Academy Releases Version 4.0 of the AMCP Format for Formulary Submissions

Alexandria, Va., May 11, 2016 — The Academy of Managed Care Pharmacy (AMCP) is pleased to announce the release of Version 4.0 of the AMCP Format for Formulary Submissions, which includes new guidance on emerging health care issues, such as biosimilars and comparative effectiveness research.

Since its initial release in 2000, the Format has provided a framework for manufacturers to submit evidence required by health care decision makers (HCDM) in their consideration of products for formulary placement.

Version 4.0 addresses various emerging contemporary issues, including biosimilars, medical devices, comparative effectiveness research and companion diagnostic tests. Version 4.0 also includes new guidance on logistical matters in updating dossiers, as well as the challenge of providing pre-approval evidence, and ongoing communication between manufacturers and HCDMs.

“We are delighted to provide this latest iteration of the Format,” says AMCP CEO Susan A. Cantrell, RPh, CAE. “The Format has long been recognized as the gold-standard for how manufacturers communicate with health care decision makers about the safety, efficacy and value of new health innovations.”

The Format is an indispensable tool for managed care pharmacists, who increasingly are presented with complex considerations related to prescription drug formulary management, says Jeff Lee, PharmD, FCCP, Chair of the Format Executive Committee.

“As prescription drug spending soars, and new effective, but expensive drugs rush to the market, pharmacists and other health care decision makers must evaluate a myriad of important clinical and economic considerations in determining the relative value and, subsequently, the appropriate placement of a product within a formulary,” Lee writes in an article on the Format in the May 2016 issue of the Journal for Managed Care & Specialty Pharmacy.

Version 4.0 has been modified to improve the usability of the Format, and some sections have undergone significant changes based on public comments. Among these, Section 3.0 on “Clinical Evidence,” and Section 5.0 on “Additional Supporting Evidence” now provide more clarity on what type of evidence goes into each section.

For example, Section 3.0 says clinical evidence “should consist of all clinical studies that support the use and value of the product reported in a clear and concise format.” Studies that should be included in this section include: (1) prospective clinical studies that investigate any aspect of the product in patients regardless of study design; and (2) retrospective studies supporting the clinical use and clinical value of the product that are conducted using existing data from chart reviews, medical and pharmacy claims, electronic medical records, or other novel sources of data.

Section 5.0 now says additional supporting evidence “should consist of all other types of evidence and studies that do not fit in Section 3.0 that support the use and value of the product reported in a clear and concise format.” Examples include clinical practice guidelines (CPGs), HTAs and systematic reviews (SRs), compendia, modeling and pharmacoeconomic studies.

As with past versions, Version 4.0 will be utilized by the AMCP eDossier System, which supports health care decision makers by digitizing the clinical and economic evidence standardized under the AMCP Format. As is the case of all dossiers based on the AMCP Format, the Academy does not endorse products described in dossiers nor does AMCP have control over dossier content, which is the responsibility of the manufacturer. Furthermore, AMCP is not responsible for decisions that result from using dossiers.

To access the Version 4.0 of the AMCP Format, visit www.amcp.org/FormatV4/. The JMCP article on the Format may be accessed at www.jmcp.org.