Revised AMCP Format For Formulary Submissions Released

Main Category: Pharmacy / Pharmacist
Article Date: 09 Oct 2009 - 4:00 PDT

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The Academy of Managed Care Pharmacy (AMCP) and Foundation for Managed Care Pharmacy (FMCP) today unveiled Version 3.0 of the AMCP Format for Formulary Submissions. Now in its 10th year, theFormat has become the industry standard by which managed care organizations request information to evaluate new and existing pharmaceuticals in real-world settings.

The Format provides a template for managed care organizations to request pharmaceutical manufacturer-prepared submissions of drug products for consideration by pharmacy and therapeutics (P&T) committees and other decision-making bodies. Manufacturers who follow the Format present clinical and economic evidence on their drugs 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.

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 P&T committees, and (2) to facilitate and streamline the acquisition of data and information and the review process for managed care organizations' pharmacists.

The AMCP Format was last updated in April 2005. The latest version clarifies submission requirements, improves usability and removes redundancies. Other changes in Version 3.0 include:

- Requirements for describing whether the expected outcomes of a drug are a cure, disease management, palliative or relief of symptoms;

- Requirements for describing drug development or post-marketing obligations as required by the federal Food and Drug Administration (FDA), such as patient registries, restricted distribution channels and other elements designed to assure the safe use of the product;

- A new subsection for unpublished data and clinical studies supporting off-label indications; and

- A new section for listing other supporting evidence, such as quality-of-life and economic outcomes, comparative studies of effectiveness and harms, assessments of adherence and studies of patient preference.

"The Format has become an indispensible tool for organizations seeking to make rational, evidence-based formulary decisions," says Judith Cahill, executive director of AMCP. "We expect demand for this latest version to increase in light of the growing focus on comparative effectiveness research and the need to ensure patients are receiving the greatest value in health care."

Managed care organizations use the Format to proactively request information from drug manufacturers when designing pharmacy benefits. "Using the Format, health plans can more confidently answer the question, 'Which drugs offer the greatest value and opportunity to improve patient heath at reasonable costs?'" says Richard Fry, Director of Programs for FMCP, who is responsible for training users in the application of the Format.

A March 2008 FMCP survey of 135 pharmacy directors, medical directors and chief executive officers of managed care plans found that three-fifths of respondents were familiar or extremely familiar with the AMCP Format. 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 submit dossiers based on the Format standards.

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.

For more information, go to http://www.amcp.org or http://www.fmcpnet.org.

Source
Academy of Managed Care Pharmacy (AMCP)
Foundation for Managed Care Pharmacy