A newly announced US Centers for Medicare and Medicaid Services (CMS) rule that gathers together all biosimilars of a single reference product under just one code has been widely criticized by drugmakers. Drugmakers warn that the rule on Medicare physician payment would reduce incentives for developing biosimilars, reduce patient access and create safety issues due to the inability to differentiate between biosimilars and reference products.
CMS previously stated that it would consider comments on the proposed rule (CMS-1631-P) before releasing its final rule [1]. However, the CMS issued final rules on 31 October 2015. This latest announcement comes in spite of doubts raised by several organizations including the Generic Pharmaceutical Association (GPhA) and Biotechnology Industry Organization (BIO).
Mr Michael Reilly, Executive Director of the Alliance for Safe Biologic Medicines (ASBM), told Bloomberg’s Health Care Blog that the CMS ‘has mistakenly treated biosimilars like generics and ignored the fact that biosimilars may, for medical reasons, be approved for a subset of indications, routes of administration, etc.’
Reimbursing all biosimilars at the same rate would penalize doctors for making choices that are in the best interests of patients, says Mr Reilly.
The 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, alarms the Biosimilars Council, a division of GPhA.
‘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,’ said Mr Chip Davis, President and CEO of GPhA. ‘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.’
Dr Bert Liang, CEO of biosimilars company Pfenex and Chairman of the Biosimilars Council, adds that there is no scientific evidence in support of blending all biosimilars into a single payment calculation, independent of the reference product.
‘While we appreciate CMS’ recognition that it would be premature to issue a rule regarding reimbursement for future interchangeable biosimilars,’ says Dr Liang, ‘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.’
Editor’s comment
Medicare is a national social insurance programme, administered by the US Federal Government since 1966. It provides health insurance for Americans aged 65 and older who have worked and paid into the system, as well as to younger people with disabilities.
Medicare Part B generally covers drugs and biologicals that are not usually self-administered, including those that are administered in a physician’s office or hospital outpatient department.
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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Concerns raised over CMS biosimilars reimbursement policy [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Dec 4]. Available from: www.gabionline.net/Reports/Authorized-generics-reduce-drug-prices
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