SOURCE: AMCP

June 30, 2005 15:33 ET

Revised AMCP Format for Formulary Submissions Released

ALEXANDRIA, VA -- (MARKET WIRE) -- June 30, 2005 -- The Academy of Managed Care Pharmacy (AMCP) has released an updated version of the AMCP Format for Formulary Submissions. Less than five years after its introduction, the Format is in use by managed care organizations that provide pharmacy coverage for more than 150 million Americans.

Version 2.1 includes a foreword by Peter J. Neumann, ScD, Associate Professor of Policy and Decision Sciences at Harvard's School of Public Health, in which he explains how the Format levels the playing field between drug manufacturers and health systems. Neumann also includes a discussion of the progress he thinks health care systems and the pharmaceutical industry need to make to ensure the Format's continuing success.

"Due to the widespread use of the Format by health plans, PBMs and the pharmaceutical industry, we intentionally avoided making any significant changes to the dossier evidentiary requirements," said Richard Fry, director of Programs for the Foundation for Managed Care Pharmacy (FMCP), the Academy's sister organization, responsible for training users in the proper application of the Format. "We think that V2.1 is better organized, and we have provided users with some much needed clarification on several issues, such as confidentiality, customization of dossiers, dossier updates and the need for pharmacoeconomic models versus budget impact models."

Aside from the basic restructuring of the document, V2.1 contains the results of discussions with the FDA and customization of economic models and barriers to adoption of the Format. The new version also recommends that manufacturers complete their dossier before product launch to avoid delays in responding to unsolicited requests from health systems, along with a list of information needed to complete the dossier and a reminder that manufacturers may not solicit health systems to request updated dossiers.

A new section, "Evidence for Pharmacogenomic Tests and Drugs," reminds clinicians and health care system decision makers to ensure the accuracy with which a test identifies a patient's genetic status, clinical status and risks and benefits of the test. The requirement to include all relevant positive and negative findings for published and unpublished studies on labeled and off-label use, safety, efficacy and effectiveness trials is emphasized. This section also states that if the manufacturers' products are registered in a public trials registry, access to this information must be provided and all relevant published and unpublished clinical and outcomes studies must be summarized.

Judith Cahill, executive director of AMCP, said, "The Academy and the Foundation are committed to maintaining the relevance of the Format and to providing a useful tool for rational, evidence-based formulary decision making. We welcome user comments at any time."

Version 2.1 of the AMCP Format may be downloaded from the AMCP website at www.amcp.org or the FMCP website at www.fmcpnet.org. The June 2005 edition of the Journal of Managed Care Pharmacy included Version 2.1 as a supplement to the publication.

The Academy of Managed Care Pharmacy's mission is to empower its members to serve society by using sound medication management principles and strategies to achieve positive patient outcomes. AMCP has more than 4,800 members nationally who provide comprehensive coverage and services to the more than 200 million Americans served by managed care. More news and information about AMCP can be obtained on their website, at www.amcp.org.

Contact Information