BACKGROUND:

As countries face increasing budget constraints, technological advance is leading to a dramatic shift in the way healthcare technology assessment (HTA) bodies evaluate and inform national pricing and reimbursement decisions. This has led the European Commission to create the Joint Clinical Assessment (JCA) initiative among the new EU-HTA regulation that aims to avoid duplication of effort to provide homogeneous outcomes across countries.

OBJECTIVES:

We aim to provide an overview of this recent initiative, as well as provide Alira Health’s outlook on the various opportunities and challenges for drug manufacturers.

METHODS:

A narrative literature search was conducted on publicly available information to draw conclusions on the JCA process and its impact for drug manufacturers.

RESULTS:

The JCA will provide qualitative and timely reports on the relative clinical effectiveness and safety of the product and will be applied to all centrally authorized drugs and some medical devices. The JCA may be preceded by Joint Scientific Consultations (JSC) involving a network of healthcare professionals and patients’ organizations that will better contextualize the unmet need, map out data and evidence required at the European level, and provide drug manufacturers with inputs to anticipate and tailor access requirements. These changes will also lead to additional evidence requirements in countries that lack HTA expertise or infrastructure.

CONCLUSIONS:

As the JCA will constitute the basis of national HTA and subsequent price negotiations which will remain at country-level, it will be an important precedent for drug manufacturers in their future interactions with HTA bodies. As the HTA environment is shifting, manufacturers will be forced to adapt and effectively shape internal and external strategies.