Robert Navarro gives a broad overview of Managed Care in his book. AMCP ( Academy of Managed Care Pharmacy) is a professional organization representing the interests of pharmacists who practice in managed care settings. The manufacturer is left with the decision to include either a costeffectiveness model, a BIM, both or nei- ther within the AMCP dossier. Value dossiers may also be called core value dossiers or global value dossiers outside of the US. Managed care PharmDs for market access: AMCP dossiers Overview Aventine Consulting is a firm specializing in market access dossiers designed to scientifically and effectively demonstrate the value of a product to payers for the purpose of achieving optimal product reimbursement. 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. In the US, dossiers are commonly referred to as AMCP dossiers, which implies compliance with the latest. 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. A US value dossier, also known as a formulary submission dossier, is a compilation of clinical and economic data on a product, within the context of a specific disease state (s), that presents the evidence-based value story for the product. 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. HEALTH PLANs, and PBMs: If you are interested in adding HepatoLOLA as a covered item under either the medical benefit or pharmacy benefit, and need more information, would like a copy of the AMCP Dossier for HepatoLOLA or you would like to schedule a clinical presentation on HepatoLOLA for the management of hepatic encephlopathy please fill out the form to the left or email us at and we will contact you shortly.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. What information should be included in the pre-approval and unapproved indication dossiers according to Format Version 4. If you are going to have P&T review HepatoLOLA prior to adding it to in-patient formulary and you would like a copy of the HepatoLOLA AMCP Dossier, please fill out the contact form or email us. Because AMCP dossiers are key to the effective provision of this information to payers, it was necessary to update the Format to align with the new legislation and FDA guidance. INSTITUTIONAL PHARMACISTS: If you are an institutional pharmacist and you would like to stock HeaptoLOLA please request your pharmacy wholesale partner to stock HepatoLOLA. This new version of the AMCP Format describes three types of dossiers that manufacturers may choose to develop: Unapproved Product Dossiers, Approved Product. PHYSICIANS, OUTPATIENT USE: Please see the 'Buy HepatoLOLA' section for outpatient ordering options. Evidera’s AMCP Dossier Development Process Evidera will work with you to design a customized approach to developing or updating an AMCP dossier. PHYSICIANS, INPATIENT USE: If you would like to have HepatoLOLA added to the inpatient formulary at your institution, please request your institution's inpatient pharmacy to review HepatoLOLA for formulary inclusion. Physicians, Pharmacists, Health Plans, and PBMs
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