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Medical Technology Guidance

Bilateral cochlear implants for children with severe-to-profound sensorineural hearing loss in both ears Published on 29 March 2018


Guidance Recommendation
The Ministry of Health's Medical Technology Advisory Committee has recommended:
  • Bilateral cochlear implants (BCI) for the management of children (<18 years old) with severe-to-profound sensorineural hearing loss in both ears who have:
    • A hearing threshold of >70 decibels hearing level (dB HL) without acoustic hearing aids (HA),
    • A hearing aid trial of 3 to 6 months, unless contraindicated or inappropriate, and
    • Parental support in the form of motivation and commitment to rehabilitation.
  • Simultaneous BCI should be provided to the eligible child (<18 years old) as early as clinically suitable.
  • For children who have received unilateral cochlear implant (CI), the second CI in the contralateral ear should be provided only if this is judged to provide sufficient benefit by the clinician.
    • The second CI should be provided by 6 years of age unless there are special conditions to consider (e.g. large vestibular aqueduct syndrome (LVAS), meningitis, irradiated ears).

Subsidy status

BCI subsidies for the abovementioned indications apply only to the CI devices (standard package) listed in the Annex.

Subsidies do not apply to replacements or upgrades of the CI or its accessories.


  
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Factors considered to inform the recommendations for subsidy


Technology evaluation

Point Item
1.1 The MOH Medical Technology Advisory Committee ("the Committee") considered the evidence presented for the technology evaluation of bilateral cochlear implants (BCI) for children with severe-to-profound sensorineural hearing loss in both ears. The Agency for Care Effectiveness conducted the evaluation in consultation with an MOH expert working group comprising clinicians, audiologists, medical social workers, and educators.
1.2 The evidence was used to inform the Committee's deliberations around five core decision-making criteria:
  • Clinical need of patients and nature of the condition
  • Overall benefit of the technology to the patient and/or the system
  • Cost-effectiveness (value for money), which covers the incremental benefit and cost of the technology compared to existing alternatives
  • Estimated annual technology cost and the number of patients likely to benefit from the technology
  • Organisational feasibility, which covers the potential impact of adopting technology, especially barriers for diffusion
1.3 Additional considerations, such as ethical or social issues related to adoption of technology, may also inform the Committee's deliberations.


Clinical need

Point Item
2.1 The Committee noted that unilateral cochlear implant (UCI) is currently subsidised for children (<18 years old) with severe-to-profound sensorineural hearing loss in both ears. Children with UCI would normally use a hearing aid (HA) in the contralateral ear (UCI-HA).
2.2 The Committee further noted that the use of a HA in the contralateral ear may not confer adequate functional hearing benefits due to insufficient residual hearing in the non-implanted ear as the ability of the HA to filter out unintended sound signals depends on its sound processing algorithms.


Overall benefit of technology

Point Item
3.1 In line with local clinical practice, the main comparator used in the evaluation was UCI-HA. The Committee noted that, compared to UCI-HA, BCI demonstrated similar short-term safety and that device failure rate was low. However, long-term safety data (>5 years) for BCI was currently lacking.
3.2 The Committee noted that a key limitation in studies on BCI for children was that there was no single measurement on functional outcomes as the assessment had to be appropriate for the age, developmental stage, and cognitive ability of the child. This contributed to the substantial heterogeneity in the studies included in the evaluation.
3.3 The Committee acknowledged that none of the studies looked at long term patient outcomes. However, compared to UCI-HA, BCI was associated with better sound localisation, similar or better speech perception and language development which may be acceptable surrogates for long term patient outcomes, such as academic performance and vocational placement.
3.4 The Committee also noted a number of published overseas position statements endorsed the use of BCI in clinically appropriate candidates, including a 2017 World Health Organization report which concluded that the benefits of BCI exceed its costs.
3.5 The Committee agreed that the benefits were greatest when CI was implanted as early as clinically suitable, and noted an age limit of 6 years old was applied in New Zealand to the funding of the second CI for children who had already received one CI. Taking into consideration the critical age of development of cortical auditory activity and inter-implant interval, the Committee agreed that the second CI should be provided by 6 years of age unless there are special conditions to consider (e.g. large vestibular aqueduct syndrome (LVAS), meningitis, irradiated ears).


Cost-effectiveness

Point Item
4.1 The local cost-effectiveness model compared BCI with UCI-HA over a lifetime period. The Committee noted that the incremental cost-effectiveness ratios (ICERs) for BCI were high and was most sensitive to utility increment and the selling price of the CI device.
4.2 Following value-based pricing (VBP) discussions with the manufacturers, the Committee noted the ICERs for BCI were in the range of $15,000 to <$45,000 per QALY gained compared with UCI-HA, and agreed that BCI for children would likely be considered an acceptable use of healthcare resources.


Estimated annual technology cost

Point Item
5.1 Based on the projection of approximately 33 new cases a year who would benefit from government subsidy for BCI, the Committee noted that the annual cost of providing BCI was estimated to be less than $1 million.
5.2 In addition, the Committee recognised that there was an existing pool of children under 6 years of age currently with one CI who would potentially benefit from subsidy for BCI. If subsidy for the second CI is provided for them, the additional one-off cost was estimated to range from $1 million to <$3 million.


Organisational feasibility

Point Item
6.1 According to local experts, there was sufficient expertise and infrastructure to manage the potential increase in clinical load, and no significant concerns over increased staff need was identified.


Additional considerations

Point Item
7.1 The Committee noted that current UCI subsidies apply only to the initial CI, and there were no subsidies for replacements or upgrades of CI and its accessories.


Recommendation

Point Item
8.1 On the basis of the evidence presented, the Committee has recommended to subsidise the CI devices (standard packages) listed in the Annex for BCI in children (<18 years old) with severe-to-profound sensorineural hearing loss in both ears who have:
  • a hearing threshold of >70 decibels hearing level (dB HL) without acoustic HAs;
  • a hearing aid trial of 3 to 6 months unless contraindicated or inappropriate; and
  • parental support in the form of motivation and commitment to rehabilitation.
8.2 In addition, the Committee also recommended the following:
  • simultaneous BCI should be provided to the eligible child as early as clinically suitable;
  • for children who have received unilateral CI, the second CI in the contralateral ear should be provided only if this is judged to provide sufficient benefit by the clinician, and the second CI should be provided by 6 years of age unless there are special conditions to consider (e.g. LVAS, meningitis, irradiated ears).
8.3 The Committee also recommended that the CI devices listed in the Annex should also be used for UCI in adults with severe-to-profound sensorineural hearing loss.
Last Updated on 29 March 2018 Back to Top