The Citizens Council provides NICE with a public perspective on overarching moral and ethical issues that NICE should take into account when producing guidance. Made up of members of the public, broadly representative of the adult UK population, the Council operates through a “citizens’ jury” style meeting, to explore and respond to a question set by NICE.

At its January 2008 meeting, the Citizens Council was asked:

• Should NICE and its advisory bodies take into account the severity of a disease when making decisions?
• If yes, should the advisory committees:

  • take severity “into consideration” alongside the cost and clinical effectiveness evidence;
  • or should severity be included in the calculation of the QALY?

The Citizens’ Council concluded, by 24 to 2, that NICE and its advisory bodies should indeed take the severity of a disease into account when making decisions. Among the 24 of us who took this view there was unanimity that rather than do so by including severity in the calculation of the QALY, it should be taken “into consideration” alongside the cost and clinical effectiveness evidence.

We reached this conclusion mainly because the process of QALY calculation already takes some account of severity, and because any changes intended to weight QALYs further in this respect will inevitably make them more complicated and harder to understand, and may also distort the model. This in turn could lessen their transparency, thereby making any attempt to understand a committee’s decision correspondingly more difficult.

The alternative - taking severity “into consideration” - would give appraisal committees more flexibility. We would not wish to see a mathematical or other formulaic approach to this task; such a step might simply recreate the rigidity of the QALY component of the decision. One possible course of action would be to add something about severity to NICE’s statement on social value judgements.

Transparency is vital to the acceptance of NICE decisions – not only in the way that committees reach them, but in how they are subsequently reported and explained. We must all be able to understand a committee’s reasoning.

We feel there is a problem with the EQ-5D questionnaire which we think is too blunt to capture all the factors relevant to the definition of a good or bad quality of life. We would prefer an approach that incorporates more of the social as well as the medical model of health and disease, and might - though we appreciate this could be difficult - take more account of the views of those who have first hand experience of the circumstances being rated.

We are not calling for the questionnaire or the QALY to be abandoned; rather we are suggesting that, in the light of experience so far, it is time they were subjected to a thoughtful and penetrating review.