List of Figures Fig 13 – Cost-effectiveness scatterplot of the Vibrant Soundbridge against no intervention………………………………………………………………………………………….130 Fig 14 – Cost-effectiveness scatterplot of the Vibrant Soundbridge against the MAXUM…131
Table 12 - Summary of comparator study characteristics included in the evaluation Study level of evidence n Outcomes Conclusion Oxford ebM NHMRC Fully implantable device: ESTEEM Barbara et al. 2011 Italy III III-3 18 adults 1.5-2 months AC and BC pure tone thresholds, Speech recognition in quiet, Quality of life beneficial results in subjects suffering from high frequency, severe bilateral sensorineural hearing loss (SNHL) Prospective, pre/post study Barbaraet al. 2014 Italy IV IV 34 adults 3 months Adverse events delayed facial nerve (FN) impairment and taste disturbances were found in a limited number of subjects. Prospective, study Chen et al. 2004 USA III III-2 7 adults 4 months AC and BC pure tone thresholds, Functional gain, Speech recognition in quiet and noise, Quality of life, Adverse events feasibility of a totally implantable middle-ear device for sensorineural hearing loss was proven Prospective, multicenter study Gerard et al. 2012 Belgium III III-3 13 adults not stated AC and BC pure tone thresholds, Functional gain, Speech recognition in quiet and noise, Quality of Life, Adverse events offers good functional and satisfaction results; however, careful selection of patients is required. The implant is safe and only associated with classic auditory implant complications Retrospective, pre/post study Monini et al. 2013 Germany III III-3 15 adults 3 months Functional gain, Speech recognition in quiet, Quality of life possible beneficial role for rehabilitation of SNHL in selected candidates and improvement of quality of life was concluded Retrospective, cohort study Memari et al. 2011 Iran III III-2 10 adults 19-40 months AC and BC pure tone thresholds, Functional gain, Adverse events surgery seems to be realtively safe. Correct selection of patients is very important and infuences postoperative results. Hearing gain in current devices is similar to conventional hearing aids, but with better subjective hearing quality. Prospective, pre/post study
Kraus et al.2011 USA III III-2 57 adults 12 months AC and BC pure tone thresholds, Functional gain, Speech recognition in quiet and noise, Quality of life, Adverse events hearing results are statistically superior to baseline, best-fit HAs for SRT and WRS and the Esteem system is safe. Prospective, multicenter study Fully implantable device: CARINA Bruschini et al. 2010 Italy IV III-3 7 adults 12-21 months AC and BC pure tone thresholds, Functional gain, Speech recognition in quiet, Quality of life is a viable treatment for moderate to severe SNHL and for mixed hearing loss and that in selected cases it could represent an alternative to conventional hearing aids. Implantation without affecting residual cochlear hearing levels and auditory performance could be shown to be similar or better than that reported with Ha's. Device proved to be well tolerated. Prospective, pre/post study Jenkins et al. 2008 USA III III-1 20 adults 12 months AC and BC pure tone thresholds, Functional gain, Speech recognition in quiet and noise, Quality of life, Adverse events feasibility and lack of deleterious effects on native hearing was shown. Significant challenges in its clinical application have been encountered, and the company is addressing these issues in design revisions. Patient subjective questionnaires demonstrated improved naturalness of sound and functional hearing that are similar to their baseline hearing aids. Prospective multicenter study Tringali et al. 2010 France III III-2 7 adults 24 montths AC and BC pure tone thresholds, Functional gain, Speech recognition in quiet, Quality of life MET seems to be a suitable and successful treatment option resulting in significant improvement in speech comprehension, especially after 6 months, in patients with severe sensorineural hearing loss. During the 24-month follow-up of this study, the MET has been a safe and effective treatment for severe hearing loss Prospective, longitudional study Partially implantable device: SOUNDTEC Hough et al. 2002 USA III III-2 103 adults 4-5 months AC and BC pure tone thresholds, Functional gain, Speech recognition in quiet and noise, Quality of life, Adverse events significant improvement in outcomes Prospective, multicenter trial
Fisch et al. 2001 Europe III III-2 47 adults 3 months Unaided pure tone audiometry, Subjective impressions of sound quality - not reported Safety of the surgical procedure was demonstrated Prospective, single arm trial Fraysse et al. 2001 France IV III-2 25 adults 22 months Unaided and aided sound field thresholds (PTA4), Speech recognition, Subjective outcomes using the APHAB Measurable benefit from the VBS in comparison with HA (superior amplification,greater ease in communication in noise) Prospective, pre/post study Garin et al. 2005 Belgium III III-2 11 adults 9-24 months Speech intelligibility in noise (55 dB) Improvement in Outcomes Retrospective, with/without Labassi et al 2005 France IV IV 1100 adults 7 years Adverse events during/after surgery Reliable middle ear implant Retrospective study Lenarz et 2001 Germany IV III-3 34 adults 6 months Unaided and aided sound field audiometry, Speech intelligibility in quiet and noise, Subjective outcomes using the PHAB questionnaire Significant improvement Retrospective, pre/post study
Luetje et al 2002 USA III III-2 53 adults 18 weeks Unaided and aided pure tone audiometry, Tympanometry and acoustic reflex measurement, Speech reception in quiet and noise, Subjective outcomes using APHAB, HDSS and SHACQ Safe and effective treatment Prospective, single arm trial Luetje et al. 2010 USA III III-3 31 adults 1-11 years Unaided and aided pure tone audiometry, Degree of device use using a questionnaire Sustained gain Retrospective, pre/post study Mosnier et al 2008 France III III-2 100 adults 5-8 years Unaided and aided sound field audiometry, Speech intelligibility in quiet (65 dB), Subjective outcomes using Vibrant Questionnaire and GBI, Adverse events Safe and effective treatment Prospective, single arm trial Pok et al. 2010 Austria IV III-3 54 adults not stated Unaided and aided pure tone audiometry, unaided and aided sound field audiometry, Speech intelligibility in quiet (65 dB, 80 dB) In cases of SNHL with unsatisfying benefit from conventional HAs, the VSB system offers an attractive and effective hearing solution Retrospective, with/without
Snik et al. 2001 Europe IV III-3 63 adults 7 months Unaided and aided pure tone audiometry, unaided and aided sound-field speech testing in noise and quite overall benefit from VSB treatment, but subpopulation with no benefit remains Retrospective, multicenter study Snik et al. 2001 Netherlands IV III-2 14 adults 7 months Aided and unaided warble tone thresholds, Speech recognition tests Most of patients benefit from VSB treatment but subgroup presented with low gain Prospective Sterkers 2003 France IV III-2 125 adults 4 years Unaided and aided, pre and post surgery pure tone thresholds, Sound Field Warble tone to determine functional gain, Speech intelligibility in quiet, Subjective outcomes using the GBI and a Vibrant benefit not validated questionnaire significant improvement, high level of satisfaction with the VSB Retrospective survey Sziklai et al. 2011 Hungary III III-2 7 adults not stated Warble tone functional gain, Speech recognition scores no significant difference Self control prospective study
Todt et al. 2005 Germany IV III-3 23 adults 5 years unaided and aided thresholds pre - post implantation, Speech discrimination in quiet and noise, Subjective outcomes using an open Questionnaire Improvement in Outcomes Retrospective, with/without Todt et al. 2002 Germany IV III-3 5 adults 1 year Unaided and aided pure tone thresholds under headphones and BC, pre- post implantation, Speech discrimination in quiet (Freiburger monosyllables test), Speech discrimination in noise, Subjective outcomes using the APHAB Questionnaire The Symphonix Soundbridge device can improve the hearing benefit of moderately to severely hearing handicapped in those with a high-frequency hearing compared with the conventional hearing aids Prospective Uziel et al. 2003 France IV III-2 6 adults 6 months Warble tone thresholds, Speech comprehension in quiet and noise, Subjective outcomes using the APHAB and HDSS Questionnaire Suitable treatment option offering advantages over conventional amplification to the hearing-impaired person with a high-frequency hearing loss Prospective, Vincent et al. 2004 France IV III-2 39 adults 2- 24 months Unaided and aided pure tone thresholds, Residual hearing pre- and post implantation Significant Improvement Retrospective, with/without
Table 17 - Functional gain comparator author n follow up PTA calculation unaided Thresholds Device Thresholds Functional Gain (unaidedmean - devicemean) mean [dB] sd mean [dB] sd range sd mean [dB] sd p Chen 2004, Esteem 5 4 months SF .5-1-2-3 kHz 62.25 - 54.25 - - - 14.75 - - Gerard 2012*, Esteem 13 not stated PT ,25 to 8 kHz 66.84 - 41.77 - - - 25 11 - Monini 2013, Esteem 15 3 months SF,125-8 kHz - - - - - - 30 - Memari 2011, Esteem 10 19-40 months SF 0,25-0,5-1-2-4 kHz - - - - - - 11.2 9.61 - Kraus 2011, Esteem 48 12 months SF .5-1-2 - - - - - - 27 - Bruschini 2010, Carina 7 12-21 months SF .5-1-2-3 kHz 62.18 6.26 35.78 4.28 11.25-36.25 8.49 26.4 8.49 p < ,05 Jenkins 2008, Carina 12 months NO DATA REPORTED Tringali 2013* , Carina 7 24 months SF .5-1-2-3 kHz - - - - - - 40.25 - Hough 2002*, SOUNDTEC 95 4-5 months SF .5-1-2-3 kHz - - - - - - 24.45 - Roland 2001*, SOUNDTEC 23 6 months SF .5-1-2-3 kHz - - - - - - 24.25 - Silverstein 2005, SOUNDTEC 64 3 months SF 0.25 - 6 kHz - - - - - - 26 - * estimated from figures SF: Sound field PT:Pure tone
Table 20 - SRT, speech in quiet comparator speech in quite Baseline unaided Initial testing/activation 3 months / 1month post-act 4 months / 2 month post-act 3 months 6 months 12 months post-op SRT Test unaided aided aided aided aided aided aided author mean [dB] sd n mean [dB] sd n mean [dB] sd n mean [dB] sd n mean [dB] sd n mean [dB] sd n mean [dB] sd n Chen et al. 2004 CID W-22 62 5 no information 43 no information 5 45 no information 5 no information no information Kraus et al.2011 CID W-22 58.9 54 30.6 54 29.4 54 Monini et al. 2013 bisyllbic words 87.5 13.1 8 56.9 11,6 8 Tringali et al. 2013 Fournier words 57 7 44 7
Table 21 - Table speech in noise VSB Speech in noise n Test Speech level Noise level SNR Outcome measure aided unaided mean change author mean [dB] sd mean [dB] sd Boeheim 2010 10 OLSA sentences adaptive 60 dB various SRT dB -1,5 1,4 4,8 5,3 6,3 Böheim 2007 9 Döring sentence test 80 dB 60 dB 20 % word score 63,3 - 35,6 - 27,7 65 dB 60 dB 5 27,8 - 9,4 - 18,4 Garin 2005 9 Fournier french words 50 dB 55 dB 5 % word score 86 18 62 28 24 55 dB 55 dB 0 69 27 37 26 32 60 dB 55 dB -5 40 28 15 26 25 Lenarz 2001 7 Göttinger sentences 65 dB 55 dB 10 % word score 62 - 28 - 34 Luetje 2002 53 R-SPIN - - 8 % word score NS - - - - Saliba 2005 8 Fournier french words adaptive 65 dB various SRT dB 54 5,8 61 7,5 7 Schmuziger 2006 10 Basler sentences 70 dB adaptive various dB SNR for SRT50 5 - 6,2 - 1,2 Todt 2005 7 Freiburger monosyllables 65 dB 60 dB 5 % word score 59,3 11,5 - - - 16 65,7 10,1 - - - Todt 2002 5 Freiburger monosyllables 65 dB 60 dB 5 % word score 74 9 - - - Uziel 2003 6 Fournier french words adaptive 60 dB various % word score NS - - - - NS: not stated
Table 23 - Subjective outcomes VSB authors n Tests used (A)PHAB for VSB GBI for VSB GHABP BN RV EC AS Total General Social Physical Unaided Aided mean sd mean sd Fraysse 2001 25 APHAB 39 35 22 21 Lenarz 2001 34 PHAB 47 45 28 29 Luetje 2002 53 PHAB, HDSS, SHACQ Mosnier 2008 77 GBI 17.8 22.8 14.1 1.7 Saliba 2005 8 APHAB 48 47 33 33 Schmutziger 2006 20 GBI 14.7 22.1 5 -5 Snik 2006 21 GBI, NCIQ, SF-36 33.9 41.5 15.7 17.6 Sterkers 2003 125 GBI 18 20 18 2 Todt 2002 5 APHAB 25 25 11 26 Uziel 2003 5 APHAB, HDSS 38 21 18 35 Edfeldt 2014 15 GHABP 25.7 18,6 96.1 15 Ihler 2014 10 GBI 38.3 47.1 11.7 18.4
Table 26 - Adverse events VSB Adverse Events VSB reported Fisch 2001 Fraysse 2001 Labassi 2005 Mosnier 2008 Luetje 2010 2006 Sterkers 2003 n studies Total n of subjects n cases incidence when reported incidence across all studies taste disturbances 6 6 3 7 4 239 26 10,9 1,86 middle ear effusion 0 1 95 0 0,00 0,00 pain 3 1 2 120 4 3,33 0,29 vertigo / dizziness 0 1 95 0 0,00 0,00 tinnitus 1 2 1 3 162 4 2,47 0,29 facial palsy 0 1 2 3 1172 7 0,60 0,50 limited benefit 3 1 95 3 3,16 0,21 headaches 2 0 2 115 2 1,74 0,14 revision surgery 1 16 12 4 3 5 1278 38 2,97 2,72 skin flap problems 9 9 2 1177 18 1,53 1,29 implant failure 27 7 2 1177 27 2,29 1,93 aural fullnes 21 1 77 21 27,3 1,50 complications 8 4 54 55 4 10 12 7 1398 147 10,5 10,52 TOTAL EVENTS 47 25 1100 77 34 20 95 1398
Table 28 - Summary of the evidence base supporting the therapeutic claims Comparison Therapeutic claim The level and quality of the evidence Statistical precision and size of the effect Consistency of the results over the trials presented Partially implantable MEI for patients with SNHL+medical condition vs. no treatment Significant improvement in sound-field hearing thresholds Level III to Level IV evidence from non-randomised pre-post or with/without studies. Reference standard in audiology is dedicated clinical follow-up. Based on clinical significance defined as a shift in threshold > 10 dB HL Demonstrated in 15/16 studies covering 377 patients Significantly better speech recognition/comprehension in quiet Meta-analysis: mean improvement of 35.69% (95% CI levels, 29.23 - 42.15), Z = 10.83 (P< 0.00001) (see Table 18) Improvement in speech comprehension scores in all seven included studies Significantly better speech recognition/comprehension in noisy situations Based on clinical significance defined as a mean change of 10% (see Table 21) Consistent improvement seen in three studies Few difficulties in understanding speech in relatively easy listening conditions, as compared to noisy conditions; and improves health in general No unaided comparison available, statistical analysis not applicable (see Table 21) Comparable values across included studies Is a safe procedure with minor adverse events resolving on their own or with local treatment Statistical analysis not applicable (see Table 26 ) Not applicable Small but non-significant shift in bone conduction thresholds over time Based on clinical significance defined as a shift in threshold < 10 dB HL Demonstrated in 5 studies at a long-term follow-up Constant functional gain over time Long-term mean FG:26 dB Short-term mean FG: 27 dB Single study by Mosnier (2008) Slight decrease in recognition/ comprehension over time, yet still significantly better outcomes than baseline Mean WRS at long-term: 81 +/-5.3%; at short-term: 89 +/- 4.0% (N=27, paired t-test, p 0.05) Single study by Mosnier (2008)
Table 31 – Overview of economic evaluations identified in the literature Publication Country Study design Intervention Comparators Perspective for analysis Outcome Comments Edfeldt et al. 2014 Sweden and Norway Cost-utility analysis VSB None Hospital Utility gain: 0,09 Cost/QALY: € 7.260 Utility values obtained before and after implantation rather than from a comparator group. Snik et al. 2006 The Netherlands analysis MEI (VSB, Otologics MET) None Healthcare system/payer Utility gain: 0,05 Cost/QALY: € 16.085 Utility values obtained before and after implantation rather than from a comparator group. Outcomes obtained for each MEI are pooled together. Alberta Health and Wellness (2011) Canada Decision model MEI (VSB, Esteem, Carina) HA, BAHA, CI Healthcare system/payer Total cost of MEI over 5 years: $2`677.497 The cost was calculated as an average of the inflated cost (5%) over 5 years. Medical Services Advisory Committee (2010) Australia analysis MEI (VSB, Otologics MET, Esteem, Rion , SOUNDTEC, TICA MEIs) BAHA, CI limited societal Average cost of MEI: $23.873 All implants deemed as being equally effective on primary outcome. Comite d'Evaluation et de Diffusion des Innovations Technologiques (2002) France Cost analysis per case MEI (VSB, Otologics MET, SOUNDTEC) None Hospital $19.173/case Information based on executive summary, full text not available in English.
For evaluating the different middle ear implant systems against each other, the MEI implantation branch of the model was cloned and the Markov states were named according to the respective devices. Individuals with mild-to-severe sensorineural hearing loss enter the model after candidacy assessment and then follow the VSB or MAXUM implantation arm of the model depending on the clinical decision. The new Markov model was populated using data from the literature. Table 33 – Base case model assumptions Assumption Comment Individuals who remain unaided are at constant risk of experiencing a recurring pathology in the same ear. It is unknown whether repeated treatment decreases the chance of an outer ear pathology to reoccur. Conservative treatment of recurring pathologies, whether succesful or not, does not alter the quality of life of individuals receiving no intervention. The succesful erradication of an outer ear condition may positivtely affect QOL, however minimum, as the pathology may reoccur. Individuals who are successfully aided do not cease to use their device. Studies demonstrate patients to stop using their device after various complications. Unsatisfactory benefit due to decreased gain or hearing loss can also be categorized as an adverse event. Surgical revision provides a full resolution of adverse events. This reflects general clinical practice. Re-implantation with a new implant ocurrs in the same ear from which a failed device is explanted from. This reflects general clinical practice. The rate of device failure and reimplantation does not vary significantly between partially implantable MEI. Differences in design and surgical application of partially implantable MEI is not large. Individuals wear their device for at least six months before potentially deciding to stop using their device. Individuals that do not experience a device failure try out their device for a few months before making a decision to stop using their device. All-cause mortality in the hearing impaired population is equal to that in the general population. Hearing loss or implantation with a partially implantable MEI does not impact mortality. D.3.3 Time horizon and outcomes used in the economic evaluation The time horizon for the economic models was 10 years. This is shorter than the time horizon proposed in the Decision Analytic Protocol; however, it is long enough for
Table 34 – The estimated rate of recurring pathologies Source Pathology n Event count Time interval Observed probability Instantaneous rate Agius 1992 Otitis externa 48 13 2 w 0,27083 1 House 2008 EAC exostosis 91 8 2 (1-15) yrs 0,08791 0,023 Ahmed 2009 Excessive cerumen 500 16 up to 2 yrs 0,03200 0,0081 Adverse events In the scope of the economic evaluation an adverse event refers to minor events that are not related to a device failure and can resolve on their own or with surgical treatment. Of the eight studies identified in Section B.6.2 that reported on safety outcomes with AMEI, four provided sufficient information over a long enough study timeframe for the Vibrant Soundbridge and Maxum/Soundtec. These studies were re-evaluated to obtain values for all possible outcomes of having an adverse event. The study characteristics and derived estimates are given in Table 35. For the VSB the weighted mean (based on sample size) of the instantaneous rates were used to derive the 6-month probability of the respective variables. Considering that individuals are at constant risk at developing an adverse event, estimated probabilities were kept constant in the model.
Table 50 - List of health states and summary of cost impacts and health outcomes included in the economic evaluation. Health state Cost of VSB Cost of MAXUM Incremental cost Effectiveness of VSB Effectiveness of MAXUM Incremental effectiveness count % count % Successful AUD 22.437 AUD 11.608 AUD 10.830 101,99% 561,3 639,3 78 39,14% Successful with complications AUD 1.691 AUD 811 AUD 880 8,29% 10,2 7,1 -3,1 -1,56% MEI failure AUD 28 AUD 16 AUD 12 0,11% 0,1 0,1 0 0,00% Cease MEI AUD 312 AUD 1.415 -AUD 1.103 -10,39% 20,8 145,2 124,4 62,42% Total AUD 24.468 AUD 13.850 AUD 10.619 100,00% 592,4 791,7 199,3 100,00%
Table 57 – The effect of different discount rates on the model comparing partially implantable MEI Strategy Cost Incremental cost Incremental effectiveness ICER 10 year undiscounted MXM implantation AUD 14.685,71 - 996,78 - - VSB implantation AUD 26.059,55 AUD 11.373,84 748,17 248,61 45,75 10-year discounted MXM implantation AUD 13.849,87 - 791,79 - - VSB implantation AUD 24.468,43 AUD 10.618,57 592,38 199,41 53,25 Table 58 –The effect of different time horizons on the model comparing partially implantable MEI Strategy Cost Incremental cost Incremental effectiveness ICER 10-year discounted MXM implantation AUD 13.849,87 - 791,79 - - VSB implantation AUD 24.468,43 AUD 10.618,57 592,38 199,41 53,25 20 year discounted MXM implantation AUD 17.168,10 - 1332,85 - - VSB implantation AUD 31.149,79 AUD 13.981,69 1026,00 306,85 45,57
years are also considered in this analysis. Section E.1 describes data sources that are selected to inform the current analysis. Section E.2 estimates the likely extent of use for insertion of a partially implantable active middle ear implant over the next five years. The projected use of implantation of a partially implantable active middle ear implant is determined on the basis of the estimated Australian population growth of 1.7 % per year (available online: ; downloaded 2015-09-23), which will influence the increase of number of patients per year. Besides the overall usage the financial implications associated with the expected usage are quantified. Section E.3 provides an estimation of changes in use and cost of other medical services. Section E.4 determines the estimated net financial implications of the proposed treatment for the MBS in each year over the next five years. Section E5 provides a detailed sensitivity analysis of the parameters used in the economic model addressing possible sources of uncertainty. An electronic spread sheet with calculations contained in section E is provided in Attachment F. E.1 Justification of the selection of sources of data A literature search, though not systematic, was carried out using the search terms “incidence OR prevalence OR epidemiology” together with common outer ear pathology terms “otitis externa OR (ear) exostosis OR earwax OR cerumen” to identify epidemiological research. The best available evidence was used to conduct the estimation of the use of the proposed listing. E.1.1 Prevalence of hearing loss in Australia according to DAP According to the decision analytical protocol provided by PASC, in Australia SNHL is the most common form of hearing loss. The overall prevalence of hearing loss ≧25 dBHTL in adults is 20.2 % for SNHL, 0.4 % for CHL and 1.6 % for MHL (Table 59). In adults, SNHL is largely caused by ageing, with most people aged over 50 years. Sensorineural hearing loss may also be caused by congenital malformation and exposure to noise or ototoxic substances. There are more adult males with hearing loss than females (26.3 % males vs. 17.1 % females). In adults, 66 % have mild hearing loss; 23 % have moderate hearing loss and 11 % have severe to profound hearing loss.
C Prevalence of SNHL in the adult population (%) Wilson et al., (1999) 20,20% 20,20% 20,20% 20,20% 20,20% 20,20% D Estimated number of Australian adults with SNHL B x C 3812099 3878765 3944889 4010474 4075066 4144342 E Proportion of patients as possible candidate for a MEI Junker et al., (2002) 0,76% 0,76% 0,76% 0,76% 0,76% 0,76% F Number of Australian adults with SNHL and candidates of a MEI D x E 28972 29479 29981 30480 30970 31497 G Prevalence of external ear pathology in the Australian population (%) see Table 34 2,95% 2,95% 2,95% 2,95% 2,95% 2,95% H Estimated number of Australian adults eligible for implantation F x G 855 870 884 899 914 929 I Minimum number of services per year H / 15 57 58 59 60 61 62 J Maximum number of services per year H / 10 85 87 88 90 91 93 K Mean number of services per year Average of I & J 71 72 74 75 76 77 As stated in the critique of the assessment report, still the calculation of number of services each year is based on the assumption that the existing pool of eligible patients could be implanted over a 10 to 15 year period, with 10 years representing a minimum and 15 years representing a maximum number of services per year. Of course this assumption may be influenced by patients’ preferences, their willingness to undergo a surgical procedure and their ability to pay out-of-pocket for additional services or device costs. “Therefore, assuming that the eligibility criteria in the proposed MBS item descriptor are adhered to, there is a potential for the number of services to be less than the estimate” given in Table 61. Taking into consideration that patients with the medical condition (i.e., candidates for the insertion of partially implantable Middle Ear Implant) are properly examined before the implantation the number of patients that are eligible for the requested intervention equals the number of patients who are candidates not taking service restrictions into accaount (e.g., hospitals/surgeons are not trained to offer the service).
Table 65 – Estimated cost to the MBS of associated post-operational services Description Method current (2016) 2017 2018 2019 2020 2021 VSB AG Cost of brain stem evoked audiometry Table 61, row K x AUD 153,95 AUD 10.930 AUD 11.084 AUD 11.392 AUD 11.546 AUD 11.700 AUD 11.854 AH Cost of follow-up conultation (ENT/audiologist) Table 61, row K x AUD 62,25 AUD 4.420 AUD 4.482 AUD 4.607 AUD 4.669 AUD 4.731 AUD 4.793 AI Cost of ENT specialist Table 61, row K x AUD 85,55 AUD 6.074 AUD 6.160 AUD 6.331 AUD 6.416 AUD 6.502 AUD 6.587 AJ Total cost to MBS of associated items AG + AH + AI AUD 21.424 AUD 21.726 AUD 22.330 AUD 22.631 AUD 22.933 AUD 23.235 Maxum/Soundtec AK Cost of ENT specialist (6 visits) Table 61, row K x AUD 85,55 * 6 AUD 36.444 AUD 36.958 AUD 37.984 AUD 38.498 AUD 39.011 AUD 39.524 AL Cost of follow-up conultation (ENT/audiologist; 3 visits) Table 61, row K x AUD 62,25 * 3 AUD 13.259 AUD 13.446 AUD 13.820 AUD 14.006 AUD 14.193 AUD 14.380 AM Total cost to MBS of associated items AC + AD + AE AUD 49.704 AUD 50.404 AUD 51.804 AUD 52.504 AUD 53.204 AUD 53.904 Table 66 – Estimated cost to the MBS of re-implantation Description Method current (2016) 2017 2018 2019 2020 2021 VSB AN Cost to MBS of re-implantation Table 62, row M *0,0272 AUD 3.625 AUD 3.676 AUD 3.778 AUD 3.829 AUD 3.880 AUD 3.931
AO Operational Table 63, row Q x 0,0272 AUD 2.126 AUD 2.156 AUD 2.216 AUD 2.246 AUD 2.276 AUD 2.306 AP Pre-operational Table 64, row AB x 0,0272 AUD 1.032 AUD 1.046 AUD 1.075 AUD 1.090 AUD 1.105 AUD 1.119 AQ Post-operational Table 65, row AJ x 0,0272 AUD 583 AUD 591 AUD 607 AUD 616 AUD 624 AUD 632 AR Total cost to MBS of AN + AO + AP + AQ AUD 7.366 AUD 7.469 AUD 7.677 AUD 7.781 AUD 7.884 AUD 7.988 Maxum/Soundtec AS Cost to MBS of re-implantation Table 62, row M x 0,01 AUD 1.333 AUD 1.351 AUD 1.389 AUD 1.408 AUD 1.426 AUD 1.445 AT Operational Table 63, row T x 0,01 AUD 477 AUD 484 AUD 498 AUD 504 AUD 511 AUD 518 AU Pre-operational Table 64, row AF x 0,01 AUD 156 AUD 159 AUD 163 AUD 165 AUD 167 AUD 170 AV Post-operational Table 65, row AM x 0,01 AUD 497 AUD 504 AUD 518 AUD 525 AUD 532 AUD 539 AW Total cost to MBS of AS + AT + AU + AV AUD 2.463 AUD 2.498 AUD 2.568 AUD 2.602 AUD 2.637 AUD 2.672 Table 67 – Estimated total cost of associated items to the MBS Description Method current (2016) 2017 2018 2019 2020 2021 VSB
Table 71.- Estimated minimum number of MEI candidates based on lower CI of proportion of candidates according to Junker et al, 2002 Description Method current (2016) 2017 2018 2019 2020 2021 Australian population ABS 24359761 24781121 25201317 25619895 26037356 26479991 Number of Australian adults ABS 18871777 19201809 19529153 19853831 20173593 20516544 Prevalence of SNHL in the adult population (%) Wilson et al., (1999) 20,20% 20,20% 20,20% 20,20% 20,20% 20,20% Estimated number of Australian adults with SNHL B x C 3812099 3878765 3944889 4010474 4075066 4144342 Minimum Proportion of patients as possible candidate for a MEI Junker et al., (2002) 0,69% 0,69% 0,69% 0,69% 0,69% 0,69% Number of Australian adults with SNHL and candidates of a MEI D x E 26303 26763 27220 27672 28118 28596 Prevalence of external ear pathology in the Australian population (%) see Table 34 2,95% 2,95% 2,95% 2,95% 2,95% 2,95% Estimated number of Australian adults eligible for implantation F x G 776 790 803 816 829 844 Minimum number of services per year H / 15 52 53 54 54 55 56 Maximum number of services per year H / 10 78 79 80 82 83 84 Mean number of services per year Average of I & J 65 66 67 68 69 70 The estimated difference in the mean number of services per year will affect the overall costs for the proposed intervention as can be seen from the calculations in Appendix G, and Table 72.
Table 79.- Summary of the deterministic sensitivity analysis of the BIA Variable Input value Number of Australian adults with SNHL and candidates of a MEI Prevalence of external ear pathology in the Australian population (%) Estimated number of Australian adults eligible for implantation Minimum number of services per year Maximum number of services per year Total costs to the MBS Overall total costs of the proposed intervention Proportion of patients 0,69% 26303 2,95% 776 52 78 AUD 253.331 AUD 1.220.936 0,85% 32403 2,95% 956 64 96 AUD 312.075 AUD 1.504.051 Prevalence of external ear pathology 3,00% - - 869 58 87 AUD 283.761 AUD 1.367.592 3,41% - - 988 66 99 AUD 322.541 AUD 1.554.496