This article is more than 5 years old. Information may no longer be current.
Physicians support proposed biosimilar naming convention
Click Here to Manage Email Alerts
In agreement with the FDA’s recent draft guidance on nonproprietary naming of biological products, six physician groups collectively sent a letter to CMS Acting Administrator Andrew Slavitt on Tuesday urging CMS to adopt unique billing codes for biosimilars, according to a press release.
The participating organizations included the Alliance for Patient Access, American Association of Clinical Endocrinologists, American College of Rheumatology, Biologics Prescribers Collaborative, Coalition of State Rheumatology Organizations, and North American Society for Pediatric Gastroenterology, Hepatology and Nutrition.
“As physicians who routinely prescribe biologic medicines and on behalf of professional organizations with numerous biologics prescribers as members, we write to urge adoption of unique Healthcare Common Procedure Coding System (HCPCS) billing codes (J-codes) for each biosimilar, unless a biosimilar is deemed by the FDA to be ‘interchangeable’ with the reference biologic,” the letter stated. “We do so based on principles arising from our commitment to patient centered care and a clinically sound prescribing process for biologics, including biosimilars. We believe the Centers for Medicare and Medicaid Services’ (CMS) proposal to assign a single HCPCS billing code and reimbursement rate to all biosimilars of a single reference product seriously jeopardizes these principles.”
According to the letter, this CMS proposal treats biosimilars like generics, which overlooks the “fundamental fact” that they are only similar, not identical, to their reference product. Furthermore, the proposal would be inconsistent with FDA policy, restrict access to a choice of biosimilars by decreasing financial incentive for competition among manufacturers, reduce safety by impairing effective traceability, and weaken the utility of claims-based research data.
“We believe a robust, competitive market based on differentiated benefits, including price, will deliver the promise of biosimilars to our patients,” the letter stated. “For that market to thrive, each biosimilar needs a separate HCPCS billing code, thereby recognizing biosimilars as a new category of medicine.”