OBJECTIVES: The National Institute of Health and Care Excellence (NICE) recommends public reimbursement of health technologies deemed cost-effective at an upper threshold of £20,000-£30,000 per additional Quality Adjusted Life Year (QALY). In 2009, NICE issued supplementary ‘End of Life’ (EoL) guidance for technologies that may extend the life of people with incurable illnesses to be assessed at a higher threshold (£50,000/QALY). One key eligibility criteria is that the treatment offers an extension to life (normally ≥3 months) versus current NHS treatment. The European Medicine Agency (EMA) is increasingly authorizing medicines for such patients at earlier stages of their clinical development, without Phase 3 data. This research analyses how NICE have evaluated the eligibility of such therapies for consideration under EoL criteria.

METHODS: NICE single technology appraisal (STA) guidance for oncology drugs was screened (01/01/2009-31/05/2017) and data on the supportive trial package and EoL consideration extracted.

RESULTS: CONCLUSIONS: NICE EoL criteria has been a positive access driver for treatments for patients with severe unmet needs. Such therapies are increasingly being approved on trial packages lacking Phase 3 data. Nevertheless, NICE have been quite flexible to date in their interpretation of the additional 3-month extension to life requirement, enabling their consideration under EoL criteria.