OBJECTIVES: EU pharma package incentivizes EU-wide product launch to 24 months after EMA marketing authorization. ATMPs can be considered the most challenging product class, given the potential for disease modification. Hence, they can give a good indication to this benchmark.

METHODS: For this analysis all six ATMPs approved by EMA in 2021/2022 have been identified. For each ATMP launch date, and access restriction have been analyzed for Spain, Italy, France, Germany, Austria, and Switzerland by respective country experts.

RESULTS: These ATMPs have received EMA approval between August 2021 and December 2022.

For Austria it can be assumed that for the majority of ATMPs formal reimbursement requests in hospitals have been submitted. Until they will become effective, reimbursement is limited to case-by-case decisions by payers.

In Spain none of these ATMPs is already reimbursed and launched: one has already completed HTA process with price negotiation ongoing, four are currently in HTA process and one is not even approved for use in Spain.

In Italy none of the ATMPs are currently reimbursed with price negotiations still ongoing for all products.

Four out of six ATMPs are already available in France, but only via early access program (EAP) and prices only being preliminary, determined by the manufacturer, and another EAP has been stopped by the manufacturer. Mean duration until approval of EAP after EC decision was 4,5 months.

Only in Germany all six ATMPs are already commercially available; mean duration until product launch with general reimbursement is four months.

For comparison: Approval for pharmaceuticals in Switzerland is outside the EMA. Only three of these ATMPs are already approved and another has been submitted so far. None is currently reimbursed.

CONCLUSIONS: So far, market access for ATMPs seems to be far away from the benchmark stipulated in the pharma package. An access gap can be observed.