![]() ![]() 27% when <4 months P <0.05) and when requested from a large manufacturer (top 25 in sales) compared with smaller manufacturers (75% vs. Food and Drug Administration (FDA) approval and dossier request was >/- 4 months (65% vs. Dossiers were more likely to be received when the time between U.S. Unlocked interactive budget impact models were included in 5 dossiers (20%), and modeling reports (without an unlocked interactive model) were included in 12 dossiers (48%). Of the 25 dossiers, 21 (84%) generally followed the AMCP Format. We received dossiers for 25 products (58%), other drug information (e.g., journal reprints, product labeling) for 10 products (23%), a formulary kit for 4 products (9%), and no response for the remaining 4 products (9%). A logistic regression model was developed to determine if dossier receipt increased the likelihood of second-tier copayment formulary placement for new product reviews.ĭossiers were requested for 43 products. A retrospective evaluation of the materials received from the manufacturers was performed. drug information center about 8 weeks before the committee meeting. A university-based clinical evaluation subcontractor requested dossiers in the AMCP Format by telephone and e-mail from the manufacturers. The pharmacy and therapeutics (P&T) committee of a mid-Atlantic health plan with approximately 3 million members reviewed 43 drug products from February 2004 through December 2005. response to a request for a product dossier prepared using the AMCP Format, and to determine if dossier receipt was associated with a favorable formulary placement. To perform an evaluation of pharmaceutical manufacturers. While dossier quality has reportedly improved over time, there is no recent research examining the response rate to dossier requests and the quality of dossiers received. Many health plans request a dossier (a standardized set of clinical and economic evidence prepared by pharmaceutical manufacturers) to provide information for consideration during the formulary decision-making process. She is an invaluable resource for our clients and team members, and OPEN Health is lucky to have the benefit of her leadership,” says Dipen Patel, vice president and executive director of OPEN Health Evidence & Access.The Academy of Managed Care Pharmacy (AMCP) Format for Formulary Submissions, a template for health plans to use in developing formulary submission guidelines, has been widely adopted since its initial release in 2000. “Beth’s reappointment to the AMCP committee is a testament to her expertise in this area. Her term on the committee will extend to the AMCP annual meeting in 2025. The next update will be the first since the AMCP issued guidelines for unapproved product dossiers, approved product dossiers, and unapproved use dossiers. The last update to the format was in December 2019 that was version 4.1, Lesher says. ![]() Although AMCP formatting is not required in submissions, it is considered the standard. Serving as a member on the format committee, she says, allows her to apply that experience to updating and improving the AMCP format guidance document.įormally called the Format for Formulary Submissions Guidance on Submission of Pre-approval and Post-approval Clinical and Economic Information and Evidence, it “supports the informed review, assessment, selection, and payment of medical products,” according to the AMCP website. ![]() ![]() “For the past 20+ years, I have worked on developing and updating AMCP dossiers for our clients,” says Lesher. The invitation to Lesher, a senior director in the Strategic Market Access Center of Excellence, testifies to her specialist expertise, and, by extension, OPEN Health’s, in a critical HEOR and Market Access function. AMCP dossiers are widely used by healthcare decision-makers in evaluating medical products in the United States. OPEN Health’s Beth Lesher, PharmD, BCPS, has been invited to serve a second term on the Academy of Managed Care Pharmacy (AMCP) Format for Formulary Submissions Committee, which issues highly influential guidance on AMCP dossiers. ![]()
0 Comments
Leave a Reply. |