Lawmakers urge CMS to reverse its biosimilars policy

INICIO/Políticas y legislación | Posted 26/05/2017 post-comment0 Post your comment

Senator Pat Roberts and Representatives Joe Barton and Anna Eshoo, along with a delegation of 52 House Members and nine Senators, have asked the Centers for Medicare & Medicaid Services (CMS) to reverse its biosimilars policy.

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The CMS, which provides health insurance for the elderly and children in the US, released a proposed rule for the reimbursement of biosimilars in July 2015 [1]. 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 [Healthcare Common Procedure Coding System (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 coding policy ‘presents a major departure from previous CMS policy and unfairly disadvantages non-interchangeable biosimilars’, according to the Generic Pharmaceutical Association (GPhA) and its Biosimilars Council [2]. Concerns have also been raised that the rule would discourage innovation, erect barriers to developing biosimilars and create safety issues due to the inability to differentiate between biosimilars and reference (brand-name) products [1].

In their 5 May 2017 letter, the lawmakers have urged the CMS ‘to reverse the current reimbursement policy and employ a separate billing code and reimbursement rate in order to give each biosimilar its own unique HCPCS code’. They added that ‘a reimbursement structure must appropriately reflect the complexity of these products and the differences between individual biosimilar products’.

In addition, they point to the fact that the Social Security Act ‘states that the calculation for reimbursing biosimilars shall be made separately, such that each biosimilar will have its own unique payment rate and unique HCPCS code’. ‘This language’, according to the group, ‘reflects congressional intent to encourage a vibrant biosimilars market’.

The CMS policy has yet to have an impact on biosimilar reimbursement. There are only two biosimilars currently being marketed in the US [Zarxio (filgrastim-sndz) and Inflectra (infliximab- dyyb)] [3]. Since they reference different originator biologicals they each have their own HCPCS code. Though this is set to change when the second infliximab biosimilar, Renflexis (infliximab-abda), hits the US market.

The Biosimilars Forum has applauded the lawmakers for their leadership. Ms Stacie Phan, President of the Biosimilars Forum, said ‘with the approval of two biosimilars that share the same reference product, it is now more pressing than ever to address this reimbursement issue’. She added that ‘unless action is taken now, this will be a critically missed opportunity to help so many who are facing serious diseases and disorders and who could benefit from biosimilars’. 

Related article
US health insurance CMS outlines biosimilar policy

1. GaBI Online - Generics and Biosimilars Initiative. Concerns raised over CMS biosimilars reimbursement policy []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 May 26]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. GPhA raises concerns over CMS biosimilars reimbursement policy []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 May 26]. Available from:
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 May 26]. Available from:

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Source: Biosimilars Forum

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