The second draft of the NICE report was released in early March. The second draft backtracks on the decision, in the first draft, to recommend simultaneous bilateral CIs for pre-lingual deaf babies and young children. It was potentially a big step forward that would have helped closed the gap between the UK and many other countries where bilateral CI provision is now the norm.

NICE has dropped the recommendation in the second draft. Instead, it only recommends bilateral CIs “in the context of research designed to generate robust evidence about the benefits to functional hearing and health-related quality of life of simultaneous or sequential bilateral compared with unilateral cochlear implantation.” The NICE committee has retained its recommendation for bilateral CIs in meningitis and deaf/blind cases. Indeed in such cases, the draft appears to take a step forward by not restricting the recommendation to simultaneous operations.

However, if the second draft holds sway, the door looks set to be closed to bilateral CIs for non-meningitis and non-deaf/blind cases, except for the lucky few involved in research studies. This is a massive step backward compared to the first draft. Indeed, compared to the current situation where some PCTs have chosen to fund bilateral CIs on an individual case basis, the door will be even more firmly closed if the text is adopted. The scope for individual PCT decisions on cases will be restricted by the NICE recommendations. Far from moving us closer to the situation in other countries, the prospects for many deaf children in the UK will have fallen further behind for the time being at least.

So what has happened in the space of three months between the first draft report and the second draft report? Part of the answer for the u-turn, paradoxically, may be that members of the NICE appraisal committee were persuaded by the case for reconsidering their earlier decision to relegate older children and adults in their thinking. The first draft report had left little hope for existing unilateral CI users seeking funding for a sequential operation, for post-lingually deaf children or for adults hoping for any bilateral provision. The second report, at least, accepts that there is a case for further research including adults and that NHS funding should be allowed for sequential operations that are part of research studies.

Despite these chinks of light for children who are current unilateral users and adults, the final report represents a massive u-turn and loss of nerve by NICE. Para 1.2 of the first draft report stated clearly in black and white: “simultaneous bilateral cochlear implantation is recommended (for prelingual children) with severe to profound deafness who do not receive adequate benefit from acoustic hearing aids.” Now, para 1.3 of the final report says: “bilateral cochlear implantation is not recommended for children…except in the context of research.”

In its first draft report, NICE observed that “bilateral cochlear implantation would afford additional gains in communication associated with improved language learning and benefits to education through improved ability to communicate and interact in the classroom” (para 4.3.12). It also “concluded that there were additional benefits of bilateral cochlear implants that had not been adequately evaluated in the published studies” (para 4.3.9). Crucially, in its first report, NICE was much more ready to show a common-sense approach that it was reasonable to take account of these benefits and not wait for the academic world of health modelling to catch up with the real world of two-sided vs one-sided hearing in the environment of the busy classroom. The NICE committee had shown itself to be persuaded by the logic and imperative of two-sided hearing and was happy for the world of research to catch up and give ‘gold standard’ proof to this common sense view. Now, in effect, everything is on hold while research is conducted.

In its second report, NICE has backtracked to a position where it observes that children have been left out of research and, because of this neglect, they will pay the price by waiting many more years for bilateral CIs. In the original report, NICE accepted that the only ‘utility’ data came from an adult study but that it was sufficiently convinced by the additional gains for children that it would not be held back by that. Thus, in its first draft, NICE pointed out “that the 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” and, second, NICE “considered that for prelingual children with severe to profound deafness this (the adult utility data) would be likely to be an underestimate” (paras 4.3.13 & 4.3.11).

The crucial part of the first NICE report said: “the Committee recognised that the economic analyses were sensitive to utility gains, and that if the gain in utility was assumed to be 0.04 or 0.05 rather than 0.03, the estimates of cost effectiveness were £31,300 and £25,500, respectively. The Committee was persuaded that at the minimum these small additional increments in utility were plausible. Therefore on balance the Committee considered that simultaneous bilateral cochlear implantation for appropriately assessed prelingual children with severe to profound deafness could be considered a cost-effective use of NHS resources” (para 4.3.11). In its second report, however, the NICE committee appears to have lost its nerve and fallen back to a position where it feels unable to form its own view and instead feels that more robust evidence is needed.

£30,000 is a magic number in terms of NHS estimates of cost effectiveness and the committee originally judged that it was reasonable to believe that children would get small incremental gains in utility compared to adults that would bring the cost-effectiveness calculation for children below the £30,000 level. In its second report, NICE ditches mention of the 0.05 utility gain that brings the figure down to £25,500 and, instead, confines itself to a cost effectiveness for simultaneous bilateral implantation of £31,900 on a 0.03 assumption and £31,300 for a 0.04 assumption (para 4.2.14). These figures assume that manufacturers discount the second device price by 50% which reflects fairly standard practice.

The big question is ‘whether all hope is lost in the current NICE appraisal?’ Given the knife-edge nature of the figures, the answer has got to be ‘no’. Undoubtedly, the change in stance in the second draft is very bad news but the second draft is not final. In the same way as a lot has changed between the first and second NICE draft, perhaps a lot more can still change. The NICE committee will go through a process of inviting further comments before making its final recommendations. Even on the limited data which NICE had earlier gone on record as saying probably underestimated the benefits for children, the £31,300/£31,900 cost-effectiveness figure is only a tiny bit above the magic £30,000 threshold. Indeed, even on the higher figure, a reduction in cost of less than 3% would bring simultaneous bilateral CI operations for children within NHS funding limits.

With a company like Cochlear earning annual profits of around A$100.1 million, up 25% on the previous year, and forecasting future profit growth in the 15-20% range*, many may feel that device manufacturers could bring the cost of second devices down. The £300 or £900 reduction needed to satisfy NHS cost-effectiveness criteria would be small beer compared to the opportunity to vastly expand the volume of devices being sold. Both short-term and long-term profits and revenues would still be enhanced by the extra sales. Not only would manufacturers be opening up a NHS bilateral market that would otherwise be closed to them but they would be giving the opportunity of bilateral hearing to a generation of children who might otherwise be denied it. The latest NICE draft gives device manufacturers such as Cochlear a chance to really live up to their promise of ‘hear, now, always’! Are they really going to let that opportunity slip by and stand in the way of a huge leap forward for a generation of deaf children?

Was the committee nobbled? This is not such an outrageous question as it seems. After all, one would expect changes between a first and second draft to reflect comments on the first draft. However, all the comments on the first draft from consultee organisations either accepted or were supportive of the first draft’s decision to recommend bilateral implantation (judging from the documents circulated by NICE with the second draft). The only exception to this was a submission from one consortium of PCT funders – the South Central Specialised Services Commissioning Group. For NICE to react to the response of one group of PCTs, and fly in the face of a whole range of comments from bodies including the Royal College of Paediatrics and Child Health, the Royal College of Physicians, all the major deaf charities, the Ear Foundation etc, seems unlikely. It would also be faintly absurd as, after all, it is the function of NICE appraisals to set the lead for PCTs not the other way round.

Was it outside events? After all, the period between the first and second draft has included controversial medical news, including the disclosure that the NHS has wasted millions in allowing drugs such as Seroxat to be prescribed for children even though its manufacturer had conducted trials that had shown the drug had little or no effect on helping depression in minors. It would not be credible for such events to affect the NICE committee since the safety and effectiveness of CIs are not in doubt.The ability of CIs to provide assistive hearing safely has never been at issue. The key question facing NICE was not safety or effectiveness but whether the benefits of two-sided hearing should be extended to CI candidates or whether funding should be restricted to one.

Ironically, if the NICE committee really did concern itself with comparing the case for bilateral CIs to health expenditure as a whole, it would have recommended bilateral CIs months or even years ago. The costs of bilateral CIs are dwarfed by the sums that the Chief Medical Officer, Sir Liam Donaldson, says could be saved by the NHS on ineffective or wasteful treatments. Presenting his Annual Report in July 2006, the Chief Medical Officer said: “With finite resources available for the provision of healthcare, it is important that effective therapies to relieve significant conditions are adopted and that ineffective interventions are abandoned” (Chief Medical Officer, Annual Report, 2005). His report highlighted four examples of ineffective treatments which alone cost the NHS tens of millions and, certainly, more than the relatively small sum it would cost to invest even in full bilateral CI services, for children and adults alike. Reporting on his findings, the Financial Times said: “more standardised procedures and protocols for treatment would also contribute to patient safety, failures of which were costing the NHS at least £3bn a year” (Donaldson highlights waste in treatments, Financial Times, July 22 2006).

Indeed, the costs of bilateral CIs are likely to be dwarfed even by the contract cancellation fees that the Department of Health is spending this year simply because of changes to central contracts with private sector health providers. According to Financial Times the costs incurred in such fees alone are likely to be at least £28 million (Watchdog poised to probe NHS deals, Financial Times, 17/18 November 2007). Background research for the 2ears2hear website estimates that the recurrent investment needed to provide bilateral CIs for the current caseload of both adults and children represents 0.012% of the NHS's total resource budget in 2007/8 (projected to be £87.6 billion in HM Treasury's 2007 Budget Report). Put another way, this is just 1/8200th of the total NHS resource budget.

When you consider these figures and look at how the second draft appraisal document flies in the face of the weight of consultee opinion in favour of bilateral CIs, the mystery deepens as to why there has been a change of mind. Maybe the idea that the committee has been nobbled is not so far fetched after all!