WHAT IS THE REIMBURSEMENT RECOMMENDATION FOR COSENTYX?: It is recommended that Cosentyx be reimbursed by public drug plans for the treatment of adult patients with moderate to severe hidradenitis suppurativa (HS) (acne inversa) who have responded inadequately to conventional systemic HS therapy only if certain conditions are met. WHICH PATIENTS ARE ELIGIBLE FOR COVERAGE? Cosentyx should only be covered to treat patients who have moderate to severe HS (Hurley stage II or III), a total abscess and nodule count of 5 or greater, and lesions in at least 2 separate areas of the body. Additionally, these are patients whose HS did not adequately respond to conventional therapy. WHAT ARE THE CONDITIONS FOR REIMBURSEMENT? Cosentyx should only be reimbursed if prescribed by a physician experienced in the management of HS but should not be reimbursed if used in combination with other biologic therapies for HS. Cosentyx should be reimbursed for ongoing treatment if there is improvement in HS after starting treatment with Cosentyx. The price of Cosentyx should be negotiated so that its total drug cost does not exceed the total drug cost of treatment with the lowest-cost adalimumab. WHY DID CANADA’S DRUG AGENCY MAKE THIS RECOMMENDATION? Evidence from 2 clinical trials showed that treatment with Cosentyx reduced severity and improved symptoms of HS after 16 weeks of treatment compared with placebo. The treatment effect of Cosentyx on HS, compared with adalimumab, after 12 to 16 weeks of treatment was uncertain based on the evidence from 1 indirect treatment comparison. Cosentyx likely meets the unmet needs identified by patients, including a safe and effective treatment that controls HS and manages symptoms of HS. Patients also identified a need for a treatment that works long term, but the evidence for a treatment effect of Cosentyx up to 52 weeks was uncertain. Based on the Canada’s Drug Agency review team’s assessment of the health economic evidence, Cosentyx does not represent good value to the health care system at the public list price. The committee determined there is not enough evidence to justify a greater cost for Cosentyx compared with adalimumab over the duration of treatment. Based on public list prices, Cosentyx is estimated to cost the public drug plans approximately $9,547,349 over the next 3 years. However, the actual budget impact is uncertain.
WHAT IS HIDRADENITIS SUPPURATIVA? HS is a skin condition characterized by abscesses that lead to tissue destruction and scarring on the skin. Key symptoms of HS are pain, itch, malodourous discharge, burning sensations, and local warmth. The estimated prevalence of HS in North America and Europe is approximately 1% of the population. UNMET NEEDS IN HIDRADENITIS SUPPURATIVA: Patients identified the following unmet needs in the treatment of HS: a safe and effective treatment that controls HS through a reduction in lesions, nodules, or draining fistulas; a treatment that works long term; and a treatment that can reduce the severity of symptoms of HS. HOW MUCH DOES COSENTYX COST? Treatment with Cosentyx is expected to cost $50,465 for the first year and $46,052 for the second year onward when administered every 2 weeks. Costs will be different for different administration schedules.