Breathing Synchronised Hypoglossal Nerve Stimulation with Inspire for Untreated Severe Obstructive Sleep Apnoea/Hypopnoea Syndrome: A Simulated Cost-Utility Analysis from a National Health Service Perspective

Abstract

Background Hypoglossal nerve stimulation (HNS) with Inspire is a novel treatment indicated for moderate or severe obstructive sleep apnoea/hypopnoea syndrome (OSAHS), intolerant to or unable to be treated with continuous positive airway pressure (CPAP). Objective The aim of this study was to assess the cost effectiveness of treating moderate or severe OSAHS, in patients intolerant to CPAP, with HNS, compared with standard care, from a National Health Service (NHS) perspective. Methods A cohort state transition model was developed to compare HNS with Inspire with no treatment in UK adult patients with moderate or severe OSAHS who have previously tried and have not responded to CPAP therapy. Published literature was applied in the model to estimate incremental cost-effectiveness ratios (ICERs; 2019 Great British pounds per qualityadjusted life-year [QALY] gained), from an NHS and personal social services (PSS) perspective, over a cohort's lifetime. Results The model base-case predicts that patients undergoing HNS will incur lifetime costs of £65,026 compared with £36,727 among untreated patients. The HNS cohort would gain 12.72 QALYs compared with 11.15 QALYs in the notreatment arm. The ICER of treating severe OSAHS with HNS is therefore estimated to be £17,989 per QALYs gained. Probabilistic sensitivity analysis found that at a threshold of £30,000/QALY, HNS has a 69% probability of being cost effective. Limitations of the model include uncertainty around the utility data that were not sourced directly from HNS clinical trials. There is further uncertainty in the relationship between change in the Apnoea-Hypopnoea Index (AHI) and reduction in ischaemic heart disease and stroke because of difficulty capturing the reduction in risk over a long time horizon in studies. Conclusions Over a patient's lifetime, HNS with Inspire is expected to be cost effective when compared with no treatment in patients with severe OSAHS who have tried and have not responded to CPAP, from an NHS perspective.

Content Comparison of Quality-of-Life Instruments Used in Economic Evaluations of Sleep Disorder Interventions: A Systematic Review

“…One retrospective case-crossover [ 64 ] and one cohort study [ 63 ] ran economic evaluations concurrently. Twenty-five studies were model based, 14 using a Markov model [ 53 , 56 , 65 , 67 – 71 , 73 , 75 , 77 , 78 , 80 , 98 ], five using a decision-tree model [ 74 , 104 – 107 ], one using both Markov and decision-tree models [ 76 ], one using a semi-Markov model [ 79 ] and one using a decision analytic model [ 81 ]. Additionally, two studies used randomised controlled trial-based modelling [ 94 , 108 ], and one used a case-control-based model [ 72 ].…”

“…The included studies were conducted mainly in the UK ( n = 12) [ 35 , 60 – 62 , 65 , 66 , 70 – 73 , 93 , 97 ], USA ( n = 11) [ 74 , 75 , 78 , 79 , 90 , 94 , 98 , 100 , 106 , 108 , 110 ] and Spain ( n = 10) [ 53 – 58 , 64 , 82 , 83 , 89 ]. Japan [ 76 , 92 , 104 , 105 ] and Canada [ 68 , 77 , 80 , 101 ] each had four studies, The Netherlands had three studies [ 59 , 95 , 99 ], and Germany [ 96 , 102 ] and France [ 69 , 85 ] had two studies each.…”

“…Most studies ( n = 28) were conducted in clinical settings, 25 in community settings, and one in a workplace environment. The economic evaluations’ time horizons ranged from 1 day [ 81 ] to a lifetime [ 65 ]. Studies were published between 2003 [ 56 ] and 2023 [ 67 ], as shown in Table 1 .…”

“…Of the 57 studies included (Table 1 ), 32 had one type of QoL apiece: 27 generic [ 53 , 56 , 59 , 63 – 65 , 67 – 69 , 71 , 72 , 74 – 77 , 79 – 81 , 93 , 94 , 97 , 98 , 103 – 105 , 108 , 110 ], four sleep specific [ 84 , 87 , 96 , 101 ], and one depression specific [ 92 ]). Thirteen studies used a combination of one generic and one sleep-specific instrument [ 35 , 54 , 55 , 57 , 58 , 82 , 83 , 85 , 88 , 90 , 95 , 99 , 102 ], nine used two generic instruments each [ 60 – 62 , 66 , 70 , 73 , 78 , 106 , 107 ], two had two sleep-specific instruments [ 89 , 91 ], one utilised one generic and one depression-specific instrument [ 110 ], and one used a combination of a generic, a sleep-specific and osteoarthritis-specific tool [ 100 ].…”

Current and novel treatment options for obstructive sleep apnoea

“…Health-economical assessment of cost-effectiveness of HNS was undertaken for the United States [ 171 ] and the NHS [ 172 ] and, by now, various healthcare systems have approved HNS, including Germany and the United States.…”