Comment on CMS-1676-P Medicare Program: Revisions to Payment Policies Under Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program – Section D: Payment for Biosimilar Biological Products under Section 1847A of the Act
September 11, 2017
Seema Verma, Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Hubert H. Humphrey Building, Room 445-G
200 Independence Avenue, SW
Washington, D.C. 20201
Dear Administrator Verma:
As physicians who routinely prescribe biologic medicines and on behalf of professional organizations with numerous biologics prescribers as members, we appreciate the opportunity to provide additional perspective on Healthcare Common Procedure Coding System (HCPCS) billing codes (J-codes) for biosimilar medicines.
We hold that unless a biosimilar is deemed by the FDA to be “interchangeable” with the reference biologic, each biosimilar should have a unique J-code, for the following reasons:
- Biosimilars are not generic drugs and CMS should not treat them as generics.
Biosimilars can only be similar to their reference product, not identical like a small-molecule generic drug. Biosimilars, like all biologics, are large molecules grown in living systems. Assigning one reimbursement code for all biosimilars of the same reference product follows the generics reimbursement policy and ignores the fundamental science.
- A single J-code policy does not properly recognize interchangeability.
One reimbursement rate makes no provision for the approval of interchangeable biosimilars. In fact, such a policy seems to treat all biosimilars for a given reference product as interchangeable. Determinations of interchangeability must be made by FDA and based solely on scientific and medical considerations. Interchangeability requires a higher level of evidence than biosimilarity.
- Grouping biosimilars of the same reference product into one J-Code creates barriers for physicians.
For any given innovative biologic, physicians will have many different biosimilars from which to choose and will seek to prescribe the right biosimilar for patients based on clinical appropriateness. Having multiple treatment options allows physicians the ability to provide individualized care. For example, there are currently two biosimilars – Inflectra and Renflexis – for the branded biologic Remicade and potentially five more in development. If the biosimilar’s list price is greater than the blended ASP, physicians could experience reimbursement losses and as such there will be instances where prescribers face financial barriers to choosing the most appropriate biosimilar medicine.
- Blended reimbursement may encourage inappropriate non-medical switching.
Despite important differences between biosimilar medicines, hospitals and payers could mandate use of the lowest cost biosimilar at any given time, reducing choice and potentially encouraging inappropriate non-medical switching back and forth between one biologic/biosimilar and another. Non-medical switching can only be justified if the FDA has determined interchangeability between the biosimilar and the reference biologic.
- Single J-Codes may reduce investment in the biosimilars market and limit therapeutic choices.
Currently, CMS prioritizes price over all other product features, which could deter innovation and may discourage manufacturers from investing in research to gain approval for all indications. Access to a choice of biosimilars is important for our patients, especially where an individual patient’s immune reaction may differ between drugs.
Price differentiation reflects that while “highly similar,” different biosimilars of the same reference product may still have important product differences, such as:
- Holding licensures for a different number of indications based on manufacturers’ data submissions;
- Having different levels of immunogenicity for different patients and their individual reactions;
- Utilizing different forms or presentations (e.g., strengths or delivery device or container closure systems) for delivery; or
- Offering different patient support programs suitable for different patients.
Manufacturers must be properly incentivized to develop innovative biosimilar products or the market will fail to prosper, which could lead to fewer treatment options and undermine the promise and purpose of the entire class of biosimilar products.
In closing, BPC believes in the promise of a biosimilars market that will yield important benefits for patients who suffer from chronic, life threatening illnesses. Biologics have revolutionized the treatment of many different cancers, autoimmune diseases and blood disorders. Biosimilars will create greater access and more therapeutic options for these patients.
We urge CMS to rethink its payment policy for biosimilars and not take a generic approach for medicines that are, by definition, not generic. BPC supports CMS’ intent to create competition in the market, but believes that different reimbursement levels for different biosimilars will go further to promote competition, create a robust market, and protect patient safety. Thank you for your consideration of the prescribers’ perspective as you make these important payment determinations.
Alliance for Patient Access
American Association of Clinical Endocrinologists
American College of Rheumatology
American Gastroenterological Association
Biologics Prescribers Collaborative
Coalition of State Rheumatology Organizations