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Updated EMA reports better suited to HTA needs

Changes to drug licensing reports are helping to support reimbursement decisions
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Changes to the way the European Medicines Agency (EMA) reports its assessment of new, approved medicines are helping to support the decision-making process of bodies that assess the cost-effectiveness of treatment.

The first outcomes report (PDF) from a collaboration between the EMA and the European network for Health Technology Assessment (EUnetHTA) concluded that, despite remaining shortcomings, the quality of documents published by the EMA after licensing a new drug had improved to better suit the needs of the bodies that decide if it can be reimbursed on a national level.

Misalignment in the data requirements from regulators and HTA bodies, such as the UK's National Institute for Health and Care Excellence (NICE), has been a bane for pharma companies since the introduction of HTA organisations at the turn of the millennium, leading to duplication of research and inconsistency in outcomes.

To help overcome this the EMA and EUnetHTA – the region-wide organisation to unite national HTA bodies – initiated a collaboration in 2010 to address issues identified by the Pharmaceutical Forum, a group comprising members from Member States, EU institutions, industry, healthcare professionals and patients.

One of the recommendations suggested by the Pharmaceutical Forum was to consider how the assessment of the effects of a medicine as contained in the EMA's European Public Assessment Reports (EPARs) can support the decision-making process of HTA bodies.

The new outcomes report, which was published in Value in Health, assessed changes to the structure and presentation of key information in these EPARs for 10 products over a two-year period to determine if they increased clarity and transparency of the outcome of the scientific-review process in order for the HTA body to make an informed decision.

These changes focused on developing a better understanding of the EMA's regulatory judgment and creating a “structured and harmonised presentation of main efficacy data”.

According to the report's authors the EPARs “showed overall high rates of compliance with the revised templates” meaning “it can be assumed that the quality of the documents has been improved”.

Of particular note was the introduction of the tabular overview of main efficacy data, which was widely adhered to.

However, improvements are recommended in the clarity of areas such as the critical discussion of the key elements of the clinical study design, including patient population, comparators, duration of the study, end points, and/or composite end-point use to help support HTA decisions.

“Some of these aspects may be present in the clinical efficacy discussion but are not visible enough or not discussed enough,” the authors noted.

Some areas also require “special attention”, including the dose recommendations, contraindications, warnings and precautions, and interactions.

Nevertheless, the authors were confident that the updated EPARs had benefits for market access: “With the improved presentation of data and information in the EPAR, it is envisaged that this regulatory document through harmonised efficacy data presentation will be more useful in the context of rapid relative effectiveness assessment by HTA bodies when they inform policymakers and healthcare decision makers in the future.”

In addition to the updated EPARs, the collaboration between EMA and EUnetHTA includes a three-year joint work plan that covers key areas for the two groups to improve collaboration, including the need for more scientific advice and early dialogue between the EMA, HTA bodies and pharma companies.

Other areas of note include scientific and methodological guidelines, post-licensing data generation and orphan drugs.

Article by
Thomas Meek

25th June 2014

From: Sales, Regulatory, Healthcare



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