What is the NICE Whole Lifecycle Approach?

NICE has set out a Whole Lifecycle Approach, supporting its strategic priority of ‘updating guidance to drive smarter spending’ by ensuring guidance remains current, reflecting the latest evidence, costs, and clinical practice. By regularly reviewing recommendations, NICE seeks to help the NHS focus spending on the technologies and treatments that deliver the greatest value and patient benefit¹. 

The Association of the British Pharmaceutical Industry (ABPI) welcomes NICE’s aim of keeping its guidance relevant, useful, and usable, and the potential for the Whole Lifecycle Approach to ensure innovative medicines are positioned within care pathways where they can provide the most benefit to patients. However, there is a risk that the approach could drive towards decisions focused more on curbing costs than supporting access to innovative treatments. As the work programme evolves, it will be critical to assess and respond to potential unintended consequences, particularly if these may impact on the timely availability of new medicines for NHS patients. It will be important that the approach does not destabilise the access that patients and clinicians rely on once NICE has recommended a medicine. This could reduce choice and weaken the predictability that underpins industry investment in new medicines in the UK, ultimately undermining the government’s ambition to be a top life sciences economy. 

The development of a Single National Formulary (SNF) is a closely related government initiative with clear links to the Whole Lifecycle Approach, as guidance published by NICE will inform decision-making in the SNF. 

The ABPI's position on the SNF is set out in a separate position paper, with considerable overlap in how we consider these initiatives will need to be progressed in order for the ABPI to support them: ‘ABPI position on the government's plans to develop a Single National Formulary in England’.

Key principles for a Whole Lifecycle Approach

1. 1Choice and clinical effectiveness. Where available, multiple effective treatment options should be recommended at the same point in a care pathway so care can be individualised and supply resilience maintained, with patient preference and clinician choice explicitly recognised within the Whole Lifecycle Approach. Consideration of how medicines are positioned in a pathway should fully align with NICE’s technology appraisal and highly specialised technologies guidance and not introduce additional restrictions.

2. 2A protected funding mandate. The funding mandate that secures NHS funding for NICE-recommended medicines should be maintained throughout the patent period, with NICE guidance retained to support this. This is essential to ensure timely and equitable access to medicines across the NHS.

3. 3Predictability and longevity of NICE decisions. Once NICE has recommended a medicine, the access that decision establishes should endure unless there is a clear clinical and evidence-based rationale for a review of guidance. This should not be triggered by cost considerations alone, and patients, clinicians, and companies should be engaged well in advance.

4. 4Room for future innovation. Wider use of off-patent medicines can support expanded patient access, but their use as comparators for new medicines must not create an insurmountable barrier to entry for new innovation in the therapy area. Better recognition of the value of new medicines in this scenario, for example through an innovation modifier, may be needed to mitigate this risk. A lifecycle approach should support both affordability and continued incentives for companies to bring future innovations to UK patients.

5. 5Stakeholder engagement. Where a Whole Lifecycle Approach activity impacts an existing medicine or appraisal, patients, clinicians, and companies affected should have robust means of input, including consultation and, where relevant, appeal, through whatever route NICE uses to generate guidance or guidelines.

6. 6Transparency and coherence. NICE should be clear and consistent about how topics are chosen, which activities are test cases and which move into business-as-usual processes, how learning is shared, and how the approach connects with the Single National Formulary. A transparent work plan and governance framework covering topic selection and prioritisation, methods and decision-making processes, stakeholder engagement, and communication of workstreams, timelines, and success metrics should be published.

7. 7Clinically driven, properly resourced, and engaged. Changes should be clinically motivated, realistic about NHS and company capacity, and preceded by a full review of feasibility and unintended consequences, with patient organisations, industry, and other key stakeholders engaged appropriately and early in the development of new approaches.

8. 8Ongoing monitoring and reporting. As the Whole Lifecycle Approach evolves and is transitioned into NICE’s business-as-usual ways of working, it should be clear how its impact is being monitored, with transparent and regular reporting.

¹  NICE’s strategic priorities in 2026 to 2027 | NICE