National Institiue for Health and Clinical Excellence

Annual Review - 2012/2013
SA

Fee-for-service consultation

NICE Scientific Advice provides fee-for-service consultation to pharmaceutical and medical technology companies. By reviewing manufacturer’s early product development plans we advise on whether these will generate relevant evidence for future submissions to NICE. To date, our clients have represented most of the top 20 pharmaceutical companies, and the programme has successfully delivered over 70 standard projects while covering all programme costs.

A number of advice models are offered including: NICE standard advice with a formal written report or advice alongside the regulatory agencies: the Medicines and Healthcare Regulatory Agency (MHRA) or the European Medicines Agency (EMA). To date, NICE participated in 16 parallel advice projects with the EMA and other HTA agencies.

This year, we have developed and launched two one-day training seminars targeted to developers of MedTech and pharmaceutical products respectively. The first was developed to enable companies to put together a value proposition for their device or diagnostic products. These also raised awareness of NICE’s Medical Technology Evaluation. Programme (MTEP)  and Diagnostic Assessment Programme (DAP).  Five seminars were run between September and November 2012.

The second event was for members of global teams developing pharmaceutical products and focussed on how evidence requirements differed from regulatory, and how to get the most from scientific advice alongside the regulators. Two seminars were run and more are planned.

Following the success of these seminars we have been asked to partner with other organisations in order to reach a wider audience of developers including at international events in 2013/14.

Seren Phillips, Associate Director of the NICE Scientific Advice Programme, said: “Feedback from the MedTech seminars was extremely positive and we want to build on this to help companies overcome some of their development challenges. In addition to running more training events we anticipate increasing advice services to MedTech companies on specific products.”

Commenting on future plans for the programme, Seren said: "We are excited about the prospect of greater international collaboration between countries and agencies giving advice to companies.”
 

 

 

To date, our clients have represented most of the top 20 pharmaceutical companies, and the programme has successfully delivered over 70 standard projects while covering all programme costs.