The director of the Spanish Agency for Medicines (AEMPS), María Jesús Lamas, gave an interview where she discusses HTA and its impact. Here are the key points:
- New Management of IPTs: The AEMPS has taken over the production of Therapeutic Positioning Reports (IPT) following the annulment of REvalMed, leveraging its prepared team and efficient approach.
- European HTA Regulation: The AEMPS is adapting to the requirements of the new regulation to perform evaluations of oncology drugs and advanced therapies (as of January 2025), rare diseases (2028), and other medications (2030).
- Proposed Evaluation Model: Separation between scientific-technical evaluation (added clinical value) and economic evaluation, followed by the consideration of ethical, social, and organizational aspects for the positioning of health technology.
- Joint Clinical Assessments (JCA): The AEMPS works on defining technical conclusions about the added clinical benefit without making subjective assessments.
- Training in Economic Evaluations: The AEMPS acknowledges the existence of professionals trained in economic evaluations, although they are not yet part of the Agency.
- Hospital Exemption: Discussion on how hospital exemption can influence research and development of advanced therapies, with the goal of reaching centralized authorization.
- Environmental Impact: Concern about how environmental issues can affect the authorization and manufacturing of medicines, with the need to balance the availability of medicines and the sustainability of the industry.
- Strategic Autonomy and Relocation: Reflection on the autonomy of the pharmaceutical industry in Europe and the implications of requiring environmental standards for production both inside and outside of Europe.
These points highlight the changes and challenges faced by the AEMPS and the Spanish health system in general, especially regarding the implementation of HTA and the evaluation of health technologies.
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