OBJECTIVES: Adoption of high-cost Advanced Therapy Medicinal Products (ATMPs) by major European economies has been extensively discussed. Relatively little attention has been given to countries with less generous budgets to manage the impact of the ATMP revolution while also maximising patient access. This study aimed to review the outcomes of health technology assessment (HTA) submissions of ATMPs in a basket of non-EU5 European countries with established HTA functions to assess the broad adoption of these products across the region.

METHODS: Countries chosen to represent the average European environment with respect to health expenditure were Belgium, Netherlands, Luxembourg, Austria, Sweden, Portugal, Poland, and Czechia. Publicly available HTA reports of ATMPs from each country were identified and relevant data were extracted for analysis. Grey and peer-reviewed literature were searched to supplement data obtained from official sources.

RESULTS: 17 ATMPs have market authorisation via the centralised process. Among the countries considered, 25 of the 82 publicly available HTA submissions of ATMPs identified resulted in a positive recommendation for general reimbursement. The average time to decision was 16.9 [range: 4–48] months. On average, only 3 ATMPs per country were approved for regular reimbursement. However, many products were under evaluation at the time of our review. The country with the greatest number of reimbursed ATMPs was Sweden (n=6). Low-quality clinical evidence and unsuitable pharmacoeconomic models were common critiques of evidence submissions. Of the available HTA reports with a negative recommendation, the most cited reason was product cost-effectiveness. A positive recommendation commonly occurred even when evidence was of low quality if a financial agreement was successfully negotiated.

CONCLUSIONS: In European countries with a typical level of pharmaceutical spending, patient access to ATMPs is limited. Alternative funding processes and financial agreements can make the difference in such products being cost-effective and achieving reimbursement.