Recently “Do France, Germany, and Italy agree on the added therapeutic value of medicines?” study has been published. According to the study, which discussed the Health Technology Assessment (HTA) of medicines in Italy, France, and Germany, a focus on the assessment of Added Therapeutic Value (ATV);
The three largest European pharmaceutical markets (Italy, France, and Germany) have implemented price and reimbursement systems that strongly emphasize the assessment of the Added Therapeutic Value (ATV) of medicines. However, these assessments are conducted separately at the country level and there are differences in their approaches.
A new European HTA regulation has been identified to be implemented from January 2025. Joint Clinical Assessments (JCAs) of oncological medicinal products and advanced therapies will be provided to Member States but will not include ATV ratings. Member States will remain responsible for concluding ATV at the national level.
A clear and consensual definition of the key criteria for ATV evaluation and interpretation is needed to reduce access inequalities and harmonize Member States’ assessments.
According to a comparison of ATV assessments among three European HTA agencies (Agenzia Italiana del Farmaco (AIFA), Haute Autorité de Santé (HAS), and Gemeinsamer Bundesausschuss (G-BA)), AIFA’s ATV assessments appeared more generous compared to HAS and G-BA. The highest level of agreement on ATV ratings was observed between HAS and G-BA.
It is important to distinguish ATV assessments from the quality of evidence. It is argued that clinical trials may be developed to meet regulatory standards without providing sufficient evidence to reduce uncertainties about the true added value of new drugs.
It is suggested that if ATV and quality of evidence are integrated, the level of agreement among HTA organizations is rather high, indicating potential for greater alignment in assessments.
The study is ongoing and it is suggested that updates may be useful to monitor trends in alignment among European HTA agencies. It is also important to include other countries in the analysis, despite existing variabilities.
In summary, the study discusses differences in ATV assessments among European HTA agencies and highlights the importance of consensus, separation of ATV and quality of evidence assessments, and the potential for greater alignment in the future.
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