Payers in the US are getting ready for the advent of biosimilars, according to a report published by biotech giant Amgen.
The Amgen survey of 40 different payers found the following about payer readiness for biosimilars:
- Based on market research, most payers are taking action to plan for biosimilars, including evaluations of alternative payment models and restructuring of historical drug tiers
- Guided by the momentum related to the commercialization of biosimilars, market research shows that many payers are meeting with external partners to discuss biosimilars
- According to market research, a primary consideration for coverage is managing the possible allowance of switching and interchangeability, yet questions remain on how this may be implemented and managed with patient safety in mind
Payers are taking varying levels of action to plan for biosimilars, these include meeting with external partners and even restructuring benefit design. One example of this is the July 2015 Centers for Medicare & Medicaid Services (CMS) biosimilars reimbursement policy. The proposed rule (CMS-1631-P) would assign a single code [Healthcare Common Procedure Coding System (HCPCS)] to all biosimilars of a particular reference product and would reimburse them based on the weighted average of their average sales price under Medicare Part B [1]. The use of such ‘bundled payment’ approaches, in which lump sum amounts are provided to cover a given episode of care, would provide incentives to choose less-costly agents and reward savings by providers. This may support greater uptake by providers or patients who otherwise may be hesitant to replace known therapies with new biosimilar alternatives.
The designation of interchangeability (or not) by the US Food and Drug Administration is likely to be an influential factor on the expected uptake of biosimilars in the US. In addition, state laws on substitution that demand communication and record keeping for any biosimilar substitution, and that also allow prescribers to prevent substitution at his/her discretion could also affect uptake of biosimilars [2]. To date, 16 US states have passed legislation requiring prescriber communication and record keeping for biosimilars [2-5].
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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 2016 Apr 22]. Available from: www.gabionline.net/Policies-Legislation/Concerns-raised-over-CMS-biosimilars-reimbursement-policy
2. Derbyshire M. Update on US state legislation on biosimilars substitution. Generics and Biosimilars Initiative Journal (GaBI Journal). 2015;4(2):95-7. doi:10.5639/gabij.2015.0402.020
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars substitution bill become law in Texas [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Apr 22]. Available from: www.gabionline.net/Policies-Legislation/Biosimilars-substitution-bill-become-law-in-Texas
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars substitution bill become law in California [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Apr 22]. Available from: www.gabionline.net/Policies-Legislation/Biosimilars-substitution-bill-becomes-law-in-California
5. GaBI Online - Generics and Biosimilars Initiative. New Jersey passes biosimilars substitution bill [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Apr 22]. Available from: www.gabionline.net/Policies-Legislation/New-Jersey-passes-biosimilars-substitution-bill
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