The National Institute for Health and Clinical Excellence (NICE) is responsible for recommending the use of new medicines and treatments within the NHS.

Appraisals involve a consultation and evaluation process featuring interested parties and an independent academic centre.

The process ends with the Appraisal Committee

Submissions and Evidence Review Reports

The Appraisal Committee receive Submissions and Evidence Review Reports. The main elements of appraisal are clinical effectiveness (including efficacy and side effects of the proposed treatment) and cost-effectiveness.


Decisions are evidence-driven, with RCT (randomised controlled trial) evidence being preferred. Expert and patient opinion may often also be required. Rigour, quality and transparency are very important in submissions.

Modelling Requirements

Clinical evidence from trials is rarely sufficient and modelling will be required in most cases to provide evidence. Methods of modelling are closely specified in guidance documentation to produce a "reference case".

Reference Case

The reference case requires the use of Quality Adjusted Life Years (QALY's) - allowing gains in both quality of life and length of life changes to be encompassed in a single measure. The incremental cost per quality adjusted life year gained (cost/QALY) is used in estimating cost effectiveness.

Quality Adjusted Life Years (QALY's)

The QALY consists of two elements - an estimate of quality of life anchored at 1 (perfect health) and 0 (death), and length of life. The quality of life weighting is derived from the general population using a process of comparison between possible choices to generate weights.

As a general rule NICE treats a QALY to be of equal worth and irrespective of other circumstances of the disease (such as severity) or the patient (such as age, sex, parental responsibility etc). The only exception is the "end of life" consideration.


Special factors are required if the incremental cost per quality-adjusted life year gained exceeds £20,000. With a fixed budget in place, this represents the estimated cost of marginal activities that would be displaced by introducing new technology.

Criteria for Appraising End of Life Treatments

In appraising end of life treatments, the following conditions have to be met:

  • life expectancy of less than 24 months,
  • treatment offers an extension of at least 3 months,
  • no alternative treatments available,
  • small patient population.

Application of Criteria

If these conditions are met for "end of life" the Appraisal Committee will consider the impact of giving greater weight to QALYs in the later stages of terminal diseases (the extended survival period is assumed to give a Quality of Life equal to that of a healthy individual of the same age); and the size of additional weight that would be necessary to make the incremental cost per QALY gained fall below the usual £20,000 threshold.

Appraisal Committee Members

The Appraisal Committee has 24 members. Their roles are both technical (to interpret evidence and arguments) and evaluative (to reach a decision as a reasonable member of the public) using agreed criteria.

The rough composition of the Appraisal Committee is 15 practicing doctors, 2 economists, a statistician, health managers, patient group representatives, a drug industry health economist, and a devices industry health economist.

The process at Appraisal Committee

The Appraisal Committee process consists of documentary evidence, presentations, expert and patient commentary with questioning by the committee, deliberation and then a vote.

Nature of NICE Decisions

NICE may endorse a product wholly or in part. It may deem it not cost effective and therefore not recommended and it may argue that the evidence is currently inadequate and endorse "in research only" use. Decisions to support drugs but restrict access to them are commonplace.


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