Medicines Australia says the gap between the number of medicines available to Australian patients and those accessible in other countries is widening.
Restrictive approval processes and falling government funding have kept 18 innovative medicines off the PBS, Medicines Australia says, urging greater investment in new therapies and sweeping reform of the health technology assessment process.
The pharmaceutical industry lobby group has argued in a new report that medicines policy and funding are leading to a growing number of “missing medicines” that are inaccessible in Australia but available in other high-income countries.
“Australia is funding a smaller and declining share of new medicines, compared to other nations and to complicate matters, even when medicines are eventually subsidised it is after considerable time, or the approval is laden with restrictions and provisions.”
Last month, Medicines Australia released a report arguing that productivity gains should play a larger role in decisions about whether treatments are funded through the PBS.
The new report named 18 “innovative therapies” – newer medicines that are an advancement over existing treatments – that were approved in comparable countries but not available in Australia.
The report said the PBS listing of medicines to treat diseases including cancer, schizophrenia, hypertension, Crohn’s disease, ulcerative colitis, haemophilia B, dermatitis and meningococcal B has been delayed due to falling investment in the PBS and approval processes.
The 18 drugs include:
- polatuzumab vedotin for diffuse large B-cell lymphoma
- trastuzumab for gastric cancer
- Lu-PSMA-617 radiopharmaceutical for prostate cancer
- xanomeline/trospium chloride for schizophrenia
- rimegepant and erenumab for migraine
- sotatercept for pulmonary arterial hypertension
- lebrikuzumab and abrocitinib for atopic dermatitis
- risankizumab and guselkumab for Crohn’s disease
- mirikizumab for ulcerative colitis
- marstacimab for haemophilia B
“At the core is a lack of investment in innovative medicines in the PBS, compounded by structural problems within Australia’s health technology assessment (HTA) and funding system, which increasingly shape global launch decisions,” the report said.
Around 25% of medicines that have been launched internationally in the past 10 years have been reimbursed in Australia, compared to 88% in the US and 46% in the UK, the report said.
“Even where medicines are funded, access is often restricted, only a minority are reimbursed for their full intended patient population for which the medicine has been found effective and safe.”
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The report said Australia has moved from being “a global leader in funding new medicines to being a laggard”.
That was due to three reasons, it said: HTA processes are slow or uncertain, delaying funding decisions; HTA evaluation frameworks do not fully capture the value of modern therapies; and budget constraints and cost-containment mechanisms affect price.
“There is clear and growing evidence that Australia is becoming a lower priority market for the launch of new medicines,” the report said.
“In a recent survey, 84% of Medicines Australia member companies indicated that Australia has deteriorated, or is expected to deteriorate, in their global launch sequence.
“A key reason is that it takes longer in Australia to secure funding for medicines that have already been assessed as safe and effective by the Australian regulator, the TGA, than in comparable countries.”
The report called for greater net investment in F1 (innovative) medicines in the PBS and implementation of the 2024 HTA review, which found that “Australia’s HTA system is outdated, overly complex, and contributes to delays in patient access”.
Medicines Australia CEO Elizabeth de Somer said: “the real number of missing medicines is likely to be much, much higher”.
“But these 18 medicines should be all the proof anyone needs that health standards in Australia are slipping and that is due to one thing – chronic underinvestment in the PBS,” she said.
“Only one in four medicines launched globally in the past decade has made it onto the PBS.
“That statistic alone should be a wake-up call, but this report shows what it actually means for patients and their doctors.
“This is not a hypothetical anymore. It is a bitter pill to swallow for patients with schizophrenia, prostate cancer, Crohn’s disease and rare conditions who are missing out on treatments already helping people elsewhere.
“I think if the public knew just how many innovative medicines are now bypassing Australia because of an outdated process, they would be justifiably alarmed.
“The time for Government to see higher spending on innovative medicines as a cost and not as a long-term investment must finish.”
Ms de Somer said there had been a decade of decline in funding for innovative medicines in the PBS, and the health technology assessment system was “slow, rigid and complex, adding further delay”.
“The 2024 HTA Review set out a clear roadmap to fix this, with more than 50 recommendations, but implementation has stalled and needs to be prioritised.”
Medicines Australia said a 2026 survey by the McKell Institute found that 43% of Australians have been prescribed a medicine that was not on the PBS, and 29% have paid for a prescription medicine not listed on the PBS in the past three years.