Reimbursement is a key component of market access for a new therapeutic intervention; once it has been approved for marketing in a region or country, and its initial price determined, the manufacturer typically submits an application to an organization (such as an insurance company or a government bodies in countries that provide government-funded healthcare) that decides whether it will reimburse the company for its use by doctors to treat patients.

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    Co-developing a drug with a diagnostic to create a stratified medicine — a therapy that is targeted to a specific patient population on the basis of a clinical biomarker — presents challenges for product developers, regulators, payers and physicians. With the aim of developing a shared framework and tools for addressing these challenges, this article presents an analysis using data from case studies in oncology and Alzheimer's disease, coupled with integrated computational modelling of clinical outcomes and economic value, to quantify the effects of decisions on key issues such as the design of clinical trials.

    • Mark R. Trusheim
    • , Breon Burgess
    •  & Michael C. Palmer

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