Managed Care and Specialty Pharmacy Stakeholders Weigh in on Strategies to Address Biosimilar Barriers

It has been well documented that prescribers have concerns about biosimilars, and that these concerns play a role in the sluggish uptake of biosimilars in the United States. However, managed care and specialty pharmacy professionals also play a crucial role in the nascent US biosimilars landscape, and results of a recent survey, published this week, sought to better understand perceptions of how barriers to biosimilars can be overcome.

The 28-item survey, conducted among the Academy of Managed Care Pharmacy (AMCP) membership and customer base, was sent to approximately 10,000 individuals, and the sample comprises the first 300 responses.

The respondents worked for managed care organizations or health plans (38%), for pharmacy benefit managers (22%), or in specialty pharmacy (40%). Their roles included pharmacy director, medical director, clinical pharmacist, formulary manager, pharmacy and therapeutics committee member, account manager, administrator, and others.

In terms of attitudes toward the safety and efficacy of biosimilars 84% of all respondents agreed that switching to a biosimilar is safe and effective for patients whose conditions are treated by reference products, but only 54% agreed with the extrapolation of indications.

Respondents were asked to rate how difficult it will be to overcome 6 hurdles to biosimilars. The below percentages of respondents rated the following barriers as either “extremely difficult” or “difficult” to overcome:

• Concerns about biosimilar safety and efficacy among prescribers: 61%
• Pricing and contracting issues: 57%
• State laws and regulations for substitution and interchangeability: 53%
• Concerns about biosimilar safety and efficacy among patients 49%
• Formulary management issues: 35%
• Concerns about biosimilar safety and efficacy among payers: 23%

With respect to approaches to overcoming barriers to biosimilars, the proportion of respondents who rated the following strategies as “extremely likely” or “likely” to have a positive impact on overcoming barriers to adoption were as follows:

• Prescriber education on switching studies: 91%
• Clear FDA guidance on substitution: 90%
• Formulary policies for treatment-naïve patients: 87%
• Prescriber education on real-world studies: 86%
• Expanded Medicare and Medicaid policies: 84%
• Reduced cost-sharing for patients: 80%

Strategies that were rated as “extremely likely” or “likely” to have a positive impact by the fewest respondents included the following:

• Required drug monitoring for patients who switch: 39%
• Incentivizing providers by quotas: 40%
• Prescriber education on billing, coding, and reimbursement: 57%

Respondents suggested a number of strategies for overcoming barriers, with 40% saying that biosimilar manufacturers must take action through such means as contracting to overcome reference products’ substantial rebates, launching at more aggressive discounts, and conducting randomized controlled studies comparing their biosimilars to current standards. Additionally, 26% said that the government must act, and suggested that the FDA and CMS have roles to play in making biosimilars available and profitable. Fifteen percent said that managed care should act, and suggested that incentivizing providers to use biosimilars, ensuring favorable formulary placement, and creating incentives to overcome lost rebates would be effective. Finally, 10% called on medical education providers to play a role, saying that patient education would be an effective means to overcome barriers.

“The findings indicate respondents’ largely positive views on the viability of numerous and diverse strategies,” conclude the authors, adding that the “first steps to applying the findings may involve discussions and deliberations about which strategies are best aligned with an organization’s goals and capabilities.”

Reference

Greene L, Singh RM, Carden MJ, Pardo CO, Lichtenstein GR. Strategies for overcoming barriers to adopting biosimilars and achieving goals of the Biologics Price Competition and Innovation Act: a survey of managed care and specialty pharmacy professionals [published online April 22, 2019]. J Manag Care Spec Pharm. doi: 10.18553/jmcp.2019.18412.