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EMA drug data to address HTA needs

EU regulator agrees joint work plan with EUnetHTA

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The European Medicines Agency (EMA) is to build its relationship with national bodies that assess the cost-effectiveness of drugs, such as the UK's National Institute of Health and Care Excellence (NICE).

The EU regulator has agreed a three-year joint work plan with EUnetHTA, which represents health technology assessment (HTA) bodies across the region.

The plan outlines key areas for the two groups to improve collaboration so that the work done by the EMA when assessing the benefits and risks of a medicine for approval in the EU can better address the needs of HTA organisations, which assess the suitability of approved medicines for national reimbursement.

If implemented, these plans would allow pharma companies to develop clinical trials better aligned to ensure market access and to reduce duplication of research.

Specific areas mentioned in the plan include the need for more scientific advice and early dialogue between the EMA, HTA bodies and pharma companies.

Other recommendations include the exchange of ideas on the development of scientific and methodological guidelines to facilitate clinical-trial design that can generate data relevant to both parties.

The development of approached for the collection of post-authorisation data once the drug is on the market and specific ways to share information on orphan drugs for rare diseases are also part of the plan.

The publication of the joint work plan is part of a collaboration between the EMA and EUnetHTA initiated in 2010 to address the recommendations made by the Pharmaceutical Forum – a group comprising members from Member States, EU institutions, industry, healthcare professionals and patients.

The recommendations included the need to improve the way data published by EU regulators contributes to relative effectiveness assessments by HTA organisations.

Article by
Thomas Meek

19th November 2013

From: Sales, Regulatory, Healthcare

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