The 2018 European Commission proposal for regulation on HTA for assessing health technologies were adopted by the European Parliament’s Committee on the Environment, Public Health and Food Safety on 13 September 2018. The committee report was endorsed in plenary on 3 October 2018. The report proposes 200 amendments to the Commission proposal
The proposal covers new medicines and certain new medical devices. It focuses the future cooperation (the ‘joint work’) on assessing clinical aspects of HTA, namely: the description of the health problem addressed by the health technology and the current use of other health technologies addressing that health problem; the description and technical characterisation of the health technology; the relative clinical effectiveness and the relative safety of the health technology. Member States would continue to be responsible for assessing non-clinical (e.g. economic, social, ethical, organisational) aspects of HTA, as well as for making decisions on pricing and reimbursement.
EUnetHTA has already published 15 guidelines that form the basis of a framework for joint clinical assessment (JCA) methodologies in the EU. The main areas covered by these documents for pharmaceuticals include comparator selection, level of evidence, evidence synthesis, health-related quality of life (HRQL) and utility measures, internal validity of studies, personalized medicine, and methods for health economic evaluations.
Two further guidelines are in the pipeline.