Member States and the European Parliament are currently discussing the European Commission’s legislative proposal for a cooperative approach on Health Technology Assessment (HTA) across Europe which could ultimately benefit patients who are experiencing delays with potentially life-changing treatments.
As the pressure on healthcare systems around the world steadily increases due to aging populations and the growing prevalence of non-communicable diseases such as diabetes, cancer and cardiovascular diseases, timely access to innovative medicines is of paramount importance. Currently, different European Member States have different procedures for HTA. This results in delays in access for patients, duplication of work and inefficient use of resources for the numerous national and regional HTA bodies, as well as a lack of predictability for industry.
Current fragmented approach is impeding patient access
HTA is the name of the procedure that assesses the value of new medicines in comparison to current treatment options. HTA looks at the clinical, social, economic and ethical impacts of new medicines. This assessment is a key resource for all EU countries to ensure an adequate level of accessibility, quality and sustainability of their individual healthcare systems.
The current HTA process for the assessment of clinical data is fragmented; varying methodologies and processes at national and/or regional levels mean that patients in some countries have to wait longer than in other countries to access innovative treatments. Such fragmentation leads to the repetition of work for national HTA bodies and for industry which ultimately lowers efficiency.
The EU Commission set out a proposal to streamline the current national clinical assessment processes and predicts that it could deliver a benefit to patients, national HTA bodies and industry players.
The EU Proposal: Four Pillar Approach
Joint clinical assessments
Joint clinical assessments cover the clinical element of HTA (i.e. safety and clinical effectiveness)
Joint scientific consultations
This would allow developers of a new health technology to seek advice from HTA bodies on the data and evidence that they are likely to need as part of a joint clinical assessment.
Identification of emerging health technologies
The European Commission is proposing an annual study identifying emerging health technologies that potentially have a major impact on patients, public health or healthcare systems early on in their development.
Voluntary cooperation across the EU in other areas, for example on health technologies other than medicines and medical devices, or on economic aspects of health technologies.
Joint clinical consultations and assessments should facilitate faster patient access
Among the four pillars outlined in the European Commission proposal on HTA, joint scientific consultations and joint clinical assessments are the most promising for patients.
The proposal to carry out joint scientific consultations (in parallel with the European Medicines Agency) is welcomed by industry. Joint consultations are a chance for pharmaceutical companies to discuss clinical data requirements during the development phase of a new medicine – evidence which is ultimately needed during joint clinical assessments.
Joint clinical assessment would replace the equivalent individual national assessments that currently take place. This avoids repetition of work at a national level while delivering greater transparency and predictability for all stakeholders.
In order for the joint clinical assessments to work well, Bayer strongly supports and recommends mandatory adoption of the joint clinical assessments by Member States. A mandatory uptake guarantees that clinical assessments are not repeated in the individual HTA processes of the Member States.
While the Commission proposes conducting joint clinical assessments at a European level, it is important to note that individual EU countries will continue to be responsible for assessing non-clinical (i.e. economic) aspects of health technology. Decisions on pricing and reimbursement will therefore remain strictly in the hands of the individual Member States.
Continually working together to ensure patient benefit
Patients, Member States and industry are set to benefit from the proposed joint clinical assessment at the European level. For patients, the availability of one joint clinical assessment report at the time of marketing authorization should expedite patient access to new medicines. For national healthcare systems, it avoids repetitive work on clinical assessments, leading to a better use of human and financial resources, while also helping Member States benefit from each other’s expertise.
Bayer welcomes the European Commission’s proposal to strengthen EU cooperation on HTA which should ultimately lead to faster patient access to innovative medicines. It also supports synergies in a common understanding of clinical evidence needs and assessment by Member States, ensuring sustainability of HTA cooperation in Europe beyond 2020.
Bayer looks forward to continuing the dialogue with Member States, the European Parliament and other stakeholders to ensure that the final text mirrors our common objective to improve solutions for patients across Europe.