Patients with severe atopic dermatitis may get access to dupilumab within months following a recommendation for PBS listing by the Pharmaceutical Benefits Advisory Committee (PBAC) .
At its March meeting the PBAC recommended the listing of dupilumab for the treatment of patients aged 12 years and older with severe atopic dermatitis who are inadequately controlled on topical therapies.
The PBAC said it acknowledged there was a “significant reduction in the extent of disease and improved patient quality of life with dupilumab over standard of care in a therapeutic area of high clinical need.”
Two previous applications to have the drug subsidised were rejected in part due to concerns about measures of disease assessment.
In last year’s application for PBS subsidy, the PBAC was told that dupilumab was expected to be an option for about 500 patients a year patients with severe AD who had not responded adequately to topical therapies, phototherapy or cyclosporin A.
The Committee was told by a clinician that patients treated with dupilumab describe treatment success as life changing as they have been able to return to normal life.
“The clinician stated that most children with atopic dermatitis improve in their teenage years; however, if the disease continues into their late teens and 20s, then they are likely to have atopic dermatitis for life.
The application for a listing, made by manufacturer Sanofi-aventis was supported by groups including ASCIA, who said that: “at the present time, if patients with atopic dermatitis fail to achieve a good response to topical management when compliance and adherence are adequate, the only option is to consider various immunosuppressive treatments, which have a weak evidence base, considerable possible side effects, long term effects and need frequent monitoring, including blood tests. An alternative to this situation is needed.”
Dupilumab was approved for registration by the TGA on 24 January 2018 for ‘the treatment moderate to severe atopic dermatitis in adult patients who are candidates for chronic systemic therapy’. The TGA-recommended dose is two consecutive initial 300 mg doses followed by 300 mg given every other week.