There’s been a win and a loss for dermatology patients in outcomes from the July PBAC meeting which were made public last week.
The Committee recommended Authority Required PBS listing of risankizumab – an anti-IL23A antibody biologic – for patients with severe chronic plaque psoriasis.
However it has, for the second time, rejected dupilumab – an IIL-4Rα blocker antibody – for adults with moderate-to-severe atopic dermatitis who are inadequately controlled on topical therapies.
As reported from the Australasian College of Dermatology ASM earlier this year, a small number of patients using dupilumab under a compassionate access program have benefitted enormously from the biologic.
The PBAC acknowledged the effectiveness of dupilumab in a therapeutic area of high clinical need, however considered that dupilumab was not cost-effective at the price proposed in the resubmission.
It said the estimated financial implications were “very high and uncertain” and that a Risk Sharing Arrangement would be necessary to manage the uncertainty in patient estimates, likely treatment duration and the potential for use outside the proposed restriction.
“The PBAC also considered that the criteria for defining the patient population for initial and continuing treatment did not appropriately consider the extent of disease in terms of the body surface area affected.”
College president Dr David Francis said that, as with psoriasis, the biologics look to be a family of drugs with promise in severe atopic dermatitis.
“Some patients have had a good response and the questions is where do they go from here?”
“The College will have a look at the basis for the decision and possibly make further representation down the track if the scientific evidence is supportive of that.”
He added it can be very complicated to prove cost-effectiveness.