The withdrawal reignites debate over whether Australia’s HTA system adequately balances cost with patient need.
Pfizer has withdrawn its application to list abrocitinib on the Pharmaceutical Benefits Scheme, despite the therapy being recommended for subsidy by the Pharmaceutical Benefits Advisory Committee in late 2024.
The company cited “unsustainable” pricing and risk-sharing arrangements as the reason for its decision, highlighting concerns about Australia’s Health Technology Assessment (HTA) framework and its impact on patient access to innovative medicines.
“We understand how important it is for Australian patients living with severe atopic dermatitis to have access to effective treatments. Unfortunately, we must share the disappointing news that Cibinqo [the brand name for abrocitinib] will not be included on the Pharmaceutical Benefits Scheme (PBS).
“While Cibinqo was recommended by the Pharmaceutical Benefits Advisory Committee (PBAC) in November 2024, Pfizer decided not to proceed with the listing based on our assessment that the expected net price level and the current Risk Share Arrangement (RSA) would make the PBS listing unsustainable for the company.”
As reported in Rheumatology Republic’s sister publication Dermatology Republic earlier this year, abrocitinib was recommended for PBS listing for adult patients with chronic severe atopic dermatitis.
The PBAC said there that while abrocitinib 100mg had an inferior clinical benefit to dupilumab, it may have a place for patients who did not respond to other systemic treatments and cannot have the higher dose for safety reasons, and for patients who want to down-titrate to the lowest effective dose.
As for the 50mg dose, the PBAC said the cost-effectiveness would be acceptable if it was listed at the same price per milligram as abrocitinib 100mg.
Staff specialist dermatologist at Sydney’s Liverpool Hospital, Associate Professor John Frew, said at the time that abrocitinib was “a useful addition to the armamentarium of therapies for AD in Australia.”
In a statement to RR this week, Pfizer said that the structure of the current Risk Share Arrangement (RSA), designed to control government expenditure on high-cost medicines, did not reflect a genuine sharing of financial risk.
“Pfizer’s decision is another example of the systemic challenges in Australia’s medicines access environment, where complex pricing and reimbursement processes and conditions can prevent patients from receiving the treatments the need when they need them,” the spokesperson said.
“Australia must urgently create more flexible, patient-focused reimbursement that balances economic considerations with patient needs.
“Pfizer Australia joins industry, patients and healthcare professionals in calling for reform to Australia’s Health Technology Assessment (HTA) to ensure patients can access the latest treatments when they need them.”
The spokesperson said Pfizer believed there was still “significant growth to come in the atopic dermatitis market”.
“We expect usage will exceed the expenditure thresholds set in the remaining years of the RSA, and that the RSA does not reflect a true sharing of risk due to the way it is structured,” they said.
“Overlaying this RSA with the already low net pricing expected for listing, we believe the average selling price for Cibinqo does not reflect the value of innovation and is commercially unsustainable.
“While intended to manage cost-effectiveness and provide government with a means of limiting expenditure, the RSA framework limits access to innovative therapies that are available elsewhere.
“This decision represents a significant setback for consumers, patient advocacy groups and healthcare professionals who continue to emphasise the critical need for more treatment options for those living with severe atopic dermatitis.”
Abrocitinib would have been the third PBS-listed treatment available for patients with severe AD. The spokesperson said the company was “exploring options for private market availability”.
Melbourne dermatologist Professor Rod Sinclair told RR the withdrawal highlighted the ongoing tensions between pharmaceutical companies and the PBS reimbursement system, particularly in areas like dermatology where treatment options remain limited compared to other high-burden chronic conditions.
“The bottom line is that patients are not getting access to the newest innovation treatments,” he said.
“We think we’ve got a first world health service, but if we’re not getting access to these medications, then we’re going to fall behind.
“I think the government’s got to think very carefully about how it funds innovation and how it funds the healthcare system. It’s a problem for government to work at how they can put values and prices on these treatments.”
Professor Sinclair, who is also the editor of Dermatology Republic, said Pfizer’s decision was deeply concerning and could lead to an even bigger problem in accessing new drugs and treatments in Australia.
He said there was a very real risk that pharmaceutical companies would bypass Australia altogether and not even apply for TGA approval to sell it privately, due to the cost. He called on the government to take urgent action.
“You can’t have it both ways. You can’t pretend to be at the forefront of innovation, providing the best, best possible medical care to the patients, and at the same time, squeezing the industry so hard that they don’t make these drugs available in Australia,” Professor Sinclair said.
“It’s what you call the thin edge of the wedge. At the moment we’ve still got access to most of the new drugs. But if this continues, in 10 years’ time, all the innovations that are happening around the world at an exponential pace, if Australia starts to miss out on these, then we’re really going backwards.”
He conceded it was a challenge for the government, but they must find a solution.
“If you think about it like the 5000m sprint; what happens is you stay with the front pack, and then you drop off, and then there’s no way back,” he said.
“This is really where we’re dropping away from the leading pack and we’re going to fall behind. This is the beginning of the end.”
