Using the best evidence possible to make informed health care decisions is a hallmark of managed care pharmacy. But making sense of the data often is no easy task, especially when it comes to analyzing pharmaceuticals and the value they bring to patients and the health care system.
Reams and reams of studies are produced on individual drug products, often creating a monumental task for health care decision makers to wade through all of the evidence. Besides the time involved, they must sift through multiple conclusions―often derived through varying methodologies―to discern how a new medicine stacks up with existing products.
AMCP has long been a champion of making this process easier. Since 2000, the AMCP Format for Formulary Submissions has provided a framework for manufacturers to submit evidence required by health care decision makers (HCDM) in their consideration of products for formulary placement. Today, the AMCP Format is widely recognized as the gold-standard for how manufacturers communicate with health care decision makers about safety, efficacy and value.
That is why I am so delighted to announce the recent release of Version 4.0 of the AMCP Format. This latest iteration addresses such emerging issues as 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 decision makers.
As Jeff Lee, PharmD, FCCP, Chair of the Format Executive Committee, aptly notes: the Format is an indispensable tool for managed care pharmacy professionals, who increasingly are presented with complex considerations related to prescription drug formulary management.
Getting it right is especially important in the face of spiking drug spending and the flood of expensive specialty pharmaceuticals coming to market.
To access the Version 4.0 of the AMCP Format, visit www.amcp.org/FormatV4/.
Author’s Note: As with past versions, Version 4.0 will be utilized by the AMCP eDossier System, which supports HCDM 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.
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