence."},{"startTime":3167.46,"endTime":3169.32,"body":"Make sure that you're not just throwing,"},{"startTime":3169.32,"endTime":3172.41,"body":"continue throwing in additional"},{"startTime":3169.32,"endTime":3172.41,"body":"evidence as it comes about."},{"startTime":3172.41,"endTime":3176.01,"body":"You have real world"},{"startTime":3172.41,"endTime":3176.01,"body":"comparative effectiveness data."},{"startTime":3176.01,"endTime":3178.56,"body":"Maybe you don't need that"},{"startTime":3176.01,"endTime":3178.56,"body":"indirect treatment comparison"},{"startTime":3178.56,"endTime":3180.48,"body":"anymore that you did five years ago."},{"startTime":3180.48,"endTime":3183.54,"body":"Continuing to build upon that, and ratify,"},{"startTime":3183.54,"endTime":3186.57,"body":"and have those open and honest"},{"startTime":3183.54,"endTime":3186.57,"body":"discussions with US payers."},{"startTime":3186.57,"endTime":3188.28,"body":"What do they want? What"},{"startTime":3186.57,"endTime":3188.28,"body":"do they want to see?"},{"startTime":3188.28,"endTime":3189.753,"body":"Is this meeting the needs?"},{"startTime":3190.89,"endTime":3192.45,"body":"Sometimes just going and saying"},{"startTime":3192.45,"endTime":3194.01,"body":"having those advisory boards"},{"startTime":3194.01,"endTime":3198.45,"body":"or just one-to-one"},{"startTime":3194.01,"endTime":3198.45,"body":"discussions in the field with"},{"startTime":3198.45,"endTime":3200.46,"body":"our health economic teams."},{"startTime":3200.46,"endTime":3203.01,"body":"What kind of data do you"},{"startTime":3200.46,"endTime":3203.01,"body":"want to see post-launch?"},{"startTime":3203.01,"endTime":3204.45,"body":"And having those open, and honest,"},{"startTime":3204.45,"endTime":3205.8,"body":"and transparent discussions"},{"startTime":3205.8,"endTime":3207.753,"body":"I think are really important in the US."},{"startTime":3208.92,"endTime":3212.28,"body":"Really acknowledging diverse"},{"startTime":3208.92,"endTime":3212.28,"body":"stakeholder evidence needs."},{"startTime":3212.28,"endTime":3213.87,"body":"Things like CAR Ts for example,"},{"startTime":3213.87,"endTime":3217.44,"body":"And, obviously, this will"},{"startTime":3213.87,"endTime":3217.44,"body":"change as more come to market,"},{"startTime":3217.44,"endTime":3220.77,"body":"but working on this treatment area,"},{"startTime":3220.77,"endTime":3223.23,"body":"we saw that access from payers"},{"startTime":3223.23,"endTime":3226.98,"body":"wasn't really an issue in"},{"startTime":3223.23,"endTime":3226.98,"body":"oncology and haematology."},{"startTime":3226.98,"endTime":3228.87,"body":"At least to start,"},{"startTime":3226.98,"endTime":3228.87,"body":"again, this will change."},{"startTime":3228.87,"endTime":3231.54,"body":"It was more on the administrative side"},{"startTime":3231.54,"endTime":3233.4,"body":"and the hospital side."},{"startTime":3233.4,"endTime":3235.41,"body":"They could only have so"},{"startTime":3233.4,"endTime":3235.41,"body":"many CAR Ts available"},{"startTime":3235.41,"endTime":3238.83,"body":"or there's challenges in"},{"startTime":3235.41,"endTime":3238.83,"body":"the manufacturer process."},{"startTime":3238.83,"endTime":3241.293,"body":"Patients weren't getting"},{"startTime":3238.83,"endTime":3241.293,"body":"access to the treatment."},{"startTime":3242.25,"endTime":3244.2,"body":"Every patient that needed"},{"startTime":3242.25,"endTime":3244.2,"body":"the treatment, obviously,"},{"startTime":3244.2,"endTime":3246.9,"body":"was not getting access to CAR Ts,"},{"startTime":3246.9,"endTime":3250.02,"body":"but that was less so"},{"startTime":3246.9,"endTime":3250.02,"body":"on the payer side here"},{"startTime":3250.02,"endTime":3251.4,"body":"and more so on the hospital."},{"startTime":3251.4,"endTime":3252.72,"body":"So how do you make sure that you have"},{"startTime":3252.72,"endTime":3255.66,"body":"the right systems in place"},{"startTime":3252.72,"endTime":3255.66,"body":"at a health system level"},{"startTime":3255.66,"endTime":3257.22,"body":"and administrative processes"},{"startTime":3257.22,"endTime":3259.44,"body":"and also the manufacturing capability."},{"startTime":3259.44,"endTime":3262.86,"body":"So I think just noting in the US that"},{"startTime":3262.86,"endTime":3265.2,"body":"just because you do have payer access,"},{"startTime":3265.2,"endTime":3268.65,"body":"it doesn't always translate"},{"startTime":3265.2,"endTime":3268.65,"body":"to patient access in the US,"},{"startTime":3268.65,"endTime":3273.18,"body":"whether that's through"},{"startTime":3268.65,"endTime":3273.18,"body":"an uninsured population"},{"startTime":3273.18,"endTime":3275.19,"body":"or administrative challenges."},{"startTime":3275.19,"endTime":3278.1,"body":"And again, a lot of these"},{"startTime":3275.19,"endTime":3278.1,"body":"aren't unique to the US,"},{"startTime":3278.1,"endTime":3281.31,"body":"but just keeping that complexity in mind"},{"startTime":3281.31,"endTime":3282.143,"body":"and not just thinking,"},{"startTime":3282.143,"endTime":3284.46,"body":"\"Oh we've done this before"},{"startTime":3282.143,"endTime":3284.46,"body":"in a different area."},{"startTime":3284.46,"endTime":3286.56,"body":"We can just go forward and"},{"startTime":3284.46,"endTime":3286.56,"body":"use the same approach.\""},{"startTime":3286.56,"endTime":3288.3,"body":"Things change daily in the US"},{"startTime":3288.3,"endTime":3290.75,"body":"and you need to continue"},{"startTime":3288.3,"endTime":3290.75,"body":"to evolve your strategy."},{"startTime":3292.38,"endTime":3293.76,"body":"- Absolutely."},{"startTime":3293.76,"endTime":3295.35,"body":"Okay, and you've alluded a bit"},{"startTime":3295.35,"endTime":3298.59,"body":"to some recent research that"},{"startTime":3295.35,"endTime":3298.59,"body":"you've done in the team."},{"startTime":3298.59,"endTime":3301.23,"body":"I believe you conducted"},{"startTime":3298.59,"endTime":3301.23,"body":"a payer insights survey"},{"startTime":3301.23,"endTime":3303.9,"body":"to understand more about"},{"startTime":3301.23,"endTime":3303.9,"body":"the evidence landscape"},{"startTime":3303.9,"endTime":3306.15,"body":"from US payer's perspective."},{"startTime":3306.15,"endTime":3309.21,"body":"I think the report's due"},{"startTime":3306.15,"endTime":3309.21,"body":"to be published quite soon,"},{"startTime":3309.21,"endTime":3312.75,"body":"but if you could give us"},{"startTime":3309.21,"endTime":3312.75,"body":"a few exclusive insights"},{"startTime":3312.75,"endTime":3313.583,"body":"from the research."},{"startTime":3313.583,"endTime":3314.416,"body":"How did you do it?"},{"startTime":3314.416,"endTime":3317.133,"body":"What were some of the"},{"startTime":3314.416,"endTime":3317.133,"body":"topics that you covered?"},{"startTime":3318.03,"endTime":3319.2,"body":"- Yeah, running up against time,"},{"startTime":3319.2,"endTime":3320.85,"body":"I'll give a one minute overview."},{"startTime":3320.85,"endTime":3322.96,"body":"So we did a 20-payer"},{"startTime":3324.0,"endTime":3326.79,"body":"in-depth interview, sorry, survey,"},{"startTime":3326.79,"endTime":3330.0,"body":"quantitatively, some qualitative insights"},{"startTime":3330.0,"endTime":3332.28,"body":"with PBMs, IDNs, MCOs,"},{"startTime":3332.28,"endTime":3334.38,"body":"with a mix of pharmacy directors,"},{"startTime":3334.38,"endTime":3337.29,"body":"medical directors, industry"},{"startTime":3334.38,"endTime":3337.29,"body":"trade relations, and actuaries"},{"startTime":3337.29,"endTime":3341.1,"body":"using our deep payer network"},{"startTime":3337.29,"endTime":3341.1,"body":"that we have access to."},{"startTime":3341.1,"endTime":3344.64,"body":"Exploring key themes, mainly"},{"startTime":3341.1,"endTime":3344.64,"body":"everything related to evidence."},{"startTime":3344.64,"endTime":3346.56,"body":"What type of evidence"},{"startTime":3344.64,"endTime":3346.56,"body":"do payers want to see?"},{"startTime":3346.56,"endTime":3348.24,"body":"How do they want to be communicated with"},{"startTime":3348.24,"endTime":3349.59,"body":"about that evidence?"},{"startTime":3349.59,"endTime":3352.14,"body":"What are some changing"},{"startTime":3349.59,"endTime":3352.14,"body":"trends and evolutions"},{"startTime":3352.14,"endTime":3353.67,"body":"in the evidence world?"},{"startTime":3353.67,"endTime":3355.14,"body":"Focusing slightly on things,"},{"startTime":3355.14,"endTime":3358.02,"body":"like IRA and ICER and other topics,"},{"startTime":3358.02,"endTime":3361.23,"body":"but really diving into what"},{"startTime":3358.02,"endTime":3361.23,"body":"evidence do they want to see."},{"startTime":3361.23,"endTime":3362.7,"body":"How are their needs changing?"},{"startTime":3362.7,"endTime":3365.97,"body":"And we'll continue to do"},{"startTime":3362.7,"endTime":3365.97,"body":"these over time to evolve."},{"startTime":3365.97,"endTime":3369.69,"body":"As mentioned, they change"},{"startTime":3365.97,"endTime":3369.69,"body":"the trends and needs,"},{"startTime":3369.69,"endTime":3372.21,"body":"and preferences change all the time."},{"startTime":3372.21,"endTime":3373.53,"body":"But the first time we will present,"},{"startTime":3373.53,"endTime":3377.37,"body":"this will be at ISPOR EU in"},{"startTime":3373.53,"endTime":3377.37,"body":"Barcelona in just three weeks."},{"startTime":3377.37,"endTime":3378.27,"body":"So if anyone's there,"},{"startTime":3378.27,"endTime":3381.33,"body":"come by and say hi to Bob"},{"startTime":3378.27,"endTime":3381.33,"body":"or I presenting our posters."},{"startTime":3381.33,"endTime":3383.673,"body":"And if not, we're happy"},{"startTime":3381.33,"endTime":3383.673,"body":"to share those after."},{"startTime":3386.04,"endTime":3387.03,"body":"- Great, thank you."},{"startTime":3387.03,"endTime":3389.64,"body":"We did have some questions"},{"startTime":3387.03,"endTime":3389.64,"body":"from the audience"},{"startTime":3389.64,"endTime":3390.87,"body":"in advance of the webinar,"},{"startTime":3390.87,"endTime":3392.4,"body":"but we are running out of time"},{"startTime":3392.4,"endTime":3394.41,"body":"so I think we've covered on"},{"startTime":3394.41,"endTime":3396.96,"body":"some of the themes that were raised,"},{"startTime":3396.96,"endTime":3398.49,"body":"but we will follow up with anyone"},{"startTime":3398.49,"endTime":3402.87,"body":"that dropped us a question"},{"startTime":3398.49,"endTime":3402.87,"body":"after the webinar."},{"startTime":3402.87,"endTime":3405.18,"body":"Yeah, I'd just like to"},{"startTime":3402.87,"endTime":3405.18,"body":"thank you both, Nicole, Bob,"},{"startTime":3405.18,"endTime":3407.04,"body":"that was a fascinating discussion."},{"startTime":3407.04,"endTime":3409.23,"body":"I think we could've filled another hour,"},{"startTime":3409.23,"endTime":3412.53,"body":"plenty of more things to talk about."},{"startTime":3412.53,"endTime":3415.17,"body":"Thank you to the audience for listening."},{"startTime":3415.17,"endTime":3416.7,"body":"As I said, we will follow up"},{"startTime":3416.7,"endTime":3418.74,"body":"if any of your questions weren't covered."},{"startTime":3418.74,"endTime":3420.84,"body":"And as Nicole said,"},{"startTime":3420.84,"endTime":3422.97,"body":"some of the team will"},{"startTime":3420.84,"endTime":3422.97,"body":"be at ISPOR next month,"},{"startTime":3422.97,"endTime":3425.61,"body":"so please do come and say hi."},{"startTime":3425.61,"endTime":3427.23,"body":"We'd love to meet you there."},{"startTime":3427.23,"endTime":3429.45,"body":"And thank you, have a good evening,"},{"startTime":3429.45,"endTime":3430.53,"body":"and a good rest of your day,"},{"startTime":3430.53,"endTime":3432.48,"body":"and we'll hope to talk to you all soon."},{"startTime":3434.22,"endTime":3435.053,"body":"- Thank you."},{"startTime":3437.07,"endTime":3438.66,"body":"- [Announcer] Thank you for watching."},{"startTime":3438.66,"endTime":3440.01,"body":"If you'd like to find out more"},{"startTime":3440.01,"endTime":3443.04,"body":"about how we could support"},{"startTime":3440.01,"endTime":3443.04,"body":"your market access goals,"},{"startTime":3443.04,"endTime":3447.96,"body":"please email info@mtechaccess.co.uk"},{"startTime":3447.96,"endTime":3452.133,"body":"or visit our website at mtechaccess.co.uk."}]}