AMCP Partnership Forum: Biosimilars--Ready, Set, Launch

• Published in: Journal of managed care & specialty pharmacy Vol. 22; no. 4; pp. 434 - 440
• Format: Journal Article
• Language: English
• Published: United States Academy of Managed Care Pharmacy 01.04.2016
• Subjects: Biosimilar Pharmaceuticals; Cooperative Behavior; Drug Approval; Drug Industry - organization & administration; Humans; Managed Care Programs - organization & administration; Patents as Topic; Pharmaceutical Services - organization & administration; Proceedings; United States; United States Food and Drug Administration
• ISSN: 2376-0540; 2376-1032
• DOI: 10.18553/jmcp.2016.22.4.434

Through 2020, reference biologic products will lose patent protection that will be worth $54 billion to the U.S. economy. Consequently, interest in biosimilars is intensifying across the health care industry. Managed care organizations (MCOs) are depending on the savings opportunity that bio-similars promise. After the first FDA approval of a biosimilar in March 2015, the Academy of Managed Care Pharmacy (AMCP) convened a biosimilar Partnership Forum on June 10-11, 2015. The goal of this forum was to address current readiness of MCOs to optimize biosimilars; identify gaps, challenges, and opportunities with regard to biosimilars; and recommend education and training content to help AMCP best meet the needs of its members and stakeholders. The forum brought together multiple stakeholders from MCOs, pharmacy benefit managers, specialty pharmacies, integrated delivery networks, federal government and standards setting organizations, consumer advocacy groups, and the pharmaceutical industry. Through a series of 4 one-hour webinars and a 1.5-day live workgroup session, participants identified current challenges and readiness issues in addressing biosimilars. These challenges included lack of a consolidated educational strategy for incorporating biosimilars into the clinical decision-making process; deficiencies in current levels of federal (e.g., the FDA) or state (e.g., departments of insurance) guidance; limited intelligence on pricing strategies and consideration of stakeholder contracting alignment and risk sharing; and operational implementation issues. Participants identified necessary tactics for executing a successful bio-similar strategy. These tactics included creating a broad multiple stakeholder coalition to support educational efforts to gain public, provider, and other stakeholder acceptance; aligning utilization incentives through reimbursement policies and programs; encouraging benefit design and stakeholder collaboration; advancing the coding and technology infrastructure to support operations, contracting, billing, reimbursement, and reporting needs; and having appropriate active surveillance mechanisms to enable assessment of the clinical performance of biosimilars and their innovator products. Participants recommended guidance for AMCP to optimally support its membership and stakeholders with educational and training programs at multiple venues; a platform for regular communications and updates; and advocacy, community promotion, and education. The AMCP Partnership Forum entitled "Biosimilars-Ready, Set, Launch" and the development of this report were supported by Abbvie, Amgen, Apotex, Boehringer, Merck, Momenta, and Sandoz.