Lack of Comparator Data Derails Otezla Coverage Bid in Germany

June 1, 2015

Germany’s healthcare cost watchdog has recommended against paying for Celgene’s Otezla, citing a lack of evidence that the psoriasis drug offers added benefit over available therapies.

The Institute for Quality and Efficiency in Health Care based its decision on a lack of convincing clinical data comparing Otezla (apremilast) with alternatives for patients with moderate to severe chronic plaque psoriasis or active psoriatic arthritis. While the company described data from placebo-controlled studies, it didn’t use them for indirect comparisons, IQWiG says.

Failure to conduct a systematic search for studies with comparators makes it unclear whether an indirect comparison would have been possible and whether it would show an added benefit, the institute adds.

The annual treatment cost for Otezla is already lower than for appropriate comparator treatments, such as AbbVie’s Humira (adalimumab) and Janssen’s Remicade (infliximab), says Celgene spokeswoman Cathy Cantone. As such, the cost to Germany of treating the target population would decrease if reimbursement was approved, she said.

IQWiG’s recommendation now goes to the Federal Joint Committee for a comment period and final decision. Cantone says the company will continue to work with the institute to attain coverage.

Last year, Otezla received FDA approval for an extended indication covering treatment-experienced and treatment-naïve patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy are appropriate. The European Commission approved the drug in January.

Failure to win coverage in Europe’s largest market could slow growth of the blockbuster drug. Otezla, which also has Canadian authorization, brought in revenues of $69.8 million in the fiscal year ended March 31, according to Celgene’s 2014 annual report. The company previously predicted that sales could reach $1.7 billion to $2 billion in 2017. — Jonathon Shacat