Healthy Skepticism Library item: 10699

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Publication type: Journal Article

Spooner JJ, Gandhi PK, Connelly SB.
AMCP Format dossier requests: manufacturer response and formulary implications for one large health plan.
J Manag Care Pharm 2007 Jan-Feb; 13:(1):37-43
http://www.ncbi.nlm.nih.gov/sites/entrez?Db=PubMed&Cmd=ShowDetailView&TermToSearch=17269835&ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum

Abstract:

BACKGROUND: 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. 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. 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.

OBJECTIVE: To perform an evaluation of pharmaceutical manufacturers. 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.

METHODS: 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. A university-based clinical evaluation subcontractor requested dossiers in the AMCP Format by telephone and e-mail from the manufacturers. drug information center about 8 weeks before the committee meeting. A retrospective evaluation of the materials received from the manufacturers was performed. A logistic regression model was developed to determine if dossier receipt increased the likelihood of second-tier copayment formulary placement for new product reviews.

RESULTS: Dossiers were requested for 43 products. 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%). Of the 25 dossiers, 21 (84%) generally followed the AMCP Format. 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%). Dossiers were more likely to be received when the time between U.S. Food and Drug Administration (FDA) approval and dossier request was >/- 4 months (65% vs. 27% when <4 months; P <0.05) and when requested from a large manufacturer (top 25 in sales) compared with smaller manufacturers (75% vs. 43%; P <0.05). Dossier receipt did not improve a product.s likelihood for preferred formulary placement; none of the new products for which dossiers were received were assigned to the second copayment tier compared with 33% of the new products with no supporting dossier. The logistic regression model failed to find any correlation between dossier receipt and preferred formulary placement.

CONCLUSIONS: Manufacturers met the request for a dossier nearly three fifths of the time. The dossiers were of high quality and generally followed the AMCP Format; the models included in dossiers varied widely in their design and utility. The product manufacturer.s size and the time between FDA approval and dossier request influenced the likelihood of dossier receipt. Receipt of a dossier did not appear to influence the likelihood of a product attaining preferred formulary status.

Keywords:
MeSH Terms: Academies and Institutes Drug Approval/methods Drug Industry/standards Drug Industry/statistics & numerical data Formularies/standards* Guidelines/standards* Health Plan Implementation/methods Humans Managed Care Programs/organization & administration Managed Care Programs/standards* Pharmaceutical Preparations/chemistry Pharmaceutical Preparations/standards United States United States Food and Drug Administration/legislation & jurisprudence United States Food and Drug Administration/standards Substances: Pharmaceutical Preparations

Notes:

Comment in:
J Manag Care Pharm. 2007 Apr;13(3):290-1; author reply 291-2.
J Manag Care Pharm. 2007 Jan-Feb;13(1):66-7.