In the EU, a product must clear two hurdles before it can reach patients. First, it must be approved by regulators, such as the European Medicines Agency (EMA), which determines if a product is safe and effective. Thereafter, the product is evaluated by health technology assessment (HTA) bodies, which determine if the product is suitable for reimbursement according to the standards of various countries.
Now, EU regulators and reimbursement bodies are teaming up in an attempt to see if they can better coordinate their assessments in the hopes of providing a more efficient and rapid assessment process.
In a 25 June 2014 statement, EMA and the European network for Health Technology Assessment (EUnetHTA)—a collection of HTA bodies—announced the publication of a new piece of research outlining how HTA bodies could take advantage of EMA's European Public Assessment Reports (EPARs).
Those reports are used to communicate the benefits and risks of a product to the public, as well as the limits of known evidence. (Example: The EPAR for Abilify)
While HTA bodies are certainly interested in the benefits and risks of a product, they're also interested in other things, like a product's social and economic impacts in relation to its costs. For example, even if a product may cost tens of thousands of dollars per year, it might be seen as worth the cost if it alleviates healthcare systems of other burdens, such as a single hospitalization each year that might cost taxpayers $100,000.
Though EMA and HTA bodies are ultimately concerned with different factors, both said that based on the similar information they are looking for, more could be done to coordinate their efforts.
Their announcement indicates that EMA is now preparing to overhaul the format of the EPAR to better accommodate information available at the time of approval that would be useful for HTA bodies
The aim of the new template is "to improve the contribution such reports can make to the assessment of relative effectiveness of medicinal products," EMA and EUnetHTA wrote in a research letter published in the journal Value in Health.
The research includes an outline of what the new study summaries might look like, which primarily seeks the addition of much more specific data in each EMA report.
"As part of this project, the EMA and EUnetHTA developed an improved structure and presentation of key information with the view to increase clarity and transparency of the outcome of the scientific-review process as reflected in the EPARs," EMA said in a statement. It was not clear if EMA had adopted the new report, or if it was still working on finalizing it.
Regulators said the cooperation between EMA and EUnetHTA would continue through at least 2015 and will "continue to facilitate the bridging between regulatory approval and access to market."
Improving the Contribution of Regulatory Assessment Reports to Health Technology Assessments—A Collaboration between the European Medicines Agency and the European network for Health Technology Assessment