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P104: Physician Perspectives on Biosimilar Substitution and Reimbursement Practices





Poster Presenter

      Ralph McKibbin

      • Chairman
      • Alliance for Safe Biologic Medicines
        United States

Objectives

The survey documents attitudes of 401 U.S. prescribers of biologics from 12 specialties on: biosimilar safety/efficacy, prescribing/switching patients, third-party switching for cost/coverage reasons, implications of interchangeability designations and distinct suffixes, and reimbursement practices.

Method

In Sept 2021, a web-based quantitative survey was conducted of 401 practicing U.S. physicians. All prescribe biologics. Participants were drawn in roughly-equal proportion from 12 specialties in which biologics are routinely prescribed and were provided an honorarium for their time.

Results

92% of respondents expressed confidence in the safety and efficacy of biosimilars. 89% would prescribe one to a new (bio-naive) patient, and 80% are comfortable switching a stable patient to a biosimilar. A majority (58%) are uncomfortable with third-party substitution for non-medical reasons; 69% of US physicians surveyed consider it “very important or critical” that patients and physicians decide the most suitable biologic to use- be it the originator or one of the biosimilars to that product. 67% of respondents consider it “very important” or “critical” that they’re able to prevent a substitution they feel is inappropriate. 71% considered it highly important that payers (public and private) should reimburse multiple products in a given class- including originator and biosimilars; 74% considered it highly important that payers consider factors other than cost when determining coverage. 81% favored a European-style access in which biosimilars and originators are both reimbursed, biosimilars may be encouraged for new patients, but automatic/pharmacy-level substitution is not permitted. Only 8% supported a Canadian-style access scenario in which only a preferred, government-chosen product is reimbursed and to which both new and stable patients must be switched. 11% were unsure. 73% of respondents feel that the distinguishing suffix the FDA requires to differentiate biosimilars from their reference products and each other does NOT suggest or imply inferiority, while 13% feel it does, and 15% are unsure. An FDA designation of “interchangeable” (meaning additional data has shown that repeated switching between originator and biosimilar will provide the same result without additional risks relative to unswitched patients) makes 57% of physicians more likely to prescribe the interchangeable biosimilar. It also makes a majority (59%) more comfortable with a pharmacy-level substitution of the interchangeable biosimilar in place of the prescribed originator product.

Conclusion

U.S. physicians are highly comfortable prescribing biosimilars, and with switching patients to a biosimilar themselves. Despite this, a majority maintain that they, with their patients, should have sole control over treatment choices including- especially the decision to switch a patient who is stable on their current biologic. Accordingly, a majority continue to have concerns with third-party-initiated switching for non-medical reasons (e.g. cost, coverage, manufacturer rebates). FDA designation of a biosimilar as "Interchangeable" (i.e. the same result can be expected after repeated switching between the originator/reference product and the biosimilar, without additional risks) shows promise as an effective means of addressing these lingering concerns for most physicians, making a majority of respondents more comfortable prescribing the biosimilar, and a majority more comfortable with a third-party substitution of the biosimilar in place of a prescribed originator product. In addition, strong majorities believed that payers should reimburse multiple biological products in a given class, including the originator along with its biosimilars; and that both private and public payers should consider factors other than cost when determining coverage.