In November, the Centers for Medicare and Medicaid Services (CMS) announced a Proposed Rule that would permit Medicare Part D plan sponsors to substitute non-interchangeable biosimilars in place of the biologic medicines now used to treat many chronic conditions such as rheumatoid arthritis, Crohn’s disease and cancer. Read ASBM’s statement on the announcement here. 

CMS accepted public comments on the Proposed Rule until January 5, 2024. ASBM was among the organizations which submitted comments. ASBM’s comments read, in part:

Automatic substitution of biosimilars is highly controversial among physicians and is banned in many countries, including most of Europe. Proposing to change this standard in the U.S. not only undermines FDA regulatory guidance and the intent of the legislation passed by Congress and the entirety of our state legislatures, but also betrays the assurances given to patients, physicians, and other organizations who have supported the protections offered by biosimilar substitution laws nationwide.

Beginning in 2013, all 50 states and Puerto Rico enacted legislation that allows for pharmacy-level, automatic substitution only for biosimilars given interchangeable status based on additional data provided to the FDA that demonstrates safe switching. Importantly, this legislation provided that all other biosimilars (i.e., those without an interchangeable status) would not be substituted at the pharmacy level without physician involvement or approval. State legislatures were able to gain support for permitting biosimilar substitution from medical societies and patient advocacy organizations nationwide, due to these assurances.

While all FDA-approved biosimilars are safe and effective, the FDA’s concept of interchangeability ensures that switching decisions also account for the unique treatment needs of individual patients. Treatment plans are not one-size-fits-all. Chronic illnesses such as arthritis, Crohn’s disease, psoriasis, and various forms of cancer often require treatment plans tailored over years of trial and error with different products before a patient’s disease or condition is stabilized. Any change to a patient’s medication, including the automatic substitution of a biosimilar for the originator biologic without physician involvement, can pose a significant risk to patient stability.
The FDA’s interchangeability standard, with its extra data requirements, has proven successful in promoting physician and patient confidence in these medicines. A 2021 survey of US physicians representing 12 therapeutic areas revealed that 57% of them would be more likely to prescribe an interchangeable biosimilar, and 59% reported that an interchangeable designation makes them more comfortable with a pharmacy-level substitution of that biosimilar in place of the prescribed originator medicine.

The dramatic change in policy proposed by CMS comes less than a year after a CMS Rule[v] permitting Part D plan sponsors to substitute interchangeable biosimilars explicitly reassured the public it would not permit substitution of non-interchangeable biosimilars because they “have not met the requirements to support a demonstration of interchangeability.” Nothing has changed regarding non-interchangeable biosimilars since last year’s CMS Rule. Non-interchangeable biosimilars still haven’t met the FDA data requirements for interchangeability and still shouldn’t be substituted by a third party without physician approval.

In summary, Section 8. Additional Changes to an Approved Formulary—Substituting Biosimilar Biological Products of the Proposed Rule stands in stark contrast to the opinions of the medical community, the wishes of patients, a decade of substitution policymaking across 50 states, the substitution policies of most advanced nations, and CMS’ own recent assurances. We respectfully urge CMS to reconsider and withdraw this rule.

Read ASBM’s full comments on the proposed policy here.

Read ASBM’s statement on the announcement of the proposed policy here.