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The National Institute for Health and Clinical Excellence ( NICE) is charged with appraising new technologies (NTs) to determine whether the NHS of England and Wales should reimburse health authorities for expenditure on them. The Appraisal Committee is required to 'take into account' various 'considerations'. These fall into two categories: (i) the results of rigorous assessments and evaluations of the clinical effectiveness and cost effectiveness of the new technology in relation to the appropriate comparator, carried out by specialist teams employing state-of-the-art analytical techniques; (ii) the considerations listed in the Methods Guide and other official documents, such as decisions of the Appeal Panel, dealt with by the application of the committee's judgements and discretion to the limited amount of relevant 'evidence' available. While formally relevant in all Appraisals the 'other considerations' play an important role only when there is a question of raising the Willingness to Pay (WTP) for an Incremental Quality Adjusted Life Year (QALY) above the normal 'threshold' of £20,000 - up to £30,000 as a 'normal' maximum, or, 'exceptionally', beyond this figure (It is repeatedly stated that there is no official limit.) If the analytical level at which these other factors are considered is to be raised to a more credible and transparent level, in much less stark contrast to that of the assessments than at present, NICE has two options. One is to make a standard WTP tariff adjustment for each such consideration and so (e.g.) bring a £33,000 ICER down to £28,000 if a consideration such as 'innovatory' were to be rated at £5,000. The other is to move to Multi-Criteria Decision Analysis as the basis for Appraisal. The Annalisa below illustrates the way this could be done. More complex MCDA programs such as Expert Choice implementing the Analytic Hierarchy Process are also available. Derived from Guide to Methods of Technology Appraisal and other NICE documents, including appeals (e.g. that on Bortezomib ): - pClEff= probability that the NT is clinically effective relative to the Comparator
- pCostE20k= probability that the NT is cost effective relative to the Comparator at a WTP below £20,000 per QALY
- Acceptability/Appropriateness/Preferences [of patients and professionals]
- Terminality= End of Life Use
- Orph/NoAlt/Rescue= NT is 'orphan drug' OR has no alternative besides Best Supportive Care OR is used in a 'Rule of Rescue' situation
- OtherEq= Other Equity considerations
- DHpriorities= clinical priority area as designated by Secretary of State for Health and Welsh Assembly Government
- HSFeasability/Impact
- Innovatoriness
- WiderSocietalConsiderations
- New Technology
- Comparator Technology
In the hypothetical example the NT is representative of a new class of drugs for a terminal condition which has shown to be highly likely to be clinically effective and to be acceptable to patients and professionals. It is in a priority area for the DH. It will, however, have a major impact on HS delivery systems. The uncertainties reflected in the Cost Effectiveness Acceptability Curve are assumed here to give it a 20% chance of being the Cost Effective option at a WTP for an incremental QALY of £20,000. All the other  Ratings are illustrative belief judgements. Note that in this example neither NT nor Comparator are relevant to the Orph/NoAlt/Rescue or Terminality Attributes, so they are both rated zero on both. Since consistency and equity require that the Attributes remain the same across all Appraisals this is the way to deal with this situation, not deleting the Attributes. Personal value judgements. Giving less weight to Cost-Effectiveness and greater weight to some 'other considerations' flips the recommendation between slide 1 (NT is not approved) and slide 2 below. Many patient and professional groups explicitly or implicily argue that Cost-Effectiveness should be given little or no weight in their case. Giving Clinical Effectiveness great weight and Cost-Effectiveness very little will usually favour the NT , as in Slide 3, even without 'other considerations' being 'taken into account'. N.B. The Chairman of the Bortezomib Appeal Panel recently denied that the AC had given Cost-Effectiveness 'unreasonable weight', thereby implying there is a 'reasonable weight'. The Methods Guide is currently under review but this appears to be focusing on the already sophisticated Assessment inputs into the Appraisal, rather than the processing of the other considerations - which has the power to increase the opportunity cost of approval by 50% or more. One of the key benefits of MCDA, following from the requirement to rate and weight, is to require greater clarity and precision in the definition of 'considerations' than exists in the present documentation (and in this illustration).
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