European Drug Regulator Wants to Work With Cost Bodies

The European Medicines Agency wants to cooperate more with health-technology bodies in European Union countries that rule on the cost-effectiveness of new treatments, the agency’s top official said.

As the agency reorganizes, it will try to coordinate with bodies, such as the U.K.’s National Institute for Health and Care Excellence, that decide whether medical systems should adopt new treatments, EMA Executive Director Guido Rasi said. Working together with the groups rather than separately should shorten the regulatory process, Rasi said.

“We can do the development in sequence or in parallel, which makes a huge difference in time, but also a difference in outcome,” Rasi said yesterday at a Bloomberg Industries health-care conference in London. “This will be a tremendous advantage for developers. You have less surprise.”

Health-technology assessment bodies usually evaluate the cost-effectiveness of new medicines after drugmakers have won approval from EMA to sell them in Europe. Pharmaceutical companies have complained that these agencies limit the market for their products in Europe and working through two regulatory processes is cumbersome, time-consuming and expensive.

“We know after you get approval at EMA your job is not finished,” Rasi said. “You have HTA bodies. You have payers. It’s very likely that the largest markets will do this. I hope to have on board the large influential HTA bodies” in the U.K., France and Germany, as well as Spain and Italy.

Fewer Breakthroughs

Rasi also said the drug regulator wants to understand why fewer applications for new drugs in Europe seek “breakthrough” drug designation than in the U.S.

“That’s a crucial question,” Rasi said. “What we want to learn is why you don’t apply, if you apply, what went wrong.”

Ninety percent of companies that sought and followed the agency’s scientific advice for their drug applications gained approval, compared with a 30 percent success rate for those who sought the guidance and ignored it, Rasi said.

EMA has been reviewing how to expand its disclosure of clinical-trial data that applicants submit and plans to publish a draft of its new policy with “meaningful change” by the end of this month, Rasi said. The agency also plans to eventually publish minutes of its human-medicines committee’s discussions and may allow limited broadcasting of those meetings in the future, he said.

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