title: Opinions regarding the Academy of Managed Care Pharmacy dossier submission guidelines: results of a small survey of managed care organizations and pharmaceutical manufacturers.
abstract: BACKGROUND
  In recent years, there has been more emphasis on determining the total value of a drug product, which includes safety and efficacy information and clinical and economic value relative to other therapies. The Academy of Managed Care Pharmacy (AMCP) Format for Formulary Submissions was intended as a tool to assist health care providers in evaluating and selecting drug products.
  
  
  OBJECTIVE
  The purpose of this research was to gain the perspectives of a sample of managed care organizations (MCOs) and pharmaceutical manufacturers regarding the AMCP Format submission and evaluation process, as well as their comments on possible future direction for these guidelines as an important part of the formulary decision-making process.
  
  
  METHODS
  A random sample of large (>1 million lives) and small (<1 million lives) MCOs was generated using telephone numbers from the National Directory of Managed Care Organizations' database. Pharmaceutical manufacturer respondents were identified from the Pharmaceutical Research and Manufacturers of America (PhRMA) Foundation's Health Outcomes Committee. Telephone interviews were conducted by 2 researchers between September 2004 and October 2005. Respondents from both pharmaceutical manufacturers and MCOs nationwide were familiar with the AMCP dossier preparation and review process, allowing us to compare perspectives from each group. The interview was designed to assess the following key areas: economic models, organizational burden, confidentiality, overall value, and future expectations.
  
  
  RESULTS
  Representatives from 20 MCOs and 7 pharmaceutical manufacturers completed the interview; 21 MCO representatives refused to participate, citing company policy. Nearly all (87.5%) of the MCO personnel contacted reviewed dossiers within their organization. However, MCO respondents indicated that only 40% of all drugs they reviewed included dossiers from the manufacturers. For drug evaluation at the level of the pharmacy and therapeutics committee, we found that drugs were compared with a variety of products, with 11 respondents reporting comparisons with a placebo, and all respondents reporting a comparison with at least 1 other branded product. On average, 53.5% of the dossiers MCOs received included budget-impact models, and 39.3% included cost-effectiveness analyses (CEAs) or cost-benefit analyses. Of the dossiers with economic models, less than half (46.2%) were deemed adequate. Nearly two thirds of MCO respondents reported that they modified the provided model with their own population statistics, as many reported that manufacturers do not make models directly applicable to their health plan population. The perspectives of the pharmaceutical manufacturers varied dramatically from the MCO respondents with regard to the inclusion of economic models. Five of the 7 respondents indicated that their companies always included an economic model in the submitted dossiers. One respondent indicated that 85% of company dossiers included models, and another reported that 50% of dossiers included CEA models. Both MCOs and pharmaceutical manufacturers commented that organizational burden was high, with 70% of both groups reporting the use of outside consultants to assist in the dossier process.
  
  
  CONCLUSIONS
  Overall, findings for this study suggest that awareness of the AMCP Format is high among MCOs and pharmaceutical manufacturers, but aligning objectives between the 2 organization types is necessary. Conceptually, proving a drug value beyond what the U.S. Food and Drug Administration requires is a reasonable request, something most respondents agreed on. However, less than half of all drugs reviewed had a dossier. In contrast to MCO respondents, pharmaceutical manufacturers appear to have a more positive outlook on the role of the AMCP Format in effectively communicating the value of a new drug product. Further steps need to be taken to improve acceptance and integration of the AMCP Format.
authors.affiliation: Department of Pharmaceutical Economics and Policy, University of Southern California, Los Angeles, CA 90033, USA. mnichol@usc.edu
authors.forename: Michael B
authors.initials: MB
authors.lastname: Nichol
authors.forename: Tara K
authors.initials: TK
authors.lastname: Knight
authors.forename: Joshua
authors.initials: J
authors.lastname: Epstein
authors.forename: Dennis H
authors.initials: DH
authors.lastname: Honda
authors.forename: Roma
authors.initials: R
authors.lastname: Tretiak
mesh_terms: D003219:Confidentiality; D004345:Drug Industry; D017850:Economics, Pharmaceutical; D019317:Evidence-Based Medicine; D005569:Formularies as Topic / Q000592:standards*; D017408:Guidelines as Topic; D006801:Humans; D007407:Interviews as Topic; D008329:Managed Care Programs; D004364:Pharmaceutical Preparations; D010593:Pharmaceutical Services
chemical_list: D004364:Pharmaceutical Preparations