The European Commission said Friday that it has officially adopted a new regulation explaining how it will cooperate more closely with the European Medicines Agency on health technology assessments (HTAs), which typically review the cost and benefits of new drugs.
The new joint clinical assessments aim to help EU member states with their own separate assessments for new medicines. But these collaborations won’t focus on economic assessments or offer any conclusions on pricing and reimbursement, the EC said.
Beginning Jan. 12, 2025, new cancer drugs and advanced technologies such as cell and gene therapies will start facing joint clinical assessments from the EC and EMA. By 2028, all orphan drugs will also face the joint assessments, and in 2030 all new medicines will fall under the new HTA regulation.
An EU member state coordination group will be created to help assess the necessary expertise to craft these joint clinical assessment reports for each new drug. The regulation notes that the reports shall not contain “any value judgment or conclusions on the overall clinical added value of the assessed health technology and shall be limited to a description of the scientific analysis.”
The EC said that pricing and reimbursement decisions will be driven by EU HTA bodies who are responsible for drawing their own conclusions on added value for their health systems.
The regulation also defines the information to be shared between the EC and EMA on the planning and forecasting of joint clinical assessments and joint scientific consultations, identifying experts to help with the joint procedures and on general scientific and technical matters related to an HTA.