Health Technology Assessment and a new EU Regulation – Part I

Part I: What is it about?

What is Health Technology?

Examples of health technologies include medicinal products, medical equipment, diagnostic and treatment methods, rehabilitation, and prevention methods.

What are Health Technology Assessments?

In recent years a number of countries have introduced so-called health technology assessments (HTA). HTA measures the added value of a new health technology compared to existing ones, analysing the safety and efficacy of a health technology in combination with an economic analysis of the intervention’s cost-effectiveness. The aim of these studies is to establish the ratio of the price of the technology to its health and quality-of-life benefits. Examples of health technologies include medicinal products, medical equipment, diagnostic and treatment methods, rehabilitation, and prevention methods.

What is the purpose of HTAs?

The main purpose of HTA is to provide policy-makers with evidence based information, so they can formulate health policies that are safe, effective, patient-focused and cost-effective. It is also used by national authorities to help decisions on which technology should be reimbursed at national level.

Regulation (EU) 2021/2282 on health technology assessment

A new harmonised regulation on health technology assessment has been adopted across the EU. Regulation (EU) 2021/2282 on health technology assessment and amending Directive 2011/24/EU entered into force in January 2022 and will apply from January 2025. The implementation work starts now, including the setting up of the necessary governance structure and preparatory documents to ensure effective application from this date. The HTA Regulation replaces the current system based on the voluntary network of national authorities (HTA Network) and the EU-funded project-based cooperation (Joint Actions EUnetHTA) with a permanent framework for joint work. The new framework covers joint clinical assessments, joint scientific consultations, the identification of emerging health technologies, and voluntary cooperation.

Why it matters

“The Regulation on health technology assessment (HTAR) contributes to improving the availability for EU patients of innovative technologies in the area of health, such as medicines and certain medical devices. It ensures an efficient use of resources and strengthens the quality of HTA across the Union.” Reference; https://ec.europa.eu/health/health-technology-assessment/regulation-health-technology-assessment_en

Interested to learn how it will impact your business should you have products or services that can/should be reimbursed at national level in the EU? Follow us on LinkedIn for our next read: “Part 2: How and when will it impact your business?”