Aging and the Quality Adjusted Life Year (QALY): the theoretical problem
| ICER | Decision | Explanation | |||
| 20 Years | 45 Years | 70 Years | |||
| 1 Year life gain for £30 000 | £30 000 | £30 000 | £30 000 | Yes to all | Within £30 000 threshold* |
| 1 Year life gain for £45 000 | £45 000 | £45 000 | £45 000 | No to all | Outside £30 000 threshold |
| 1 Year life gain at end of life for £45 000 | £45 000 | £45 000 | £45 000 | Yes to all | Within de facto EOL rules threshold† |
| Normal life expectancy gain for £450 000 | £8000 | £13 000 | £30 000 | Yes to all | Within £30 000 threshold* |
| Normal life expectancy gain at end of life for £700 000 | £13 000 | £20 000 | £47 000 | Yes to all | Within de facto EOL rules threshold† |
| Normal life expectancy gain for £1 million | £18 000 | £28 000 | £67 000 | Yes only to under 50s?‡ | |
An explanation of end-of-life (EOL) supplementary advice as presented in National Institute for Health and Clinical Excellence (NICE) documentation.
EOL stands for end of life. It refers to supplementary advice issued by NICE to the appraisal committees, to be taken into account when appraising treatments that may be life-extending for patients with a short life expectancy, and that are licensed for indications affecting small numbers of patients with incurable illnesses. The additional advice will apply when such treatments have an incremental cost-effectiveness ratio (ICER) in excess of the upper end of the range normally approved by the appraisal committees, using the most plausible ICER agreed by the committee generated by the ‘reference case’ outlined in the Institute's guide to the methods of technology appraisal, and that may offer demonstrable survival benefits over current NHS practice. The current appraisal methodology recognises that there will be circumstances in which it may be appropriate to recommend the use of treatments with high reference case ICER. The appraisal committee has, in the past, made recommendations above the normal threshold range when it has explicitly identified additional benefits not readily captured in the reference case. This has occurred when the treatment involved has been life extending, licensed or otherwise indicated for small populations with incurable illnesses. This formalises the position of EOL and the supplementary advice should be applied in the following circumstances and when all the criteria referred to below are satisfied:
The treatment is indicated for patients with a short life expectancy, normally less than 24 months and there is sufficient evidence to indicate that the treatment offers an extension to life, normally of at least an additional 3 months, compared with current NHS treatment, and the treatment is licensed or otherwise indicated for small patient populations. When the conditions described are met, the appraisal committee will consider the impact of giving greater weight to quality-adjusted life-years (QALY) achieved in the later stages of terminal diseases, using the assumption that the extended survival period is experienced at the full quality of life anticipated for a healthy individual of the same age, and the magnitude of the additional weight that would need to be assigned to the QALY benefits in this patient group for the cost effectiveness of the technology to fall within the current threshold range. In addition, the appraisal committees will need to be satisfied that the estimates of the extension to life are robust and can be shown or reasonably inferred from either progression-free survival or overall survival (taking account of trials in which crossover has occurred and been accounted for in the effectiveness review), and the assumptions used in the reference case economic modelling are plausible, objective and robust.
↵* NICE methods guide states the threshold should be £20 000–30 000. In practice the exceptional circumstances allowing the upper end of the scale prevail.
↵† The EOL rules allow for the greater valuation of life years in terminal (<2 years to live) illness. The de-facto valuation has been 1.67, ie, an implied threshold change to £50 000 per QALY.
↵‡ A circumstance yet to arise. See text.