Advice on generating relevant evidence

Our clients have represented many of the top 20 pharmaceutical companies and the programme has successfully delivered over 100 projects.

Established in 2009, NICE Scientific Advice (SA) provides fee-for-service consultation to developers of pharmaceuticals, medical devices and diagnostics. By reviewing early product development plans we can advise companies on whether these will generate relevant evidence for future submissions to NICE or other evaluations to enable market access. Advice can be requested on medicines, devices, diagnostics, regenerative and orphan designation products.

We have worked with over 40 different organisations in a wide variety of clinical areas. Our clients have represented many of the top 20 pharmaceutical companies and the programme has successfully delivered over 100 projects.

NICE SA also offers advice alongside regulators – the European Medicines Agency (EMA) and Medicines and Healthcare Products Regulatory Agency (MHRA). To date we have participated in over 20 parallel advice procedures with the EMA and other Health Technology Assessment bodies from Europe.

We are playing an active role in the Shaping European Early Dialogues (SEED) Consortium led by the French Haute Autorité de Santé. These multi-stakeholder advice pilots explore scenarios for conducting early dialogues between European HTA agencies and pharmaceutical and medical device manufacturers during the development phase. NICE will participate in 10 pilots by February 2015.

We continue to expand our educational offering by running two introductory HTA seminars for the developers of devices and diagnostics and for regulatory and clinical professionals in pharmaceutical companies. In addition to running these seminars in England, in December 2013 we successfully delivered a seminar to the developers of MedTech products in Tel Aviv, Israel.

In 2013, NICE SA made five site visits to pharmaceutical companies to meet with global development teams and introduce Scientific Advice and the processes for engaging with the service. We plan to expand this activity in the coming years to educate industry leaders about HTA requirements and the benefits of early engagement with NICE.

Leeza Osipenko, Associate Director for Scientific Advice, said:  “Under the Scientific Affairs programme established earlier this year, the team is set for expansion with three new members of staff joining us in 2014.

“We look forward to continuing the provision of high quality services to our clients and developing new offerings to smaller companies and in particular to the MedTech sector.”