OBJECTIVES:

Starting January 2025, all advanced therapy medicinal products (ATMPs) and oncology drugs will be mandated to undergo a joint clinical assessment (JCA) at European level. JCAs have been previously trialed by EUnetHTA, most recently in Joint Action 3 (JA3). This research explores the impact of historic EU co-operation, assessing whether drugs evaluated under EUnetHTA JA3 have received faster/divergent outcomes by participating national European health technology assessment (HTA) bodies.

METHODS:

JA3 JCAs (2016-2021) were identified as well as the associated HTA appraisal from NICE, HAS, SMC, TLV, NCPE, AIFA, ZIN, Medicinradet and AOTMiT. The time period from European Medicines Agency (EMA) marketing authorization (MA) to the national HTA reimbursement date was calculated, and a two-tailed t-test assessed significance.

RESULTS:

There were 20 EUnetHTA pharmaceutical JCAs in JA3, of which 15 achieved MA. Overall, 60 associated HTA appraisals were identified, 44 HTA appraisals were positive (including positive with restrictions) and 16 were negative.

7/15 EUnetHTA JCAs were positive in their interpretation of the clinical data, however, at the national level a positive reimbursement decision was reached in only 1/7 of the corresponding assessments by HAS (ASMR>III), Medicinradet and AOTMiT; 2/7 by TLV and SMC; 3/7 by AIFA and NICE.

There was no difference in the time to reimbursement if the national HTA agency was involved in the development of the JCA vs. not involved (302.7 vs. 288.1 days, respectively; p=0.782).

CONCLUSIONS:

This research highlights that positive JCAs do not necessarily translate to positive reimbursement decisions at the national level, where reimbursement is dependent on the country-level HTA framework, budget impact and/or cost-effectiveness. It also provides promising results that under the new HTA Regulation, involvement in a JCA may not impact national reimbursement timelines.