What remains at the National Level?

What remains at the National Level?

Pricing and reimbursement of health technologies under the regulation will not be decided at the European level. These decisions are taken by the respective Member States applying their national HTA and decision-making process. They shall give due consideration to the output of the JCA report, (if  available or expected at the time of a national HTA).

Member States can as well decide on the added value of a health technology in the context of their specific healthcare system and shall consider the parts of available JCA reports relevant in that context.

If one considers the lifecycle of a new medicinal product from inception to the point of usage in healthcare, under the HTAR , Figure 7 shows a high-level overview that can be drawn:

Figure 7: Overview of regulatory and HTA processes under the HTAR

Adapted from: Extrapolation of data Need for innovative HTA methods. Goetsch (2023) Zorginstituut Nederland. Available at: Dias nummer 1 (rsnn.nl)