Regulation 7 of the National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013 requires NICE to specify a time period within which integrated care boards (ICBs), NHS England and, with respect to their public health functions, local authorities must comply with the recommendations in this evaluation. Ordinarily, this time period is within 3 months of the date of final guidance publication.
Under Regulation 7(5), if NICE considers it appropriate, NICE must specify a longer period if the health technology cannot be appropriately administered until training, additional health service infrastructure requirements and or other health services resources including staff are in place. The NICE manual on health technology evaluations states that NHS England may request a longer time to implement technologies when the potential net budget impact is expected to exceed £20 million per year in any of the first 3 financial years of its use in the NHS.
NHS England submitted a funding variation request, on behalf of NHS providers and ICBs, to extend the time needed to comply with the recommendations.
NHS England's funding variation request includes the following justification:
Availability of services: Weight management services are not routinely commissioned in primary care. Therefore, time is needed to develop coordinated and sustainable service models.
Clinical capacity: The recommendation cannot be safely implemented within 3 months because there is insufficient capacity to deliver tirzepatide in primary care. To meet this resource need, healthcare professionals will require training.
Inequity of access: In the absence of an extension to the time required to comply with the recommendations, it is likely that:
there would be inconsistent access to tirzepatide, leading to inequality of access and patient outcomes
services that already exist would need to be decommissioned to provide the resources required to deliver tirzepatide.
Budget impact: The anticipated costs of implementing the recommendation exceed the budget impact test of £20 million in each of the first 3 years.
NICE's Guidance Executive considered NHS England's funding variation request, informed by responses to a formal process of stakeholder consultation. NHS England, with those on whose behalf it makes the funding variation request, has responsibility for implementing the service changes necessitated by this recommendation. NICE should be cautious and sure of its judgement before requiring the provision of services that NHS England does not consider can be provided safely and equitably. NHS England has indicated that it does not yet have in place the arrangements that it considers necessary to provide tirzepatide to the full extent recommended in this guidance within the usual 3‑month timeframe. NHS England's position, in setting out what it believes it needs to do to put the necessary arrangements in place, and the timescale for doing so, has credibility.
NICE fully understands the concerns put forward by consultees who object to the considerably extended implementation period. Any additional delay in accessing recommended treatments is, of course, undesirable. However, NHS England's plans to put in place new service delivery models reflect compelling evidence presented by NHS England that the current arrangements expose the service and its patients to the risks associated with inadequate resources. In addition, it is apparent from its initial proposal and response to consultation that NHS England is making a considerable effort to ensure that patients for whom a delay in access to tirzepatide represents the greatest risk will have access to it under the planned interim commissioning policy. This policy should be made available to ICBs within 4 weeks of final guidance publication.
NICE's Guidance Executive accepted that a funding variation is justified. However, NICE has made the following amendments and clarifications to NHS England's implementation proposals (outlined in sections 4.8 to 4.13).
NHS England proposed a total guidance implementation period of 12 years, in 3 parts:
A: an additional 90 days before any requirement on ICBs to fund tirzepatide, providing a 180‑day implementation period
B: after the 180 days, a period of 3 years in which eligibility will increase in stages to around 220,000 patients, selected based on health need and clinical benefit, and
C: after this, up to a maximum of a further 9 years, dependent upon maturation of the obesity treatment pathway in primary care.
NICE is required by its legal obligations to specify a maximum period for implementation. In the circumstances, NICE accepts that a maximum period of 12 years may be necessary, and, accordingly, specifies that period. However, NICE also considers that there is substantial uncertainty in this estimate, and there is likely to be scope to complete implementation within a significantly shorter period. Accordingly, NICE recommends an initial implementation period of not more than 3 years for a subset of the eligible population, using this period to test and make the necessary arrangements to safely and efficiently scale a variety of implementation service models including digital support for patients.
NICE will evaluate relevant evidence generated during the initial guidance implementation period of up to 3 years and review the effectiveness of the service delivery pilots. NICE may then set a revised timeline for the second phase of the guidance implementation period. A review conducted within the first 3 years will provide evidence on the most clinically and cost-effective service delivery models which could be used to shorten the total guidance implementation timeframe.
NHS England requested a delay of 6 months to the funding requirement for all eligible patients. Considering the responses from the consultation, NICE recommends mandated funding of tirzepatide:
within 3 months from final guidance publication for all patients accessing specialist weight management services at that time and subsequently, since these services and the associated wraparound care is already established
must be made available from 6 months of final guidance publication for a phased introduction of delivery to eligible cohorts, at a minimum, in line with NHS England's interim commissioning policy, since NICE accepts that it will take time for commissioners to establish effective services in primary care.
The qualifying comorbidities specified by NHS England in its implementation proposal do not align with the population eligible for tirzepatide as recommended in section 1 of this guidance. NHS England's interim commissioning policy, that will manage access to tirzepatide during the extended funding variation period, must ensure that tirzepatide is delivered to the full eligible population within the maximum period of 12 years, based on cohort prioritisation led by clinical need. The marketing authorisation for tirzepatide states that adults with a BMI between 27 kg/m2 and less than 30 kg/m2 must have at least 1 weight-related comorbidity. It gives the following examples of weight-related comorbidities, however this list is not exhaustive: hypertension; dyslipidaemia; obstructive sleep apnoea; cardiovascular disease; prediabetes; type 2 diabetes mellitus. Non-alcoholic fatty liver disease was also included as a modelled complication in the economic model that was accepted and used by the committee in its decision making to establish tirzepatide's cost effectiveness. The eligible population within NICE's guidance includes adults with a body mass index (BMI) of at least 35 kg/m2 (or a lower threshold, usually reduced by 2.5 kg/m2, for people from South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean ethnic backgrounds) and at least 1 weight-related comorbidity. The comorbidities listed in the marketing authorisation and used as baseline characteristics in the model (listed above) are the key weight-related comorbidities that should be considered within NHS England's interim commissioning policy. However, other important comorbidities, for example learning disabilities and severe and enduring mental illness, should also be considered in the interim commissioning guidance and prioritisation statement. NICE estimates that the total eligible population is 3.4 million people, and expects that the interim commissioning guidance and prioritisation statement led by clinical need will identify at least 220,000 people eligible for tirzepatide to be funded within the first 3 years of implementation.
NHS England proposed prioritising patients according to BMI and the number of qualifying comorbidities. Based on responses to the funding variation consultation and the evaluation committee discussion, NICE recommends a modified approach to clinical prioritisation of the eligible population that is more closely aligned with expert opinion, an example of which is the joint position statement by the Society for Endocrinology and Obesity Management Collaborative UK on phased introduction for new medical therapies for weight management (PDF only). In line with the NICE manual on health technology evaluations, NHS England is developing an interim commissioning policy that will apply to phase-in funding and that will manage access to tirzepatide during the extended funding variation period, describing how patient cohorts will be prioritised in line with these recommendations. To support this, NHS England will produce a new prioritisation statement with relevant clinical experts, considering both referral prioritisation in specialist weight management services and priority cohorts in other settings (including primary care-based services).
NICE will conduct a formal review to be completed within 3 years from the date of final guidance publication. This will consider:
characterisation and quantification of the cohorts prescribed tirzepatide, including the common comorbidities for adults with a BMI of at least 35 kg/m2 (or a lower threshold, usually reduced by 2.5 kg/m2, for people from South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean ethnic backgrounds)
real-world evidence on service implementation, associated costs and service uptake
a comparison of the different service models trialled, including their feasibility and relative clinical and cost effectiveness, and
whether any changes to the recommendations in section 1 are appropriate.
Information on the proposed service delivery models was redacted from the funding variation documentation NICE consulted on, and there is very limited detail with which these can be assessed. While it is not NICE's role to specify service delivery models, it is essential that a range of approaches is tested and evaluated, including the use of digital technologies. Comments received from stakeholders during consultation suggested that NHS England's proposals rely very heavily on general practice and overestimate the activity that would be required in this service. Therefore, data describing the models adopted by NHS England or ICBs, and their implementation, outcomes and costs, will be further considered at the review point described above. To inform this review with relevance to the whole eligible population recommended in the guidance, it will be important to ensure that service delivery models are tested in populations with a range of eligible BMIs and comorbidities.
The eligible population for tirzepatide is described in this guidance, and can be summarised as adults with a BMI of at least 35 kg/m2 (or a lower threshold, usually reduced by 2.5 kg/m2, for people from South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean ethnic backgrounds) and at least 1 weight-related comorbidity. NICE estimates that the total eligible population is 3.4 million people, and expects that an interim commissioning policy will identify at least 220,000 people in England eligible for tirzepatide to be funded within the first 3 years of implementation.
Prioritisation of cohorts for treatment will be based on a prioritisation statement led by clinical need and produced by NHS England that considers both referral prioritisation in specialist weight management services and priority cohorts in other settings, including primary care-based services.
ICBs are required to fund tirzepatide:
within 3 months for all patients accessing specialist weight management services at that time, and subsequently
from 6 months to support a phased introduction of delivery to other eligible cohorts.
NHS England will make available to ICBs an interim commissioning policy outlining how patient cohorts should be prioritised and the service models that are recommended during this initial implementation within 4 weeks of final guidance publication.
NICE will evaluate data collected during the first phase of guidance implementation, within the first 3 years. It will consider whether to revise the maximum total 12‑year implementation period and whether NHS England should produce an updated interim commissioning policy for the remaining implementation period.
This variation of the implementation period is made under Section 7(5) of the Regulations.
The Welsh ministers have issued directions to the NHS in Wales on implementing NICE technology appraisal guidance. The All-Wales Weight Management Pathway sets out that weight management medication will only be prescribed within a specialist service, where clinically indicated, and only in combination with a behavioural (lifestyle) intervention that includes a reduced-calorie diet and increased physical activity. Tirzepatide will be available for Local Health Boards in Wales to prescribe should they wish to use it within those specialist services from the publication of NICE's final guidance. However, further work will be undertaken to determine whether it is appropriate to make tirzepatide available through arrangements other than specialist weight management services, and if so the nature of those arrangements. Welsh Ministers will make a decision regarding any extended use of tirzepatide in due course. At such a time and when a decision is taken about when, how and whether tirzepatide is made available for use outside the current arrangements set out within the All-Wales Weight Management Pathway, Welsh Ministers will write to NICE outlining those arrangements.
When NICE recommends a treatment 'as an option', the NHS must make sure it is available within the period set out in the paragraphs above. This means that, if a patient has overweight or obesity and the healthcare professional responsible for their care thinks that tirzepatide is the right treatment, it should be available for use, in line with NICE's recommendations, the funding variation request, and NHS England's and NHS Wales' strategies for implementation.
NICE will complete a review no later than 3 years from the date of the final guidance publication, and sooner if possible. This will consider real-world evidence on service implementation, associated costs and service uptake. Sections 4.18 to 4.23 provide additional detail on the evidence that should be collected to address areas of uncertainty.
Further characterisation and quantification of the cohort prescribed tirzepatide should be collected during this 3‑year period. This should describe the common comorbidities for adults with a BMI of at least 35 kg/m2 (or a lower threshold, usually reduced by 2.5 kg/m2, for people from South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean ethnic backgrounds), and which of these may change if there is a reduction in BMI.
In addition to the direct costs of tirzepatide, data should be collected on costs associated with the implementation of services including the costs of service delivery, upskilling and education materials.
To keep the burden of data collection to a minimum, real-world evidence should be generated from routine data collections. Most of the real-world evidence is expected to be available from existing primary care sources.
Real-world evidence could be generated from routine data assets such as Clinical Practice Research Datalink (CPRD), which contains the largest cohort of primary care data in the UK. Other routes to accessing primary care data include the OpenSAFELY platform and federated analysis from subnational secure data environments.
Real-world evidence that is generated directly from weight management services should be collected within the Community Services Data Set. Real-world evidence that is generated from secondary care services should be captured in Hospital Episode Statistics.
NICE will work with NHS England to further specify the data to be collected in the full evidence generation plan.