The Academy of Managed Care Pharmacy today released its updated Format for Formulary Submissions, Version 4.0, which enables health care decision-makers and biopharmaceutical companies to exchange evidence regarding the safety, efficacy and value of new health technologies to inform formulary decisions. This updated version addresses the evolving health care environment, considerations for comparative effectiveness research (CER), companion diagnostics, and the importance of ongoing communication and evidence exchange throughout a product life-cycle, including pre-approval and as evidence matures. Guidance on logistical matters related to updating dossiers, the challenge of providing pre-approval evidence and ongoing communication between manufacturers and health care decision-makers is provided as well.
The National Pharmaceutical Council (NPC) commends the leadership of the Format Executive Committee for ensuring that considerations related to treatment benefit, value and affordability are carefully evaluated and balanced when making treatment decisions. In addition, the Council is pleased with the recognition and inclusion of NPC research, tools and partnerships such as the role of CER and its appropriate evaluation, the importance of considering how treatments work for both individuals and populations of patients and the assessment of evidence for companion diagnostic tests in the updated version. NPC had submitted comments last year as part of the Format’s revision process.
An article outlining the Format changes was published today in the Journal of Managed Care and Specialty Pharmacy. Additional information about these changes also will be shared on an AMCP webinar on May 4.