Does Regulatory Speed Equate to HTA Approval and Swift Reimbursement?

OBJECTIVES: To understand if New Chemical Entities (NCEs) which underwent an accelerated regulatory approval process between 2021 and 2022 have benefited from swift reimbursement compared to NCEs without an accelerated assessment. Also, if there is a noticeable difference in reimbursement timelines when considering oncology verses non-oncology NCEs.

METHODS: A review of the EMA human medicines highlights for 2021 and 2022 was conducted, in conjunction with the individual country pricing sources. The time to reimbursement in France, Germany and the UK, was investigated for those New Chemical Entities (NCEs) that 1) gained EMA Marketing Authorisation between January 2021 and Dec 2022, 2) underwent an accelerated assessment or that the EMA deemed to have made “significant progress” in their therapy areas.

RESULTS: The Oncology NCEs subject to the accelerated assessment generally achieved reimbursement much more quickly than the non-oncology NCEs (1/2 as quickly in France, 1/3 as quickly in Germany). When the reimbursement time for the products that made significant progress was considered by therapy area, in France the timings were similar whilst in Germany the timelines for the oncology “significant progress” products achieved reimbursement in half the time as the non-oncology products.

CONCLUSIONS: While it appears that generally oncology NCEs subject to accelerated assessment will achieve faster reimbursement than their non-oncology counterparts the effect of the “significant progress” the NCE makes in the therapy area differs by market.