Potential Clinical and Economic Outcomes of Over-the-Counter Hearing Aids in the US.

Importance: Over-the-counter (OTC) hearing aids are now available in the US; however, their clinical and economic outcomes are unknown. Objective: To project the clinical and economic outcomes of traditional hearing aid provision compared with OTC hearing aid provision. Design, Setting, and Participants: This cost-effectiveness analysis used a previously validated decision model of hearing loss (HL) to simulate US adults aged 40 years and older across their lifetime in US primary care offices who experienced yearly probabilities of acquiring HL (0.1%-10.4%), worsening of their HL, and traditional hearing aid uptake (0.5%-8.1%/y at a fixed uptake cost of $3690) and utility benefits (0.11 additional utils/y). For OTC hearing aid provision, persons with perceived mild to moderate HL experienced increased OTC hearing aid uptake (1%-16%/y) based on estimates of time to first HL diagnosis. In the base case, OTC hearing aid utility benefits ranged from 0.05 to 0.11 additional utils/y (45%-100% of traditional hearing aids), and costs were $200 to $1400 (5%-38% of traditional hearing aids). Distributions were assigned to parameters to conduct probabilistic uncertainty analysis. Intervention: Provision of OTC hearing aids, at increased uptake rates, across a range of effectiveness and costs. Main Outcomes and Measures: Lifetime undiscounted and discounted (3%/y) costs and quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICERs). Results: Traditional hearing aid provision resulted in 18.162 QALYs, compared with 18.162 to 18.186 for OTC hearing aids varying with OTC hearing aid utility benefit (45%-100% that of traditional hearing aids). Provision of OTC hearing aids was associated with greater lifetime discounted costs by $70 to $200 along with OTC device cost ($200-$1000/pair; 5%-38% traditional hearing aid cost) due to increased hearing aid uptake. Provision of OTC hearing aids was considered cost-effective (ICER<$100 000/QALY) if the OTC utility benefit was 0.06 or greater (55% of the traditional hearing aid effectiveness). In probabilistic uncertainty analysis, OTC hearing aid provision was cost-effective in 53% of simulations. Conclusions and Relevance: In this cost-effectiveness analysis, provision of OTC hearing aids was associated with greater uptake of hearing intervention and was cost-effective over a range of prices so long as OTC hearing aids were greater than 55% as beneficial to patient quality of life as traditional hearing aids.

The Cost Utility of Nonpregnancy Laboratory Monitoring for Persons on Isotretinoin Acne Therapy.

We sought to project the 1-year cost utility of nonpregnancy laboratory monitoring cessation among patients initiating isotretinoin. We conducted a model-based cost utility analysis comparing (i) current practice (CP) and (ii) cessation of nonpregnancy laboratory monitoring. Simulated 20-year-old persons initiating isotretinoin were maintained on therapy for 6 months, unless taken off because of laboratory abnormalities in CP. Model inputs included probabilities of cell-line abnormalities (0.12%/wk), early cessation of isotretinoin therapy after detection of an abnormal laboratory result (2.2%/wk, CP only), quality-adjusted life-years (0.84-0.93), and laboratory monitory costs ($5/wk). We collected adverse events, deaths, and quality-adjusted life-years and costs (2020 USD) from a health care payer perspective. Over 1 year, and for 200,000 people on isotretinoin in the United States, the CP strategy resulted in 184,730 quality-adjusted life-years (0.9236 per person), and nonpregnancy laboratory monitoring resulted in 184,770 quality-adjusted life-years (0.9238 per person). The CP and nonpregnancy laboratory monitoring strategies resulted in 0.08 and 0.09 isotretinoin-related deaths, respectively. Nonpregnancy laboratory monitoring was the dominating strategy, realizing $24 million savings per year. No variation of a single parameter across its plausible range changed our cost utility findings. Cessation of laboratory monitoring could realize savings of $24 million per year for the US health care system and improve patient outcomes, with negligible effects on adverse events.

The potential cost-effectiveness of novel cord blood therapies in children with autism spectrum disorder.

OBJECTIVE: To model the long-term clinical and economic outcomes of potential cord blood therapy in autism spectrum disorder (ASD). STUDY DESIGN: Markov microsimulation of ASD over the lifespan was used to compare two strategies: 1) standard of care (SOC), including behavioral and educational interventions, and 2) novel cord blood (CB) intervention in addition to SOC. Input data reflecting behavioral outcomes included baseline Vineland Adaptive Behavior Scale (VABS-3), monthly VABS-3 changes, and CB intervention efficacy on adaptive behavior based on a randomized, placebo-controlled trial (DukeACT). Quality-adjusted life-years (QALYs) were correlated to VABS-3. Costs for children with ASD ($15,791, ages 2-17 years) and adults with ASD ($56,559, ages 18+ years), and the CB intervention (range $15,000-45,000) were incorporated. Alternative CB efficacy and costs were explored. RESULTS: We compared model-projected results to published data on life-expectancy, mean VABS-3 changes, and lifetime costs. Undiscounted lifetime QALYs in the SOC and CB strategies were 40.75 and 40.91. Discounted lifetime costs in the SOC strategy were $1,014,000, and for CB ranged from $1,021,000-$1,058,000 with CB intervention cost ($8,000-$45,000). At $15,000 cost, CB was borderline cost-effective (ICER = $105,000/QALY). In one-way sensitivity analysis, CB cost and efficacy were the most influential parameters on CB ICER. CB intervention was cost-effective at costs<$15,000 and efficacies ≥2.0. Five-year healthcare payer projected budgetary outlays at a $15,000 CB cost were $3.847B. CONCLUSIONS: A modestly effective intervention designed to improve adaptive behavior in autism can be cost-effective under certain circumstances. Intervention cost and efficacy most affected the cost-effectiveness results and should be targeted to increase economic efficiency.

Model-Projected Cost-Effectiveness of Adult Hearing Screening in the USA.

BACKGROUND: While 60% of older adults have hearing loss (HL), the majority have never had their hearing tested. OBJECTIVE: We sought to estimate long-term clinical and economic effects of alternative adult hearing screening schedules in the USA. DESIGN: Model-based cost-effectiveness analysis simulating Current Detection (CD) and linkage of persons with HL to hearing healthcare, compared to alternative screening schedules varying by age at first screen (45 to 75 years) and screening frequency (every 1 or 5 years). Simulated persons experience yearly age- and sex-specific probabilities of acquiring HL, and subsequent hearing aid uptake (0.5-8%/year) and discontinuation (13-4%). Quality-adjusted life-years (QALYs) were estimated according to hearing level and treatment status. Costs from a health system perspective include screening ($30-120; 2020 USD), HL diagnosis ($300), and hearing aid devices ($3690 year 1, $910/subsequent year). Data sources were published estimates from NHANES and clinical trials of adult hearing screening. PARTICIPANTS: Forty-year-old persons in US primary care across their lifetime. INTERVENTION: Alternative screening schedules that increase baseline probabilities of hearing aid uptake (base-case 1.62-fold; range 1.05-2.25-fold). MAIN MEASURES: Lifetime undiscounted and discounted (3%/year) costs and QALYs and incremental cost-effectiveness ratios (ICERs). KEY RESULTS: CD resulted in 1.20 average person-years of hearing aid use compared to 1.27-1.68 with the screening schedules. Lifetime total per-person undiscounted costs were $3300 for CD and ranged from $3630 for 5-yearly screening beginning at age 75 to $6490 for yearly screening beginning at age 45. In cost-effectiveness analysis, yearly screening beginning at ages 75, 65, and 55 years had ICERs of $39,100/QALY, $48,900/QALY, and $96,900/QALY, respectively. Results were most sensitive to variations in hearing aid utility benefit and screening effectiveness. LIMITATION: Input uncertainty around screening effectiveness. CONCLUSIONS: We project that yearly hearing screening beginning at age 55+ is cost-effective by US standards.

Estimated Monetary Value of Future Research Clarifying Uncertainties Around the Optimal Adult Hearing Screening Schedule.

Importance: Adult hearing screening is not routinely performed, and most individuals with hearing loss (HL) have never had their hearing tested as adults. Objective: To project the monetary value of future research clarifying uncertainties around the optimal adult hearing screening schedule. Design, Setting, and Participants: In this economic evaluation, a validated decision model of HL (DeciBHAL-US: Decision model of the Burden of Hearing loss Across the Lifespan) was used to simulate current detection and treatment of HL vs hearing screening schedules. Key model inputs included HL incidence (0.06%-10.42%/y), hearing aid uptake (0.54%-8.14%/y), screening effectiveness (1.62 × hearing aid uptake), utility benefits of hearing aids (+0.11), and hearing aid device costs ($3690). Distributions to model parameters for probabilistic uncertainty analysis were assigned. The expected value of perfect information (EVPI) and expected value of partial perfect information (EVPPI) using a willingness to pay of $100 000 per quality-adjusted life-year (QALY) was estimated. The EVPI and EVPPI estimate the upper bound of the dollar value of future research. This study was based on 40-year-old persons over their remaining lifetimes in a US primary care setting. Exposures: Screening schedules beginning at ages 45, 55, 65, and 75 years, and frequencies of every 1 or 5 years. Main Outcomes and Measures: The main outcomes were QALYs and costs (2020 US dollars) from a health system perspective. Results: The average incremental cost-effectiveness ratio for yearly screening beginning at ages 55 to 75 years ranged from $39 200 to $80 200/QALY. Yearly screening beginning at age 55 years was the optimal screening schedule in 38% of probabilistic uncertainty analysis simulations. The population EVPI, or value of reducing all uncertainty, was $8.2 to $12.6 billion varying with willingness to pay and the EVPPI, or value of reducing all screening effectiveness uncertainty, was $2.4 billion. Conclusions and Relevance: In this economic evaluation of US adult hearing screening, large uncertainty around the optimal adult hearing screening schedule was identified. Future research on hearing screening has a high potential value so is likely justified.

Validation of the Decision model of the Burden of Hearing loss Across the Lifespan (DeciBHAL) in Chile, India, and Nigeria.

Background: There is no published decision model for informing hearing health care resource allocation across the lifespan in low- and middle-income countries. We sought to validate the Decision model of the Burden of Hearing loss Across the Lifespan International (DeciBHAL-I) in Chile, India, and Nigeria. Methods: DeciBHAL-I simulates bilateral sensorineural hearing loss (SNHL) and conductive hearing loss (CHL) acquisition, SNHL progression, and hearing loss treatment. To inform model inputs, we identified setting-specific estimates including SNHL prevalence from the Global Burden of Disease (GBD) studies, acute otitis media (AOM) incidence and prevalence of otitis-media related CHL from a systematic review, and setting-specific pediatric and adult hearing aid use prevalence. We considered a coefficient of variance root mean square error (CV-RMSE) of ≤15% to indicate good model fit. Findings: The model-estimated prevalence of bilateral SNHL closely matched GBD estimates, (CV-RMSEs: 3.2-7.4%). Age-specific AOM incidences from DeciBHAL-I also achieved good fit (CV-RMSEs=5.0-7.5%). Model-projected chronic suppurative otitis media prevalence (1.5% in Chile, 4.9% in India, and 3.4% in Nigeria) was consistent with setting-specific estimates, and the incidence of otitis media-related CHL was calibrated to attain adequate model fit. DeciBHAL-projected adult hearing aid use in Chile (3.2-19.7% ages 65-85 years) was within the 95% confidence intervals of published estimates. Adult hearing aid prevalence from the model in India was 1.4-2.3%, and 1.1-1.3% in Nigeria, consistent with literature-based and expert estimates. Interpretation: DeciBHAL-I reasonably simulates hearing loss natural history, detection, and treatment in Chile, India, and Nigeria. Future cost-effectiveness analyses might use DeciBHAL-I to inform global hearing health policy. Funding: National Institutes of Health (3UL1-TR002553-03S3 and F30 DC019846).

Evidence gaps in economic analyses of hearing healthcare: A systematic review.

BACKGROUND: Hearing loss is a common and costly medical condition. This systematic review sought to identify evidence gaps in published model-based economic analyses addressing hearing loss to inform model development for an ongoing Lancet Commission. METHODS: We searched the published literature through 14 June 2020 and our inclusion criteria included decision model-based cost-effectiveness analyses that addressed diagnosis, treatment, or prevention of hearing loss. Two investigators screened articles for inclusion at the title, abstract, and full-text levels. Data were abstracted and the studies were assessed for the qualities of model structure, data assumptions, and reporting using a previously published quality scale. FINDINGS: Of 1437 articles identified by our search, 117 unique studies met the inclusion criteria. Most of these model-based analyses were set in high-income countries (n = 96, 82%). The evaluated interventions were hearing screening (n = 35, 30%), cochlear implantation (n = 34, 29%), hearing aid use (n = 28, 24%), vaccination (n = 22, 19%), and other interventions (n = 29, 25%); some studies included multiple interventions. Eighty-six studies reported the main outcome in quality-adjusted or disability-adjusted life-years, 24 of which derived their own utility values. The majority of the studies used decision tree (n = 72, 62%) or Markov (n = 41, 35%) models. Forty-one studies (35%) incorporated indirect economic effects. The median quality rating was 92/100 (IQR:72-100). INTERPRETATION: The review identified a large body of literature exploring the economic efficiency of hearing healthcare interventions. However, gaps in evidence remain in evaluation of hearing healthcare in low- and middle-income countries, as well as in investigating interventions across the lifespan. Additionally, considerable uncertainty remains around productivity benefits of hearing healthcare interventions as well as utility values for hearing-assisted health states. Future economic evaluations could address these limitations. FUNDING: NCATS 3UL1-TR002553-03S3.

Cost-effectiveness and budget impact of immediate antiretroviral therapy initiation for treatment of HIV infection in Côte d'Ivoire: A model-based analysis.

INTRODUCTION: The Temprano and START trials provided evidence to support early ART initiation recommendations. We projected long-term clinical and economic outcomes of immediate ART initiation in Côte d'Ivoire. METHODS: We used a mathematical model to compare three potential ART initiation criteria: 1) CD4 <350/µL (ART<350/µL); 2) CD4 <500/µL (ART<500/µL); and 3) ART at presentation (Immediate ART). Outcomes from the model included life expectancy, 10-year medical resource use, incremental cost-effectiveness ratios (ICERs) in $/year of life saved (YLS), and 5-year budget impact. We simulated people with HIV (PWH) in care (mean CD4: 259/µL, SD 198/µL) and transmitted cases. Key input parameters to the analysis included first-line ART efficacy (80% suppression at 6 months) and ART cost ($90/person-year). We assessed cost-effectiveness relative to Côte d'Ivoire's 2017 per capita annual gross domestic product ($1,600). RESULTS: Immediate ART increased life expectancy by 0.34 years compared to ART<350/µL and 0.17 years compared to ART<500/µL. Immediate ART resulted in 4,500 fewer 10-year transmissions per 170,000 PWH compared to ART<350/µL. In cost-effectiveness analysis, Immediate ART had a 10-year ICER of $680/YLS compared to ART<350/µL, ranging from cost-saving to an ICER of $1,440/YLS as transmission rates varied. ART<500/µL was "dominated" (an inefficient use of resources), compared with Immediate ART. Immediate ART increased the 5-year HIV care budget from $801.9M to $812.6M compared to ART<350/µL. CONCLUSIONS: In Côte d'Ivoire, immediate compared to later ART initiation will increase life expectancy, decrease HIV transmission, and be cost-effective over the long-term, with modest budget impact. Immediate ART initiation is an appropriate, high-value standard of care in Côte d'Ivoire and similar settings.

Clinical Benefits and Cost-Effectiveness of Laboratory Monitoring Strategies to Guide Antiretroviral Treatment Switching in India.

Current Indian guidelines recommend twice-annual CD4 testing to monitor first-line antiretroviral therapy (ART), with a plasma HIV RNA test to confirm failure if CD4 declines, which would prompt a switch to second-line ART. We used a mathematical model to assess the clinical benefits and cost-effectiveness of alternative laboratory monitoring strategies in India. We simulated a cohort of HIV-infected patients initiating first-line ART and compared 11 strategies with combinations of CD4 and HIV RNA testing at varying frequencies. We included adaptive strategies that reduce the frequency of tests after 1 year from 6 to 12 months for virologically suppressed patients. We projected life expectancy, time on failed first-line ART, cumulative 10-year HIV transmissions, lifetime cost (2014 US dollars), and incremental cost-effectiveness ratios (ICERs). We defined strategies as cost-effective if their ICER was <1 × the Indian per capita gross domestic product (GDP, $1,600). We found that the current Indian guidelines resulted in a per person life expectancy (from mean age 37) of 150.2 months and a per person cost of $2,680. Adding annual HIV RNA testing increased survival by ∼8 months; adaptive strategies were less expensive than similar nonadaptive strategies with similar life expectancy. The most effective strategy with an ICER <1 × GDP was the adaptive HIV RNA strategy (ICER $840/year). Cumulative 10-year transmissions decreased from 27.2/1,000 person-years with standard-of-care to 20.9/1,000 person-years with adaptive HIV RNA testing. In India, routine HIV RNA monitoring of patients on first-line ART would increase life expectancy, decrease transmissions, be cost-effective, and should be implemented.

The Clinical and Economic Impact of Attaining National HIV/AIDS Strategy Treatment Targets in the United States.

Background: The US National HIV/AIDS Strategy (NHAS) aims for 72% (90% diagnosed times 80% of those virally suppressed) viral suppression among persons with human immunodeficiency virus (HIV) by 2020. We examined the clinical and economic impact of reaching this target, in the general US population and among black men who have sex with men (MSM), the group with the highest HIV prevalence. Methods: Using a mathematical simulation, we project the 5- and 20-year clinical outcomes, costs, and incremental cost-effectiveness ratios for (1) Current Pace of detection, linkage, retention, and virologic suppression and (2) NHAS investments in expanded testing ($24-$74 per test) and adherence ($400 per person-year), calibrated to achieve 72% suppression by 2020. We examined alternative rates of testing, retention, and suppression and the efficacy and cost of adherence interventions. Results: Compared with Current Pace over 20 years, NHAS averted 280000 HIV transmissions (80000 in black MSM) and 199000 (45000) deaths and saved 2138000 (453000) years of life, while increasing costs by 23%. The incremental cost-effectiveness ratio for NHAS compared with Current Pace was $68900 per quality-adjusted life-year ($38300 for black MSM) and was most sensitive to antiretroviral therapy costs. Conclusions: Reaching NHAS targets would yield substantial clinical benefits and be cost-effective in both the general US and black MSM populations.

Do Less Harm: Evaluating HIV Programmatic Alternatives in Response to Cutbacks in Foreign Aid.

BACKGROUND: Resource-limited nations must consider their response to potential contractions in international support for HIV programs. OBJECTIVE: To evaluate the clinical, epidemiologic, and budgetary consequences of alternative HIV program scale-back strategies in 2 recipient nations, the Republic of South Africa (RSA) and Côte d'Ivoire (CI). DESIGN: Model-based comparison between current standard (CD4 count at presentation of 0.260 × 109 cells/L, universal antiretroviral therapy [ART] eligibility, and 5-year retention rate of 84%) and scale-back alternatives, including reduced HIV detection, no ART or delayed initiation (when CD4 count is <0.350 × 109 cells/L), reduced investment in retention, and no viral load monitoring or second-line ART. DATA SOURCES: Published RSA- and CI-specific estimates of the HIV care continuum, ART efficacy, and HIV-related costs. TARGET POPULATION: HIV-infected persons, including future incident cases. TIME HORIZON: 5 and 10 years. PERSPECTIVE: Modified societal perspective, excluding time and productivity costs. OUTCOME MEASURES: HIV transmissions and deaths, years of life, and budgetary outlays (2015 U.S. dollars). RESULTS OF BASE-CASE ANALYSIS: At 10 years, scale-back strategies increase projected HIV transmissions by 0.5% to 19.4% and deaths by 0.6% to 39.1%. Strategies can produce budgetary savings of up to 30% but no more. Compared with the current standard, nearly every scale-back strategy produces proportionally more HIV deaths (and transmissions, in RSA) than savings. When the least harmful and most efficient alternatives for achieving budget cuts of 10% to 20% are applied, every year of life lost will save roughly $900 in HIV-related outlays in RSA and $600 to $900 in CI. RESULTS OF SENSITIVITY ANALYSIS: Scale-back programs, when combined, may result in clinical and budgetary synergies and offsets. LIMITATION: The magnitude and details of budget cuts are not yet known, nor is the degree to which other international partners might step in to restore budget shortfalls. CONCLUSION: Scaling back international aid to HIV programs will have severe adverse clinical consequences; for similar economic savings, certain programmatic scale-back choices result in less harm than others. PRIMARY FUNDING SOURCE: National Institutes of Health and Steve and Deborah Gorlin MGH Research Scholars Award.

The Anticipated Clinical and Economic Effects of 90-90-90 in South Africa.

BACKGROUND: The Joint United Nations Programme on HIV/AIDS (UNAIDS) 90-90-90 global treatment target aims to achieve 73% virologic suppression among HIV-infected persons worldwide by 2020. OBJECTIVE: To estimate the clinical and economic value of reaching this ambitious goal in South Africa, by using a microsimulation model of HIV detection, disease, and treatment. DESIGN: Modeling of the "current pace" strategy, which simulates existing scale-up efforts and gradual increases in overall virologic suppression from 24% to 36% in 5 years, and the UNAIDS target strategy, which simulates 73% virologic suppression in 5 years. DATA SOURCES: Published estimates and South African survey data on HIV transmission rates (0.16 to 9.03 per 100 person-years), HIV-specific age-stratified fertility rates (1.0 to 9.1 per 100 person-years), and costs of care ($11 to $31 per month for antiretroviral therapy and $20 to $157 per month for routine care). TARGET POPULATION: South African HIV-infected population, including incident infections over the next 10 years. PERSPECTIVE: Modified societal perspective, excluding time and productivity costs. TIME HORIZON: 5 and 10 years. INTERVENTION: Aggressive HIV case detection, efficient linkage to care, rapid treatment scale-up, and adherence and retention interventions toward the UNAIDS target strategy. OUTCOME MEASURES: HIV transmissions, deaths, years of life saved, maternal orphans, costs (2014 U.S. dollars), and cost-effectiveness. RESULTS OF BASE-CASE ANALYSIS: Compared with the current pace strategy, over 5 years the UNAIDS target strategy would avert 873 000 HIV transmissions, 1 174 000 deaths, and 726 000 maternal orphans while saving 3 002 000 life-years; over 10 years, it would avert 2 051 000 HIV transmissions, 2 478 000 deaths, and 1 689 000 maternal orphans while saving 13 340 000 life-years. The additional budget required for the UNAIDS target strategy would be $7.965 billion over 5 years and $15.979 billion over 10 years, yielding an incremental cost-effectiveness ratio of $2720 and $1260 per year of life saved, respectively. RESULTS OF SENSITIVITY ANALYSIS: Outcomes generally varied less than 20% from base-case outcomes when key input parameters were varied within plausible ranges. LIMITATION: Several pathways may lead to 73% overall virologic suppression; these were examined in sensitivity analyses. CONCLUSION: Reaching the 90-90-90 HIV suppression target would be costly but very effective and cost-effective in South Africa. Global health policymakers should mobilize the political and economic support to realize this target. PRIMARY FUNDING SOURCE: National Institutes of Health and the Steve and Deborah Gorlin MGH Research Scholars Award.