The European collaboration on health technology assessments under the HTA (Health Technology Assessment) Regulation is now well underway.
Totally 15 medicines are currently undergoing the same process, and several more assessments are expected to start during 2026. These reports provides a joint European assessment of the medicine’s relative clinical effectiveness and safety.
NOMA actively involved in the collaboration
“It is important that expertise and assessment capacity are utilised as efficiently as possible across European countries. Several experts at DMP have been actively involved in this collaboration,” says Trygve Ottersen, Director General of NOMA
For medicines covered by the HTA Regulation, the Joint Clinical Assessment report will provide a common European assessment of relative clinical effectiveness and safety. Economic evaluations, appraisal processes and reimbursement or implementation decisions will continue to be conducted at national level by each individual country.
Encouraging early dialogue with suppliers
NOMA has now updated its submission templates for health technology assessments to align with the requirements and processes under the European HTA Regulation.
“We encourage suppliers and marketing authorisation holders to engage in early dialogue with DMP regarding the national HTA process where needed. We have already established constructive collaboration with industry stakeholders on the implementation of this framework, and we intend to continue that close cooperation,” says Ottersen.
There are several different types of health technology assessments, each with distinct documentation requirements.
Updated submission templates
To clarify which parts of the submission dossier are now covered through the European JCA process, NOMA has updated the national documentation templates for submissions.
Important information for suppliers:
- NOMA offers early national dialogue meetings with suppliers to clarify the Norwegian PICO and provides pre-submission meetings to guide companies on additional documentation requirements for national assessments.
- The first submissions under the new framework will function as pilot procedures, and processes may be adjusted based on experience gained during implementation.
- Suppliers may submit requests for national health technology assessments before the public release of the JCA report. However, DMP will not initiate formal assessment procedures until the JCA report has been published.