HTA Regulation: Procedure and Impact on Regulatory Processes in Spain, France, Germany, and Italy

OBJECTIVES: The European regulation on HTA aims to standardize the evaluations of medicines within the European Union to determine the safety and relative effectiveness. This study explores the challenges and potential of the HTA regulation and the JCA in the BIG4: Spain, France, Germany, and Italy.

METHODS: Documents published by the European HTA coordination group were examined and compared with national regulations on pricing and reimbursement procedures.

RESULTS: In all four countries, the choice of comparators is responsibility of the national regulatory bodies. In Spain, France, and Italy, the choice begins with the comparator proposed by the company. In Germany, is the regulatory agency to directly select the comparator. Additionally, the HTA regulation during the scooping process requires regulators to identify comparators early during the EMA evaluation, but currently none of the four countries has implemented this procedure. Indirect comparisons in Germany adhere to the HTA guidelines, whereas France uses different methods. In Italy and Spain, while indirect comparisons are permitted, specific methodological guidelines are lacking.

CONCLUSIONS: Spain and Italy must revise their drug evaluation procedures and national regulations, particularly concerning the pricing and reimbursement process. In Italy, rules governing early submission need amendments.