Download AMCP`s Format for Formulary Submission

AMCP’s Format for Formulary Submissions
The Academy of Managed Care Pharmacy (AMCP) created the Format for Formulary Submissions to
help all health systems that evaluate medications for use by their patients. The Format is a set of
guidelines, a template that drug companies can use to prepare submissions of new and existing
pharmaceuticals for a health system's Pharmacy and Therapeutics (P&T) Committee. Manufacturers
who follow these guidelines generate a standardized set of clinical and economic evidence, providing
health systems with a broader and more accurate analysis of a drug's impact on a patient population. As
a result, health plans can more confidently answer the question: “Which drugs offer the greatest
opportunity to improve patient heath at reasonable costs, thus providing good value?” Previously, P&T
Committees often received drug information passively from pharmaceutical manufacturers that was
biased and of poor quality. In this era of dramatically increasing drug costs, biotechnology, and
information availability, the Format empowers health systems to pro-actively request specific
information from manufacturers that will allow them to more accurately determine the total value that a
drug brings to their population as the basis for accepting or rejecting a drug for its formulary.
AMCP’s Format does not focus on reducing drug spending; in fact there will be cases where drug
spending will increase. Rather, it urges health systems to formally request that drug companies present a
standardized “dossier” containing detailed information, not only on the drug’s safety and efficacy, but
also on its overall clinical and economic value relative to alternative therapies. Once the value
proposition is understood, then a more logical decision can be made about the use of the drug in
question. There are two important goals for the Format process: 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.
A distinguishing feature of the Format is its use as an unsolicited request from a health system to a
manufacturer for all available clinical and economic information necessary to assess the overall clinical
utility and value that a product brings to a specific patient population and health care system. The
Format prescribes the layout for the information in the “dossier,” recommending that companies include
both published and unpublished studies with both positive and negative results, data on off-label uses,
information on the drug’s place in therapy, related disease management strategies, and an economic
model to provide evidence of the product’s value. The use of the Format thereby improves access to
material that has been difficult to obtain in the past. It also enables manufacturers to submit such data
within regulatory constraints mandated by the Food and Drug Administration. The Format calls for the
parties to engage in substantive discussion so that requests are clearly understood and replies are specific
to the needs of a given health plan’s population.
The Foundation for Managed Care Pharmacy estimates that health systems that cover approximately 150
million Americans have adopted the Format or a similar decision-making process. These include
national and regional managed health care systems, pharmacy benefit management companies, the
Department of Defense, some hospitals systems and state Medicaid agencies.
The Format is now viewed as an industry standard. As such, it is an important part of the ongoing
movement toward evidence-based medicine with the potential to serve as a national, unifying template
for P&T committees to consider clinical and economic information in a systematic and rigorous fashion.
October, 2005