![]() ![]() ![]() Formalize a process for providing feedback to pharmaceutical companies on dossier quality and transparency.Train formulary committee members regarding the potential value of the Academy of Managed Care Pharmacy guidelines (the Format).Be vigilant and cautious when reviewing clinical and economic evidence in dossiers, especially with lower-cost and “me-too†drugs.However, concerns persist about the quality of the clinical data and the economic analyses in dossiers therefore, plans should: About half of dossiers included economic analyses, but these analyses had relatively low levels of compliance with recommended practices.ĭossiers being submitted under AMCP Format provide an opportunity for health plans to evaluate a drug’s clinical and economic evidence. Dossiers often included clinical data to support off-label indications, but concerns persist about their quality. ![]() Economic analyses of high-cost products and innovative products had higher compliance with recommended practices.Ĭonclusions: Drug companies are submitting dossiers of evidence to formulary committees. The economic analyses had low levels of compliance with standards: only 43% performed sensitivity analysis 38% stated the study perspective 37% discussed relevant treatment alternatives 20% stated assumptions clearly and 18% mentioned caveats to conclusions. Of 115 dossiers submitted between 20, 53 (46%) included economic analyses. Results: Evidence to support off-label indications often was included in 2003 dossiers, but the information was less extensive and of poorer quality than data for labeled indications. We compared economic analyses for high-cost (30-day treatment cost > $1000) versus low-cost products, and for "innovative" versus "me-too" drugs. Methods: Dossiers were audited with a data collection form to judge the types of clinical studies used to support labeled and off-label indications, and the quality and transparency of economic analyses. For dossiers submitted in 2003, we examined the clinical studies included. Study Design: We reviewed the quality of economic analyses in dossiers submitted to Premera Blue Cross Health Plan (Mountlake Terrace, Washington enrollment 1.6 million) between January 2002 and September 2005. Robert Navarro gives a broad overview of Managed Care in his book.Objective: To investigate the quality and complete-ness of clinical and economic data in dossiers submitted by drug companies to a health plan using Academy of Managed Care Pharmacy guidelines (the Format) for formulary submissions. Value dossiers may also be called core value dossiers or global value dossiers outside of the US. The official AMCP format can be found on their website and is updated periodically: For country submissions outside the US, HEOR teams tends to develop broader value dossiers so that affiliates can modify them as relevant for local submissions. There are separate formats for unapproved product AMCP dossiers and approved product dossiers in the US. In the United States, the standard format is that set forth by the Academy for Managed Care Pharmacy (AMCP) and the deliverable is known as an AMCP dossier. HEOR teams in pharma work on these dossiers as part of a product launch and update them throughout the product life cycle as new data emerge. Payers may also ask for updated dossiers periodically as new data emerge or new decisions have to be made. They are often a good starting point for the payer to get oriented to a drug or disease space and may lead to follow-up questions on specific data. Dossiers are a standard launch deliverable and are created and shared by manufacturers depending on the processes and laws in a given country. Payers around the world require data on product clinical trials, disease state burden, health economics, and other relevant information as part of the process of evaluating whether or not to cover a drug for reimbursement- this information is often shared in the form of a compendium (or dossier) developed by the manufacturer seeking reimbursement. ![]()
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