NICE’s Scientific Advice team has produced its first guidance on how pharma companies can improve clinical trial design to meet the needs of patients and generate evidence for health technology assessment (HTA).
The Scientific Advice team is a consultancy offshoot from the cost effectiveness watchdog, providing a fee-based service to biopharma, medical devices and diagnostics companies.
It has today announced the completion of its first piece of advice on the design of a ‘patient preference’ study – these aim to capture patient insights which can then be incorporated into the clinical development programmes for new treatments.
The advice was provided to Novartis, and looked at a patient preference study for people with respiratory condition chronic obstructive pulmonary disease (COPD).
In the last financial year, NICE Scientific Advice generated £1.8m, income which makes a modest contribution to sustaining the agency, which has seen its funding cut back and its workload increased in recent years. Faced with a budget shortfall, NICE is introducing new fees for life science companies submitting products for appraisal from April.
The Scientific Advice team says it hopes that the Novartis pilot will encourage more companies to seek its advice on the development of such studies.
NICE anticipates that its advice to Novartis on COPD will guide early evidence generation, helping to transform study design and improve the quality of current processes. The aim is to support the development of new products to treat COPD patients.
Jeanette Kusel
Jeanette Kusel, Director of NICE Scientific Advice said: “We are delighted to be able to shape our offering to suit the requirements of Novartis by offering advice and guidance on their patient preference study, which should help it to generate the data required to help future products meet the needs of COPD patients.”
Nigel Cook, Head of Decision Support & Insights, Global Patient Access at Novartis said: “The scientific advice provided by NICE, together with the patient representative and other external experts, has been very valuable to Novartis; both in endorsing the approach to gathering early patient preference data to inform evidence generation plans, and in regard to valuable input received to improve the design of the COPD patient preference study.
“Collecting certain outcome data alongside the patient preferences, one of the advice recommendations, will also help in correlating the preference results with current NICE processes for evaluating new treatments.
“We see this engagement during the project design phase as a positive step, helping to ensure the results serve the interests of the different stakeholders: industry, NICE and the patient community”.
NICE’s drive to raise funds from fees for technology appraisals and via the standalone Scientific Advice unit has raised concerns among some that it could compromise the agency’s decision-making. NICE makes it clear, however, that paying for scientific advice has no bearing on technology appraisals, and won’t guarantee a positive recommendation.