Summary
We, in partnership with the Office for Life Sciences (OLS), are keen to generate high quality evidence to support a pilot to test service delivery models, outside of hospital settings, that can increase access to the newest and most effective obesity drugs for eligible patients living with obesity in selected areas across England. The pilot will be delivered by NHS England working closely with the Office of Health Improvement and Disparities within the Department of Health and Social Care.
The Health and Social Care Delivery Research (HSDR) Programme is looking to commission a research team to carry out an evaluation alongside the roll out of the pilot in England. Subject to successful commissioning, this service is expected to commence between late 2023 and early 2024. Funding for this research will be dependent on the roll out of the intervention. Successful applicants will be expected to contract and start work rapidly and to report meaningful intermediate data early in the contract period.
It is expected that research funded through this call will ultimately increase the evidence base to understand the feasibility, acceptability, clinical outcome and cost of such a service change and any potential business case to support wider roll out.
Background
In March 2023, the National Institute for Health and Care Excellence (NICE) published guidance recommending the use of Semaglutide (Wegovy) for adults with a Body Mass Index (BMI) of at least 35 and one weight-related comorbidity or BMI of 30-34.9, who also meet the criteria for referral to a specialist weight management service. Clinical trials have showed that people taking Semaglutide alongside supportive care lost, on average, 12% more of their body weight than those taking a placebo alongside behavioural weight management support. Another drug, Tirzepatide is also showing strong results in clinical trials and is being appraised by NICE for weight loss with final guidance expected in March 2024, subject to licensing.
NICE advised that the weight loss drug Wegovy is used within a specialist weight management service. Wegovy launched in the UK on 4 September 2023 and is available on the NHS as an option for weight management in specialist weight management services. Currently, these services are mainly based in hospitals which means that around 20,000 to 40,000 people per year could have access to this treatment on the NHS, when there are further eligible patients who could potentially benefit.
The pilots will explore how approved drugs (Wegovy and potentially Tirzepatide, if it gets the necessary approvals) can be made safely available to more people in the eligible patient population by exploring new specialist weight management service delivery models where these treatments are provided outside of a hospital setting. The proposed service models to be piloted are still to be confirmed but are expected to include prescribing initiated in General Practice with behavioural weight management support provided in the community and/or digitally/virtually. Other service delivery models may also be tested.
Scope
What is the feasibility, acceptability, health outcome and cost of provision of Semaglutide (and potentially Tirzepatide), accompanied by specialist weight management support, through new service models outside of hospital settings for the eligible patient population?
Some specific areas of interest have been identified:
Feasibility
- evidence is required on the feasibility of specific elements of the delivery infrastructure, including the provision of specialist weight management services in the community and/or digitally/virtually, a training package for general practitioners and an electronic patient eligibility assessment and stratification tool
- the impact of delivering the pilot on general practice, including on general practitioner activity
Safety and acceptability
- monitoring and assessment of the safety of prescribing these drugs and side effect management in general practice
- the acceptability of the service delivery models to the clinician, other health care professionals and service users
Health and social outcomes and cost
- the short and long-term impact of the service models on health outcomes for patients including weight loss and change in risk factors for weight-related co-morbidities
- changes in patients’ health-related quality of life over the duration of the pilot
- changes in labour market participation (a current government priority)
- costings for each service delivery model with a view to completing comparative cost-effectiveness analysis (of the delivery models, rather than the product(s)) if required
Impact on health inequalities and population groups
- differences in access, experience, and outcomes across population groups, including underserved communities, with consideration of the impact on health inequalities
- we would also be interested to understand behavioural effects on drug treatment adherence for those who are prescription cost exempt
Proposed study design
Proposals are likely to be for mixed-methods studies led by a team with a track record in national multi-site evaluations of complex organisational interventions, with a range of qualitative and quantitative methodological expertise, including experience in accessing, analysis and linkage of routine datasets. The team should have experience of successful engagement with national and local health service decision-makers, digital service providers, staff and patients. The NIHR is looking for a well-designed research study, with strong theoretical grounding, to deliver robust national and international learning, strengthen the evidence base on the use of obesity medications outside of hospital settings and provide actionable learnings to inform potential wider roll out of one or more new service models.
Deadline for proposals
The successful applicants will be required to carry out an evaluation alongside the roll out of the weight loss drug pilots in England which will begin in late 2023/early 2024 (to be confirmed). The duration of this evaluation will be approximately 3 years, with interim findings expected at intervals to be agreed.