Scientific Advice - generating evidence for health technology assessment in the NHS

Established in 2009, NICE Scientific Advice (SA) provides fee-for-service consultation to developers of healthcare technologies. By reviewing early product development plans, we advise companies on how to generate relevant evidence for future submissions to NICE or other evaluations to enable market access. Advice can be requested on medicinal products, including orphan, ultra-orphan indications and cell and gene therapies, medical devices and diagnostics. We now offer advice on antibiotics, and welcome requests from companies developing screening tests and non-therapeutic vaccines.

We have worked with over 80 different organisations in a wide variety of clinical areas. Our clients have represented 18 of the top 20 pharmaceutical companies and the programme has successfully delivered over 175 projects. Since the introduction of our services for small and medium enterprises (SMEs), we have seen an increase in the number of smaller companies seeking advice and have already worked with 25 different SMEs. For our national advisory service we introduced a patient engagement programme, and to-date we have successfully run 10 projects which have involved patient representatives.

Between January 2009 and December 2015, Alzheimer’s disease was the most common indication for which scientific advice from NICE was requested. The procedures represented nearly half (13 out of 27) of the scientific advice given for products aimed at treating diseases of the nervous system. The top 5 remaining indications involved products developed in rheumatoid arthritis (7), type I or type II diabetes (7), non-small cell lung carcinoma (7), asthma (6) and prostate cancer (5). Across all types of procedures, NICE Scientific Advice has addressed a total of 1754 questions asked by companies.

Developments in 2015/16

2015/16 has seen the Scientific Advice team grow from 12 to 16 members. The focus last year has been on maintaining our core advice services and developing the EMA-HTA offering with our European partners. We have participated in 14 EMA-HTA procedures, 10 national advice projects, 1 joint advice project with the MHRA and 2 Early Dialogues as part of the Shaping European Early Dialogues (SEED) and EUNetHTA initiatives.

We have continued working on the META (Medtech Early Technical Assessment) Tool, a facilitator-led online tool for developers of medical devices and diagnostics. The META 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. We recently received approval from the Department of Health to proceed with the next phase of development and testing and we anticipate roll out of the service towards the end of the year.

We have agreed to take part in a number of Early Dialogues as part of EUNetHTA Joint Action 3. These will continue to build on the work done in Joint Action 2 and the SEED pilots and will run over the next two years, with the aim to eventually transition into a financially sustainable model.

We continue to run our popular educational seminars for developers of pharmaceuticals, medical devices & diagnostics and cell & gene therapies and have increased the frequency of the seminars due to demand. We have also formed a partnership with MaRS EXCITE, a Canadian-based organisation that connects promising medical technology innovators with stakeholders across the healthcare system. As part of the agreement, MaRS will refer a number of small and medium sized companies to NICE to seek scientific advice on their evidence generation plans.

Over the past year, we have taken part in over 40 external speaking engagements, meetings and events.