Pricing and Policies for Biosimilars Are Announced
- By BSTQ Staff
The Centers for Medicare and Medicaid Services (CMS) plans to begin paying for biosimilars through its Part B, Part D and state coverage policies by this summer, according to a question-and-answer document released in April. As with standard drugs, coverage determinations will be based on the manufacturer’s wholesale acquisition cost and the average sales price of the biosimilar. Medicare will pay 106 percent of the wholesale cost of the product until the average sales price can be determined, at which time coverage will be set at the average sales price plus 6 percent of the average price for the reference product.
The reimbursement codes for biosimilars, which are different than for their reference products, were expected to be released July 1, with reimbursements applying retroactively to the biosimilar’s U.S. Food and Drug Administration’s approval date — the first of which came in March for Sandoz’s Zarxio (filgrastim-sndz). According to the Biotechnology Industry Organization, the distinct codes are a positive step because they recognize that biosimilars are not inherently identical to their reference products and will ensure CMS reimburses for them properly. More guidelines will be released as necessary. The current policy documents can be accessed at www.fdanews.com/04-03-15-CMSbiosimilars.pdf.
