The PBS Update March 2026: Landmark Ipi–Nivo Listing + Toripalimab and Cabozantinib

Australia’s PBS has introduced it’s first pan-tumour reimbursement listing for the immunotherapy combination nivolumab plus ipilimumab. In this inaugural episode of PBS Update, Professor Craig Underhill and Rachael Babin break down the key oncology changes from the March 2026 PBS update, including new listings for toripalimab and cabozantinib.

Follow PBS Update for regular discussions on PBS listings and oncology policy changes affecting Australian healthcare professionals.

Visit the Show Notes for links to the PBS updates discussed in this episode and to send us audio feedback or questions for future episodes.

Transcript

Welcome And Series Purpose

SPEAKER_01 0:00

Hello and welcome to PBS Updates, a new short series from the Oncology podcast where we break down the latest changes to Australia's pharmaceutical benefits scheme and what they mean for oncology practice. This is Rachel Bavin from the Oncology Network, and I'm joined by Professor Craig Underhill. In this series, we take a quick look at the recent oncology and hematology updates, what's changed, which patients may benefit, and what clinicians should know. For more detail and ongoing coverage of cancer medicines, you can also visit oncolynetwork.com.au. So if you want a fast practical overview of the latest PBS developments, you're in the right place. Let's get into it.

SPEAKER_00 0:45

G'day, g'day, g'day, and welcome to our new series, PBS Update. It's a Kiwi-free zone because we're going to be talking about the Australian PBS. And it's a delight to have Rachel Babin here. How are you, Rachel?

SPEAKER_01 1:02

I'm very well. Hello, Greg. It's uh nice to be your uh sidekick on the mic for a change rather than behind the mic.

SPEAKER_00 1:10

Yes. Don't be nervous. I'll be gentle.

SPEAKER_01 1:15

Why thank you?

SPEAKER_00 1:16

Yeah, so why this series? Do you think this is filling a need for people?

Why Short-Form PBS Updates

SPEAKER_01 1:21

It is something that we have had a lot of feedback on over the years when we've done our journal podcast episodes. And the BBS updates have always been quite a small section in those much longer episodes. And so we thought it would be really helpful just to roll this content into a short form format, make it really accessible for the listeners, so that everyone, no matter where you are in Australia, can stay up to date with the latest updates. Now we've just had the March update a few days ago. Um, but we're also gonna highlight a couple of things from the last December update as well.

SPEAKER_00 2:01

Fantastic. Yeah, we've got, of course, the big news from March 2026, the first uh tumour agnostic indication for epilumimab and navoli mab. And we then we'll also mention a couple of other new drugs that have gone onto the PBS in the last few months.

SPEAKER_01 2:21

So, yeah, great. Our first uh pan tumour listing. This is exciting. So can you tell us what's the details?

March Headlines And Context

First Tumour-Agnostic Listing Details

SPEAKER_00 2:28

Yeah, my understanding is in the US they've had these pan tumor listings, uh tumor agnostic listings for some time. This is the first one, I think, in Australia, for Navolumab and Epulumab. So it'll enable pretty broad access for treatment of advanced metastatic cancers that are deemed to be immunoresponsive. It's a real paradigm shift. It will open up access to these drugs, in particular to rare cancers, which won't have to go through the costly process of an additional listing on the PBS, but it does actually put some responsibility back to clinicians, patients, and the system to I guess to use this process wisely where there is evidence. And it's going to be really interesting to see the uptake of the drugs going forward. But we'll talk about that a bit more. So this is basically going to replace a whole lot of other listings, including for unresectable stage three or four malignant melanoma, likely advanced or metastatic non-smell lung cancer, stage four clear cell variant, renal cell cancer, recurrent or metastatic squamous cell carcinoma of the of the head and neck, unresectable stage four malignant melanoma, stage four non-small cell lung cancer, advanced or metastatic gastrosophageal cancer, and unresectable metastatic urethelial carcinoma. So that was the listings for these drugs in the past. It's now going to be all replaced by one code, which means some clinicians are annoyed they had to reduce prescriptions for the drugs. But I guess that's a small price to pay for this opening up of access uh to other indications. That we really fast track the use of these drugs as studies are published. We won't have to then go through a year or two's lag to see the drug being used.

SPEAKER_01 4:23

And if we're talking about advanced and metastatic disease, there's uh patients that that time really is of their essence. And the Minister for Health and Aging, Mark Butler, did a big press conference and indicated that they think 5,000 patients will benefit. It's very rare to have a listing that is for rare cancers that can immediately uh impact so many people.

Impact On Access And Rare Cancers

SPEAKER_00 4:49

Yeah, that's right. So rare cancers, each one is rare, right? Uh but altogether, rare cancers make up a substantial proportion of the tumour burden tumour landscape. And so uh as is is expected, some 5,000 patients will benefit. And the real benefit is going to be in those rare cancers. We've talked on the Oncology Journal Club podcast about the most series of papers that's been run in multiple sites in Australia, including regional sites, treating patients with IP NEVO in some rare cancers like biliary cancer, rare gyne cancers, and we've seen that benefit. And so the difficulty is that though it may take years or never to get those individual cancers listed. So the problem's now solved. There was an interesting newsletter from COSA strongly supporting this, as of other groups like the private cancer physicians of Australia and the Medical Oncology Group of Australia. They sort of paused though and gave some guidance and said, you know, there really does still need to be rational use of these drugs in line with the evidence base as it accumulates. There maybe needs to be some tools to support decision making when uncertainty is high. And there needs to be adequate monitoring data collection for acute chronic and late toxicities of the drugs in real-world settings to facilitate risk stratification, clinical and treatment decision making, so that people can actually have robust discussions with their patients and deciding whether to use these drugs. So a colleague in Vendigo's, um, Sam Harris, big shout out to Sam, told me recently that they were planning that to kind of recommend, not mandate, but recommend within their own service that if any of the clinicians were thinking about using this indication, the patient should be discussed at an MDT so that they discuss the evidence. And our regional trials network uh is considering whether we should build uh a database, uh a registry, and so that our sites could enter information on tumour type response or not, duration of response and any unusual toxicities. So again, we can collect that real-world evidence and help build the evidence base for the use of these drugs.

SPEAKER_01 7:07

So it's um cautious optimism, perhaps, or as you said, uh responsible use. Yeah, it's an interesting development.

SPEAKER_00 7:17

Yeah, very much.

SPEAKER_01 7:18

Do you think it's gonna happen more?

Toripalimab for nasopharyngeal carcinoma

SPEAKER_00 7:19

Well, yeah, I think Rachel, maybe this is a test case. Maybe if the PBAC, PBS, and government is happy with how it goes if it suddenly not prescribed to 50,000 strains rather than 5,000. You know, maybe they'll be happy and there'll be other tumor agnostic indications for other therapies as well. So it's really putting the onus back on clinicians to discuss the risk-benefit with their patient and use these drugs in a rational way.

SPEAKER_01 7:48

But is that empowering as a clinician that you have a bit more freedom rather than just boxes that you tick and say, right, this is the next treatment line?

Replacing Multiple Indications With One Code

SPEAKER_00 7:59

Yeah, absolutely. Um it's interesting of note the indications for locally advanced metastatic tumours and they've maintained the listing for these drugs in the neo-adjuvant setting in melanoma. And there may still be been listings in other neoadjuvant or adjuvant settings. So it is empowering, I think. One of the real problems is we, you know, we go to a conference, we see a landmark study, clear benefit to patients presented and discussed. And then there can be a year or two or more delay in getting the drug listed, and we're sitting across the desk from patients who could benefit from that drug. So empowerment is a good word. Empowerment with responsibility as well, as a group, as an industry, to use these drugs wisely. They're not without life-changing consequences if patients have um serious side effects.

SPEAKER_01 8:54

And so do you think this will have an impact internationally? Do you think other countries will be looking at us and being Well, yeah.

SPEAKER_00 9:01

That's a good question. The Australian drug reimbursement system is seen internationally as probably one of the most robust one of the benchmarks. So it's it is possible that other countries will look at that and consider the same approach.

Cabozantinib for neuroendocrine tumours

SPEAKER_01 9:19

Fantastic. And so what else is important for the listeners to know about, Greg? Anything from December?

Responsible Use And Real-World Data

SPEAKER_00 9:25

So there's been a couple of other interesting drugs listed recently. I'm gonna state this wrong, I'm sure, but people can mock me later. Teripollomab for recurrent or metastatic nasopharyngia or carcinoma. So this is based on a study called the Jupiter 2 study, and that was a study of adding tripolomab PD1 inhibitor to standard chemotherapy phase three study done in China, Taiwan, and Singapore. Um and this drug got a listing in the US. The study showed a progression-free survival difference of 21 months versus eight months, which was the primary input in the study, but median survival with a follow-up of 36 months, so significant improvement as well. It was not reached in the trip MAB group and 33 months in the placebo group, but the hazard ratio was 0.63, it was highly significant. This drug has immune-related adverse events as we'd expect from a PDL1 inhibitor, with immune-related adverse events seen in 54% patients, grade three or higher 9.6 of that's people admitted to hospital in about 10% of patients. So it comes back to that previous discussion about epinevo, which is a higher rate of grade three. These are not insubstantial drugs to give. But nevertheless, a clear benefit. So this is a relatively rare cancer in the Australian population, much higher prevalence in Southeast Asia and China. And so again, this is uh first time that we've seen this drug listed in Australia.

SPEAKER_01 11:06

Also of note was the December listing of Cabozantinib. What's your thoughts on that?

Epcoritamab update in DLBCL

SPEAKER_00 11:11

It's got a listing previously been used in recurrent cleasyl carcinoma and other renal cancers, but now it has a listing in pancreatic and extra pancreatic neurendocontumers, and that was based on again a single study, a phase three study in two cohorts of patients, one with progressive extra pancreatic neuroncontumer and another cohort of pancreatic neurendocontumers. These patients all have had to have failed radionucleide treatment and targeted therapy or both. But again, this drug was active. The primary in point was progression-free survival. The difference was 13.8 months versus four months. And the data as published, the overall survival data was immature, but on the basis of this study called Cabernet, that's Cabernet C-A-B-I-N-E-T, not Cabernet the wine, but Cabernet as in the cabinet. This drug's listed now in Australia for this rare neuron consumers.

SPEAKER_01 12:10

Fantastic. So we go from a large group of patients affected in the March update to small groups. Exactly. Yeah.

MDTs, Registries, And Monitoring

SPEAKER_00 12:20

And this is one of the dangers now with the Ipinevo listing. Will that kind of study like cabinet get done, or will people just start throwing Ipinevo at their patients who progress standard therapy? So I think again, we still need to support people accessing clinical trials and putting people on on clinical trials as a first manoeuvre rather than IpineVo now just default in everybody.

SPEAKER_01 12:44

Yeah, that's an interesting point how the clinical trials landscape might be impacted over the coming years. This is a nuanced situation.

Compassionate access schemes

SPEAKER_00 12:53

Yeah, that's right. Then the last one I wanted to mention was Epcorritomab, which is a bi-specific antibody now approved in Australia for refractory or relapsed diffuselage B cell lymphoma. That is a drug I haven't had personal experience in using, but I think it's probably the first bi-specific antibody that's been approved in Australia. If anyone knows otherwise, please message us on our WAPSAT group. You can go onto the Journal Club tab on the Oncology Network website, click on the web WhatsApp icon and send us a comment or a voice note about this issue or anything else we've mentioned today, be interested in people's feedback. So this drug attaches to the CD20 antigens on the lymphoma cells and the CD3 antigens on the T cells, bringing them together, and then the T cell releases cytokines that can directly attack the lymphoma. So that's the biological kind of rationale. And so, yeah, this drug is now approved for these refractory uh patients.

SPEAKER_01 13:59

Well, fantastic, and thank you for including a hematology update as well. We know we have hematology listeners, and indeed, as you yourself did, clinicians that are working across particular regional rural areas, medical oncology and hematology. So thanks for including that one. And thank you also for mentioning about the new voice notes WhatsApp system we've set up. So please tell us if it's helpful. Uh give us your feedback. Tell us if there's something else that you think we should be mentioning. We always love to hear from our listeners.

Will More Agnostic Listings Follow

SPEAKER_00 14:33

Yeah, and I'm just wondering, industry people might want to message us about any compassionate access schemes, which are quite hard sometimes for people to know about and keep up with. And so if you have a compassionate access scheme opening, let us know and we'll mention it on the podcast as well.

SPEAKER_01 14:50

Absolutely. So we do have a whole industry spotlight section on the website. So that's on Colegynetwork.com.au. If you go to Industry Spotlight, you'll see there all the cancer drugs news updates. We have coverage on some of the things that we've talked about as well. So a bit more in-depth information if people would like to learn more. So yeah, get in touch and let us know what you think. We hope it's helpful.

SPEAKER_00 15:16

Thank you, Rachel. I think it is important though, just to remember our disclaimer for this segment.

SPEAKER_01 15:21

Absolutely. Please go ahead, Craig.

SPEAKER_00 15:23

Please don't take what we say at face value. Please do your own research, do your own due diligent checked drug indication, be across the efficacy and toxicity data. Discuss it with your patients before embarking on prescribing any of these bloody difficult to say drugs.

SPEAKER_01 15:37

Perfect. Thank you, Craig.

SPEAKER_00 15:40

See you next time.

Neoadjuvant Exceptions And Clinician Empowerment

SPEAKER_01 15:41

See you next time for the next PBS update. Thank you. That's all for this episode of PBS Updates. For more information on the listings we discussed and for ongoing coverage of cancer medicines, visit oncologynetwork.com.au where you'll find news, analysis, and resources for oncology professionals. If you're working in industry and have details of compassionate access schemes or upcoming PBS changes you'd like us to share with the oncology community, feel free to get in touch. And don't forget to check out the Oncology Journal Club podcast if you'd like to hear more analysis and pearls of wisdom from Professor Craig Underhill. This podcast is proudly produced by the Oncology Network. Thanks for listening.