The National Institute for Health and Clinical Excellence (NICE) published its final appraisal determination on CIs – both unilateral and bilateral CIs – on 2 September 2008. Its recommendations on bilateral CIs were challenged in an appeal on 26 November 2008, by South Central Specialised Commissioning Group and Yorkshire & The Humber Specialised Commissioning Group, but this appeal was rejected as announced publicly by NICE on Wednesday 28 January 2009.
NICE has fully endorsed CIs as a cost-effective medical intervention. It is to be hoped that this will help iron out inconsistencies in the provision of CI services and put an end to the current post-code lottery that even candidates for unilateral CIs currently face with their primary care trusts (PCTs). The recommendations from NICE have completed their final stage of development (called the final appraisal determination or FAD). The NICE recommendations will now become guidance to the NHS that local PCTs and CI centres will be expected to follow although, frustratingly, three months has to be allowed for the appellants to consider whether they wish to mount a judicial review challenge to the NICE decision.
The NICE report takes a major step forward by recommending simultaneous bilateral CIs for children. It also recommends simultaneous bilateral CIs for adults who are blind or who have other disabilities that increase their reliance on auditory stimuli as a primary sensory mechanism for sensory awareness. NICE also recommends that children and adults who have unilateral implants, and who may now be considered to have met the criteria for simultaneous bilateral CIs, should be offered the option of a second CI subject to discussion the of the benefit they will receive.
These are very welcome developments. They bring the NHS a long way towards the standard of treatment that exists in other countries. However, many adults will have to continue to rely on just one CI. NICE feels that more research is needed on the benefit of bilateral cochlear implantation compared with unilateral cochlear implantation in adults with severe to profound deafness. It has set a review date of February 2011 to look again at its recommendations.
Apart from people affected by visual impairment, NICE has closed the door on bilateral CIs for adults, at least until 2011, even though it acknowledges that “utility data used in this analysis were associated with some uncertainty because they were derived from a small number of adults over a short follow-up period.” This makes further research into the benefits of bilateral CI for adults even more important and, indeed, NICE recommends that this takes place.
However, even on current utility data, the case for bilateral CIs in adults bears re-examination. The NICE draft report notes that simultaneous bilateral CIs in adults would meet NHS cost-effectiveness criteria if manufacturers provided a discount of “75% on the second system.” Small changes in the utility data would reduce the size of the discount needed still further. Current discounts are already as high as 50% and there are other cost savings to be made in moving from unilateral to bilateral CIs. NICE could invite implant manufacturers and CI centres to examine ways of developing a bilateral model that could close the cost-benefit gap and deliver cost-savings that would satisfy NICE cost-benefit criteria for adults.