The discontinuations of Joint Clinical Assessments (JCA) under the EU-HTA to date can be traced back to different regulatory and methodological causes.
- For Zumrad (sasanlimab), the procedure was discontinued after the EMA marketing authorisation application was withdrawn.
- By contrast, the procedures for catequentinib, Tacquell and sintilimab failed because of substantial deficiencies in the submitted JCA dossiers under Article 9 of the EU-HTA Regulation. The main shortcomings included incomplete evidence searches, inadequate PICO-specific analyses, insufficient descriptions of the methods, and missing presentations of results and documentation.
- The discontinuations so far therefore point less to a fundamental lack of clinical efficacy evidence than to the high methodological and formal requirements of the new EU-HTA procedure.
- You can find the detailed reasons for the discontinuation of the procedures under EU-HTA in the individual procedures.