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Many countries use the cost-effectiveness thresholds recommended by the World Health Organization's Choosing Interventions that are Cost-Effective project (WHO-CHOICE) when evaluating health interventions. This project sets the threshold for cost-effectiveness as the cost of the intervention per disability-adjusted life-year (DALY) averted less than three times the country's annual gross domestic product (GDP) per capita. Highly cost-effective interventions are defined as meeting a threshold per DALY averted of once the annual GDP per capita. We argue that reliance on these thresholds reduces the value of cost-effectiveness analyses and makes such analyses too blunt to be useful for most decision-making in the field of public health. Use of these thresholds has little theoretical justification, skirts the difficult but necessary ranking of the relative values of locally-applicable interventions and omits any consideration of what is truly affordable. The WHO-CHOICE thresholds set such a low bar for cost-effectiveness that very few interventions with evidence of efficacy can be ruled out. The thresholds have little value in assessing the trade-offs that decision-makers must confront. We present alternative approaches for applying cost-effectiveness criteria to choices in the allocation of health-care resources.

Severe posttraumatic stress disorder (PTSD) is a prevalent and debilitating condition in the United States. and globally. Using pooled efficacy data from six phase 2 trials, therapy using 3,4-methylenedioxymethamphetamine (MDMA) appeared cost-saving from a payer's perspective. This study updates the cost-effectiveness analysis of this novel therapy using data from a new phase 3 trial, including the incremental cost-effectiveness of the more intensive phase 3 regimen compared with the shorter phase 2 regimen. We adapted a previously-published Markov model to portray the costs and health benefits of providing MDMA-assisted therapy (MDMA-AT) to patients with chronic, severe, or extreme PTSD in a recent phase 3 trial, compared with standard care. Inputs were based on trial results and published literature. The trial treated 90 patients with a clinician administered PTSD scale (CAPS-5) total severity score of 35 or greater at baseline, and duration of PTSD symptoms of 6 months or longer. The primary outcome was assessed 8 weeks after the final experimental session. Patients received three 90-minute preparatory psychotherapy sessions, three 8-hour active MDMA or placebo sessions, and nine 90-minute integrative psychotherapy sessions. Our model calculates the per-patient cost of MDMA-AT, net all-cause medical costs, mortality, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). We reported results from the U.S. health care payer's perspective for multiple analytic time horizons, (base-case is 30 years), and conducted extensive sensitivity analyses. Costs and QALYs were discounted by 3% annually. Costs were adjusted to 2020 U.S. dollars according to the medical component of the U.S. Bureau of Labor Statistics' Consumer Price Index (CPI). MDMA-AT as conducted in the phase 3 trial costs $11,537 per patient. Compared to standard of care for 1,000 patients, MDMA-AT generates discounted net health care savings of $132.9 million over 30 years, accruing 4,856 QALYs, and averting 61.4 premature deaths. MDMA-AT breaks even on cost at 3.8 years while delivering 887 QALYs. A third MDMA session generates additional medical savings and health benefits compared with a two-session regimen. Hypothetically assuming no savings in health care costs, MDMA-AT has an ICER of $2,384 per QALY gained. MDMA-AT provided to patients with severe or extreme chronic PTSD is cost-saving from a payer's perspective, while delivering substantial clinical benefit.

Chronic posttraumatic stress disorder (PTSD) is a disabling condition that generates considerable morbidity, mortality, and both medical and indirect social costs. Treatment options are limited. A novel therapy using 3,4-methylenedioxymethamphetamine (MDMA) has shown efficacy in six phase 2 trials. Its cost-effectiveness is unknown. To assess the cost-effectiveness of MDMA-assisted psychotherapy (MAP) from the health care payer's perspective, we constructed a decision-analytic Markov model to portray the costs and health benefits of treating patients with chronic, severe, or extreme, treatment-resistant PTSD with MAP. In six double-blind phase 2 trials, MAP consisted of a mean of 2.5 90-minute trauma-focused psychotherapy sessions before two 8-hour sessions with MDMA (mean dose of 125 mg), followed by a mean of 3.5 integration sessions for each active session. The control group received an inactive placebo or 25-40 mg. of MDMA, and otherwise followed the same regimen. Our model calculates net medical costs, mortality, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios. Efficacy was based on the pooled results of six randomized controlled phase 2 trials with 105 subjects; and a four-year follow-up of 19 subjects. Other inputs were based on published literature and on assumptions when data were unavailable. We modeled results over a 30-year analytic horizon and conducted extensive sensitivity analyses. Our model calculates expected medical costs, mortality, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio. Future costs and QALYs were discounted at 3% per year. For 1,000 individuals, MAP generates discounted net savings of$103.2 million over 30 years while accruing 5,553 discounted QALYs, compared to continued standard of care. MAP breaks even on cost at 3.1 years while delivering 918 QALYs. Making the conservative assumption that benefits cease after one year, MAP would accrue net costs of $ 7.6 million while generating 288 QALYS, or $26,427 per QALY gained. MAP provided to patients with severe or extreme, chronic PTSD appears to be cost-saving while delivering substantial clinical benefit. Third-party payers are likely to save money within three years by covering this form of therapy.

[This corrects the article DOI: 10.1371/journal.pone.0263252.].

Efficiency as quantified and promoted by cost-effectiveness analysis sometimes conflicts with equity and other ethical values, such as the “rule of rescue” or rights-based ethical values. We describe the utilitarian foundations of cost-effectiveness analysis and compare it with alternative ethical principles. We find that while fallible, utilitarianism is usually superior to the alternatives. This is primarily because efficiency – the maximization of health benefits under a budget constraint – is itself an important ethical value. Other ethical frames may be irrelevant, incompatible with each other, or have unacceptable implications. When alternatives to efficiency are considered for precedence, we propose that it is critical to quantify the trade-offs, in particular, the lost health benefits associated with divergence from strict efficiency criteria. Using an example from HIV prevention in a high-prevalence African country, we show that favoring a rights-based decision could result in 92–118 added HIV infections per $100,000 of spending, compared to one based on cost-effectiveness.

Psilocybin-assisted therapy (PAT) has been shown in early trials to reduce the symptoms of treatment-resistant depression (TRD). This study evaluated the cost-effectiveness of PAT as a third-line treatment for major depressive disorder compared to standard of care (SOC). We used an individual-level, probabilistic simulation model that portrays representative US adults with TRD who receive SOC (pharmacotherapy, psychotherapy, electroconvulsive therapy, and esketamine nasal spray) and PAT over 12 months. We assumed the total cost of PAT was $5000, which we varied in sensitivity analyses ($3000–20,000). We calculated total costs, health effects (in terms of quality-adjusted life years [QALYs] gained), and incremental cost-effectiveness ratio (ICER) from limited healthcare and societal perspectives. PAT leads to an additional 0.031 QALYs and $3639 costs compared to SOC over 12 months, giving an ICER of $117,517 per QALY gained from a limited healthcare perspective. Using a $150,000 cost-effectiveness threshold, PAT had a 75% probability of being the cost-effective choice, and it was associated with a lower expected loss than SOC ($301 vs. $1307). Results were sensitive to uncertainty in model parameters, particularly the cost of PAT. PAT had a 1% probability of being cost-effective when its overall costs were $10,000 and 95% when its costs were $3000. This cost-effectiveness analysis found that when its costs are $5000 or less, PAT may offer economic value compared to available TRD treatments. Future studies can explore ways to reduce the cost of PAT and to understand its long-term effectiveness in maintaining remission and reducing the risk of relapse.

Consistent with observational studies, a randomized controlled intervention trial of adult male circumcision (MC) conducted in the general population in Orange Farm (OF) (Gauteng Province, South Africa) demonstrated a protective effect against HIV acquisition of 60%. The objective of this study is to present the first cost-effectiveness analysis of the use of MC as an intervention to reduce the spread of HIV in sub-Saharan Africa. Cost-effectiveness was modeled for 1,000 MCs done within a general adult male population. Intervention costs included performing MC and treatment of adverse events. HIV prevalence was estimated from published estimates and incidence among susceptible subjects calculated assuming a steady-state epidemic. Effectiveness was defined as the number of HIV infections averted (HIA), which was estimated by dynamically projecting over 20 years the reduction in HIV incidence observed in the OF trial, including secondary transmission to women. Net savings were calculated with adjustment for the averted lifetime duration cost of HIV treatment. Sensitivity analyses examined the effects of input uncertainty and program coverage. All results were discounted to the present at 3% per year. For Gauteng Province, assuming full coverage of the MC intervention, with a 2005 adult male prevalence of 25.6%, 1,000 circumcisions would avert an estimated 308 (80% CI 189-428) infections over 20 years. The cost is 181 dollars (80% CI 117-306 dollars) per HIA, and net savings are 2.4 million dollars (80% CI 1.3 million to 3.6 million dollars). Cost-effectiveness is sensitive to the costs of MC and of averted HIV treatment, the protective effect of MC, and HIV prevalence. With an HIV prevalence of 8.4%, the cost per HIA is 551 dollars (80% CI 344-1,071 dollars) and net savings are 753,000 (80% CI 0.3 million to 1.2 million dollars). Cost-effectiveness improves by less than 10% when MC intervention coverage is 50% of full coverage. In settings in sub-Saharan Africa with high or moderate HIV prevalence among the general population, adult MC is likely to be a cost-effective HIV prevention strategy, even when it has a low coverage. MC generates large net savings after adjustment for averted HIV medical costs.

In a Perspective accompanying Hill and colleagues, Elliot Marseille and James Kahn compare the history of pricing and availability of ART for HIV with that of the new HCV drugs and discuss strategies for providing treatment in LMIC even in the face of high costs.

Background The mismatch between the global burden of surgical disease and global health funding for surgical illness exacerbates disparities in surgical care access worldwide. Amidst competing priorities, governments need to rationally allocate scarce resources to address local needs. To build an investment case for surgery, economic data on surgical care delivery is needed. This study focuses on femur fractures. Methods This prospective cohort study at Soroti Regional Referral Hospital (SRRH), captured demographic, clinical, and cost data from all surgical inpatients and their caregivers at SRRH from February 2018 through July 2019. We performed descriptive and inferential analyses. We estimated the cost effectiveness of intramedullary nailing relative to traction for femur fractures by using primary data and making extrapolations using regional data. Results Among the 546 patients, 111 (20.3%) had femur fractures and their median [IQR] length of hospitalization was 27 days [14, 36 days]. The total societal cost and Quality Adjusted Life Year (QALY) gained was USD 61,748.10 and 78.81 for femur traction and USD 23,809 and 85.47 for intramedullary nailing. Intramedullary nailing was dominant over traction of femur fractures with an Incremental Cost Effectiveness Ratio of USD 5,681.75 per QALY gained. Conclusion Femur fractures are the most prevalent and most expensive surgical condition at SRRH. Relative to intramedullary nailing, the use of femur traction at SRRH is not cost effective. There is a need to explore and adopt more cost-effective approaches like internal fixation.