acting administrator, centers for medicare & medicaid ... reimbursement based on average costs...
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1034 S. Brentwood Blvd., Suite 600 | St. Louis, MO USA 63117 | Tel: 972.861.0503 | Fax: 214.242.3391 | www.psoriasiscouncil.org
September 8, 2015 Mr. Andrew Slavitt Acting Administrator, Centers for Medicare & Medicaid Services Department of Health and Human Services Hubert H. Humphrey Building, Room 445-G 200 Independence Avenue, SW Washington, DC 20201 Dear Acting Administrator Slavitt: The International Psoriasis Council (IPC) Biosimilars Working Group wishes to express our significant concerns regarding the Center for Medicare and Medicaid Services’ (CMS) 2016 Physician Fee Schedule proposed rule. The IPC is a dermatology-led, voluntary, global, nonprofit organization dedicated to innovation across the full spectrum of psoriasis through research, education, and patient care. As key opinion leaders in the field of psoriasis, IPC members endeavor to provide the best safe and effective treatment options for our patients. The proposed rule is potentially harmful to the health and safety of psoriasis patients as well as being detrimental to the development and growth of biosimilars. Under this rule, it is proposed to group all biosimilar products of a reference originator biologic under the same code and to reimburse these biosimilars based on the sale of the average price within a shared code. We do not agree with this proposal for three specific reasons:
1) In this rule, biosimilars are treated as generics (multi source drugs), which is in direct contrast to the biosimilar definition as stated by the FDA http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm241718.htm. Biosimilar products are complex proteins that may differ greatly in efficacy and safety depending on manufacturing practices of the developers. Short-term approval studies may show similar efficacy and safety profiles with originator drugs, however, the long-term efficacy and safety of biosimilars will only be determined post-approval over time. It is a mistake to assume that long-term studies with biosimilars will show no major differences with originator products. Thus, it is scientifically inaccurate to treat all biosimilars to a reference product as a single product, given that they are unique therapeutic entities. Unique products should receive unique codes and associated payments.
2) Reimbursement based on average costs of all biosimilars to the same reference
products will not incentivize manufacturers to create high quality biosimilars for the market. Without competition, there will be fewer available biosimilar treatment options, and costs of biosimilars may not be low enough to improve access to these drugs for psoriasis patients. Indeed, the promise of biosimilars is that they will be safe and effective agents that will increase access for those patients who need them because of lower costs. In other words, the cost scheme as outlined now in the proposal undermines the main reason for developing biosimilars in the first place, i.e., to decrease drug cost and increase drug access.
3) Coding of the biosimilars of a specific reference product under one code complicates the tracking of adverse events for each product. This makes comparative safety studies nearly impossible to perform. It is imperative to have accurate pharmacovigilance practices in place for each biosimilar product on the market to ensure the safety of patients over time.
The IPC Biosimilars Working Group appreciates the opportunity to comment on the CMS proposed rule for biosimilar reimbursement. We urge CMS to consider a full revision of the rule in order to promote safe and effective biosimilar development for the future. For more information please contact: IPC Biosimilars Working Group Chairman Andrew Blauvelt MD, MBA [email protected], phone: 503-‐245-‐1525 IPC Biosimilars Working Group Members: Craig Leonardi MD Sergio Chimenti MD, PhD Lluis Puig MD Murlidhar Rajagopalan MD Ricardo Romiti MD Lone Skov MD, PhD Jay Wu MD Claus Zachariae MD, DMSci Errol Prens MD, PhD Helen Young MB, ChB, PhD, MRCP Ron Vender MD, FRCPC Arnon Cohen MD MPH PhD Joelle van der Walt PhD