US biosimilars reimbursement rule could discourage patient access, says GPhA

The Biosimilars Council, a division of the US Generic Pharmaceutical Association (GPhA), says it is disappointed today by the Centers for Medicare & Medicaid Services’ (CMS) decision to group all biosimilars together under one payment calculation and billing code in Medicare Part B, while using a different code for the reference product.

“It is unfortunate that CMS chose to ignore the strong reservations expressed by experts from all corners of the supply chain, leading biosimilar manufacturers and others urging the agency to provide non-interchangeable biosimilars with their own independent billing codes and payment calculations. This final rule is likely to discourage investment in biosimilar therapies, making it harder for patients to access these new products in the United States,” said Chip Davis, president and chief executive of the GPhA.

“There is no scientific evidence that suggests it would be appropriate to blend all biosimilar products into a single payment calculation, independent of the reference product," said Bert Liang, CEO of Pfenex and chairman of the Biosimilars Council. “While we appreciate CMS’ recognition that it would be premature to issue a rule regarding reimbursement for future interchangeable biosimilars, placing all non-interchangeable products in a single code independent of the reference product is still misguided. Non-interchangeable products are solely compared to the reference product, and not one another, making this arrangement highly unusual.”