European cooperation on joint health technology assessments of medicinal products and medical devices has been developed over several years. Over the past year, the work has gained considerable momentum. The first joint European health technology assessment, known as a Joint Clinical Assessment (JCA) report, was adopted this spring. Three new reports have now been published, and 15 products are currently undergoing assessment through the new process.
The reports provide a joint assessment of the relative clinical effectiveness and safety of a product compared with the treatment options currently in use. The assessments are carried out by two EU/EEA Member States and are subsequently reviewed and approved through the European HTA cooperation framework.
Taking a leading role
Since the beginning of the cooperation, NOMA has taken a leading role in several working groups, including the HTA Coordination Group. NOMA Director General Trygve Ottersen chairs the European network of Heads of HTA Agencies.
“We are now seeing positive and exciting developments across Europe, as we work together to make better use of our scientific expertise and resources and to make our processes more efficient. The overarching goal is to provide a faster and better basis for decisions that are in the best interests of patients,” says Trygve Ottersen, Director General of NOMA.
Two products currently being assessed by NOMA
One of the two products currently being assessed by NOMA is the gene therapy lunsotogene parvec, for an inherited form of hearing loss in adults and children. The other is a medical device intended for use in the cardiovascular system.
“It is important that health services are able to prioritise new medical products that provide significant added benefit compared with products already in use. There can be substantial differences between new products in this respect. Ultimately, it is about making the best possible use of society’s resources for the benefit of the population as a whole,” says Ottersen.
An important part of European cooperation also involves joint scientific advice, known as Joint Scientific Consultations (JSCs). These consultations give developers of medical devices and medicinal products the opportunity to receive advice from HTA bodies at an early stage of planning their clinical studies. The advice covers the planned clinical study, as well as the information and evidence requirements that will underpin a subsequent joint health technology assessment (JCA).
“Through both health technology assessments and scientific advice, the new HTA Regulation has the potential to strengthen Europe and Norway in several ways: by supporting innovation, enhancing competitiveness and improving preparedness in a challenging geopolitical situation. We have already achieved a great deal, but there will be challenges ahead. All stakeholders will need to learn, and the system will need to continue to evolve,” Ottersen concludes.
Go to the European Commision webpage concerning JCA. On this page you may click on the link "Joint clinical asessment tracker" in order to see an overview of ongoing JCAs.