Our scientific advice service was launched in 2009. So far we have provided fee-for-service consultation to more than 80 different developers of healthcare technologies.
By reviewing product development plans early on, we can advise companies on how to generate the relevant evidence needed for future submissions to NICE or other market access evaluations.
Developers can request our advice on medicinal products, including orphan, ultra-orphan indications as well as cell and gene therapies, medical devices and diagnostics. We also offer advice on antibiotics, and welcome requests from companies developing screening tests and non-therapeutic vaccines.
In October 2016, we began participating in the United States’ Food and Drug Administration (FDA) payer programme for the medtech industry.
This collaboration will support medical technology developers in getting the evidence they need for regulatory approval and to demonstrate the value of their product. The overall aim is to speed up patients’ access to the best new technologies.
Leeza Osipenko, associate director of the NICE Scientific Advice programme said:
“In their efforts to get a product to market, companies can get caught out. To win regulatory approval in the US, companies give the FDA data on the safety and efficacy of their devices. But although they often do enough to win FDA approval, they need additional evidence to prove to the organisations who would actually pay for those devices that they are cost-effective and clinically-effective.
“To help companies overcome this hurdle, NICE’s Scientific Advice programme has joined forces with the FDA in the Payer Communication Taskforce. Early engagement should help medical technology makers to design their development programmes better to produce the data needed both to obtain regulatory approval and to persuade the payers of the value of their product.”
In March 2017, we announced that we are working with the London School of Economics’ (LSE) health division on how medicines, medical devices and tests are evaluated for cost effectiveness.
In addition both NICE and LSE Health will develop educational courses for the industry and public sector covering the evidence and methods used in health technology appraisal in the UK. NICE will also support LSE Health students working on MSc dissertations in related fields.
The collaboration highlights a shared commitment to improving the overall health of the population through informing health policy and practice and in the development, advancement and evaluation of research methodologies.
Professor Carole Longson MBE, executive director of the centre for health technology evaluation at NICE, said:
“This collaboration will enhance the potential of both organisations to deliver top quality educational events and research projects for the benefit of the UK and international healthcare systems.”
Professor Elias Mossialos, Director of LSE Health, said: “This is an exciting development that consolidates our long standing relationship with NICE and opens up exciting opportunities for future collaboration.”