- •Advanced therapy medicinal products (ATMPs) are highly innovative therapies. Their high costs and uncertain value claims raise concerns among health technology assessment bodies and payers, yet little is known about the experiences with health technology assessment of ATMPs.
- •Key considerations underlying the reimbursement recommendations of ATMPs were identified and assessed in Scotland, The Netherlands, and England using the EUnetHTA Core Model.
- •This study provides insights in supporting and opposing considerations for individual products and on a member state level. Besides the therapeutic effectiveness and cost-effectiveness domains, the social, ethical, and legal domains seem to bare considerable weight.
Medicinal Products and Jurisdictions
- 1.HTA body is linked to a European jurisdiction.
- 2.HTA jurisdiction is part of the EU at time of data collection (June 2020).
- 3.The HTA body is the primary institute with legal remits within the jurisdiction.
- 4.The HTA body systematically published HTA reports in the public domain.
- 5.The published reports are written in a language understood by the researchers (ie, English or Dutch).
Identified ATMPs and HTA Reports
Identification of (Key) Consideration
Positive, Restricted, and Negative Recommendations
Role of Uncertainties and Mitigating Factors
- Coppens D.G.M.
- Kanters T.A.
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