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Insights on the New EU Health Technology Assessment Regulation (HTAR)

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Today at Revio, we are reviewing and providing insights on Regulation (EU)

2021/2282 on Health Technology Assessment (HTAR), which entered into force on January 11, 2022, and will apply from January 12, 2025. After this date, the Regulation will undergo a five-year implementation phase, concluding in January 2030.

Health Technology Assessment Regulation

Health Technology Assessment (HTA) evaluates information about the medical, economic, social, and ethical aspects of health technology, such as medicinal products, diagnostic and treatment equipment, and prevention methods.

While regulators like the European Medicines Agency (EMA) focus on the efficacy, safety, and quality of medicinal products for authorization recommendations, HTA bodies assess how new technologies compare to current standards. HTA typically considers therapeutic effects, potential side effects, influence on quality of life, and means of administration, alongside economic and social factors like patient cost implications and healthcare system impacts.

Currently, HTA regulation is managed by Member States, resulting in varied HTA systems, national legislations, procedures, methodologies, and assessment criteria. The HTAR aims to improve the availability of innovative technologies, such as medicines and certain medical devices, for EU patients. It ensures efficient resource use and enhances HTA quality across the Union by introducing a common methodology and approach for Joint Scientific Consultation (JSC) and Joint Clinical Assessment (JCA).

Joint Scientific Consultation

The JSC is a non-binding scientific advice process providing feedback from regulators and HTA bodies from different Member States on evidence-generation plans, supporting decision-making on marketing authorization and reimbursement of new medicines. Consultations can occur before or after a product is placed on the EU market. The objective is to help generate optimal and robust evidence that satisfies the needs of both regulators and HTA bodies. This procedure will be available from January 2025.

Joint Clinical Assessment

The Joint Clinical Assessment is a streamlined process involving multiple European Member States in a joint HTA of a medicinal product or medical device. The main goal of this procedure is to avoid duplication of work at the national level, increase consistency and quality of assessments, and ultimately facilitate patient access. The procedure is expected to take place during the national price and reimbursement stage and will include the participation of patients, clinical experts, and other relevant experts. This procedure will be available in a phased scope for medicines. Starting in January 2025, it will be available for cancer drugs and advanced therapy medicinal products (ATMPs). From January 2028, it will include orphan medicines. By January 2030, after the implementation phase, the Joint Clinical Assessment will reach its full scope.

The Stakeholder Network

The HTAR also involves the creation of the HTA Stakeholder Network, established to facilitate contributions from a wide range of stakeholders to HTA-related policy development in the Member States. This Network was formed through an open call for applications that closed in February 2023. Eligibility criteria for participation in this network included proof of engagement in HTA, relevant professional expertise, geographical EU coverage, and communication and dissemination capabilities.

Conclusion

The HTAR, which will apply starting next year, signifies the co-creation of a new system with inclusiveness and transparency as key principles of joint work. This is based on the commitment of patients and healthcare professionals to ensure smooth implementation.

For more information on the new HTA Regulation, check it out here.

https://health.ec.europa.eu/health-technology-assessment/regulation-health-technology-assessment/implementation-regulation-health-technology-assessment_en

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