Academy Releases Revised AMCP Format for Formulary Submissions

Alexandria, Va., January 25, 2013 — The Academy today released Version 3.1 of the AMCP Format for Formulary Submissions. Version 3.1 adds important new guidelines regarding the development and use of AMCP Format-based dossiers for specialty pharmaceuticals and companion diagnostic tests and the place of comparative effectiveness research within the context of the FormatChanges are limited to the inclusion of three new addenda that are intended to:  

  • Clarify the use of Comparative Effectiveness Research within the context of the Format;
  • Clarify evidence requirements for and use of the Format when considering Specialty Pharmaceuticals; and
  • Clarify evidence requirements for and use of the Format when considering Companion Diagnostic Tests

Now in its 13th year, the Format has become the industry standard by which managed care organizations request information to evaluate new and existing pharmaceuticals for formulary placement, coverage and reimbursement decisions.

“The Format has become an indispensible tool for organizations seeking to make rational, evidence-based formulary decisions,” says AMCP Chief Executive Office Edith A. Rosato, RPh, IOM. “We expect demand for this latest version to increase in light of the growing focus in these three areas and the need to ensure patients are receiving the greatest value in health care.”

Since the release of Version 3.0 in September 2009, AMCP has received numerous inquiries regarding the development and use of AMCP Format-based dossiers for specialty pharmaceuticals and companion diagnostic tests and the place of comparative effectiveness research within the context of the Format

In order to maintain the Format as a “living document” that continues to track with the current trends in technology assessment for coverage and reimbursement, the AMCP Format Executive Committee, with the approval of the AMCP Board of Directors, made the decision to provide further guidance in the aforementioned three areas. 

“Using the Format, health care decision makers can more confidently answer the question, ‘Which drugs offer the greatest value and opportunity to improve patient heath at reasonable costs?’” says Pete Penna, PharmD, Chair of the AMCP Format Executive Committee.

About the Format 

Managed care organizations and other health care systems use the Format to proactively request information from manufacturers when evaluating pharmaceuticals and other related health care technologies and designing pharmacy benefits.

Current users of the Format include numerous national and regional health insurers, pharmacy benefit managers, the Department of Defense, hospital systems and state Medicaid agencies. Most drug firms prepare product dossiers based on the Format guidelines.

Two important goals for the Format process are (1) to improve the quality, timeliness, scope and relevance of the data and information made available for pharmacy and therapeutics (P&T) committees and medical technology assessment committees, and (2) to facilitate and streamline the acquisition of data and information and the review process for managed care organizations’ pharmacists.

The Format provides a template for health care systems to request manufacturer-prepared submissions of drug products and other health technologies for consideration by P&T committees, Medical Technology Review committees, and other coverage and reimbursement decision-makers.

The evidence requirements contained in the AMCP Format are intended for use by manufacturers of pharmaceuticals, biologics, vaccines, and companion diagnostic tests who are responding to an unsolicited request from a health care system to support reimbursement and/or formulary placement consideration of a new product, new indication, or new formulation of an existing product. Manufacturers who follow the Format present clinical and economic evidence on their products via standardized dossiers.

The Format allows clinical staff in health care systems to formally evaluate the completeness of submissions received and to easily add results of the health system’s own literature reviews and analysis. Thus P&T committees and other decision making bodies are able to compare the effects of formulary alternatives on clinical outcomes, value and economic consequences for the entire health system. 

The Academy does not endorse products described in dossiers, nor does AMCP have control over dossier content. Dossier content is the responsibility of the manufacturer, and the Academy is not responsible for any decision that would result from using the information included in a dossier. 

The AMCP Format for Formulary Submissions Version 3.1 is available here. For more information, visit http://www.amcp.org/practice-resources/amcp-format-formulary-submisions/.