The latest policy document from the European Commission on Strengthening of the EU cooperation on Health Technology Assessment (HTA), outlines multiple scenarios for HTA harmonisation. Most of these scenarios encourage enhanced cooperation. This begs the question: Are HTA processes destined for closer cooperation, potentially even moving towards an ‘EMA like’ process, or will the current individual country assessments prevail?
Currently, HTA are estimated to cost €30,000– €100,000 per assessment. Therefore, publication of one joint multi-country report could lead to significant savings. To be clear the EU commission acknowledges that pricing and reimbursement is the sole prerogative of the member states, but efficiencies can be achieved by harmonising HTA processes.
One of the early initiatives on European cooperation on HTA was the EUnetHTA Joint Action 1 (2010–2012), which lead to Joint Action 2 and the recently announced Joint Action 3 (JA3). Joint Action 3 was launched on the 1st June 2016 and will run until 2020 with a budget of ~EUR20 million. The Joint Action initiatives have focused on developing common HTA methodologies, piloting joint Relative Effectiveness Assessment (REA) and Full HTA reports, and on developing and maintaining common tools. So far over 20 joint reports and 20 early dialogues have been undertaken under these initiatives and it is envisaged that another 80 joint reports and 35 early dialogues will be conducted under JA3.
In parallel, the EU HTA network was set up in 2013. This network involves representatives of health ministries or competent authorities responsible for HTA and focuses on shaping HTA strategy and policy aspects. Whilst the body is voluntary, all EU member states have applied, showing the desire for closer cooperation on HTAs.
Given these recent developments in HTA cooperation and harmonisations, the European Commission report outlines five potential scenarios for the continuing evolution of HTA:
The status quo – Joint Action until 2020
HTA is regulated and organised at national/regional level. In parallel, the Commission and the Member States have set up a voluntary cooperation mechanism through the Joint Actions and the HTA Network. This is the current scenario, under which there is relatively limited harmonisation of HTA process. The default scenario is that manufacturers are required to go to each individual member state, where an HTA assessment is undertaken. Also, the initiative would cease once the funding period is completed in 2020.
Long-term voluntary cooperation (financed by the EU beyond 2020)
Under this scenario, the current model will continue beyond 2020, when JA3’s funding ceases. The main difference to scenario one is that the short-term financing of Joint Actions will be replaced by a long-term mechanism so the sustainability of the cooperation is ensured and improved. The funding would primarily be used to develop tools and methodologies. In the longer term, manufacturers could choose whether they require individual or joint HTA.
Cooperation on collection, sharing and use of common tools and data
This scenario represents a more integrated approach and requires a legal framework for HTA cooperation, enabling the efforts by national bodies to be compatible, shared and used. It would facilitate cooperation of Member States, and ultimately allow production of joint REA reports on a voluntary basis. This option is likely to appeal to industry, as it would provide a clear pathway for the implementation of HTA assessments.
Cooperation on production of joint REA reports and their uptake (cooperation on clinical/medical matters)
Scenario four envisages that Member States jointly produce REAs, which are available to all through a shared database. The REAs would then be used for individual country pricing and reimbursement decisions. The cooperation would be limited to REA reports. The assessment of non-clinical domains (such as cost effectiveness) would remain under the responsibility of Member States.
Cooperation on production of joint Full HTA reports and their uptake (cooperation on cost-effectiveness)
Scenario five envisages the joint production of full HTA reports, including an assessment of clinical/medical, economic, ethical, legal and organisational domains. Significant country/context-specific data would be required. The proposal does not specify whether participation in assessment development and uptake was mandatory or voluntary. Structures, process and a potential organisation would be required to make this scenario a success.
In summary, scenarios one and two are essentially maintaining the current status quo, which is largely based on voluntary cooperation from all stakeholders and depending on EU funding. Scenarios 3, 4 and 5 are of increasing complexity regarding the harmonisation of HTAs. Options 4 and 5 would require establishing a permanent central structure in charge of managing the preparation, coordination and follow-up of joint HTA reports. This could bring higher added value in terms of quantity, quality and ensured uptake of the joint reports. Depending on its implementation, this could be very positive for manufactures and patients alike, as it could significantly reduce time and resources to get new products to patients.
Overall, the European Commission expects more cooperation between HTA authorities in the future. How far and how fast HTA cooperation is achieved, will partly depend on the success of Joint Action 3. It will also depend on the Member States themselves and the political will to drive HTA cooperation forward. Currently, there are pros and cons for pharmaceutical manufacturers. But whatever the final scenario, manufacturers must keep engaging in the process and discussion, to ensure that they positively influence the outcome.