Europe
The new European Health Technology Assessment (HTA) regulation came into force in January. The main goals of this EU HTA regulation (EU HTAR) are: to improve and speed up the availability of innovative medicines and medical devices to patients across the EU; to ensure efficient use of resources; and to strengthen the quality of HTAs. Until now, European countries have been separately investigating the costs and benefits of a new drug before deciding whether or not to reimburse it. With the introduction of the EU HTAR, this clinical assessment is done collectively: the so-called Joint Clinical Assessment (JCA). Manufacturers of medicines or devices submit an EU-wide dossier for this purpose.
The new rules are being introduced in stages. From today, the EU HTAR will apply to new cancer drugs and advanced therapies (ATMPs). Orphan drugs will follow in three years, in January 2028. And from 2030, all new medicines will be covered by the HTA rules. The assessment of the product value and the subsequent decisions on reimbursement and pricing of the new product will remain within the competence of individual member states.
Furthermore, the EU HTAR entails that clinical assessment must be completed within 30 days of a medicine’s approval. And that patients and healthcare providers are systematically consulted during the preparation of assessments, along with other stakeholders in the field.
Source: EU HTAR van kracht – Vereniging Innovatieve Geneesmiddelen