The European Network for HTA (EUnetHTA) was set up in 2006, to promote more collaboration and harmonisation in the EU, by linking national Health Technology Assessment (HTA) agencies, research institutions and health ministries. EUnetHTA was built to find the answer to a single question: How to create, facilitate, and promote sustainable Health Technology Assessment (HTA) cooperation in Europe?
To help address this question, EUnetHTA has developed and is piloting a joint relative effectiveness HTA, known as joint assessments, produced by at least four EUnetHTA partners in different European countries. The aim of these joint assessments is the production and use of reliable, timely, transparent reports to support patients’ access to effective health technologies.
These joint assessments currently focus on the clinical considerations of an HTA using the processes, guidelines and the HTA Core Model®, developed by EUnetHTA over the past nine years. To date, five joint assessments have been completed with six assessments currently on-going.
In May this year, EUnetHTA published an assessment of how HTA bodies and companies were utilising these joint assessment evaluations.
HTA organisation considerations:
Whist 18 EU countries reported using at least one joint assessment within their HTA evaluations, it is clear the majority of HTA bodies are only using these reports as background information, rather than extracting the information and using it to inform their own decision making. For example, only seven HTA bodies used the systematic literature searches conducted as part of the joint assessment, with the remaining HTA bodies requesting the information from the company or conducting their own systematic literature reviews. The HTA bodies reported the following three reasons for not using the joint assessment results within their own HTA evaluation
- the requirement to prepare reports in their national language
- the requirement to use a specified report structure
- the timing of the availability of the EUnetHTA assessment
The extent to which timing is a limiting factor varies by country, with the timing of EUnetHTA assessments less of an issue for countries where pharmaceuticals typically go later to market.
The European Federation Pharmaceutical Industry Association (EFPIA) have also recently conducted a survey with HTA bodies to determine what the limiting barriers are to implementing a standard HTA assessment. The concerns identified were aligned with those highlighted by EUnetHTA. EFPIA have highlighted that it would be relatively straight forward for these issues to be addressed, should there be a willingness from the HTA bodies to do so.
Company considerations:
From a company perspective, the feedback is a little more encouraging. All the pharmaceutical companies involved in a joint assessment used the report produced by EUnetHTA in their subsequent local HTA submissions. However, they all noted that they have to adapt the report to meet local HTA requirements. No company submitted the joint assessment report as a stand-alone document.
The limiting factors by companies were identified as:
- Reporting structure: Company submission must use a specified structure
- Language: Company submission must be in the national language
- Timing: The EUnetHTA documents were not available
- Relevance: Different content information was needed by different HTA bodies
What next?
So, where does this leave EUnetHTA and the joint assessment pilots? It is clear that EUnetHTA have taken onboard the criticism and amended the process to reduce the time taken to produce an assessment. It is also clear EUnethHTA is achieving some of its core aims, for example, Croatia has recently implemented the EUnethHTA methodology into their national HTA assessments and will embed the findings from EUnetHTA joint assessments into their evaluations. Other countries have also implemented part of EUnethHTA tools into their national assessments. However, for the major EU countries there appears to be little appetite for them to adapt their processes to be aligned with EUnetHTA’s processes they continue to demand that companies adhere to their local HTA methodologies and templates.
These EUnetHTA pilot joint assessments have shown that through EUnetHTA stakeholders can collaborate successfully to produce European reports of relative efficacy. However, the current process still needs to be modified to address the issues raised by the pilot. There also needs to be more willingness from HTA bodies to adapt their current processes to enable these joint assessments to be integrated into local assessments to facilitate patient access to new therapies.