HTA Quarterly | Spring 2017

The National Institute for Health and Care Excellence (NICE) has gained notoriety for its evidence-based appraisal guidance on health technologies which include medicines, medical devices, diagnostic techniques, surgical procedures, and health promotion activities. We examine the procedures for technology appraisal by NICE and we explore the appeals process when a decision is challenged.

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Despite being hailed as the future of oncology, given the high cost of therapy and payer skepticism toward new oncologic agents, obtaining coverage and reimbursement for immunotherapy (IO) therapies can be difficult. We take a look at the challenges of obtaining approval from global HTA authorities and local market payers, and we will present some potential solutions to address evaluator concerns.

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While nearly all international market access stakeholders are familiar with the global value dossier (GVD), with ever-increasing demands by health technology assessment (HTA) agencies, it is becoming more difficult to create an impactful, descriptive, and useful document that supports local product submissions. We review the current state of the GVD, the challenges associated with developing an effective GVD, and key actions that can be undertaken to optimize the utility of the GVD.

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