Generating relevant evidence for technology assessment
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 they will generate relevant evidence for future submissions to NICE or other evaluations to enable market access. Advice can be requested on medicines, devices and diagnostics including orphan and ultra-orphan products. This year we started offering advice to the developers of antibiotics and screening tests, and plan to expand the service to include non-therapeutic vaccines.
We have worked with over 50 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 135 projects. For our standard advisory service we introduced a patient engagement programme, and to-date we have successfully run 4 projects which have included patient representatives.
Developments in 2014/15
In 2014/15 we launched an advisory service for SMEs (small-medium enterprises). This sector continues to grow and play a more prominent role in innovative product development. We offer a discounted advisory service to the SMEs and encourage investors and consulting companies working with these biotech and medtech companies to seek payers’ perspective early on in the product development cycle.
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 40 parallel advice procedures with the EMA and other Health Technology Assessment bodies from Europe and we currently have three ongoing projects with the MHRA.
We have played an active role in the Shaping European Early Dialogues (SEED) Consortium led by the French Haute Autorité de Santé. These multi-stakeholder advice pilots explored scenarios for conducting early dialogues between European HTA agencies and pharmaceutical and medical device manufacturers during the development phase. NICE has participated in 11 pilots from May 2014 to July 2015.
We continue to expand our educational offering by running three introductory HTA seminars for the developers of devices and diagnostics, for regulatory and clinical professionals in pharmaceutical companies and for developers of regenerative medicines. In addition to running these seminars in England, we have run seminars abroad in Israel, North America and Russia.
Leeza Osipenko, Associate Director for Scientific Advice, said:
“It’s been a very successful year for Scientific Advice: we expanded the team and increased outputs by 70%. NICE SA established many new lines of business and our aim now is to turn them into mainstream work and retain our leadership position as a top HTA Scientific Advice service in the world.”
In September 2014, we started developing a facilitator-led online tool for developers of medical devices and diagnostics. The META (Medtech Early Technical Assessment) Tool aims to provide interactive, affordable support to help companies assess their product development plans by refining the value proposition for their product and identifying areas in which they may be able to generate further clinical or economic evidence to support it. The tool is still in the early stages of development but we anticipate rolling it out early in 2016.
NICE SA visits pharmaceutical companies to meet with global development teams and introduce Scientific Advice and the processes for engaging with the service. We will continue to expand this activity in the coming years to educate industry leaders about HTA requirements and the benefits of early engagement with NICE.
Over the past year, we have taken part in 26 public speaking engagements/conferences.