NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE GUIDANCE EXECUTIVE (GE) Consideration of consultation responses on review proposal Review of TA166; Deafness (severe to profound) - cochlear implants This guidance was issued January 2009 with a review date of February 2011. Background At the GE meeting of 12 April 2011 it was agreed we would consult on the review plans for this guidance. A four week consultation has been conducted with consultees and commentators and the responses are presented below. Proposal put to consultees: Rationale for selecting this proposal A review of the guidance should be transferred to the static guidance list. The new evidence published since TA166 was issued is either not relevant to the research questions recommended in TA166 or is not expected to change the current recommendations. In view of this, it is recommended that this guidance should be transferred to the static guidance list. GE is asked to consider the original proposal in the light of the comments received from consultees and commentators, together with any responses from the appraisal team. It is asked to agree on the final course of action for the review. Recommendation post consultation: The guidance should be transferred to the static guidance list 1. 1 Guidance is placed on the static list when it is clear that there is no new research available that would have any material effect on the current guidance. Topics on the static list may be transferred back to the active list for further appraisal if new evidence becomes available that is likely to have a material effect on the last guidance issued.
Respondent Response to proposal Details Comment from Technology Appraisals British Association of Audiological Physicians British Cochlear Implant Group Agree BAAP are in favour of your proposal in this matter. Comment noted No objection There are 7 recent reviews which would support the process of bilateral CI in adults outside of the United Kingdom. 1. Otol Neurotol. 2011 Jan 28. Assessment of Electrode Placement and Audiological Outcomes in Bilateral Cochlear Implantation. 2. Laryngoscope. 2010 May;120 Suppl 2:S17-44. Worldwide trends in bilateral cochlear implantation. 3. J Am Acad Audiol. 2010 Jan;21(1):35-43 Performance over time on adults with simultaneous bilateral cochlear implants. 4. Laryngoscope. 2009 Dec;119(12):2395-401 Bilateral cochlear implantation: current concepts, indications, and results. 5. Ear Hear. 2010 Apr;31(2):296-8 Bilateral and unilateral cochlear implant users compared on speech perception in noise. 6. Curr Opin Otolaryngol Head Neck Surg. 2009 Oct;17(5):351-5 Bilateral cochlear implantation: current concepts. 7. Otol Neurotol. 2009 Apr;30(3):313-8. Subjective and objective results after bilateral cochlear implantation in adults. Comment noted. Correspondence from the British Cochlear Implant Group referred to in the proposal paper confirms that there is currently no new evidence available to necessitate a review of TA166 and therefore the British Cochlear Implant Group have no objections to the proposal that TA166 should be placed on the static guidance list.
Respondent Response to proposal Details Comment from Technology Appraisals Department of Health No comment The Department of Health has no further comments to make. MED-EL UK Agree We concur that there is little recent evidence available concerning some of the questions posed by NICE. However, a number of clinical trials and economic studies are on-going that will contribute high quality evidence to the knowledge base in this area, especially with respect to bilateral cochlear implantation in children. Initial results from some of these studies are expected soon. In this context it should also be noted that a number of these trials on bilateral cochlear implantation are not included in the NICE list of on-going trials. There are also studies on-going in the area of hearing preservation surgery that are not included in the list. Advances in the latter area allow for the preservation of patients residual hearing in the lower frequencies despite implantation of a cochlear device, thus providing patients with a more natural hearing. Comments noted.
Respondent Response to proposal Details Comment from Technology Appraisals MED-EL UK (continued) This growing body of evidence and in particular the increasing experience with cochlear implants in society can be expected to underscore the benefits of hearing implant technology not only to persons with hearing loss, but to society as a whole. Children who receive cochlear implants at a young age are more likely to be able to enjoy a mainstream education and attain the same educational and professional credentials as hearing persons. Furthermore, the ability to mainstream most cochlear implant users means that there is less need for the costly infrastructure geared to the special educational needs of persons with severe to profound hearing loss. In fact, many schools for the deaf have either closed their doors or have changed their focus to adapt to the considerable shift in the needs of people with hearing loss. Such changes represent significant cost savings that are not captured in cost-effectiveness studies that focus on the costs and benefits of cochlear implantation in individual patients. Given the continued expansion in the body of knowledge and the evidence base on cochlear implants, we look forward to the next review of this technology by NICE. Currently, however, we support the recommendation to move the technology appraisal to the static list until the next scheduled review or until significant new evidence becomes available. Public Health Wales NHS Trust Agree The Public Health Wales NHS Trust agrees with the proposal that the guidance should be moved to the static list. Comment noted
Respondent Response to proposal Details Comment from Technology Appraisals Royal College of Physicians Agree We agree with the NICE recommendation with regard to the above consultation. Comment noted Royal College of Paediatrics and Child Health Agree The College is not aware of any new evidence that justifies a full review of this NICE guidance, and so agrees that the guidance should be transferred to the static list. However, whenever this guidance is reviewed in the future, we think that more recommendations should be offered on measuring outcomes. The current audit tool associated with this guidance recommends providing evidence-based information and auditing whether eligibility criteria are met for unilateral or bilateral cochlear implants. This audit would be improved by also measuring the time intervals between diagnosis of profound deafness, age when aids supplied (if appropriate) and age when cochlear implants are provided. Even if there is no good agreement on the exact value of these time intervals, it would be useful to compare performance between centres offering cochlear implants. Comment noted. Healthcare Improvement Scotland No comment We have no comment to make on the proposal to place the above guidance on the static list. Comment noted Royal College of Nursing No comment There are no comments to make at this stage. Comment noted
No response received from: Manufacturers/sponsors Advanced Bionics Sarl Cochlear Europe Neurelec Patient/carer groups Afiya Trust Auditory Verbal UK Black Health Agency British Deaf Association Catholic Deaf Association Chinese National Healthy Living Centre Christian Deaf Link UK Cochlear Implanted Children s Support Group Counsel and Care Deafblind UK deafplus DELTA Ear Foundation Equalities National Council Hearing Concern LINK Ménière's Society Muslim Council of Britain Muslim Health Network National Association of Deafened People National Cochlear Implant Users Association National Deaf Children s Society General Association of British Health-Care Industries (ABHI) Board of Community Health Councils in Wales Care Quality Commission Commissioning Support Appraisals Service Department of Health, Social Services and Public Safety for Northern Ireland EUCOMED Medicines and Healthcare products Regulatory Agency (MHRA) National Association of Primary Care NHS Alliance NHS Commercial Medicines Unit NHS Confederation Scottish Medicines Consortium Comparator manufacturers GNResound (hearing aids) Oticon UK (hearing aids) Phonak UK (hearing aids) Siemens hearing instruments (hearing aids) Starkey Laboratories (hearing aids) Relevant research groups Hearing Research Trust Help Ear & Allied Research
Royal Association for Deaf People Royal National Institute for the Deaf Sense South Asian Health Foundation Specialised Healthcare Alliance UK Council on Deafness Professional groups Association of Surgeons of Great Britain and Ireland British Academy of Audiology British Association for Service to the Elderly British Association of Community Doctors in Audiology British Association of Educational Audiologists British Association of Otolaryngologists, Head & Neck Surgeons British Association of Teachers of the Deaf British Geriatrics Society British Society of Audiology British Society of Hearing Aid Audiologists Royal College of Anaesthetists Royal College of General Practitioners Royal College of Speech and Language Therapists Royal College of Surgeons MRC Clinical Trials Unit National Institute for Health Research Research Institute for the Care of Older People University College London Department of Phonetics and Linguistics Assessment Group National Institute for Health Research Health Technology Assessment Programme Tbc Associated Guideline Groups National Collaborating Centre for Women and Children s Health Associated Public Health groups tbc Others NHS Bradford and Airedale
NHS Hertfordshire Welsh Assembly Government GE paper sign-off: Janet Robertson, Associate Director Technology Appraisals Programme Contributors to this paper: Technical Lead: Christian Griffiths Technical Adviser: Fiona Rinaldi Project Manager: Andrew Kenyon 15th June 2011