A leading dermatologist has hailed a win for patients after the PBAC backed a lifting of the PBS funding cap for severe atopic eczema medicines.
It follows an extensive campaign by dermatology groups to expand the cap, known as a risk sharing arrangement (RSA), which currently includes dupilumab and upadacitinib.
In a speech at the ACD’s annual scientific meeting in May, Professor George Varigos stressed such deeds were common elements in the Australian Government’s PBS funding deals for high cost medicines with drug companies, which agree to cover those costs once the pass an agreed ceiling after listing.
But while the subsidisation caps generally had an important role in averting cost blowouts, the RSA in place for severe atopic eczema was leading to unintended consequences, Professor George Varigos told the meeting.
Originally agreed with Sanofi prior to the listing of dupilumab (Dupixent) in 2021, he said upadacitinib was later included under same deal prior to its listing in 2022.
As a result, the RSA was now disincentivising other companies with treatments for the condition because the ceiling – meant to cover five years – was already in danger of being reached, said Professor Varigos, the head of dermatology at Royal Melbourne Hospital.
“Any other medicine that comes in for that disease … will be under the same cap,” he said.
“So any other pharma coming in now will say my chances of getting subsidised is very low, I’m going to be giving out the drug for free.”
The upshot was in Australia there were three therapies approved for AD, but only two listed on the PBS, compared to six in the USA and Europe, said Professor Varigos, who said he had no financial relationships with any relevant pharmaceutical companies.
Given the demand, he noted Sanofi had applied to the PBAC to raise the cap, but had been knocked back last year.
But at its July meeting, the PBAC acceded to a second application to expand the available funding to account for patients with severe AD of the hands and/or face.
“In providing this advice, the PBAC noted that such use was not accounted for in the original RSA caps,” it said in an outcome statement released last month (link here).
“However, given the apparent quality of life impacts of disease affecting the hands and/or face appear similar to that for the whole body, [we] considered that use in these patients is likely to be cost-effective.”
On the other hand, it rejected a submission to further expand funding based on an increased proportion of patients inadequately controlled on topical corticosteroids, saying it had been provided insufficient evidence to support such a move.
Professor Varigos welcomed the announcement but warned it was limited and therefore unlikely to result in a surge of new PBS listings for the condition.
“It is a start, but not enough for the many patients and likely to limit the newer options,” he told the limbic.
“The RSA has a purpose but it should not interfere with prescribing decisions.”
Meanwhile, the PBAC supported funding a biosimilar of adalimumab for indications including severe chronic plaque psoriasis and moderate to severe hidradenitis suppurativa.
Branded Ardaclip (Cipla), the medicine would be available in in the form of 40 mg in 0.4 mL pre-filled syringe (PFS) and pre-filled pen (PFP) and 80 mg in 0.8 mL PFS as biosimilar brands of Humira.
It also recommended the listing of relatlimab and nivolumab under the Section 100 highly specialised drugs program for melanoma.