The PDE-4 inhibitor apremilast (Otezla) is now available on the PBS for the treatment of severe chronic plaque psoriasis in patients who have failed treatment with or who are contraindicated or intolerant to methotrexate.
The listing, which comes into effect from 1 January will allow more 5000 people to gain access to the treatment which would otherwise cost $7500 a year, according to the Minister for Health
The drug has been approved by the TGA since 2015 for the treatment of plaque psoriasis and active psoriatic arthritis, but it has taken six application to the PBAC to gain a listing on the PBS.
In its sixth review the PBAC acknowledged submission from clinicians who highlighted the long-term durability of patient responses to apremilast treatment and the overall low rates of adverse events after the initial titration period.
The committee said there was a clinical need for an alternative therapy for psoriasis and reaffirmed its 2017 advice that “apremilast would provide some patients with a safer, longer term treatment option compared to cyclosporin, which has limitations of its therapeutic use in psoriasis to no more than two years.”
The listing was welcomed by Associate Professor Peter Foley, Director of Research at the Skin Health Institute, said the availability of new treatment would give dermatologists greater flexibility to tailor treatment to the needs of individual patients.
However drugs for eczema have had their bids for PBS listings rejected or delayed by the PBAC application process.
At its November meeting the PBAC did not recommend listing of crisaborole for the treatment of mild to moderate atopic dermatitis in patients aged 2 years and older.
The PBAC also provided further advice in relation the conditions applying to its March 2020 recommendation to list dupilumab for the treatment of patients with chronic severe atopic dermatitis who have had an inadequate response to topical therapies. The committee responding to a revised proposal from sponsor Sanofi on costs and usage estimates, which must be settled before the drug is listed on the PBS.