In July 2015 the CMS, which provides health insurance for the elderly and children in the US, released a proposed rule for the reimbursement of biosimilars [1]. However, despite various groups raising concerns about the proposal the policy was finalized in 2015 and took effect on 1 January 2016 [2].

The rule (CMS-1631-P) assigns a single code (HCPCS) to all biosimilars of a particular reference product and reimburses them based on the weighted average of their average sales price under Medicare Part B. However, concerns have been raised that this could ‘unfairly disadvantages non-interchangeable biosimilars’ [2], as well as discourage innovation, erect barriers to developing biosimilars and create safety issues due to the inability to differentiate between biosimilars and reference (brand-name) products [3].

The latest comments on the biosimilars policy come after the CMS issued a request for comments on the proposed revision of its payment policies in the Federal Register publication of 21 July 2017.

The six groups include the Alliance for Patient Access, American Association of Clinical Endocrinologists, American College of Rheumatology, American Gastroenterological Association, Biologics Prescribers Collaborative (BPC) and the Coalition of State Rheumatology Organizations.

The groups’ comments urge the CMS to consider the following points:

• Biosimilars are not generics and CMS should not treat them as generics
• A single J-Code policy does not properly recognize interchangeability
• Grouping biosimilars of the same reference product into one J-Code creates barriers for physicians
• Blended reimbursement may encourage inappropriate non-medical switching
• Single J-Codes may reduce investment in the biosimilars market and limit therapeutic choices

For these reasons they believe that ‘unless a biosimilar is deemed by the US Food and Drug Administration to be “interchangeable” with the reference biologic, each biosimilar should have a unique J-code’.

Related articles
Lawmakers urge CMS to reverse its biosimilars policy

US health insurance CMS outlines biosimilar policy

References
1. GaBI Online - Generics and Biosimilars Initiative. Concerns raised over CMS biosimilars reimbursement policy [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 10]. Available from: www.gabionline.net/Policies-Legislation/Concerns-raised-over-CMS-biosimilars-reimbursement-policy
2. GaBI Online - Generics and Biosimilars Initiative. GPhA raises concerns over CMS biosimilars reimbursement policy [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 10]. Available from: www.gabionline.net/Policies-Legislation/GPhA-raises-concerns-over-CMS-biosimilars-reimbursement-policy
3. GaBI Online - Generics and Biosimilars Initiative. Lawmakers urge CMS to reverse its biosimilars policy [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 10]. Available from: www.gabionline.net/Policies-Legislation/Lawmakers-urge-CMS-to-reverse-its-biosimilars-policy 

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2017 Pro Pharma Communications International. All Rights Reserved.