Increased responsibility for providing a complete data set, including economic impact information Provides the opportunity to establish the value of a new product with evidence A new competitive environmentġ1 AMCP Format: Implications for Health Plans Improve the timeliness, quality, scope, and relevance of information available to healthcare system evaluators (P&T Committees or other technology assessment committees) Streamline the data acquisition and review process for healthcare system staff (eg, pharmacists)ġ0 AMCP Format: Implications for the Pharmaceutical Industry The AMCP Foundation supports the Format 3 Revisions (v3.1 addenda added in December 2012) Format Executive Committee Education and Training: The AMCP Foundation supports programs to educate managed care pharmacists about the Format and use of evidence in formulary decision-making > 45 programs to >1400 attendees from > 300 organizations 2005 – 2008: The AMCP Foundation supports comprehensive evaluation of the Format Audit of the quality and completeness of dossier information Survey of health plans use and value of the FormatĦ Updates in Version 3.1 Changes to this version are limited to the inclusion of three addenda: Companion Diagnostic Tests Comparative Effectiveness Research Specialty Pharmaceuticalsħ The AMCP Format is: a process to obtain a standardized set of data and information about a drug from its manufacturer to support reimbursement and/or formulary placement considerationĨ Role of the Format Support informed selection of pharmaceuticals, biologics, and vaccines by: Standardizing and communicating product and supporting program information requirements Requiring projections of product impact on both the organization and its enrolled patient population Requesting information on the value of products Making evidence and rationale supporting all choice(s) more clear, transparent and evaluable by decision makers Regence BlueShield (WA State) – Regence Guidelines BCBS Colorado Guidelinesġ999 Academy of Managed Care Pharmacy (AMCP) Committee organized to draft standard unsolicited request for evidence to support formulary deliberations 2000 – AMCP Format Version 1.0 AMCP Board of Directors approves AMCP Format as a generalized unsolicited request AMCP Board mandates evaluation of the AMCP Format 2002 – AMCP Format Version 2.0 2005 – AMCP Format Version 2.1 2005 – WellPoint Health Technology Assessment Guidelines Version 5.1 2009 – AMCP Format Version 3.0 2012– AMCP Format Version 3.1 RESPONSE Regional efforts to improve access to better and more complete evidence by specifying information needs. But, this information was not included in product labels despite systematic attempts (FDMA SEC 114, etc.) DDMAC regulates content of information from manufacturer to health care professionals and health plans – Relatively little data beyond what is included in the label. PROBLEM Growing recognition that information (Formulary Kits) on new products provided by PhRMA to health plans and other payers was promotional and insufficient to inform evidence-based decision-making Rise of HEOR units within PhRMA to generate evidence of product value. Presentation Developed for the Academy of Managed Care Pharmacy February 2015
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