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EMA forges closer ties with HTA umbrella group

Agrees joint work plan with the European Network for Health Technology Assessment

EMAThe EMA has extended a partnership with the organisation representing Europe’s health technology assessment (HTA) bodies, aimed at improving access to medicines, for another three years.

The agreement of a joint work plan between the EU regulator and the European Network for Health Technology Assessment (EUnetHTA) for 2017-2020 will take the collaboration between the two organisations - which has the goal of improving the efficiency and quality of assessment processes - out to the 10-year mark.

Among the highlights of the work plan is a new joint platform for parallel consultation, which was set up in the summer to allow drug developers to get advice from the EMA and HTAs such as the UK’s National Institute for Health and Care Excellence (NICE) in parallel rather than sequentially.

The aim is to develop “a single process that reflects the evidence generation needs of both regulators and HTAs”, says the document. As patients are at the heart of both EMA and EUnetHTA’s missions, patient representatives will be involved in parallel consultations so that their views and experiences can be incorporated into the discussions.

“Regulators and HTA bodies have different responsibilities with regards to medicines. What unites us is a common goal of getting to the market more high-quality medicines that address unmet needs of millions of patients in the EU,” said EMA head Guido Rasi.

“By working together, EMA and EUnetHTA help medicine developers to improve clinical research and become more efficient in generating the evidence each of us needs for good decision-making.”

There is also an initiative for the EMA to share information with EUnetHTA at the point of market entry, which will be used to support relative effectiveness assessments (REAs), a recently-introduced tool to try to standardise the assessment process for new medicinal products and avoid duplicating work by different HTAs.

The two organisations will also collaborate on the development of post-licensing evidence-generating tools, such as patient registries that can be used to create real-world data, and the exchange of that data.

Other projects will look at how the regulator and HTAs define unmet medical need and medical innovation and examine the way orphan medicines are regulated, and the EMA and EUnetHTA plan to hold bilateral meetings twice a year to progress the various actions.

“This work plan shows a broad commitment from the regulatory as well the HTA side to find clear synergy in our activities,” said EUnetHTA’s director Wim Goettsch.

“I believe that there is a common sentiment that these activities are essential to make our processes more transparent, efficient and timely for patients, producers and other key stakeholders.”

Following regulatory approval, HTA bodies assess the value of the medicine versus other treatments available and provide recommendations to payers and other decision-makers. While there is some overlap between evidence requirements of regulators and HTA bodies, each may have specific requirements that need to be accounted for in the development plan.

Article by
Phil Taylor

22nd November 2017

From: Regulatory



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