Preferences and experiences of pediatricians on implementing national guidelines on universal routine screening of adolescents for major depressive disorder: A qualitative study.

BACKGROUND: To explore the preferences of pediatricians for key factors around the implementation of universal routine screening guidelines for major depressive disorder in adolescent patients in a primary care setting. METHOD: Semi-structured qualitative interviews were conducted with U.S. pediatricians. Participants were recruited by convenience sampling and snowball sampling. Qualitive data were summarized using thematic analysis to identify themes relevant to preferences around implementing screening strategies for adolescent patients. Recruitment ended upon reaching thematic saturation when no new themes were revealed. RESULTS: Of the 14 participants, 11 identified as female, 3 male, 10 white, and 4 Asian. Top themes among pediatrician participants were around the screening modality (14/14 participants), screening validity (14/14), time barriers (14/14), and confidentiality barriers (12/14). Less frequently mentioned themes by pediatricians were workplace coordination and logistics (7/14), alternative starting ages for screening (7/14), more frequent screenings than annual screenings (3/14), and additional clinical training regarding depression diagnosis and treatment (2/14). LIMITATIONS: Pool of interviewed participants was limited by diversity in terms of geography, race/ethnicity, or practice settings. CONCLUSIONS: To promote the uptake of universal routine screening of adolescent major depression, pediatricians expressed it was important to address key implementation factors regarding the screening modality, screening validity, time constraints, and confidential care concerns in a primary care delivery context. Findings could be used to inform the development of implementation strategies to facilitate depression screening in primary care. Future research is needed to quantitively assess decisions and tradeoffs that pediatricians make when implementing universal screening to support adolescent mental health.

Cost-effectiveness of surgical treatment of thumb carpometacarpal joint arthritis: a value of information study.

BACKGROUND: Thumb carpometacarpal (CMC) joint arthritis is one of the most prevalent arthritic conditions commonly treated with trapeziectomy alone or trapeziectomy with ligament reconstruction and tendon interposition (LRTI). We evaluate the cost-effectiveness and value of perfect and sample information of trapeziectomy alone, LRTI, and non-operative treatment. METHODS: A societal perspective decision tree was modeled. To understand the value of future research in comparing quality-of-life after trapeziectomy, LRTI, and non-operative management we characterized uncertainty by fitting distributions to EQ-5D utility data published from the United Kingdom hand surgery registry. We used Monte Carlo simulation for the probabilistic sensitivity analysis and to evaluate the value of perfect and sample information. RESULTS: Both trapeziectomy alone and LRTI were cost-effective compared to non-operative management ($2,540 and $3,511/QALY respectively). Trapeziectomy alone (base case total cost $8,251, QALY 14.08) was dominant compared to LRTI (base case total cost $8,798, QALY 13.34). However, probabilistic sensitivity analysis suggested there is a 12.5% chance LRTI may be preferred at a willingness-to-pay of $50,000/QALY. Sensitivity analysis revealed postoperative utilities are the most influential factors in determining cost-effectiveness. The value of perfect information was approximately $1,503/person. A study evaluating the quality-of-life of 1,000 patients in each arm undergoing trapeziectomy alone or LRTI could provide an expected $1,117 of information value. With approximately 40,000 CMC arthroplasties performed each year in the U.S., the annual value is close to $45 million. CONCLUSIONS: Trapeziectomy without LRTI appears to be the most cost-effective procedure in treating late-stage CMC arthritis and should be considered as first-line surgical treatment. There is substantial societal value in conducting additional research to better understand the relative quality-of-life improvements gained from these two common hand surgeries.

Cost-effectiveness of Aflibercept Monotherapy vs Bevacizumab First Followed by Aflibercept If Needed for Diabetic Macular Edema.

Importance: The DRCR Retina Network Protocol AC showed no significant difference in visual acuity outcomes over 2 years between treatment with aflibercept monotherapy and bevacizumab first with switching to aflibercept for suboptimal response in treating diabetic macular edema (DME). Understanding the estimated cost and cost-effectiveness of these approaches is important. Objective: To evaluate the cost and cost-effectiveness of aflibercept monotherapy vs bevacizumab-first strategies for DME treatment. Design, Setting, and Participants: This economic evaluation was a preplanned secondary analysis of a US randomized clinical trial of participants aged 18 years or older with center-involved DME and best-corrected visual acuity of 20/50 to 20/320 enrolled from December 15, 2017, through November 25, 2019. Interventions: Aflibercept monotherapy or bevacizumab first, switching to aflibercept in eyes with protocol-defined suboptimal response. Main Outcomes and Measures: Between February and July 2022, the incremental cost-effectiveness ratio (ICER) in cost per quality-adjusted life-year (QALY) over 2 years was assessed. Efficacy and resource utilization data from the randomized clinical trial were used with health utility mapping from the literature and Medicare unit costs. Results: This study included 228 participants (median age, 62 [range, 34-91 years; 116 [51%] female and 112 [49%] male; 44 [19%] Black or African American, 60 [26%] Hispanic or Latino, and 117 [51%] White) with 1 study eye. The aflibercept monotherapy group included 116 participants, and the bevacizumab-first group included 112, of whom 62.5% were eventually switched to aflibercept. Over 2 years, the cost of aflibercept monotherapy was $26 504 (95% CI, $24 796-$28 212) vs $13 929 (95% CI, $11 984-$15 874) for the bevacizumab-first group, a difference of $12 575 (95% CI, $9987-$15 163). The aflibercept monotherapy group gained 0.015 (95% CI, -0.011 to 0.041) QALYs using the better-seeing eye and had an ICER of $837 077 per QALY gained compared with the bevacizumab-first group. Aflibercept could be cost-effective with an ICER of $100 000 per QALY if the price per dose were $305 or less or the price of bevacizumab was $1307 per dose or more. Conclusions and Relevance: Variability in individual needs will influence clinician and patient decisions about how to treat specific eyes with DME. While the bevacizumab-first group costs still averaged approximately $14 000 over 2 years, this approach, as used in this study, may confer substantial cost savings on a societal level without sacrificing visual acuity gains over 2 years compared with aflibercept monotherapy.

Cost-effectiveness of Staple Line Reinforcement in Laparoscopic Sleeve Gastrectomy.

OBJECTIVE: To perform a cost-effectiveness analysis of staple-line reinforcement in laparoscopic sleeve gastrectomy. SUMMARY OF BACKGROUND DATA: Exponential increases in surgical costs have underscored the critical need for evidence-based methods to determine the relative value of surgical devices. One such device is staple-line reinforcement, thought to decrease bleeding rates in laparoscopic sleeve gastrectomy. METHODS: Two intervention arms were modeled, staple-line reinforcement and standard nonreinforced stapling. Bleed and leak rates and 30-day treatment costs were obtained from national and state registries. Quality-adjusted life-year (QALY) values were drawn from previous literature. Device prices were drawn from institutional data. A final incremental cost-effectiveness ratio was calculated, and one-way and probabilistic sensitivity analyses were performed. RESULTS: A total of 346,530 patient records from 2012 to 2018 were included. Complication rates for the reinforced and standard cohorts were 0.05% for major bleed in both cohorts ( P = 0.8841); 0.45% compared with 0.59% for minor bleed ( P < 0.0001); and 0.24% compared with 0.26% for leak ( P = 0.4812). Median cost for a major bleed was $5552 ($3287, $16,817) and $2406 ($1861, $3484) for a minor bleed. Median leak cost was $9897 ($4589, $21,619) and median cost for patients who did not experience a bleed, leak, or other serious complication was $1908 ($1712, $2739). Mean incremental cost of reinforced stapling compared with standard was $819.60/surgery. Net QALY gain with reinforced stapling compared with standard was 0.00002. The resultant incremental cost-effectiveness ratio was $40,553,000/QALY. One-way and probabilistic sensitivity analyses failed to produce a value below $150,000/QALY. CONCLUSIONS: Compared with standard stapling, reinforced stapling reduces minor postoperative bleeding but not major bleeding or leaks and is not cost-effective if routinely used in laparoscopic sleeve gastrectomy.

Cost-Effectiveness of Hepatitis B Testing and Vaccination of Adults Seeking Care for Sexually Transmitted Infections.

BACKGROUND: The estimated number of people living with hepatitis B virus (HBV) infection acquired through sexual transmission was 103,000 in 2018, with an estimated incidence of 8300 new cases per year. Although hepatitis B (HepB) vaccination is recommended by the Advisory Committee for Immunization Practices for persons seeking evaluation and treatment for sexually transmitted infections (STIs), prevaccination testing is not yet recommended. Screening may link persons with chronic hepatitis B to care and reduce unnecessary vaccination. METHODS: We used a Markov model to calculate the health impact and cost-effectiveness of 1-time HBV testing combined with the first dose of the HepB vaccine for adults seeking care for STI. We ran a lifetime, societal perspective analysis for a hypothetical population of 100,000 aged 18 to 69 years. The disease progression estimates were taken from recent cohort studies and meta-analyses. In the United States, an intervention that costs less than $100,000 per quality-adjusted life-year (QALY) is generally considered cost-effective. The strategies that were compared were as follows: (1) vaccination without HBV screening, (2) vaccination and hepatitis B surface antigen (HBsAg) screening, (3) vaccination and screening with HBsAg and anti-HBs, and (4) vaccination and screening with HBsAg, anti-HBs, and anti-HBc. Data were obtained from Centers for Medicare & Medicaid services reimbursement, the Centers for Disease Control and Prevention vaccine price list, and additional cost-effectiveness literature. RESULTS: Compared with current recommendations, the addition of 1-time HBV testing is cost-saving and would prevent an additional 138 cases of cirrhosis, 47 cases of decompensated cirrhosis, 90 cases of hepatocellular carcinoma, 33 liver transplants, and 163 HBV-related deaths, and gain 2185 QALYs, per 100,000 adults screened. Screening with the 3-test panel would save $41.6 to $42.7 million per 100,000 adults tested compared with $41.5 to $42.5 million for the 2-test panel and $40.2 to $40.3 million for HBsAg alone. CONCLUSIONS: One-time HBV prevaccination testing in addition to HepB vaccination for unvaccinated adults seeking care for STI would save lives and prevent new infections and unnecessary vaccination, and is cost-saving.

Assessing patient perception of risk in ocular stem cell therapies.

A wide variety of stem cell-derived therapies are under development for the treatment of retinal degeneration. In order to better understand patient perspectives about these therapies, we assessed risk tolerance using an in-person survey of 178 patients at an academic eye center. Risk of malignancy served as a hypothetical, readily understood, and serious adverse event to be considered in trade for potential visual improvement from a stem cell-derived treatment. The results indicate that patients were willing to trade visual improvement against a risk of malignancy that far exceeds actual risk. Two novel findings were that older patients and those with an intermediate level of visual loss were particularly risk tolerant. The quantitative survey results provide a step toward understanding patient perspectives that will, over the long term, guide the development of ocular stem cell-derived therapies.

A machine learning approach for the prediction of overall deceased donor organ yield.

BACKGROUND: Optimizing organ yield (number of organs transplanted per donor) is a potentially modifiable way to increase the number of organs available for transplant. Models to predict the expected deceased donor organ yield have been developed based on ordinary least squares regression and logistic regression. However, alternative modeling methodologies incorporating machine learning may have superior performance compared with conventional approaches. METHODS: We evaluated the predictive accuracy of 14 machine learning models for predicting overall organ yield in a cross-validation procedure. The models were parameterized using data from the Organ Procurement and Transplantation Network database from 2000 to 2018. The inclusion criteria for the study were adult deceased donors between 18 and 84 years of age that had at least 1 organ procured for transplantation. RESULTS: A total of 89,520 donors met the inclusion criteria. Their mean (standard deviation) age was 44 (15) years, and approximately 58% were male. Our cross-validation analysis showed that a tree-based gradient boosting model outperformed the remaining 13 models. Compared with the currently used prediction models, the gradient boosting model improves prediction accuracy by reducing the mean absolute error between 3 and 11 organs per 100 donors. CONCLUSION: Our analysis demonstrated that the gradient boosting methodology had the best performance in predicting overall deceased donor organ yield and can potentially serve as an aid to assess organ procurement organization performance.

Costs of Managing Diabetic Macular Edema With Good Visual Acuity With Aflibercept, Laser, or Observation: DRCR Retina Network Protocol V.

PURPOSE: Because eyes with center-involved diabetic macular edema (CI-DME) and good baseline visual acuity (VA) showed no difference in VA loss when managed initially with observation, laser, or aflibercept, understanding the estimated costs of these strategies to the US population is relevant for health care planning. DESIGN: Preplanned cost analysis from a randomized controlled trial (DRCR Retina Network Protocol V). METHODS: Total costs for managing participants with CI-DME and good baseline VA assigned to aflibercept (n = 226), laser (n = 240), or observation (n = 236) during the 2-year multicenter trial were calculated. Observation or laser groups initiated aflibercept if VA decreased. The aflibercept group received injections up to every 4 weeks. Using epidemiological data and extrapolating costs, 10-year costs of care for all persons with CI-DME and good baseline VA throughout the United States were caluclated. RESULTS: Assuming that all patients in the United States with CI-DME and good baseline VA received aflibercept initially, 10-year costs were projected to be $28.80 billion compared with $14.42 billion if initially receiving laser treatment or $15.70 billion if initially observed, with aflibercept added if VA worsened in the laser or observation arms. CONCLUSIONS: Similar VA outcomes on average are obtained by initially managing CI-DME and good baseline VA with laser or observation strategies instead of immediately using aflibercept. Although any 1 of these 3 strategies might be warranted depending on an individual's specific circumstances, on a societal level, cost savings might be achieved with these first 2 approaches.

Assessment of National Organ Donation Rates and Organ Procurement Organization Metrics.

Importance: Organ transplant is a life-saving procedure for patients with end-stage organ failure. In the US, organ procurement organizations (OPOs) are responsible for the evaluation and procurement of organs from donors who have died; however, there is controversy regarding what measures should be used to evaluate their performance. Objective: To evaluate OPO performance metrics using combined mortality and donation data and quantify the associations of population demographics with donation metrics. Design, Setting, and Participants: This national cohort study includes data from the US organ transplantation system from January 2008 through December 2017. All individuals who died within the US, as reported by the National Death index, were included. Exposures: Death, organ donation, and donation eligibility. Main Outcomes and Measures: Evaluation of the variation in donation metrics and the use of ineligible donors by OPO and demographic subgroup. Results: This study included 17 501 742 deaths and 75 769 deceased organ donors (45 040 men [59.4%]; 51 908 White individuals [68.5%]). Of these donors, 15 857 (20.9%) were not eligible, as defined by the OPOs. The median donation metrics by OPO were 0.004 (range, 0.002-0.012) donors per death, 0.89 (range, 0.68-1.30) donors per eligible death, and 0.72 (range, 0.57-0.86) eligible donors per eligible death. The OPOs in the upper quartile of the overall eligible donors per eligible death metric were in the upper quartile of annual rankings on 90 of 140 occasions (64.3%). There was little overlap in top-performing OPOs between metrics; an OPO in the upper quartile for 1 metric was also in the upper quartile for the other metrics on 37 of 570 occasions (6.5% of the time). The median donor eligibility rate, defined as the number of eligible donors per donor, was 0.79 (range, 0.61-0.95) across OPOs. Age (eg, 65 to 84 years, coefficient, -0.55 [SE, 0.03]; P < .001; vs those aged 18 to 34 years), sex (male individuals, -0.09 [SE, 0.02]; P < .001; vs female individuals), race (eg, Black individuals, 0.35 [SE, 0.02]; P < .001; vs White individuals), cause of death (eg, central nervous system tumor, 0.48 [SE, 0.08]; P < .001; vs anoxia), year (eg, 2016-2017: -0.10 [SE, 0.03]; P < .001; vs 2008-2009), and OPO were associated with the use of ineligible donors; OPO was a significant factor associated with performance in all metrics (χ256, 500.5; P < .001; coefficient range across individual OPOs, -0.15 [SE, 0.09] to 0.75 [SE, 0.09]), even after accounting for population differences. Female and non-White individuals were significantly less likely to be used as ineligible donors. Conclusions and Relevance: We demonstrate significant variability in OPO performance rankings, depending on which donation metric is used. There were significant differences in OPO performance, even after accounting for differences in potential donor populations. Our data suggest significant variation in use of ineligible donors among OPOs, a source for increased donors. The performance of OPOs should be evaluated using a range of donation metrics.

Cost-Effectiveness of Treatments after Closed Extraarticular Distal Radius Fractures in Older Adults from the WRIST Clinical Trial.

BACKGROUND: This study performs an economic analysis of volar locking plate, external fixation, percutaneous pinning, or casting in elderly patients with closed distal radius fractures. METHODS: This is a secondary analysis of the Wrist and Radius Injury Surgical Trial, a randomized, multicenter, international clinical trial with a parallel nonoperative casted group of patients older than 60 years with surgically indicated, extraarticular closed distal radius fractures. Thirty-Six-Item Short-Form Health Survey-converted utilities and total costs from Medicare were used to calculate quality-adjusted life-years and incremental cost-effectiveness ratio. RESULTS: Casted patients were self-selected and older (p < 0.001) than the randomized surgical cohorts, but otherwise similar in sociodemographic characteristics. Quality-adjusted life-years for percutaneous pinning were highest at 9.17 and external fixation lowest at 8.81. Total costs expended were $16,354 for volar locking plates, $16,012 for external fixation, $11,329 for percutaneous pinning, and $6837 for casting. The incremental cost-effectiveness ratios for volar locking plates and external fixation were dominated by percutaneous pinning and casting. The ratio for percutaneous pinning compared to casting was $28,717. Probabilistic sensitivity analysis revealed a 10, 5, 53, and 32 percent chance of volar locking plate, external fixation, percutaneous pinning, and casting, respectively, being cost-effective at the willingness-to-pay threshold of $100,000 per quality-adjusted life-year. CONCLUSIONS: Casting is the most cost-effective treatment modality in the elderly with closed extraarticular distal radius fractures and should be considered before surgery. In unstable closed fractures, percutaneous pinning, which is the most cost-effective surgical intervention, may be considered before volar locking plates or external fixation.

Cost-effectiveness of the Adaptive Implementation of Effective Programs Trial (ADEPT): approaches to adopting implementation strategies.

BACKGROUND: Theory-based methods to support the uptake of evidence-based practices (EBPs) are critical to improving mental health outcomes. Implementation strategy costs can be substantial, and few have been rigorously evaluated. The purpose of this study is to conduct a cost-effectiveness analysis to identify the most cost-effective approach to deploying implementation strategies to enhance the uptake of Life Goals, a mental health EBP. METHODS: We used data from a previously conducted randomized trial to compare the cost-effectiveness of Replicating Effective Programs (REP) combined with external and/or internal facilitation among sites non-responsive to REP. REP is a low-level strategy that includes EBP packaging, training, and technical assistance. External facilitation (EF) involves external expert support, and internal facilitation (IF) augments EF with protected time for internal staff to support EBP implementation. We developed a decision tree to assess 1-year costs and outcomes for four implementation strategies: (1) REP only, (2) REP+EF, (3) REP+EF add IF if needed, (4) REP+EF/IF. The analysis used a 1-year time horizon and assumed a health payer perspective. Our outcome was quality-adjusted life years (QALYs). The economic outcome was the incremental cost-effectiveness ratio (ICER). We conducted deterministic and probabilistic sensitivity analysis (PSA). RESULTS: Our results indicate that REP+EF add IF is the most cost-effective option with an ICER of $593/QALY. The REP+EF/IF and REP+EF only conditions are dominated (i.e., more expensive and less effective than comparators). One-way sensitivity analyses indicate that results are sensitive to utilities for REP+EF and REP+EF add IF. The PSA results indicate that REP+EF, add IF is the optimal strategy in 30% of iterations at the threshold of $100,000/QALY. CONCLUSIONS: Our results suggest that the most cost-effective implementation support begins with a less intensive, less costly strategy initially and increases as needed to enhance EBP uptake. Using this approach, implementation support resources can be judiciously allocated to those clinics that would most benefit. Our results were not robust to changes in the utility measure. Research is needed that incorporates robust and relevant utilities in implementation studies to determine the most cost-effective strategies. This study advances economic evaluation of implementation by assessing costs and utilities across multiple implementation strategy combinations. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02151331 , 05/30/2014.

Cost-Effectiveness of Testing and Treatment for Hepatitis B Virus and Hepatitis C Virus Infections: An Analysis by Scenarios, Regions, and Income.

OBJECTIVES: Testing and treatment for hepatitis B virus (HBV) and hepatitis C virus (HCV) infection are highly effective, high-impact interventions. This article aims to estimate the cost-effectiveness of scaling up these interventions by scenarios, regions, and income groups. METHODS: We modeled costs and impacts of hepatitis elimination in 67 low- and middle-income countries from 2016 to 2030. Costs included testing and treatment commodities, healthcare consultations, and future savings from cirrhosis and hepatocellular carcinomas averted. We modeled disease progression to estimate disability-adjusted life-years (DALYs) averted. We estimated incremental cost-effectiveness ratios (ICERs) by regions and World Bank income groups, according to 3 scenarios: flatline (status quo), progress (testing/treatment according to World Health Organization guidelines), and ambitious (elimination). RESULTS: Compared with no action, current levels of testing and treatment had an ICER of $807/DALY for HBV and -$62/DALY (cost-saving) for HCV. Scaling up to progress scenario, both interventions had ICERs less than the average gross domestic product/capita of countries (HBV: $532/DALY; HCV: $613/DALY). Scaling up from flatline to elimination led to higher ICERs across countries (HBV: $927/DALY; HCV: $2528/DALY, respectively) that remained lower than the average gross domestic product/capita. Sensitivity analysis indicated discount rates and commodity costs were main factors driving results. CONCLUSIONS: Scaling up testing and treatment for HBV and HCV infection as per World Health Organization guidelines is a cost-effective intervention. Elimination leads to a much larger impact though ICERs are higher. Price reduction strategies are needed to achieve elimination given the substantial budget impact at current commodity prices.

Cost-effectiveness of Recurrent Dupuytren Contracture Treatment.

Importance: Owing to its tendency to recur, Dupuytren contracture often requires multiple treatments, which places additional economic burden on health care. The likelihood of contracture recurrence varies not only with treatment but also with disease characteristics, such as contracture severity and location, but prior cost-effectiveness analyses of Dupuytren contracture treatments have not considered these patient-specific disease characteristics. Objective: To identify the most cost-effective treatment regimen for patients with recurrent Dupuytren contracture. Design, Setting, and Participants: This economic evaluation was conducted with state-transition microsimulation modeling using data from published studies and Medicare. A simulated cohort of 10 000 individuals with Dupuytren contracture was created. Patients could transition yearly between the following health states: symptom-free, symptomatic, and death. Available treatments were collagenase clostridium histolyticum injection, percutaneous needle aponeurotomy (PNA), and limited fasciectomy (LF); individuals randomly chose any treatment when symptomatic. Patients were limited to 3 rounds of treatment for a contracture affecting 1 joint, totaling 27 unique combinations. If the contracture recurred after 3 treatments, patients lived with the disease for the remainder of life. Exposures: PNA, collagenase clostridium histolyticum injection, or LF. Main Outcomes and Measures: Quality-adjusted life-years (QALYs), total costs (in US dollars), and incremental cost-effectiveness ratios (ICERs). A willingness-to-pay threshold of $100 000 per quality-adjusted life-year was used to assess cost-effectiveness. Results: For the base case scenario of a patient aged 60 years with recurrent, low-severity metacarpophalangeal (MCP) joint contracture, repeated PNA treatment was the only cost-effective treatment (2 PNA treatments followed by LF vs 3 PNA treatments, ICER [Monte Carlo SE]: $212 647/QALY [$36 000/QALY]). For recurrent high-severity MCP joint contractures, treatment regimens composed of PNA and LF were cost-effective (ICER [Monte Carlo SE], $93 932/QALY [$16 500/QALY]). LF was cost-effective for high-severity MCP joint contracture (ICER [Monte Carlo SE], $98 624/QALY [$26 233/QALY]). For recurrent proximal interphalangeal (PIP) joint contractures, PNA was the only cost-effective treatment, regardless of severity (eg, 2 PNA treatments followed by LF vs 3 PNA treatments for low-severity PIP joint contracture, ICER [Monte Carlo SE]: $263 726/QALY [$29 000/QALY]). Any combination with collagenase clostridium histolyticum injection compared with 3 PNA treatments had an ICER greater than $100 000 per QALY. Probabilistic sensitivity analysis estimated a 44%, 15%, 41%, and 52% chance of a regimen consisting of only PNA being cost-effective in low-severity MCP, high-severity MCP, low-severity PIP, and high-severity PIP joint contractures, respectively. Conclusions and Relevance: The results of this study suggest that LF is a cost-effective intervention for recurrent high-severity MCP joint contractures. For recurrent low-severity MCP joint contractures and PIP joint contractures of all severity levels, PNA was the only cost-effective intervention. Collagenase clostridium histolyticum injections were not a cost-effective intervention for recurrent Dupuytren contracture and should not be preferred over PNA or LF.

Cost-Effectiveness of Hepatocellular Carcinoma Surveillance: An Assessment of Benefits and Harms.

INTRODUCTION: The value of hepatocellular carcinoma (HCC) surveillance is defined by the balance of benefits, i.e., early tumor detection, and potential harms, related to false positive and indeterminate results. Although physical harms can be observed in 15%-20% of patients with cirrhosis undergoing HCC surveillance, previous cost-effectiveness analyses have not incorporated costs of harms. We aimed to evaluate the cost-effectiveness of HCC surveillance including both benefits and harms. DESIGN: We constructed a Markov model to compare surveillance strategies of ultrasound (US) alone, US and alpha fetoprotein (AFP), and no surveillance in 1 million simulated patients with compensated cirrhosis. Harms included imaging and biopsy in patients undergoing surveillance for HCC. Model inputs were based on literature review, and costs were derived from the Medicare fee schedule, with all costs inflated to 2018 dollars. The primary outcome was the incremental cost-effectiveness ratio per incremental quality-adjusted life-year. RESULTS: In the base case analysis, US with AFP was the dominant strategy over both US alone and no surveillance. In a probabilistic sensitivity analysis, US with AFP was the most cost-effective strategy in 80.1% of simulations at a willingness-to-pay threshold of $100,000 per quality-adjusted life-year. In our threshold analyses, an HCC incidence >0.4% per year and surveillance adherence >19.5% biannually were necessary for US with AFP to be cost-effective compared with no surveillance. DISCUSSION: Accounting for both surveillance-related benefits and harms, US and AFP is more cost-effective for HCC surveillance than US alone or no surveillance in patients with compensated cirrhosis.

Cost-effectiveness of Finger Replantation Compared With Revision Amputation.

Importance: Traumatic digit amputation is the most common type of amputation injury, but the cost-effectiveness of its treatments is unknown. Objective: To assess the cost-effectiveness of finger replantation compared with revision amputation. Design, Setting, and Participants: This economic evaluation was conducted using data from the Finger Replantation and Amputation Challenges in Assessing Impairment, Satisfaction, and Effectiveness (FRANCHISE), a retrospective, multicenter cohort study at 19 centers in the United States and Asia that enrolled participants from August 1, 2016, to April 12, 2018. Model variables were based on the FRANCHISE database, Centers for Medicare & Medicaid Services, and published literature. A total of 257 participants with unilateral traumatic finger amputations treated with revision amputation or replantation distal to the metacarpophalangeal joint and at least 1 year of follow-up after treatment were included in the analysis. Exposures: Revision amputation or replantation of traumatic finger amputations. Main Outcomes and Measures: Main outcome measures were quality-adjusted life-years (QALYs), total costs (in US dollars), and incremental cost-effectiveness ratios (ICERs). A willingness-to-pay threshold of $100 000 per QALY was used to assess cost-effectiveness. Results: Of the 257 study participants (mean [SD] age, 46.7 [15.9] years; 221 [86.0%] male), 178 underwent finger replantation and 79 underwent revision amputation. In a base case of a 46.7-year-old patient, replantation was associated with QALY gains of 0.30 (95% credible interval [CrI], -0.72 to 1.38) for single-finger (not thumb), 0.39 (95% CrI, -1.00 to 1.90) for thumb, 1.69 (95% CrI, -0.13 to 3.76) for multifinger excluding thumb, and 1.27 (95% CrI, -2.21 to 5.04) for multifinger including thumb injury patterns. Corresponding ICERs for replantation compared with revision amputation were $99 157 per QALY for single-finger (not thumb), $66 278 per QALY for thumb, $18 388 per QALY for multifinger excluding thumb, and $21 528 per QALY for multifinger including thumb injury patterns. Sensitivity analysis revealed that age at time of injury, life expectancy, postinjury utility, wages, and time off work for recovery had the strongest associations with cost-effectiveness. Probabilistic sensitivity analysis revealed the following chances of replantation being cost-effective: 47% in single-finger (not thumb), 52% in thumb, 78% in multifinger excluding thumb, and 64% in multifinger including thumb injury patterns. Conclusions and Relevance: With proper patient selection, replantation of all finger amputation patterns, whether single-finger or multifinger injuries, may be cost-effective compared with revision amputation. Multifinger replantations had a higher probability of being cost-effective than single-finger replantations. Cost-effectiveness may depend on injury pattern and patient factors and thus appears to be important for consideration when patients and surgeons are deciding whether to replant or amputate.

Five-Year Cost-effectiveness of Intravitreous Ranibizumab Therapy vs Panretinal Photocoagulation for Treating Proliferative Diabetic Retinopathy: A Secondary Analysis of a Randomized Clinical Trial.

Importance: The DRCR Retina Network Protocol S randomized clinical trial suggested that the mean visual acuity of eyes with proliferative diabetic retinopathy (PDR) treated with ranibizumab is not worse at 5 years than that of eyes treated with panretinal photocoagulation (PRP). Moreover, the ranibizumab group had fewer new cases of diabetic macular edema (DME) with vision loss or vitrectomy but had 4 times the number of injections and 3 times the number of visits. Although 2-year cost-effectiveness results of Protocol S were previously identified, incorporating 5-year data from Protocol S could alter the longer-term cost-effectiveness of the treatment strategies from the perspective of the health care system. Objective: To evaluate 5- and 10-year cost-effectiveness of therapy with ranibizumab, 0.5 mg, compared with PRP for treating PDR. Design, Setting, and Participants: A preplanned secondary analysis of the Protocol S randomized clinical trial using efficacy, safety, and resource utilization data through 5 years of follow-up for 213 adults diagnosed with PDR and simulating results through 10 years. Interventions: Intravitreous ranibizumab, 0.5 mg, at baseline and as frequently as every 4 weeks based on a structured retreatment protocol vs PRP at baseline for PDR; eyes in both groups could receive ranibizumab for concomitant DME with vision loss. Main Outcomes and Measures: Incremental cost-effectiveness ratios (ICERs) of ranibizumab therapy compared with PRP were evaluated for those with and without center-involved DME (CI-DME) and vision loss (Snellen equivalent, 20/32 or worse) at baseline. Results: The study included 213 adults with a mean (SD) age of 53 (12) years, of whom 92 (43%) were women and 155 (73%) were white. The ICER of the ranibizumab group compared with PRP for patients without CI-DME at baseline was $582 268 per quality-adjusted life-year (QALY) at 5 years and $742 202/QALY at 10 years. For patients with baseline CI-DME, ICERs were $65 576/QALY at 5 years and $63 930/QALY at 10 years. Conclusions and Relevance: This study suggests that during 5 to 10 years of treatment, ranibizumab, 0.5 mg, as given in the studied trial compared with PRP may be within the frequently cited range considered cost-effective in the United States for eyes presenting with PDR and vision-impairing CI-DME, but not for those with PDR but without vision-impairing CI-DME. Substantial reductions in anti-vascular endothelial growth factor cost may make the ranibizumab therapy cost-effective within this range even for patients without baseline CI-DME. Trial Registration: ClinicalTrials.gov identifier: NCT01489189.

Additional resource needs for viral hepatitis elimination through universal health coverage: projections in 67 low-income and middle-income countries, 2016-30.

BACKGROUND: The World Health Assembly calls for elimination of viral hepatitis as a public health threat by 2030 (ie, -90% incidence and -65% mortality). However, WHO's 2017 cost projections to achieve health-related Sustainable Development Goals did not include the resources needed for hepatitis testing and treatment. We aimed to estimate the incremental commodity cost of adding scaled up interventions for testing and treatment of hepatitis to WHO's investment scenarios. METHODS: We added modelled costs for implementing WHO recommended hepatitis testing and treatment to the 2017 WHO cost projections. We quantified additional requirements for diagnostic tests, medicines, health workers' time, and programme support across 67 low-income and middle-income countries, from 2016-30. A progress scenario scaled up interventions and a more ambitious scenario was modelled to reach elimination by 2030. We used 2018 best available prices of diagnostics and generic medicines. We estimated total costs and the additional investment needed over the projection of the 2016 baseline cost. FINDINGS: The 67 countries considered included 230 million people living with hepatitis B virus (HBV) and 52 million people living with hepatitis C virus (HCV; 90% and 73% of the world's total, respectively). Under the progress scenario, 3250 million people (2400 million for HBV and 850 million for HCV) would be tested and 58·2 million people (24·1 million for HBV and 34·1 million for HCV) would be treated (total additional cost US$ 27·1 billion). Under the ambitious scenario, 11 631 million people (5502 million for HBV and 6129 million for HCV) would be tested and 93·8 million people (32·2 million for HBV and 61·6 million for HCV) would be treated (total additional cost $58·7 billion), averting 4·5 million premature deaths and leading to a gain of 51·5 million healthy life-years by 2030. However, if affordable HCV medicines remained inaccessible in 13 countries where medicine patents are protected, the additional cost of the ambitious scenario would increase to $118 billion. Hepatitis elimination would account for a 1·5% increase to the WHO ambitious health-care strengthening scenario costs, avert an additional 4·6% premature deaths, and add an additional 9·6% healthy life-years from 2016-30. INTERPRETATION: Access to affordable medicines in all countries will be key to reach hepatitis elimination. This study suggests that elimination is feasible in the context of universal health coverage. It points to commodities as key determinants for the overall price tag and to options for cost reduction strategies. FUNDING: WHO, United States Centers for Disease Control and Prevention, Unitaid.

Population Health And Economic Impacts Of Reaching Chronic Hepatitis B Diagnosis And Treatment Targets In The US.

The National Academies of Sciences, Engineering, and Medicine have concluded that eliminating the public health problem of chronic hepatitis B is feasible. We examined the economic and public health impact of reaching the World Health Organization targets of having 90 percent of chronic hepatitis B cases diagnosed and 80 percent being treated by 2030 in the United States with an annual incremental increase in screening and treatment rates. To reach the targets by 2030 would require screening approximately 14.5 million adults in at-risk populations to diagnose an estimated 870,000 undiagnosed cases and would result in substantial health gains: an increase of 16.5 million quality-adjusted life-years (QALYs), and reductions in liver-related deaths of 37 percent and in cases of compensated cirrhosis of 24 percent, decompensated liver cirrhosis of 51 percent, and liver cancer of 35 percent. Achieving the targets by 2030 would be highly cost-effective at $103 per QALY and would be cost-saving if the antiviral drug price were no more than $114 per month. Achieving them by 2025 would be cost-saving and would reduce liver-related deaths by 47 percent.

Cost effectiveness of regorafenib as second-line therapy for patients with advanced hepatocellular carcinoma.

BACKGROUND: Regorafenib, a multikinase inhibitor, has demonstrated prolonged survival by 2.8 months as a second-line agent in patients with hepatocellular carcinoma (HCC) who progress on sorafenib therapy. The objective of the current study was to examine the cost effectiveness of regorafenib for the treatment of HCC. METHODS: The authors constructed a Markov simulation model of patients with unresectable HCC and Child-Pugh A cirrhosis who received treatment with regorafenib versus best supportive care. Model inputs for regorafenib effectiveness and rates of adverse events in patients with HCC were based on published clinical trial data and literature review. Quality-adjusted life years (QALYs) were calculated along with the incremental cost-effectiveness ratio (ICER) of regorafenib therapy. One-way sensitivity analyses also were conducted simultaneously on all model parameters and on various Monte-Carlo simulation parameters, and the regorafenib cost threshold at which cost effectiveness would be achieved was determined. RESULTS: Regorafenib provided an increase of 0.18 QALYs at a cost of $47,112. The ICER for regorafenib, compared with best supportive care, was $224,362. In 1-way sensitivity analyses, there were no scenarios in which regorafenib was cost effective. In cost threshold analysis, regorafenib would have to be priced at or below $67 per pill to be cost effective at an ICER of $100,000. CONCLUSIONS: Regorafenib is not cost effective as a second-line agent in the treatment of HCC, with a marginal increase in QALYs at a high cost. Lowering the cost of regorafenib or improving the selection of patients who can achieve maximal survival benefit would improve its value as a second-line treatment option for patients with HCC. Cancer 2017;123:3725-3731. © 2017 American Cancer Society.

Cost-effectiveness of Intravitreous Ranibizumab Compared With Panretinal Photocoagulation for Proliferative Diabetic Retinopathy: Secondary Analysis From a Diabetic Retinopathy Clinical Research Network Randomized Clinical Trial.

Importance: The Diabetic Retinopathy Clinical Research Network Protocol S randomized clinical trial results suggest that ranibizumab is a reasonable treatment alternative to panretinal photocoagulation (PRP) when managing proliferative diabetic retinopathy (PDR), with or without concomitant baseline diabetic macular edema (DME). However, ranibizumab injections are costly. Thus, it would be useful to examine the relative cost-effectiveness of these 2 treatment modalities. Objective: To evaluate incremental cost-effectiveness ratios of 0.5-mg ranibizumab therapy vs PRP for PDR. Design, Setting, and Participants: Preplanned secondary analysis using efficacy, safety, and resource utilization data through 2 years of follow-up at 55 US sites for 213 adults with PDR. Data were collected from February 2012 to January 2015. Interventions: Intravitreous 0.5-mg ranibizumab at baseline and as frequently as every 4 weeks based on a structured retreatment protocol or PRP at baseline for PDR. Eyes in both groups could receive ranibizumab for concomitant DME. Main Outcomes and Measures: Incremental cost-effectiveness ratios of ranibizumab compared with PRP evaluated within 2 prespecified subgroups for the study eye: with baseline vision-impairing (Snellen equivalent 20/32 or worse) DME and without baseline vision-impairing DME. Results: The study included 305 adults with PDR, the mean age was 52 years, 44% were women, and 52% were white. Of the 46 participants with PDR and vision-impairing DME at baseline, 21 were assigned to the ranibizumab group and 25 to the PRP group (plus ranibizumab for DME). Among the remaining participants without baseline vision-impairing DME, 80 and 87 were in the ranibizumab and PRP groups, respectively. For participants with and without baseline vision-impairing DME, the incremental cost-effectiveness ratios of ranibizumab therapy compared with PRP were $55 568/quality-adjusted life-year and $662 978/quality-adjusted life-year, respectively, over 2 years. Conclusions and Relevance: Over 2 years, compared with PRP, 0.5-mg ranibizumab as given in this trial is within the $50 000/quality-adjusted life-year to $150 000/quality-adjusted life-year range frequently cited as cost-effective in the United States for eyes presenting with PDR and vision-impairing DME, but not for those with PDR without vision-impairing DME. Trial Registration: Clinicaltrials.gov Identifier: NCT01489189.