Tumour-agnostic access to nivolumab and ipilimumab will cut costs and expand hope for thousands of Australians.
Thousands of Australians with advanced and metastatic cancers now have affordable access to combination immunotherapy following what the federal government describes as a world-first pan-tumour listing on the Pharmaceutical Benefits Scheme.
Federal health minister Mark Butler said that from now, nivolumab (Opdivo) and ipilimumab (Yervoy) would be subsidised under a single tumour-agnostic PBS listing, allowing prescribing based on clinical judgement rather than tumour type.
The decision marks the first time a cancer immunotherapy has received a pan-tumour PBS listing in Australia, shifting the access paradigm from indication-specific reimbursement to a clinician-determined model for eligible patients with unresectable advanced or metastatic disease.
“For the first time in the world, there will be a PBS reimbursement for this highly effective drug for every single cancer type, provided that the relevant clinician is satisfied that the patient will respond to it,” Mr Butler said at a press conference in Adelaide on Sunday.
“In the almost four years I’ve been health minister, this is one of the most exciting announcements I’ve had the privilege of making.
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“It is going to make a huge difference in giving hope and extended lives to literally thousands and thousands of Australians who are battling advanced cancer.”
The combination of nivolumab, a PD-1 inhibitor, and ipilimumab, a CTLA-4 inhibitor, has been PBS-listed for specific malignancies for several years.
Patients with rarer cancers or tumour subtypes outside existing listings have typically been ineligible for subsidy, however, despite emerging evidence of benefit. In those cases, treatment costs could exceed $100,000 per course.
Eligible patients will now pay a maximum of $25 per script, or $7.70 with a concession card.
The listing follows years of submissions from sponsors, two positive recommendations from the Pharmaceutical Benefits Advisory Committee, and sustained advocacy from patient groups including Rare Cancers Australia. It also removes the “once in a lifetime” rule for patients requiring treatment for more than one cancer type.
Professor Rachel Roberts-Thomson, an oncologist at The Queen Elizabeth Hospital, described the change as a turning point for Australian oncology practice.
“Previously on our PBS we needed to prescribe ipilimumab and nivolumab based on a patient’s cancer type and specifics,” she told the press conference.
“But from today, we are able to prescribe not based on the cancer type that the patient has, but more as a tumour agnostic approach for those who we feel will benefit.
“I can envisage that there will be benefits for patients with advanced melanoma and particularly with the ocular melanoma subtype which is melanoma arising from the eye. I can envisage that there’ll be a group of patients with lung cancer who will benefit from this announcement today and also a subset of patients with advanced colorectal cancer who will benefit and be able to access combination treatment.
“And there’ll be other rarer cancers that patients have that previously wouldn’t have access to immunotherapy that now do.
“It really is a very game changer today and we’re very pleased about this announcement.”
For clinicians, the reform removed a long-standing tension between evidence-informed decision-making and financial toxicity.
“I think with this comes a lot of responsibility because we have this option, we have to prescribe carefully and with our patient’s best interest at heart,” said Professor Roberts-Thomson.
“But it is really gratifying not to have that extra conversation about the cost of treatment, to know that the PBS will be able to cover that cost for our patients because it really does take away a heavy part of those conversations if that’s not the case. It does really make it more streamlined better.
“We can focus on the things that really matter, really trying to help that patient respond to their treatment, using the literature, evidence to then guide our treatment decisions.”
Christine Cockburn, CEO of Rare Cancers Australia, said the decision ended a structural inequity that had disproportionately affected patients with less common cancers.
“What this means in the real world today is that when a clinician would like to prescribe these immunotherapies to the patient sitting in front of them, they can tell them that they have an immunotherapy that will work in their own systems,” she said.
“They don’t have to have the next conversation, which up until today was, “and you’ll have to find tens of thousands of dollars to access it, I’m really sorry.”
“At Rare Cancers Australia, we’ve helped many, many people raise enormous amounts of money to access these medicines. That will no longer be a reality.
“This listing means there is equity and hope for those with rare cancers. And again, we thank and acknowledge all the effort that’s gone into this really world first listing for immunotherapies.”
Ms Cockburn paid tribute to Rare Cancers co-founders Kate and Richard Vines, who started advocating for pan-tumour eight years ago.
“They have used their voice to bring about meaningful change, and this decision is the culmination of years of collaboration and determination,” she said.
“We are encouraged to see long-standing barriers finally begin to shift. This decision proves that meaningful reform is possible when government takes a pragmatic and patient-centred approach and patients, clinicians, industry and policymakers work together to tackle access barriers.
“Our focus remains on ensuring fast and fair access to treatments for every person with a rare cancer, by maintaining this momentum. What we hope for now is a clear path for other medicines to be listed in this way.”
