Industry Welcomes Mandatory EU Joint Clinical Assessments For HTA
Executive Summary
Draft proposals to improve EU-wide cooperation on health technology assessments, including mandatory joint clinical assessments, have won support from EFPIA, the European Federation of Pharmaceutical Industries and Associations.
New legislative proposals from the European Commission aim to reinforce cooperation among EU member states on health technology assessments (HTAs), including mandatory cooperation in joint clinical assessments, scientific dialogues, horizon scanning and voluntary cooperation in other areas. The proposals, which apply to innovative products, are a “positive step,” according to EFPIA, the European Federation of Pharmaceutical Industries and Associations.
Currently different member states have different procedures for HTA, which means a lack of predictability and higher costs for companies, delays in access for patients, duplication of work and inefficient use of resources for the numerous national and regional HTA bodies. The commission believes that these issues cannot be solved through voluntary approaches to joint work, as decades of project-based EU cooperation have shown. It adds that the current project-based EU level cooperation is funded only in the short-term and is not guaranteed to continue.
“EFPIA believes that joint clinical assessments will facilitate faster access, avoid duplication at national level and deliver greater consistency, clarity and predictability for everyone involved in the process” – EFPIA
The commission hopes that its proposed Regulation on Health Technology Assessment and amendments to Directive 2011/24/EU on patients' rights in cross-border healthcare will improve the situation by ensuring greater cooperation across Europe on joint clinical assessments, joint scientific consultations, joint horizon scanning and voluntary cooperation in other areas.
Joint clinical assessments would be one of the most important “proponents” of forthcoming joint work, according to the commission. These will cover medicines and some medical devices. They would be carried out for new active substances undergoing Europe’s centralized marketing authorization procedure and existing products when marketing authorization is being extended to a new indication.
Commissioner for Health and Food Safety, Vytenis Andriukaitis told the Pink Sheet that it would be the most innovative products that would come under scrutiny, for example “advanced and individualized therapies and those based on new concept of innovation.” The assessments would look at whether the product in question offers real innovation or simply “innovation on paper that creates nothing new” and whether it offers additional value compared to existing treatments.
Andriukaitis emphasized that the mandatory joint clinical assessments would only cover the clinical element of HTA and that the non-clinical side, for example, economic, ethical, social or organizational elements of the overall assessments, would remain matters for individual member states. He added that member states would be able to draw their own conclusions on the overall added value of the product.
According to the proposals, there is no obligation for member states to actually conduct an HTA on a product that has undergone a joint clinical assessment. However, if member states do choose to carry out an HTA on such products, use of the joint clinical assessment report is mandatory. Andriukaitis emphasized that there will be a safeguard clause that would allow member states to carry out a clinical assessment using a different methodology to the one outlined in the proposals. This could be invoked on the grounds of protecting health, but member states would have to notify the commission of their decision and justify it.
The joint clinical assessment report would be available around the time of the commission’s final decision on whether to grant marketing authorization, which the commission hopes would be timely for decision making in member states.
A Member State Coordination Group on HTA would be established and be made up of representatives from national HTA authorities and bodies. Among other duties, the group would oversee the joint clinical assessments. According to Andriukaitis, the door could still be open for England’s influential HTA body NICE to take part, depending on the details of the Brexit deal the UK strikes with the EU.
Joint Scientific Consultations And Horizon Scanning
The commission’s proposals also allow for developers of health technologies to request a joint scientific consultation. This would allow companies to seek advice from HTA bodies on the data and evidence that they are likely to need as part of a potential joint clinical assessment.
The commission is also 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.
The proposals also ensure that further voluntary cooperation across the EU is possible in other areas, for example on health technologies other than medicines and medical devices, or on economic aspects of health technologies.
The European Parliament and the Council of the EU must now discuss the proposed regulation before it can be adopted and enter into force. After the new legislation becomes applicable, there is likely to be a three-year transition period to allow member states to adapt to the new system.
Reactions
According to EFPIA, continued collaboration on how to introduce innovative new therapies will be vital. “HTA is an important part of that process, informing health care decision makers about the relative value of health technologies. In our view, the Commission’s proposals represent a positive, collective step forward in supporting access to new treatments for patients across Europe,” said EFPIA director general Nathalie Moll
The federation believes that joint clinical assessments will lead to faster access and avoid duplication of work at a national level, and deliver more consistency and predictability for all involved in the process. Meanwhile, it thinks that the joint scientific consultations will help ensure that development programs meet the data and evidence demands of regulatory and clinical benefit assessments. And joint horizon scanning will allow for better management and planning of the introduction of important new therapies.
Nevertheless, the federation adds a caveat. “Like with any substantial policy development, there will be areas of implementation that require further examination and discussion.” It says that it looks forward to further dialogue with all stakeholders to make sure the proposals “achieve the shared goal of improving the availability of innovative health solutions to patients across Europe.”
From the editors of Scrip Regulatory Affairs