A hemophilia treatment from Roche Holding AG subsidiary Genentech is slated for analysis by a U.S. price advisory group, joining a list of gene therapies and several new biologic drugs that will be assessed for cost-effectiveness in the upcoming year.
Emicizumab, a monoclonal antibody targeting a blood clot inhibitor in hemophilia A patients, is under review by the U.S. Food and Drug Administration, with a decision expected in the first quarter of 2018.
Also known as ACE910, emicizumab has attracted mounting attention for what could be an effective yet highly risky new form of treatment. Safety issues including death have clouded recent trial results. Since then, Roche has openly battled with Shire plc over whether the Dublin-based company's coagulant drug Feiba, used in combination with emicizumab, played a role in the adverse events.
On Roche's recent second-quarter earnings call, Daniel O'Day, CEO of the company's pharmaceuticals unit, said it was too early to discuss pricing the drug.
The Institute for Clinical and Economic Review, the cost advisory group, is inviting public input until Sept. 6 and plans to release a draft scoping document about a week later, with more details on the focus of its study.
The eventual draft report will be the subject of a March 2018 meeting of the New England Comparative Effectiveness Public Advisory Council, a panel of medical experts that will vote on policy and pricing guidelines.
ICER reports have increasingly played a role payers' coverage decisions for newer and high-cost drugs. It also recently partnered with the Department of Veterans Affairs to incorporate analyses in the agency's decision-making for about 5 million patients.