In 2000, the Academy of Managed Care Pharmacy (AMCP), a national professional society of pharmacists in managed care environments, adapted, revised, and then endorsed guidelines called the AMCP Format for Formulary Submission (hereafter, the Format), and began actively encouraging health plans nationwide to implement them. 5 This growing reliance on formularies, combined with the increase in the availability and acceptance of cost-effectiveness analyses, led to the issuance of new guidelines that called for a standardized process and format for the submission of clinical and economic evidence to support consideration of formulary listing in private health plans. 4 With rapid increases in drug spending in the 1990s, public and private health plans as well as pharmacy benefit management (PBM) companies began to use formularies more aggressively in an attempt to contain costs. Although formulary committees have used clinical and pharma-coeconomic data to aid their decision-making processes for some time, the information was used informally, and great variation existed across plans. 1-3 The movement toward formulary guidelines has evolved over the past decade. The trend reflects 2 broader movements in healthcare, one toward evidence-based medicine and the other toward explicit consideration of cost-effectiveness or "value for money" arguments. In recent years, health plan officials have worked to standardize and improve the processes by which they decide whether and how to list new drugs for formularies, with the goal of grounding decisions in stronger clinical and economic evidence. Formalize a process for providing feedback to pharmaceutical companies on dossier quality and transparency.Train formulary committee members regarding the potential value of the Academy of Managed Care Pharmacy guidelines (the Format).Be vigilant and cautious when reviewing clinical and economic evidence in dossiers, especially with lower-cost and “me-too†drugs.However, concerns persist about the quality of the clinical data and the economic analyses in dossiers therefore, plans should: About half of dossiers included economic analyses, but these analyses had relatively low levels of compliance with recommended practices.ĭossiers being submitted under AMCP Format provide an opportunity for health plans to evaluate a drug’s clinical and economic evidence. Dossiers often included clinical data to support off-label indications, but concerns persist about their quality. Economic analyses of high-cost products and innovative products had higher compliance with recommended practices.Ĭonclusions: Drug companies are submitting dossiers of evidence to formulary committees. The economic analyses had low levels of compliance with standards: only 43% performed sensitivity analysis 38% stated the study perspective 37% discussed relevant treatment alternatives 20% stated assumptions clearly and 18% mentioned caveats to conclusions. Of 115 dossiers submitted between 20, 53 (46%) included economic analyses. Results: Evidence to support off-label indications often was included in 2003 dossiers, but the information was less extensive and of poorer quality than data for labeled indications. We compared economic analyses for high-cost (30-day treatment cost > $1000) versus low-cost products, and for "innovative" versus "me-too" drugs. Methods: Dossiers were audited with a data collection form to judge the types of clinical studies used to support labeled and off-label indications, and the quality and transparency of economic analyses. For dossiers submitted in 2003, we examined the clinical studies included. Study Design: We reviewed the quality of economic analyses in dossiers submitted to Premera Blue Cross Health Plan (Mountlake Terrace, Washington enrollment 1.6 million) between January 2002 and September 2005. Objective: To investigate the quality and complete-ness of clinical and economic data in dossiers submitted by drug companies to a health plan using Academy of Managed Care Pharmacy guidelines (the Format) for formulary submissions.
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