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Reimbursement Submissions and Dossiers
Private agencies (e.g., managed care organizations [MCOs] and hospitals), US government payers (e.g., Medicaid and Medicare), and other government agencies (e.g., National Institute for Health and Clinical Excellence [NICE] in the UK) throughout the world require standardized formats for submitting pharmaceutical reimbursement dossiers. In the US, the Academy of Managed Care Pharmacy (AMCP) Format for Formulary Submissions is the preferred format for a large number of MCOs and other payers; however, some health plans such as WellPoint have their own guidelines for health technology assessments. Similarly, in the UK, NICE has developed a standardized submission format.
Reimbursement dossiers typically integrate information from burden of illness studies, clinical trials, patient-reported health benefits, and economic models. We use these components to develop scientifically sound, evidence-based submissions that communicate the value of your product.
Our health outcomes team knows the evidence requirements for developing reimbursement dossiers, and we understand how vital it is for your commercial success for a new drug to be accepted on formularies. To expedite multiple submissions, we have developed an efficient process for creating, organizing, editing, accessing, and maintaining information required for formulary submissions to multiple domestic and international agencies and authorities, which helps streamline your formulary submissions.
Our Regulatory and Health Outcomes Strategy team can help you prepare successful reimbursement dossiers.
