SBU and the HTA Regulation

What is the HTAR? 

The HTAR first came into effect in January 2025 in order to coordinate the assessment of medicinal products and certain medical devices at an EU level.

The regulation requires the authorities of member states to jointly assess the relative effectiveness and safety of new health technologies. Relative effectiveness and safety are metrics used to compare these aspects of one treatment in relation to another. Such assessments will then inform the decisions made by each member state on subsidising or financing medicines and certain health technologies.

The aims of this new collaborative initiative are to expedite access to new health technologies for patients, support the member states in their assessment and advisory activities, reduce the administrative burden and promote innovation and growth in the EU.

The bodies participating in the governing HTAR processes in Sweden are the Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU) and the Dental and Pharmaceutical Benefits Agency (TLV).

How will the HTAR be implemented?

The HTAR will be implemented in four phases. The first phase, which commenced on 12 January this year, covered cancer drugs and advanced therapy medicinal products (ATMP). Certain medical devices and orphan drugs will be subsequently included.

As of 2030, all medicinal products that undergo the central European Medicines Agency (EMA) regulatory procedure for centralised marketing authorisation will be included in the process. It is estimated that the number of joint clinical assessments will amount to around 120 applications annually.

Medical devices will be subjected to regular selection with a focus on high-risk products (class IIb and III, such as ventilators, pacemakers and implants) along with in vitro diagnostic medical devices classified as class D.

The HTAR also covers scientific advice, the identification of new health technologies (horizon scanning) and the possibility of voluntary cooperation in areas outside the scope of mandatory cooperation.

How is SBU working with the HTAR?

To ensure a smooth transition and the efficient application of the HTAR, SBU and other relevant authorities have been aligning national processes with the new EU requirements. SBU has also been involved in the preparatory work at EU level, contributing to the development of common guidelines and regulations, which is essential to ensuring that the joint clinical assessments are of a consistently high standard and of use to member state decision-making.

At a national level, SBU joined TLV and the Swedish Medical Products Agency last year to explore possible avenues of collaboration among Swedish government agencies (see report, in Swedish).

It is the responsibility of SBU to gather opinions from Swedish patient associations in the initial stage when the scope of the joint clinical assessment is to be determined through a PICO process (STEP 2. Determination of PICO). The TLV will simultaneously be gathering the opinions of clinical experts on the PICO measures.

The PICO process sets the questions that an assessment is to answer, and in this regard it is important that the Swedish patient perspective is safeguarded. SBU will be arranging instruction sessions for the relevant patient associations on the HTAR and the work it will entail. This year, these sessions will be targeted primarily at patient associations focusing on cancer and ATMP.