The QMN Weekly Bulletin
Pharmaceuticals / Regulatory Affairs / Submissions and Approvals

EC Pilot to Test Benefits of Early Talks Between Drugmakers, HTAs

Jan. 3, 2014

The European Commission is launching a pilot program to help drugmakers avoid last-minute conflicts with health technology assessors as they are bringing products to market.

During the pilot, HTAs and companies will engage in direct discussions about the HTA’s requirements for efficacy and cost-effectiveness, and the type of evidence needed (design of trials, duration, type of events/endpoints, comparators) for approval, a recent call for interest states.

Drugmakers will get nonbinding advice on product development, while being enlightened about different HTA and regulatory requirements across the EU, the document says, and interested drugmakers are urged to apply for participation.

Seven drugs will be selected from among volunteers for the pilot; drug candidates should be pre-Phase III. Six to seven HTA bodies will participate in each multi-HTA early dialogue. The pilots are scheduled to begin in March and run through January 2015.

The pilots — to be conducted by the Shaping European Dialogues, or SEED, Consortium under a Commission contract — will initially involve seven novel drugs. Three of the seven will involve face-to-face meetings with the European Medicines Agency and multiple HTAs. The other four will involve only HTAs.

The SEED Consortium comprises 14 national and regional HTA entities led by France’s Haute Autorité de Santé. The pilots echo U.S. efforts to encourage early dialogue between medtech developers, the FDA and Centers for Medicare & Medicaid Services, which determines which new technologies the government will fund. Last month, the agencies extended for two more years a parallel review pilot for devices, saying they need more time to evaluate the program’s effectiveness.

The Commission’s call for interest will remain until October 2014. Applications received after the first seven candidates are selected may be considered for a reserve list in the event one of the participants halts product development, SEED says.

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