LONDON – The European Parliament has voted in favor of a new regulation on health technology assessment (HTA), a significant step towards creating a pan-European system for conducting cost-effectiveness appraisals.
The aim of the legislation is to end duplicate national assessments undertaken to determine the added value of new drugs and medical devices.
Soledad Cabezon Ruiz, member of the European Parliament (MEP) who steered the proposal through, likened it to the HTA equivalent of the European Medicines Agency (EMA).
There were mixed reactions from industry, with pharma welcoming the prospect of a single appraisal to replace the string of national assessments their products currently undergo. But there is concern the European Parliament had watered down a proposal which would have required all member states to use the joint HTAs, and stop conducting their own.
The med-tech sector, on the other hand, would come under the scope of comprehensive HTA for the first time and is more resistant, making the case that it should not fall within the scope of HTA until implementation of other new EU regulations relating to the sector, is complete.
Currently, more than 50 national HTA bodies are operating in the EU, using different methodologies and requiring companies to provide varied types of evidence to show their products offer greater medical benefits and to support pricing and reimbursement decisions.
That is distorting market access, impeding uptake of innovative therapies and medical devices and constraining economic growth, according to the European Commission, which drew up the regulation.
The regulation is deliberately framed around ending perceived distortions in the EU single market, to avoid any accusations the Commission is stepping into national health care policy, which under the EU principle of subsidiarity is entirely the jurisdiction of member states.
"The Commission's proposal was a timely proposal," Cabezon Ruiz said, opening the debate on Wednesday. Research has to be better aligned with medical needs and high prices reined back to promote sustainability of Europe's publicly funded health care systems, she said.
The regulation, "will improve the access of European citizens to medicines and new health products."
Cabezon Ruiz pointed a finger at new cancer drugs, saying that despite prices increasing up to 10-fold, only 15 percent of products have been shown to increase survival by more than five years. While the drugs may have met the safety and clinical efficacy standards required by EMA to get to market, they have not all proved to be cost-effective.
The current system in which member states carry out their own HTA evaluations results in time-consuming and costly duplication. But it also means there is a lost opportunity, "to improve the available clinical evidence, to direct the priorities of research to the medical needs of patients, to improve the quality of research, and ultimately, access to medicines," Cabezon Ruiz said.
In particular, she said there needs to be more evidence of the cost effectiveness of medical devices.
Pharma may have railed against HTA since it was first introduced to the system by the U.K.'s National Institute for Health and Care Excellence, following its formation in 1999. However, with HTA now a regular feature across Europe, the industry is broadly in favor of a system for conducting single assessments.
"It makes sense to join forces to provide one, high quality clinical assessment for use across Europe," said Nathalie Moll, director general of the European Federation of Pharmaceutical Industries and Associations. "This will support better decision-making and ultimately benefit all patients," she said.
However, Moll is not pleased that the European Parliament did not back the Commission's original proposal that member states be required to use joint HTA assessments in their national pricing and reimbursement processes, leaving the door open for countries to conduct their own "complementary assessments."
As Moll noted, member states would have a duty to ensure joint clinical assessments are "of high quality and fit for national use." Given this, "It should follow [member states] have confidence in their own work and that of their peers," she said.
Only by guaranteeing the use of joint HTAs and avoiding unnecessary duplication, can patients really benefit from the increased consistency, speed, transparency and quality of assessments, Moll said.
The risk in allowing "complementary assessment" is that rather than reducing complexity, the legislation introduces a fourth layer of pan-European HTA, to add to EMA scrutiny, national HTA and pricing and reimbursement.
The regulation clearly says joint HTAs would remain distinct from pricing and reimbursement decisions, so member states can have no concerns about subsidiarity, said Moll.
The industry body Medtech Europe (MTE) had lobbied hard for amendments to the legislation, which it views as more relevant to pharma and not necessarily appropriate for medical technologies.
"Any new regulation should not create an extra layer of assessments, nor duplicate any elements already answered by the new medical device and in vitro diagnostic regulations that are currently being implemented," MTE said.
There needs to be a clear distinction between the role of CE marking and HTA and there should be "an appropriate phase-in" of medical technology into the new HTA regulatory framework, once the medical device and in vitro diagnostic regulations are fully implemented and operational, MTE said.
The regulation next goes to the third arm of the EU, the European Council, for consideration by national ministers.
The proposed pan-EU system for HTA will build on the existing voluntary network, Eunethta, which is funded by the European Commission. The network has been in operation since 2009, providing the framework for national HTA bodies to work together on joint assessments. The regulation envisages the Commission continues to fund Eunethta as the body coordinating joint HTA.