The European Commission (EC) has recently set out its draft proposal for adopting an EU-wide health technology assessment (HTA), to determine the clinical efficacy of a product. The aim of the proposal is to improve patient access and reduce resources (from both a member state and pharmaceutical industry perspective) required to determine the clinical effectiveness of new treatments. However, will this be the case in practice, or will this new EU legislation result in an additional hurdle to achieving patient access, requiring additional resources?
The EC’s case for an EU wide HTA clinical assessment is based on some well-grounded realities:
- Currently, market access for innovative technologies is impeded and distorted due to differing national or regional processes and methodologies for HTAs and decision makers across Europe
- There is a lack of business predictability, higher costs for industry, delays in access to technologies, and negative effects on innovation
- There is significant duplication of work for national HTA bodies resulting in inefficient use of resources and limited transparency for patients
The proposal would overhaul the current largely national approach to HTA, and includes provisions for the mandatory use of common HTA tools, methodologies and procedures across the EU to perform:
- Joint clinical assessments focusing on the most innovative and potentially impactful medical technologies for maximum EU-added value
- Joint scientific consultations whereby developers of a medical technology can seek the advice of HTA authorities on what type of data and evidence is likely to be required in the submission for HTA
- Identification of emerging medical technologies to help ensure that the most promising health technologies for patients and health systems are identified early and included in the joint work.
Commissioner Vytenis Andriukaitis has stated that “We now have an opportunity to establish a mechanism that ensures that HTA is used to its maximum potential throughout the EU. I believe that joint assessments would not only help patients to have access to the most effective health technologies, but would also contribute to the sustainability of health care systems.”
However, these proposals have been met with a cool response from individual member states, notably France and Germany. Particular concerns include the mandatory adoption of clinical assessments, and the fact that cooperation into the assessment is not voluntary. They feel that the EC is overstepping its boundaries with regards to its health policies and that HTA assessments should remain a member state activity.
It is clear from the level of resistance posed by Health Ministers at a recent EC meeting that amendments will have to be made to the proposal if it is to be approved by the European parliament in October. There is hope within the EC that the member states’ concerns over the proposal can be addressed, for example by enabling member states to conduct additional clinical assessments if they were not included within the joint clinical assessment. The EC have however, stated that the mandatory adoption of the joint HTA is a core aspect of the proposal and will not be removed.
So, what does this mean for pharmaceutical companies?
- Earlier submission of HTA dossiers. The EC propose to publish the clinical assessment shortly after European Medicines Agency (EMA) approval. They envisage the assessment starting around the time of Committee for Medicinal Products for Human Use (CHMP) opinion. Whilst this may lead to faster pricing and reimbursement approval by decision makers, it does mean that companies will need to prepare the HTA dossier prior to CHMP opinion. It is worth noting that the new National Institute of Health Care and Excellence (NICE) procedure has a similar timeline, indicating that as a result of Brexit, companies are likely to have to prepared two comprehensive HTA submissions prior to CHMP opinion! This could have a significant impact on company resources during a time when the company is traditionally focused on the EMA submission
- Theoretically, companies will only have to make one clinical assessment submission which should increase transparency, reduce resources and also minimise uncertainty over how the clinical benefit will be determined. However, any economic considerations, such as cost effectiveness analysis, will still be conducted at a member state level, as will pricing and reimbursement negotiations. This means that a country level pricing and reimbursement submissions will still be required, thereby limiting the resource savings from a joint clinical assessment
- The extra cooperation should particularly benefit smaller countries, especially considering the high quality of assessments by some member states. Many Eastern European states still do not have the capabilities to do their own HTA, and rely on the findings of bigger countries like Germany and the UK, therefore this could facilitate patient access for these countries
- The ongoing joint scientific consultations will continue to support companies in understanding the payer relevant data required for clinical assessments, thereby providing insights into how to amend their Phase III clinical trial designs.
The EC are confident that an EU-wide HTA clinical assessment is a positive step for pharmaceutical companies, with Commission Vice-President Jyrki Katainen stating that “Healthcare companies will benefit from clearer rules and greater predictability”.
The EC, under the Austrian presidency, will continue to discuss this proposal with the aim of adopting its position in October. The rules will become applicable three years after the adoption. A further three-year transitional period is granted for EU countries to fully adapt to the new system. During this transition period the EC expect the number of joint clinical assessments to gradually increase from 10 to 15 assessments in the first year of operation, rising to around 65 joint clinical assessments towards the end