OBJECTIVES: In light of process modifications, increased political focus, and financial pressures, we sought to carry out a targeted review (TR) of health technology assessments (HTA). We reviewed HTA reports from Australia, Canada, England, France, Germany, and Italy to examine whether HTA bodies are positively assessing ATMP products. We also examined general trends in these markets to identify if ATMP products achieve positive recommendations at a different rate.

METHODS: We performed a TR of HTA reports published during 2023, selecting for ATMPs. The outcome of ATMP assessments was recorded, as well as the key rationale for the decision. This TR included assessments carried out in 2022 for which an outcome was not published until 2023 and excluded assessments published in 2024.

RESULTS: A total of 58 assessment procedures were identified for ATMP products during 2023, of which 54 resulted in positive outcomes. (Australia 6, Canada 6, England 10, France 10, Germany 17, and Italy 5) This represents a 93% positive recommendation rate, compared to 89% across all products. It is worth noting that the positive recommendation rate dropped to 84% for orphan drugs, suggesting ATMP drugs are finding more favourable reimbursement conditions compared to general pharmaceuticals, which in turn attract better reimbursement outcomes than orphan drugs.

CONCLUSIONS: Whilst this research suggests conditions ATMP reimbursement are improving, it also highlights previously reported issues for orphan drugs, notably lower reimbursement rates, often based upon data paucity. Further research is required to explore these issues.