Alexandria, Va., April 5, 2019 — The Biologics Price Competition and Innovation Act (BPCIA) of 2009 created an FDA approval pathway for biosimilars that aimed to expanded patient access to these more affordable therapies. But formidable barriers, including concerns about safety and efficacy among prescribers and state laws on substitution and interchangeability, have hindered biosimilar adoption. A new survey conducted by AMCP and PRIME Education assesses various strategies that managed care and specialty pharmacy professionals could adopt to overcome such barriers and boost biosimilar utilization. The results were recently published in AMCP’s Journal of Managed Care and Specialty Pharmacy.
Barriers that were rated 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%
Strategies seen as “extremely likely” or “likely” to have a positive impact on overcoming barriers were:
• 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%
Read the full report, “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”
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