OBJECTIVES: Health technology assessments (HTAs) act as the authorities to socialized funding of medicine in Europe. A positive HTA evaluation is essential for successful access and reimbursement. HTAs are becoming increasingly collaborative to promote transparency/objectivity and streamline drug review.

A new pan-European HTA regulation established January 2022 will require member states to give “due consideration” to joint clinical assessment (JCA) reports in their national HTA assessments starting in 2025. The JCA will focus on the clinical domain of HTAs but will not focus on economic assessments. Additionally, member states will remain free to conduct complementary clinical and non-clinical analyses.

METHODS: This regulation review considers the potential impact of widespread European adoption of the JCA as a new requirement for HTAs. N=8 ex-payer stakeholder interviews across Germany, France, Italy, and Spain add a primary research perspective on the impact of JCA.

RESULTS: As the EMA previously streamlined the European regulatory process, the JCA could do the same for clinical HTA assessments. These efficiencies may be attractive for manufacturers since only one clinical submission plus local economic assessment across Europe could be necessary. Conversely, the JCA may introduce redundancy if countries maintain their national approach in addition to the JCA process.

A major driver for JCA adoption will be the extent to which local clinical value priorities are reflected in the cross-board assessment and if, and how, environment differences (e.g., variation in local historic standard of care) can be accommodated.

CONCLUSIONS: The degree to which the JCA drives efficiency and lowers barriers to broad and speedy access remains unclear. Member states may forego their national clinical assessment processes completely, and use the JCA in its place, or conduct their own supplemental clinical assessment resulting in redundancy. For full integration, and thus substitution, states will need to have confidence in JCA’s parameters and evaluation criteria.