Introduction:
The article is a translation and summary of the draft royal decree for regulating the evaluation of health technologies (ETS) in Spain. ETS includes the assessment of clinical and non-clinical aspects of medical technologies, such as medicines, medical devices, diagnostic tools, and procedures. The aim is to provide data to inform decisions regarding the incorporation, funding, pricing, reimbursement, or divestment of these technologies within the public health system.
The key objective of ETS is aligning Spanish regulations with European Union regulations (EU Regulation 2021/2282) on health technology assessment, while respecting the competencies of Spanish authorities.
How does the new Spanish HTA process reflect their attitude toward JCA regulation?
The new Spanish Health Technology Assessment (HTA) process, as outlined in the orginal Spanish text document reflects a cautious yet collaborative attitude toward the Joint Clinical Assessment (JCA) regulation established by the European Union (EU) under Regulation (EU) 2021/2282. Here are the key points that illustrate this:
- Alignment with EU Regulation: The Spanish HTA process will aim to be fully aligned with the JCA framework introduced by the EU. This is evident in the emphasis on developing a national HTA framework that is consistent and complementary to the JCA, while still respecting Spain's specific competencies and requirements.
- Clinical Evaluation Integration: The Spanish process will integrate the JCA findings into its evaluations, particularly in the domain of clinical assessments. Spain commits to using the JCA results as a foundation, avoiding duplication of effort, but retains the right to conduct additional clinical evaluations when necessary, especially if national conditions or specificities require it.
- Autonomy in Non-Clinical Evaluations: While Spain will align with the clinical aspects of the JCA, it will maintain autonomy over non-clinical evaluations, such as economic, social, and ethical aspects. The economic evaluation will provide useful information for decision-making within the framework established by regulation through a robust evaluation that considers the value of health technology from the perspective of relative effectiveness, the social value of health technology and the impact on health-related quality of life.
"This information will identify the efficiency of the new technology compared to the available alternatives, as well as the analysis of its budgetary impact."
- Implementation Flexibility: The Spanish process will retain flexibility, particularly in cases where the JCA does not fully capture national health system realities. This will allow Spain to adapt the JCA findings to local contexts, ensuring that the HTA outcomes are relevant and actionable within the Spanish healthcare system.
- Collaborative Governance: Spain’s governance structure for HTA includes mechanisms for coordination with the EU’s JCA, indicating a willingness to cooperate and integrate European-wide assessments while ensuring that national interests are considered.
Spanish HTA timeline
According to the original Spanish text document, the Spanish Health Technology Assessment (HTA) process has established specific timelines, particularly when a product is assessed by the Joint Clinical Assessment (JCA) under the European Union regulations. Here are the key points regarding these timelines:
- Initiation: The Spanish HTA process will begin promptly after the completion of the JCA, ensuring there are no unnecessary delays. This alignment with the JCA allows for a swift transition from the European to the national level.
- Assessment Period: The national HTA body will aim to complete its assessment within a specified period following the JCA's conclusions. This period ensures that the product could quickly move toward pricing and reimbursement decisions within Spain.
- Additional Evaluations: While the timeline for the clinical evaluation will be closely aligned with the JCA, any required non-clinical assessments, such as economic evaluations or considerations of ethical and social aspects, are conducted concurrently or immediately following the JCA process.
- Final Decision: The entire HTA process will be structured to ensure that a final decision is reached in a timely manner, typically within a few months after the JCA. This ensures that products are not delayed in reaching the market due to extended evaluation periods.
Conclusion
In conclusion, the new Spanish Health Technology Assessment (HTA) process demonstrates a balanced approach to integrating European Union regulations, particularly the Joint Clinical Assessment (JCA), into its national framework. By aligning with the JCA while retaining autonomy over non-clinical evaluations and allowing flexibility for national adjustments, Spain ensures that its HTA process is both collaborative and context-sensitive. The established timelines further reflect Spain's commitment to timely and transparent evaluations, facilitating the effective incorporation of medical technologies into the public health system while safeguarding national interests.
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Reference
Spain’s New Health Technology Assessment (HTA) Framework: https://www.sanidad.gob.es/normativa/audiencia/home.htm
