Developing Criteria for Health Economic Quality Evaluation Tool.

OBJECTIVES: Because existing publication guidelines and checklists have limitations when used to assess the quality of cost-effectiveness analysis, we developed a novel quality assessment tool for cost-effectiveness analyses, differentiating methods and reporting quality and incorporating the relative importance of different quality attributes. METHODS: We defined 15 quality domains from a scoping review and identified 72 methods and reporting quality attributes (36 each). After designing a best-worst scaling survey, we fielded an online survey to researchers and practitioners to estimate the relative importance of the attributes in February 2021. We analyzed the survey data using a sequential conditional logit model. The final tool included 48 quality attributes deemed most important for assessing methods and reporting quality (24 each), accompanied by a free and web-based scoring system. RESULTS: A total of 524 participants completed the methodology section, and 372 completed both methodology and reporting sections. Quality attributes pertaining to the "modeling" and "data inputs and evidence synthesis" domains were deemed most important for methods quality, including "structure of the model reflects the underlying condition and intervention's impact" and "model validation is conducted." Quality attributes pertaining to "modeling" and "Intervention/comparator(s)" domains were considered most important for reporting quality, including "model descriptions are detailed enough for replication." Despite its growing prominence, "equity considerations" were not deemed as important as other quality attributes. CONCLUSIONS: The Criteria for Health Economic Quality Evaluation tool allows users to differentiate methods and reporting as well as quantifies the relative importance of quality attributes. Alongside other considerations, it could help assess and improve the quality of cost-effectiveness evidence to inform value-based decisions.

Assessing the impact of grief on quality of life, work productivity, and health outcomes for parents bereaved from SMA: A study protocol.

BACKGROUND: U.S. cost-effectiveness recommendations suggest that analyses should include all costs and effects relevant to the decision problem [1]. However, in many diseases, including spinal muscular atrophy (SMA), few studies have evaluated bereaved family outcomes after a child has died, neglecting potential impacts on their health-related quality of life (HRQoL), work productivity, and mental health. Additionally, grief-related outcomes are rarely included in economic evaluations. This manuscript outlines the protocol of a study that will estimate the HRQoL, work functioning, and mental health of bereaved parents of children with SMA type 1 to determine how outcomes vary based on parent's sex and the time since a child's death. METHODS: This study will involve two phases. In Phase 1, we will conduct a literature review to identify prior research that has measured how parental grief impacts HRQoL, work productivity, and mental health. We will also interview four bereaved parents of children with SMA type 1, stratified by parent sex and time since their child's death, and analyze findings using a thematic analysis. In Phase 2, we will develop a survey draft based on Phase 1 findings. Parents bereaved from SMA type 1 will review our survey draft and we will revise the survey based on their feedback. We will send a cross-sectional survey to approximately 880 parents bereaved from SMA type 1. We will analyze findings from the survey to investigate whether the severity of grief symptoms is correlated with HRQoL, productivity, depression and anxiety symptom severity. We will also evaluate whether the mean scores of grief and each of the outcomes vary significantly when stratified by parent sex and the time since the child's death. DISCUSSION: Our results will provide preliminary information on how parental grief can impact HRQoL, productivity, and mental health outcomes over time. Increasing the availability of family outcomes data will potentially assist organizations performing health economic evaluations, such as the Institute of Clinical and Economic Review (ICER) in the U.S. This research will also help to inform the development of future economic guidelines on this topic.

Cost-effectiveness of exome and genome sequencing for children with rare and undiagnosed conditions.

PURPOSE: This study aimed to estimate the cost-effectiveness of exome sequencing (ES) and genome sequencing (GS) for children. METHODS: We modeled costs, diagnoses, and quality-adjusted life years (QALYs) for diagnostic strategies for critically ill infants (aged <1 year) and children (aged <18 years) with suspected genetic conditions: (1) standard of care (SOC) testing, (2) ES, (3) GS, (4) SOC followed by ES, (5) SOC followed by GS, (6) ES followed by GS, and (7) SOC followed by ES followed by GS. We calculated the 10-year incremental cost per additional diagnosis, and lifetime incremental cost per QALY gained, from a health care perspective. RESULTS: First-line GS costs $15,048 per diagnosis vs SOC for infants and $27,349 per diagnosis for children. If GS is unavailable, ES represents the next most efficient option compared with SOC ($15,543 per diagnosis for infants and $28,822 per diagnosis for children). Other strategies provided the same or fewer diagnoses at a higher incremental cost per diagnosis. Lifetime results depend on the patient's assumed long-term prognosis after diagnosis. For infants, GS ranged from cost-saving (vs all alternatives) to $18,877 per QALY (vs SOC). For children, GS (vs SOC) ranged from $119,705 to $490,047 per QALY. CONCLUSION: First-line GS may be the most cost-effective strategy for diagnosing infants with suspected genetic conditions. For all children, GS may be cost-effective under certain assumptions. ES is nearly as efficient as GS and hence is a viable option when GS is unavailable.

The cost-effectiveness of treatments for attention deficit-hyperactivity disorder and autism spectrum disorder in children and adolescents: a systematic review.

Economic evaluations can help decision makers identify what services for children with neurodevelopmental disorders provide best value-for-money. The aim of this paper is to review the best available economic evidence to support decision making for attention deficit-hyperactivity disorder (ADHD) and autism spectrum disorder (ASD) in children and adolescents. We conducted a systematic review of economic evaluations of ADHD and ASD interventions including studies published 2010-2020, identified through Econlit, Medline, PsychINFO, and ERIC databases. Only full economic evaluations comparing two or more options, considering both costs and consequences were included. The quality of the studies was assessed using the Drummond checklist. We identified ten studies of moderate-to-good quality on the cost-effectiveness of treatments for ADHD and two studies of good quality of interventions for ASD. The majority of ADHD studies evaluated pharmacotherapy (n = 8), and two investigated the economic value of psychosocial/behavioral interventions. Both economic evaluations for ASD investigated early and communication interventions. Included studies support the cost-effectiveness of behavioral parenting interventions for younger children with ADHD. Among pharmacotherapies for ADHD, different combinations of stimulant/non-stimulant medications for children were cost-effective at willingness-to-pay thresholds reported in the original papers. Early intervention for children with suspected ASD was cost-effective, but communication-focused therapy for preschool children with ASD was not. Prioritizing more studies in this area would allow decision makers to promote cost-effective and clinically effective interventions for this target group.

Psychometric Performance of the SF-6D Quality of Life Measure in an Outpatient Population with Bipolar Disorder.

BACKGROUND: Bipolar disorder is among the top 10 causes of disability worldwide. The Short-Form Six-Dimension (SF-6D) is a frequently used measure of preference-based health-related quality of life (HRQOL). However, this measure's psychometric performance has not been tested in outpatient patients with bipolar disorder. AIMS OF THE STUDY: This study assessed the psychometric properties of the SF-6D, including convergent validity, known-groups validity, and responsiveness. METHODS: We examined convergent validity between the SF-6D and four condition-specific measures of functioning (LIFE-RIFT), life satisfaction (QLESQ), depressive symptoms (MADRS), and manic symptoms (YMRS). We used known-groups validity tests to compare the SF-6D health utility values estimated for patients in different clinical states, including depression, mania, hypomania, and recovered. We assessed the responsiveness of the SF-6D by comparing the sensitivity of the SF-6D utility values to longitudinal changes in the four condition-specific measures during the same period of time. We conducted all analyses using data from 2,627 participants in the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) clinical trial. RESULTS: The SF-6D demonstrated moderate (0.3-0.7) convergence with the LIFE-RIFT, QLESQ, and MADRS measures. Convergence with the manic symptoms measure (YMRS) was weak (<0.3). For known-groups validity, the SF-6D distinguished the recovered state from the three symptomatic clinical states. For responsiveness, the measure did not show floor or ceiling effects. The SF-6D utility value increased when mental health improved, with a small ES of 0.3 over the 1-year period, which was comparable to the four condition-specific measures. DISCUSSION: The SF-6D demonstrated moderate convergent validity, moderate responsiveness, and it can distinguish the differences between known-groups that had been identified in literature. The SF-6D may be a suitable measure of preference-based HRQOL for patients with bipolar disorder, but caution is needed due to its lower convergence with the YMRS mania scale. LIMITATIONS: The subsample of patients in manic episode was small, which may reduce the reliability of study findings regarding this specific clinical state. In terms of generalizability, the STEP-BD study sample is based on patients who received treatment in bipolar specialty clinics affiliated with academic medical centers, which may be different from other outpatient clinics. IMPLICATIONS FOR HEALTH CARE PROVISION AND USE: The mean health utility value for patients with hypomania is significantly lower than the mean value for recovered patients. This finding emphasizes the importance of treating hypomania. IMPLICATION FOR HEALTH POLICIES: This study validates an existing approach toward generating health utility values for bipolar disorder. These utility values can be used to create quality-adjusted life years (QALYs), which are the most commonly used measure of health benefit in cost-effectiveness studies. IMPLICATIONS FOR FURTHER RESEARCH: Studies with larger samples of patients with mania are needed to study measures of health utility in this patient population.

Implementation of Medical Homes in Federally Qualified Health Centers.

BACKGROUND: From 2011 through 2014, the Federally Qualified Health Center Advanced Primary Care Practice Demonstration provided care management fees and technical assistance to a nationwide sample of 503 federally qualified health centers to help them achieve the highest (level 3) medical-home recognition by the National Committee for Quality Assurance, a designation that requires the implementation of processes to improve access, continuity, and coordination. METHODS: We examined the achievement of medical-home recognition and used Medicare claims and beneficiary surveys to measure utilization of services, quality of care, patients' experiences, and Medicare expenditures in demonstration sites versus comparison sites. Using difference-in-differences analyses, we compared changes in outcomes in the two groups of sites during a 3-year period. RESULTS: Level 3 medical-home recognition was awarded to 70% of demonstration sites and to 11% of comparison sites. Although the number of visits to federally qualified health centers decreased in the two groups, smaller reductions among demonstration sites than among comparison sites led to a relative increase of 83 visits per 1000 beneficiaries per year at demonstration sites (P<0.001). Similar trends explained the higher performance of demonstration sites with respect to annual eye examinations and nephropathy tests (P<0.001 for both comparisons); there were no significant differences with respect to three other process measures. Demonstration sites had larger increases than comparison sites in emergency department visits (30.3 more per 1000 beneficiaries per year, P<0.001), inpatient admissions (5.7 more per 1000 beneficiaries per year, P=0.02), and Medicare Part B expenditures ($37 more per beneficiary per year, P=0.02). Demonstration-site participation was not associated with relative improvements in most measures of patients' experiences. CONCLUSIONS: Demonstration sites had higher rates of medical-home recognition and smaller decreases in the number of patients' visits to federally qualified health centers than did comparison sites, findings that may reflect better access to primary care relative to comparison sites. Demonstration sites had larger increases in emergency department visits, inpatient admissions, and Medicare Part B expenditures. (Funded by the Centers for Medicare and Medicaid Services.).

Excluding patients from transplant due to social support: Results from a national survey of transplant providers.

Social support is used to determine transplant eligibility despite lack of an evidence base and vague regulatory guidance. It is unknown how many patients are disqualified from transplantation due to inadequate support, and whether providers feel confident using these subjective criteria to determine eligibility. Transplant providers (n = 551) from 202 centers estimated that, on average, 9.6% (standard deviation = 9.4) of patients evaluated in the prior year were excluded due to inadequate support. This varied significantly by United Network for Organ Sharing region (7.6%-12.2%), and by center (21.7% among top quartile). Significantly more providers used social support in listing decisions than believed it ought to be used (86.3% vs 67.6%). Nearly 25% believed that using social support in listing determinations was unfair or were unsure; 67.3% felt it disproportionately impacted patients of low socioeconomic status. Overall, 42.4% were only somewhat or not at all confident using social support to determine transplant suitability. Compared to surgical/medical transplant providers, psychosocial providers had 2.13 greater odds of supporting the criteria (P = .03). Furthermore, 69.2% supported revised guidelines for use of social support in listing decisions. Social support criteria should be reconsidered in light of the limited evidence, potential for disparities, practice variation, low provider confidence, and desire for revised guidelines.

How important is social support in determining patients' suitability for transplantation? Results from a National Survey of Transplant Clinicians.

BACKGROUND: National guidelines require programmes use subjective assessments of social support when determining transplant suitability, despite limited evidence linking it to outcomes. We examined how transplant providers weigh the importance of social support for kidney transplantation compared with other factors, and variation by clinical role and personal beliefs. METHODS: The National survey of the American Society of Transplant Surgeons and the Society of Transplant Social Work in 2016. Using a discrete choice approach, respondents compared two hypothetical patient profiles and selected one for transplantation. Conditional logistic regression estimated the relative importance of each factor; results were stratified by clinical role (psychosocial vs medical/surgical providers) and beliefs (outcomes vs equity). RESULTS: Five hundred and eighy-four transplant providers completed the survey. Social support was the second most influential factor among transplant providers. Providers were most likely to choose a candidate who had social support (OR=1.68, 95% CI 1.50 to 1.86), always adhered to a medical regimen (OR=1.64, 95% CI 1.46 to 1.88), and had a 15 years life expectancy with transplant (OR=1.61, 95% CI 1.42 to 1.85). Psychosocial providers were more influenced by adherence and quality of life compared with medical/surgical providers, who were more influenced by candidates' life expectancy with transplant (p<0.05). For providers concerned with avoiding organ waste, social support was the most influential factor, while it was the least influential for clinicians concerned with fairness (p<0.05). CONCLUSIONS: Social support is highly influential in listing decisions and may exacerbate transplant disparities. Providers' beliefs and reliance on social support in determining suitability vary considerably, raising concerns about transparency and justice.

Utilization of health care services among Medicare beneficiaries who visit federally qualified health centers.

BACKGROUND: Previous studies have disagreed on whether patients who receive primary care from federally qualified health centers (FQHCs) have different utilization patterns than patients who receive care elsewhere. Our objective was to compare patterns of healthcare utilization between Medicare beneficiaries who received primary care from FQHCs and Medicare beneficiaries who received primary care from another source. METHODS: We compared characteristics and ambulatory, emergency department (ED), and inpatient utilization during 2013 between 130,637 Medicare beneficiaries who visited an FQHC for the majority of their primary care in 2013 (FQHC users) and a random sample of 1,000,000 Medicare fee-for-service (FFS) beneficiaries who did not visit an FQHC (FQHC non-users). We then created a propensity-matched sample of 130,569 FQHC users and 130,569 FQHC non-users to account for differences in observable patient characteristics between the two groups and repeated all comparisons. RESULTS: Before matching, the two samples differed in terms of age (42% below age 65 for FQHC users vs. 16% among FQHC non-users, p < 0.001 for all comparisons), disability (52% vs. 24%), eligibility for Medicaid (56% vs. 21%), severe mental health disorders (17% vs. 10%), and substance abuse disorders (6% vs. 3%). FQHC users had fewer ambulatory visits to primary care or specialist providers (10.0 vs. 12.0 per year), more ED visits (1.2 vs. 0.8), and fewer hospitalizations (0.3 vs. 0.4). In the matched sample, FQHC users still had slightly lower utilization of ambulatory visits to primary care or specialist providers (10.0 vs. 11.2) and slightly higher utilization of ED visits (1.2 vs. 1.0), compared to FQHC users. Hospitalization rates between the two groups were similar (0.3 vs. 0.3). CONCLUSIONS: In this population of Medicare FFS beneficiaries, FQHC users had slightly lower utilization of ambulatory visits and slightly higher utilization of ED visits, compared to FQHC non-users, after accounting for differences in case mix. This study suggests that FQHC care and non-FQHC care are associated with broadly similar levels of healthcare utilization among Medicare FFS beneficiaries.

Association Between Patient-Centered Medical Home Capabilities and Outcomes for Medicare Beneficiaries Seeking Care from Federally Qualified Health Centers.

BACKGROUND: Patient-centered medical home (PCMH) models of primary care have the potential to expand access, improve population health, and lower costs. Federally qualified health centers (FQHCs) were early adopters of PCMH models. OBJECTIVE: We measured PCMH capabilities in a diverse nationwide sample of FQHCs and assessed the relationship between PCMH capabilities and Medicare beneficiary outcomes. DESIGN: Cross-sectional, propensity score-weighted, multivariable regression analysis. PARTICIPANTS: A convenience sample of 804 FQHC sites that applied to a nationwide FQHC PCMH initiative and 231,163 Medicare fee-for-service beneficiaries who received a plurality of their primary care services from these sites. MAIN MEASURES: PCMH capabilities were self-reported using the National Committee for Quality Assurance's (NCQA's) 2011 application for PCMH recognition. Measures of utilization, continuity of care, quality, and Medicare expenditures were derived from Medicare claims covering a 1-year period ending October 2011. KEY RESULTS: Nearly 88% of sites were classified as having PCMH capabilities equivalent to NCQA Level 1, 2, or 3 PCMH recognition. These more advanced sites were associated with 228 additional FQHC visits per 1000 Medicare beneficiaries (95% CI: 176, 278), compared with less advanced sites; 0.02 points higher practice-level continuity of care (95% CI: 0.01, 0.03); and a greater likelihood of administering two of four recommended diabetes tests. However, more advanced sites were also associated with 181 additional visits to specialists per 1000 beneficiaries (95% CI: 124, 232) and 64 additional visits to emergency departments (95% CI: 35, 89)-but with no differences in inpatient utilization. More advanced sites had higher Part B expenditures ($111 per beneficiary [95% CI: $61, $158]) and total Medicare expenditures of $353 [95% CI: $65, $614]). CONCLUSIONS: Implementation of PCMH models in FQHCs may be associated with improved primary care for Medicare beneficiaries. Expanded access to care, in combination with slower development of key PCMH capabilities, may explain higher Medicare expenditures and other types of utilization.

Paving the path for implementation of clinical genomic sequencing globally: Are we ready?

Despite the emerging evidence in recent years, successful implementation of clinical genomic sequencing (CGS) remains limited and is challenged by a range of barriers. These include a lack of standardized practices, limited economic assessments for specific indications, limited meaningful patient engagement in health policy decision-making, and the associated costs and resource demand for implementation. Although CGS is gradually becoming more available and accessible worldwide, large variations and disparities remain, and reflections on the lessons learned for successful implementation are sparse. In this commentary, members of the Global Economics and Evaluation of Clinical Genomics Sequencing Working Group (GEECS) describe the global landscape of CGS in the context of health economics and policy and propose evidence-based solutions to address existing and future barriers to CGS implementation. The topics discussed are reflected as two overarching themes: (1) system readiness for CGS and (2) evidence, assessments, and approval processes. These themes highlight the need for health economics, public health, and infrastructure and operational considerations; a robust patient- and family-centered evidence base on CGS outcomes; and a comprehensive, collaborative, interdisciplinary approach.

Family Spillover Effects: Are Economic Evaluations Misrepresenting the Value of Healthcare Interventions to Society?

The societal impacts of health interventions are seldom incorporated into health economic evaluations, including the impact that illness can have on informal or unpaid caregivers and other family members (i.e., "family spillover effects"). Previous research has demonstrated that by excluding family spillover effects, the value of health interventions may be underestimated on average. In this commentary, we discuss how the inclusion of spillover effects influences how we value interventions and, given the extent to which caregiver/family effects are largely not captured or known, propose ways in which these data could be more systematically collected or estimated and used by researchers. These recommendations include prioritizing data collection alongside clinical trials and patient registries, engaging expert opinion panels, and developing mapping algorithms for estimating caregiver/family utility values from non-preference-based caregiver health-related quality-of-life measures and/or from patient preference-based measures.

Key drivers of family-level utility of pediatric genomic sequencing: a qualitative analysis to support preference research.

Given that pediatric genomic sequencing (GS) may have implications for the health and well-being of both the child and family, a clearer understanding of the key drivers of the utility of GS from the family perspective is needed. The purpose of this study is to explore what is important to caregivers of pediatric patients regarding clinical GS, with a focus on family-level considerations. We conducted semi-structured interviews with caregivers (n = 41) of pediatric patients who had been recommended for or completed GS that explored the scope of factors caregivers considered when deciding whether to pursue GS for their child. We analyzed the qualitative data in multiple rounds of coding using thematic analysis. Caregivers raised important family-level considerations, in addition to those specifically for their child, which included wanting the best chance at good quality of life for the family, the ability to learn about family health, the impact on the caregiver's well-being, privacy concerns among family members, and the cost of testing to the family. We developed a framework of key drivers of utility consisting of four domains that influenced caregivers' decision making: underlying values, perceived benefits, perceived risks, and other pragmatic considerations regarding GS. These findings can inform measurement approaches that better capture the utility of pediatric GS for families and improve assessments of the value of clinical GS.

Cost-effectiveness of oseltamivir treatment for children with uncomplicated seasonal influenza.

OBJECTIVE: To evaluate the cost-effectiveness of oseltamivir treatment for seasonal influenza in children and consider the impact of oseltamivir resistance on these findings. STUDY DESIGN: We developed a model to evaluate 1-year clinical and economic outcomes associated with 3 outpatient management strategies for unvaccinated children with influenza-like-illness: no antiviral treatment; diagnostic testing and oseltamivir treatment when positive; and empiric oseltamivir treatment. The model depicted a hypothetical non-pandemic influenza season with a 29% level of oseltamivir resistance in circulating viruses, and 14% to 54% probability of seasonal influenza with influenza-like-illness. Strategies were compared with incremental cost-effectiveness ratios. RESULTS: In our primary analysis, empiric oseltamivir treatment consistently produced the greatest benefit. The incremental cost-effectiveness of this alternative, compared with testing and treating, was <$100,000 per quality-adjusted life year gained in all age groups except the oldest. The testing strategy was consistently more effective compared with no treatment and cost between $25,900 and $71,200 per quality-adjusted life year gained, depending on age. Results were sensitive to the prevalence of oseltamivir resistance in circulating viruses. CONCLUSION: Empiric oseltamivir treatment of seasonal influenza is associated with favorable cost-effectiveness ratios, particularly in children aged 1 to <12 years, but ratios are highly dependent on the prevalence of oseltamivir resistance among circulating influenza viruses.

Economic outcomes of percutaneous coronary intervention with drug-eluting stents versus bypass surgery for patients with left main or three-vessel coronary artery disease: one-year results from the SYNTAX trial.

OBJECTIVES: To evaluate the cost-effectiveness of alternative approaches to revascularization for patients with three-vessel or left main coronary artery disease (CAD). BACKGROUND: Previous studies have demonstrated that, despite higher initial costs, long-term costs with bypass surgery (CABG) in multivessel CAD are similar to those for percutaneous coronary intervention (PCI). The impact of drug-eluting stents (DES) on these results is unknown. METHODS: The SYNTAX trial randomized 1,800 patients with left main or three-vessel CAD to either CABG (n = 897) or PCI using paclitaxel-eluting stents (n = 903). Resource utilization data were collected prospectively for all patients, and cumulative 1-year costs were assessed from the perspective of the U.S. healthcare system. RESULTS: Total costs for the initial hospitalization were $5,693/patient higher with CABG, whereas follow-up costs were $2,282/patient higher with PCI due mainly to more frequent revascularization procedures and higher outpatient medication costs. Total 1-year costs were thus $3,590/patient higher with CABG, while quality-adjusted life expectancy was slightly higher with PCI. Although PCI was an economically dominant strategy for the overall population, cost-effectiveness varied considerably according to angiographic complexity. For patients with high angiographic complexity (SYNTAX score > 32), total 1-year costs were similar for CABG and PCI, and the incremental cost-effectiveness ratio for CABG was $43,486 per quality-adjusted life-year gained. CONCLUSIONS: Among patients with three-vessel or left main CAD, PCI is an economically attractive strategy over the first year for patients with low and moderate angiographic complexity, while CABG is favored among patients with high angiographic complexity.

Incentivizing Drug Development in Serious Mental Illness.

Serious mental illness (SMI) imposes a significant burden on individuals and society. Individuals living with SMI have worse expected health, education, and career outcomes during their lifetime. Although treatments exist, pharmaceutical innovation in this area has lagged many other disease areas, despite an important need for new treatments. This report describes barriers that have hindered innovation and the development of new drugs for SMI, including science and research, regulatory, and health system barriers. To address these barriers, this report presents policies that may incentivize investment in this area.

Trends in Author-Reported Cost-Effectiveness Thresholds in the United States from 1995 to 2018: Implications for Discount Rates.

BACKGROUND: Decisions based on cost-effectiveness analyses (CEAs) using equal discount rates for health and cost outcomes are consistent with using a constant cost-effectiveness threshold over time. We sought to analyze trends in author-reported cost per quality-adjusted life-year (QALY) thresholds from CEAs published for the US setting over 24 y to retrospectively assess whether the recommended equal discount rates for costs and health were consistent with trends in the CEA literature. METHODS: We used the Tufts CEA Registry to assess whether author-reported cost-effectiveness thresholds changed in CEAs published for the US setting between 1995 and 2018 and back-calculated the implied discount rate for health based on these trends for inflation-adjusted cost-effectiveness thresholds and an annual discount rate for costs of 3%. RESULTS: We found 1995 CEAs published for the US setting and found that average nominal and inflation-adjusted cost-effectiveness thresholds increased over that time period. The discount rate for health would need to equal 2.43% to 2.48% (depending on the subset of CEAs analyzed) to be consistent with the observed trends in inflation-adjusted author-reported cost-effectiveness thresholds. We also found that restricting our analysis to currency years between 1995 and 2014 would result in a back-calculated discount rate for health of 2.99% to 3.28%. CONCLUSIONS: We found that CEA researchers have implicitly assumed that inflation-adjusted cost-effectiveness thresholds in the United States have been increasing over time (1995-2018), which is inconsistent with the recommended and prevailing choice of equal discount rates for health and cost outcomes. Our results are sensitive to the cutoff year used in the analysis. HIGHLIGHTS: We show visually and through equations that the recommended and prevailing practice of using equal discount rates for cost and health outcomes in cost-effectiveness analyses (CEAs) logically implies a constant inflation-adjusted cost-effectiveness threshold over time.Using data from the Tufts CEA Registry, we found that author-reported cost-effectiveness thresholds used in CEAs published for the US setting with currency years between 1995 and 2018 increased over time (both with and without adjustment for inflation).Assuming an annual discount rate for costs equal to 3%, the discount rate for health would need to equal approximately 2.5% to preserve consistency across decisions taken at different dates given the observed trends in inflation-adjusted author-reported cost-effectiveness thresholds.This finding depends on the cutoff year used in the analysis (data from currency years 1995-2014 would support use of equal discount rates, whereas data after 2014 would suggest a sharper trend toward increasing cost-effectiveness thresholds).

Herd Immunity Effects in Cost-Effectiveness Analyses among Low- and Middle-Income Countries.

BACKGROUND: Herd immunity (HI) is a key benefit of vaccination programs, but the effects are not routinely included in cost-effectiveness analyses (CEAs). OBJECTIVE: This study investigated how the inclusion of HI in CEAs may influence the reported value of immunizations in low- and middle-income countries (LMICs) and illustrated the implications for COVID-19 immunization. METHODS: We reviewed immunization CEAs published from 2000 to 2018 focusing on LMICs using data from the Tufts Medical Center CEA Registries. We investigated the proportion of studies that included HI, the methods used, and the incremental cost-effectiveness ratios (ICERs) reported. When possible, we evaluated how ICERs would change with and without HI. RESULTS: Among the 243 immunization CEAs meeting inclusion criteria, 44 studies (18%) included HI. Of those studies, 11 (25%) used dynamic transmission models, whereas the remainder used static models. Sixteen studies allowed for ICER calculations with and without HI (n = 48 ratios). The inclusion of HI always resulted in more favorable ratios. In 20 cases (42%), adding HI decreased the ICERs enough to cross at least one or more common cost-effectiveness benchmarks for LMICs. Among pneumococcal vaccination studies, including HI in the analyses decreased seven of 24 ICERs enough to cross at least one cost-effectiveness benchmark. CONCLUSION: The full value of immunization may be underestimated without considering a scenario in which HI is achieved. Given the evidence in pneumococcal CEAs, COVID-19 vaccine value assessments should aim to show ICERs with and without HI to inform decision-making in LMICs.