AMCP Format Dossier Requests: Manufacturer Response and Formulary Implications for One Large Health Plan

Abstract

he pharmacy and therapeutics (P&T) committees of health plans have traditionally requested drug information from pharmaceutical manufacturers to assist them in the formulary review process. Until the turn of the century, manufacturers often responded to this request by providing information regarding potential price rebates and sending formulary kits containing marketing materials and clinical trial reprints.1 Concerns pertaining to the comprehensiveness and veracity of information provided by manufacturers led to the development of formulary submission guidelines, which served to formalize, standardize, and expand the information required for formulary review.2 In 2000, the Academy of Managed Care Pharmacy (AMCP) developed its Format for Formulary Submissions, a template for health plans to use to develop their own formulary submission guidelines. 3 The Format has since been modified several times, most recently in April 2005. 4 While the use of formulary submission guidelines was slow to evolve, 5 they have come into widespread use, with more than 50 health plans, pharmacy benefit managers, hospitals, state Medicaid programs, or other public agencies (covering more than 100 million people) adopting the AMCP Format or a Format-like process. 6The centerpiece of the formulary submission process is the dossier, a standardized set of clinical and economic evidence prepared by pharmaceutical manufacturers and presented to health plans in response to unsolicited requests, for the plans' consideration during the formulary decision-making process. Many health plans questioned the quality of the first sets of dossiers they received, citing what they perceived to be poorly constructed dossiers containing incomplete or unreliable data. 7,8 While the quality and completeness of dossiers have reportedly improved over time, 9,10 recent research examining the response rate 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 AMCPFormat by telephone and e-mail from the manufa...

Pharmaceutical Technology Assessment: Perspectives from Payers

“…Our rating scales also supported the finding by Spooner et al (2007) that the availability of AMCP Format-based dossiers had limited influence in the formulary decisions. 6 We also found abide in caring for the state's Medicaid population, the information collected from the 3 participating Medicaid agencies may not be generalizable. Second, our small sample size and variability in approaches for PTA and in each plan's unique set of obligations (e.g., plan rules/charter, for-profit vs. nonprofit status, external clients, target patient populations, and so forth) may also limit generalizability.…”

“…Recent published literature provides only limited information on formulary reviews (e.g., whether formulary decision makers use a systematic process to assess available evidence), types of evidence considered, timing for reviews, and other specifics of the formulary decision-making process. [2][3][4][5][6][7][8][9][10][11][12] Moreover, private initiatives such as the Academy of Managed Care Pharmacy (AMCP) Format for Formulary Submissions dossiers for submitting evidence, federal initiatives in comparative effectiveness research (CER), and the passage of health care reform legislation in 2010 are likely to have significantly impacted the amount and type of health-related evidence available for decision makers.…”

Manufacturer Response to AMCP Format Dossier Requests

“…Those changes must be made in accordance with the approval procedures described by Block and following 60 days notice to the Centers for Medicare & Medicaid Services (CMS), state pharmacy assistance programs, prescribers, network pharmacies, pharmacists, and "affected enrollees." 1 There are other types of formulary changes that are not considered maintenance changes, such as changing preferred or nonpreferred formulary drugs, adding utilization management, removing dosage forms, increasing cost sharing on preferred drugs (unrelated to the reasons stated above), or exchanging therapeutic alternatives (either by formulary addition/removal or tier exchanges). For these additional types of formulary changes approved by CMS, Part D plans should make such formulary changes only if enrollees currently taking the affected drug are exempt from the formulary change for the remainder of the plan year.…”

“…Janet 1 Case study reports by individual plans provide a context for understanding the diffusion of the Format's use. Although secondary to the study' s main focus, their comments on a possible relationship between formulary placement and dossier submission raise a critical issue in a voluntary process such as this-will manufacturers see their interests better served by voluntarily submitting a dossier or is opting out without a downside risk?…”

Opinions Regarding the Value and Use of the AMCP Format Still Unknown

“…Spooner et al claimed that 68% of the dossiers received by one MCO included ap harmacoeconomic or disease management impact model. 5 Approximately half of the dossiers in the Nichols et al study contained economic models that wereregarded as being adequate by MCOs. In the Spooner et al study,20% of the models wereunlocked, interactive budget impact models, whereas the other 48% essentially contained only reports on the analysis performed instead of actual models.…”