A systematic review on reporting quality of economic evaluations for negotiated glucose-lowering drugs in China national reimbursement drug list.

BACKGROUND: This study aimed to examine the reporting quality of existing economic evaluations for negotiated glucose-lowering drugs (GLDs) included in China National Reimbursement Drug List (NRDL) using the Consolidated Health Economic Evaluation Reporting Standards 2013 (CHEERS 2013). METHODS: We performed a systematic literature research through 7 databases to identify published economic evaluations for GLDs included in the China NRDL up to March 2021. Reporting quality of identified studies was assessed by two independent reviewers based on the CHEERS checklist. The Kruskal-Wallis test and Mann-Whitney U test were performed to examine the association between reporting quality and characteristics of the identified studies. RESULTS: We have identified 24 studies, which evaluated six GLDs types. The average score rate of the included studies was 77.41% (SD:13.23%, Range 47.62%-91.67%). Among all the required reporting items, characterizing heterogeneity (score rate = 4.17%) was the least satisfied item. Among six parts of CHEERS, results part scored least at 0.55 (score rate = 54.79%) because of the incompleteness of characterizing uncertainty. Results from the Kruskal-Wallis test and Mann-Whitney U test showed that model choice, journal type, type of economic evaluations, and study perspective were associated with the reporting quality of the studies. CONCLUSIONS: There remains room to improve the reporting quality of economic evaluations for GLDs in NRDL. Checklists such as CHEERS should be widely used to improve the reporting quality of economic researches in China.

An exploratory analysis of the cost-effectiveness of insulin glargine 300 units/mL versus insulin glargine 100 units/mL over a lifetime horizon using the BRAVO diabetes model.

BACKGROUND: This analysis assessed the cost-effectiveness of insulin glargine 300 units/mL (Gla-300) versus insulin glargine 100 units/mL (Gla-100) in insulin-naïve adults with type 2 diabetes (T2D) inadequately controlled with oral antidiabetic drugs (OADs). METHODS: Costs and outcomes for Gla-300 versus Gla-100 from a US healthcare payer perspective were assessed using the BRAVO diabetes model. Baseline clinical data were derived from EDITION-3, a 12-month randomized controlled trial comparing Gla-300 with Gla-100 in insulin-naïve adults with inadequately controlled T2D on OADs. Treatment costs were calculated based on doses observed in EDITION-3 and 2020 US net prices, while costs for complications were based on published literature. Lifetime costs ($US) and quality-adjusted life-years (QALYs) were predicted and used to calculate incremental cost-effectiveness ratio (ICER) estimates; extensive scenario and sensitivity analyses were conducted. RESULTS: Lifetime medical costs were estimated to be $353,441 and $352,858 for individuals receiving Gla-300 and Gla-100 respectively; insulin costs were $52,613 and $50,818. Gla-300 was associated with a gain of 8.97 QALYs and 21.12 life-years, while Gla-100 was associated with a gain of 8.89 QALYs and 21.07 life-years. This resulted in an ICER of $7522/QALY gained for Gla-300 versus Gla-100. Thus, Gla-300 was cost-effective versus Gla-100 based on a willingness-to-pay threshold of $50,000/QALY. Compared with Gla-100, Gla-300 provided a net monetary benefit of $3290. Scenario and sensitivity analyses confirmed the robustness of the base case. CONCLUSION: Gla-300 may be a cost-effective treatment option versus Gla-100 over a lifetime horizon for insulin-naïve people in the United States with T2D inadequately controlled on OADs.

Racial/Ethnic Disparities in Use of Angiotensin II Receptor Type 2/4 Stimulatory Vs. Inhibitory Antihypertensive Among Hypertensive Adults in the USA.

OBJECTIVES: Studies showed angiotensin II type 2 receptor/angiotensin II type 4 receptor (AT2R/AT4R) stimulatory antihypertensive was associated with a lower risk of dementia and cognitive impairment compared to the inhibitory one. This study aimed to identify the racial and ethnic differences in using these agents among the USA adults with hypertension. METHODS: A cross-sectional study was conducted using data from the Medical Expenditure Panel Survey (MEPS, 2016-2019). Individuals with a diagnosis of hypertension or self-reported hypertension and without dementia or Alzheimer's disease diagnosis were included in the analysis. We applied two multivariable logistic regressions to compare racial/ethnic differences in AT2R/AT4R stimulatory antihypertensive use and AT2R/AT4R inhibitory antihypertensive use, adjusting for covariates. RESULTS: Twenty-four thousand five hundred eighty-one individuals with hypertension and without dementia or Alzheimer's disease were identified. Among non-Hispanic Whites, 72.39% were using AT2R/AT4R inhibitory antihypertensive agents, vs. 66.97% using AT2R/AT4R stimulatory antihypertensive agents. In contrast, both non-Hispanic Black and Asian Americans were using more AT2R/AT4R stimulatory agents than inhibitory ones (16.40% vs. 12.16% and 4.79% vs. 3.43%, respectively). Compared to non-Hispanic White, non-Hispanic Black (OR 1.980, 95% CI 1.839-2.132) and non-Hispanic Asian Americans (OR 1.545, 95% CI 1.356-1.761) were significantly associated with higher odds of prescribing AT2R/AT4R stimulatory agents, while Hispanics (OR 0.744, 95% CI 0.685-0.808) were associated with lower odds of prescribing AT2R/AT4R inhibitory agents compared to non-Hispanic Whites. CONCLUSIONS: The results showed that the high-dementia risk populations like non-Hispanic Black and Asian American races are proportionally prescribed with higher use of low-dementia risk antihypertensive agents, compared to non-Hispanic Whites.

Geographic variation and racial disparities in adoption of newer glucose-lowering drugs with cardiovascular benefits among US Medicare beneficiaries with type 2 diabetes.

BACKGROUND: Prior studies have shown disparities in the uptake of cardioprotective newer glucose-lowering drugs (GLDs), including sodium-glucose cotranwsporter-2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP1a). This study aimed to characterize geographic variation in the initiation of newer GLDs and the geographic variation in the disparities in initiating these medications. METHODS: Using 2017-2018 claims data from a 15% random nationwide sample of Medicare Part D beneficiaries, we identified individuals diagnosed with type 2 diabetes (T2D), who had ≥1 GLD prescriptions, and did not use SGLT2i or GLP1a in the year prior to the index date,1/1/2018. Patients were followed up for a year. The cohort was spatiotemporally linked to Dartmouth hospital-referral regions (HRRs), with each patient assigned to 1 of 306 HRRs. We performed multivariable Poisson regression to estimate adjusted initiation rates, and multivariable logistic regression to assess racial disparities in each HRR. RESULTS: Among 795,469 individuals with T2D included in the analyses, the mean (SD) age was 73 (10) y, 53.3% were women, 12.2% were non-Hispanic Black, and 7.2% initiated a newer GLD in the follow-up year. In the adjusted model including clinical factors, compared to non-Hispanic White patients, non-Hispanic Black (initiation rate ratio, IRR [95% CI]: 0.66 [0.64-0.68]), American Indian/Alaska Native (0.74 [0.66-0.82]), Hispanic (0.85 [0.82-0.87]), and Asian/Pacific islander (0.94 [0.89-0.98]) patients were less likely to initiate newer GLDs. Significant geographic variation was observed across HRRs, with an initiation rate spanning 2.7%-13.6%. CONCLUSIONS: This study uncovered substantial geographic variation and the racial disparities in initiating newer GLDs.

Incremental burden on health-related quality of life, health service utilization and direct medical expenditures associated with cognitive impairment among non-institutionalized people with diabetes aged 65 years and older.

AIMS: To quantify the incremental health and economic burden associated with cognitive impairment (CI) among non-institutionalized people with diabetes ≥65 years in the United States. MATERIALS AND METHODS: Using 2016-2019 Medical Expenditure Panel Surveys data, we identified participants ≥65 years with diabetes. We used propensity score weighting to quantify the CI-associated incremental burden on health-related quality of life measured by the 12-item Short Form Survey (SF-12), including the mental component summary score, physical component summary score and health utility. We also compared the annual health service utilization and expenditures on ambulatory visits, prescriptions, home care, emergency room (ER), hospitalizations and total annual direct medical expenditures. RESULTS: We included 5094 adults aged ≥65 with diabetes, of whom 804 had CI. After propensity score weighting, CI was associated with a lower mental component summary score (-8.4, p < .001), physical component summary score (-5.2, p < .001) and health utility (-0.12, p < .001). The CI group had more ambulatory visits (+4.4, p = .004) and prescriptions (+9.9, p < .001), with higher probabilities of having home care (+11.3%, p < .001) and ER visits (+8.2%, p = .001). People with CI spent $5441 (p < .001) more annually, $2039 (p = .002) more on prescriptions, $2695 (p < .001) more on home care and $118 (p < .001) more on ER visits. There is no statistically significant difference in the utilization and expenditure of hospitalizations. CONCLUSION: CI was associated with worse health-related quality of life, higher health service utilization and expenditures. Our findings can be used to monitor the health and economic burden of CI in non-institutionalized older persons with diabetes.

Medical expenditure trajectory and HbA1c progression prior to and after clinical diagnosis of type 2 diabetes in a commercially insured population in the USA.

INTRODUCTION: Medical expenditures of individuals with type 2 diabetes escalate before clinical diagnosis. How increases in medical expenditures are related to glucose levels remains unclear. We examined changes in HbA1c and medical expenditures in years prior to and shortly after type 2 diabetes diagnosis. RESEARCH DESIGN AND METHODS: Using insurance claims and laboratory test results from a commercially insured population in the USA, we built three (2014, 2015, 2016) longitudinal cohorts with type 2 diabetes up to 10 years before and 2 years after the diagnosis (index year). We identified diabetes diagnosis using International Classification of Diseases, Ninth Revision and Tenth Revision codes and antidiabetic medication use. We ran two individual fixed regression models with annual total medical expenditures and average HbA1c values as dependent variables and number of years from diagnosis as the main independent variable and examined the risk-adjusted movement of the outcomes. RESULTS: Our study included 9847 individuals (83 526 person-years). Medical expenditures and HbA1c levels increased before and peaked at the diagnosis year. Medical expenditures were $8644 lower 10 years and $5781 lower 1 year before diagnosis compared with the index year. HbA1c was 12.18 mmol/mol (1.11 percentage points) and 3.49 mmol/mol (0.32 percentage points) lower, respectively. Average annual increases in medical expenditures and HbA1c values over the prediagnosis period were $318 and 0.97 mmol/mol (0.09 percentage points), respectively. CONCLUSIONS: Medical expenditures and HbA1c values followed similar trajectories before and after diabetes diagnosis. Our results can inform economic evaluations of programs and policies aimed at preventing type 2 diabetes.

Cost-effectiveness analysis of monthly, 3-monthly, and 6-monthly long-acting injectable and oral paliperidone in adults with schizophrenia.

BACKGROUND: Paliperidone is among the most cost-effective antipsychotics in adults with schizophrenia, and it has different formulations, including oral paliperidone extended-release (ER) and long-acting injectable (LAI) paliperidone formulations administered every month (PP1M), 3 months (PP3M), or 6 months (PP6M). However, cost-effectiveness analyses comparing different paliperidone formulations were limited. OBJECTIVE: To compare the cost-effectiveness across different paliperidone formulations. METHODS: A Markov model was developed to simulate 1,000 adults aged 40 years with stable schizophrenia transitioning among stable disease-medication adherent, stable disease-medication nonadherent, relapse with hospitalization, relapse with ambulatory care, and death states every 3 months for 5 years. Drug costs were estimated using the prices listed in the Veterans Affairs Federal Supply Schedule, and costs for treating complications were estimated from published studies. All costs were estimated from the US health care system perspective and standardized to 2022 US dollars using the Consumer Price Index Inflation Calculator. Quality-adjusted life-years (QALYs) were estimated using relapse rates from randomized clinical trials and health-related quality of life scores from observational studies. The estimated future costs and QALYs were discounted at 3%. We reported incremental net monetary benefits between alternative formulations at the $50,000 willingness-to-pay (WTP) threshold with a positive value indicating cost-effectiveness. The impact of parameter uncertainty on study outcomes was assessed using 1-way deterministic and probabilistic sensitivity analyses. RESULTS: In adults with schizophrenia stabilized with paliperidone ER, switching to LAI formulations was associated with increased QALY (PP1M = 0.05, PP3M = 0.14, PP6M = 0.15) and increased cost (PP1M = 49,433, PP3M = 26,698, PP6M = 26,147), leading to a negative incremental net monetary benefit (PP1M = -$46,804, PP3M = -$19,508, PP6M = -$18,886) compared with continuing ER. Among LAI formulations, PP6M was cost-saving with the most QALYs gained (cost = $63,277, QALY = 3.731), followed by PP3M (cost = $63,828, QALY = 3.729) and PP1M (cost = $86,563, QALY = 3.638). At the $50,000 WTP threshold, the probabilities for PP1M, PP3M, and PP6M being cost-effective compared with paliperidone ER were 0.4%, 10.2%, and 9.8%, respectively. The probability of PP6M being cost-effective was 92.6% for the PP6M-PP1M pair and 55.2% for the PP6M-PP3M pair, and 91.1% of PP3M use was cost-effective in the PP3M-PP1M pair. The results were generally robust in the sensitivity analyses, even at the $190,000 WTP threshold. CONCLUSIONS: For patients with schizophrenia stabilized with paliperidone ER, switching to LAI formulations was not cost-effective, suggesting the high drug costs for LAI may not justify the improved quality of life within 5 years. Among LAI formulations, PP6M was cost-effective over PP1M and PP3M.

Implication of dental insurance status on patterns of pre-radiation dental extraction and risk of osteoradionecrosis of the jaw in head-and-neck cancer patients.

Oral toxicities such as osteoradionecrosis can be minimized by dental screening and prophylactic dental care prior to head and neck (HN) radiation therapy (RT). However, limited information is available about how dental insurance interacts with prophylactic dental care and osteoradionecrosis. To address this gap in knowledge, we conducted a cohort study of 2743 consecutive adult patients treated with curative radiation for HN malignancy who underwent pre-radiation dental assessment and where required, prophylactic dental treatment. Charts were reviewed to determine patient demographics, dental findings, dental treatment and development of osteoradionecrosis following radiation. Three insurance cohorts were identified: private-insured (50.4 %), public-insured (7.3 %), being patients with coverage through government-funded disability and welfare programs, and self-pay (42.4 %). More than half the public-insured patients underwent prophylactic pre-radiation dental extractions, followed by self-pay patients (44 %) and private-insured patients (26.6 %). After a median follow-up time of 4.23 years, 6.5 % of patients developed osteoradionecrosis. The actuarial rate of osteoradionecrosis in the public-insured patients was 14.7 % at 5-years post-RT, compared to 7.5 % in private-insured patients and 6.7 % in self-pay patients. On multivariable analysis, dental insurance status, DMFS160, age at diagnosis, sex, tumor site, nodal involvement, years smoked and gross income were all significant risk factors for tooth removal prior to HN radiation. However, only public-insured status, tumor site and years smoked were significant risk factors for development of osteoradionecrosis. Our findings demonstrate that lack of comprehensive dental coverage (patients who self-pay or who have limited coverage under public-insured programs) associates strongly with having teeth removed prior to HN RT. Nearly 1 in 6 patients covered under public-insurance developed osteoradionecrosis within 5 years of completing their treatment. Well-funded dental insurance programs for HN cancer patients might reduce the number of pre-RT extractions performed in these patients, improving quality of life post-RT.

A New Type 2 Diabetes Microsimulation Model to Estimate Long-Term Health Outcomes, Costs, and Cost-Effectiveness.

OBJECTIVES: This study aimed to develop a microsimulation model to estimate the health effects, costs, and cost-effectiveness of public health and clinical interventions for preventing/managing type 2 diabetes. METHODS: We combined newly developed equations for complications, mortality, risk factor progression, patient utility, and cost-all based on US studies-in a microsimulation model. We performed internal and external validation of the model. To demonstrate the model's utility, we predicted remaining life-years, quality-adjusted life-years (QALYs), and lifetime medical cost for a representative cohort of 10 000 US adults with type 2 diabetes. We then estimated the cost-effectiveness of reducing hemoglobin A1c from 9% to 7% among adults with type 2 diabetes, using low-cost, generic, oral medications. RESULTS: The model performed well in internal validation; the average absolute difference between simulated and observed incidence for 17 complications was < 8%. In external validation, the model was better at predicting outcomes in clinical trials than in observational studies. The cohort of US adults with type 2 diabetes was projected to have an average of 19.95 remaining life-years (from mean age 61), incur $187 729 in discounted medical costs, and accrue 8.79 discounted QALYs. The intervention to reduce hemoglobin A1c increased medical costs by $1256 and QALYs by 0.39, yielding an incremental cost-effectiveness ratio of $9103 per QALY. CONCLUSIONS: Using equations exclusively derived from US studies, this new microsimulation model achieves good prediction accuracy in US populations. The model can be used to estimate the long-term health impact, costs, and cost-effectiveness of interventions for type 2 diabetes in the United States.

Cost-effectiveness analysis of once-daily insulin glargine 300 U/mL versus insulin degludec 100 U/mL using the BRAVO diabetes model.

AIMS: A cost-effectiveness analysis was conducted to compare insulin glargine 300 U/mL (Gla-300) versus insulin degludec 100 U/mL (IDeg-100) in insulin-naïve adults with type 2 diabetes (T2D) sub-optimally controlled with oral anti-diabetic drugs (OADs). METHODS: The BRAVO diabetes model was used to assess costs and outcomes for once-daily Gla-300 versus once-daily IDeg-100 from a US healthcare sector perspective. Baseline clinical data were based on BRIGHT, a 24-week, non-inferiority, randomised control trial comparing Gla-300 and IDeg-100 in adults with T2D sub-optimally controlled with OADs (with or without glucagon-like peptide-1 receptor agonists). Treatment costs were based on doses observed in BRIGHT as well as net prices. Costs associated with complications were based on published literature. Lifetime costs (US$) and quality-adjusted life-years (QALYs) were predicted and used to calculate incremental cost-effectiveness ratio estimates; extensive scenario and sensitivity analyses were conducted. RESULTS: Overall lifetime medical costs were estimated to be $327,904 and $330,154 for people receiving Gla-300 and IDeg-100, respectively; insulin costs were $43,477 and $44,367, respectively. People receiving Gla-300 gained 8.024 QALYs and 18.55 life-years, while people receiving IDeg-100 gained 7.997 QALYs and 18.52 life-years. Because Gla-300 was associated with a cost-saving of $2250 and 0.027 additional QALYs, it was considered to be dominant compared with IDeg-100. Results of the scenario and sensitivity analyses confirmed the robustness of the base case results. CONCLUSION: Gla-300 was the dominant treatment option compared with IDeg-100 based on the willingness-to-pay threshold of $50,000/QALY. Results remained robust against a wide range of alternative assumptions on key parameters.

Dissipation and dietary exposure risk assessment of spinosad, thiocyclam, and its metabolite nereistoxin in cucumber and groundwater for different population groups.

A QuEChERS (quick, easy, cheap, effective, rugged, and safe) technique using ultrahigh-performance liquid chromatography with tandem mass spectrometry for the analysis of spinosad (spinosyn A + spinosyn D), thiocyclam, and nereistoxin in cucumber was developed with mean recoveries of 93-104%, relative standard deviations of ≤9%, and limits of quantification of 0.01 mg/kg. Field trials of spinosad and thiocyclam were performed in 12 representative cultivating areas in China. Field trial results indicate that spinosyn A and spinosyn D easily dissipated in cucumber with half-lives of 2.48-6.24 and <3 days, respectively. Nereistoxin was produced after thiocyclam application and was more persistent than its parent. The terminal residues of spinosad were all below the maximum residue limits (0.2 mg/kg) in China, whereas the terminal concentration of nereistoxin (calculated as the stoichiometric equivalent of thiocyclam), which was much higher than that of thiocyclam, was far beyond the maximum residue limits of thiocyclam in cucumber (0.01 mg/kg) established by the European Union. The predicted no-effect concentrations of spinosyn A, spinosyn D, thiocyclam, and nereistoxin leaching into groundwater were estimated using China-PEARL (Pesticide Emission Assessment at Regional and Local scales) models after application. However, the dietary (food and water) exposure risk quotient for different populations was below 1 with a preharvest interval set at 5 days after the last application, indicating that the application of spinosad and thiocyclam in cucumber was unlikely to pose unacceptable risk for human health. This study provides data for the safe use of spinosad and thiocyclam in cucumber ecosystem.

Exacerbation of financial burden of insulin and overall glucose-lowing medications among uninsured population with diabetes.

BACKGROUND: Approximately 7.4 million Americans with diabetes used insulin. This study aimed to document the 10-year trend of insulin and other glucose-lowering medications expenditure among insured and uninsured populations and to examine the impact of insulin out-of-pocket (OOP) payment and insurance status on glucose-lowering medication OOP expenditure. METHODS: We extracted data from the Medical Expenditure Panel Survey (2009-2018) to document trends in the expenditure of insulin among people with diabetes. Total expenditures and OOP spending per person were documented on insulin and noninsulin glucose-lowering medications among insured and uninsured populations. Multivariable regression was applied to assess the association of insulin OOP payment and insurance status on glucose-lowering medication OOP expenditure. RESULTS: Although insulin usage was stable over the decades, total insulin expenditure almost doubled per person per year after the Affordable Care Act (ACA) regardless of the insurance status. The OOP cost of insulin by the uninsured population increased from $1678 per person per year in the pre-ACA period to $2800 per person per year in the post-ACA period. After the ACA was enacted, the uninsured population had $403.96 and $143.64 more on OOP costs than the people with public and private insurance, respectively. CONCLUSION: For insured people, the rising financial burden of insulin was borne mainly by insurance. The uninsured population is bearing a heavy burden due to the high price of insulin. Policymakers should take action to reduce the insulin price and improve the transparency of the insulin pricing process.

Healthcare Utilization and Mortality After Hospice Live Discharge Among Medicare Patients With and Without Alzheimer's Disease and Related Dementias.

BACKGROUND: Little is known about post-discharge outcomes among patients who were discharged alive from hospice. OBJECTIVE: To compare healthcare utilization and mortality after hospice live discharge among Medicare patients with and without Alzheimer's disease and related dementias (ADRD). DESIGN: Retrospective cohort study using Medicare claims data of a 20% random sample of Medicare fee-for-service (FFS) patients. PARTICIPANTS: A total of 153,696 Medicare FFS patients experienced live discharge from hospice between 2014 and 2019. MEASURES: Two types of burdensome transition (type 1: live discharge from hospice followed by hospitalization and subsequent hospice readmission; type 2: live discharge from hospice followed by hospitalization with the patient deceased in the hospital), acute care utilization, hospice readmission, and mortality in the 30 and 180 days after live discharge and between live discharge and death. RESULTS: Compared with non-ADRD patients, ADRD patients were less likely to experience burdensome transitions (type 1: adjusted odds ratio [aOR], 0.94; 95% confidence interval [CI], 0.90-0.98; type 2: aOR, 0.70; 95% CI, 0.65-0.75), more likely to have ED visits (aOR, 1.05; 95% CI, 1.01-1.09), less likely to die (aOR, 0.71; 95% CI, 0.69-0.73), and less likely to be readmitted to hospice (aOR, 0.86; 95% CI, 0.84-0.89) 30 days after live discharge. Results of 180-day post-discharge outcomes were largely consistent with results of 30-day outcomes. Among patients who died as of December 31, 2019, ADRD patients were less likely to be hospitalized (aOR, 0.88; 95% CI, 0.85-0.92) and more likely to be readmitted to hospice (aOR, 1.12; 95% CI, 1.08-1.16) between live discharge and death. Significant racial/ethnicity disparities in acute care utilization and mortality after live discharge existed in both ADRD and non-ADRD groups. CONCLUSION: ADRD patients had lower mortality, a longer survival time, a lower rate of hospitalization, and an initially lower but gradually increasing rate of hospice readmission than non-ADRD patients after hospice live discharge. These different trajectories warrant further investigation of the eligibility of their initial hospice enrollment. Black patients had significantly worse outcomes after hospice live discharge compared with White patients.

Association of Household Income at Diagnosis With Financial Toxicity, Health Utility, and Survival in Patients With Head and Neck Cancer.

Importance: While several studies have documented a link between socioeconomic status and survival in head and neck cancer, nearly all have used ecologic, community-based measures. Studies using more granular patient-level data are lacking. Objective: To determine the association of baseline annual household income with financial toxicity, health utility, and survival. Design, Setting, and Participants: This was a prospective cohort of adult patients with head and neck cancer treated at a tertiary cancer center in Toronto, Ontario, between September 17, 2015, and December 19, 2019. Data analysis was performed from April to December 2021. Exposures: Annual household income at time of diagnosis. Main Outcome and Measures: The primary outcome of interest was disease-free survival. Secondary outcomes included subjective financial toxicity, measured using the Financial Index of Toxicity (FIT) tool, and health utility, measured using the Health Utilities Index Mark 3. Cox proportional hazards models were used to estimate the association between household income and survival. Income was regressed onto log-transformed FIT scores using linear models. The association between income and health utility was explored using generalized linear models. Generalized estimating equations were used to account for patient-level clustering. Results: There were 555 patients (mean [SD] age, 62.7 [10.7] years; 109 [20%] women and 446 [80%] men) included in this cohort. Two-year disease-free survival was worse for patients in the bottom income quartile (<$30 000: 67%; 95% CI, 58%-78%) compared with the top quartile (≥$90 000: 88%; 95% CI, 83%-93%). In risk-adjusted models, patients in the bottom income quartile had inferior disease-free survival (adjusted hazard ratio, 2.13; 95% CI, 1.22-3.71) and overall survival (adjusted hazard ratio, 2.01; 95% CI, 0.94-4.29), when compared with patients in the highest quartile. The average FIT score was 22.6 in the lowest income quartile vs 11.7 in the highest quartile. In adjusted analysis, low-income patients had 12-month FIT scores that were, on average, 134% higher (worse) (95% CI, 16%-253%) than high-income patients. Similarly, health utility scores were, on average, 0.104 points lower (95% CI, 0.026-0.182) for low-income patients in adjusted analysis. Conclusions and Relevance: In this cohort study, patients with head and neck cancer with a household income less than CAD$30 000 experienced worse financial toxicity, health status, and disease-free survival. Significant disparities exist for Ontario's patients with head and neck cancer.

Medical Costs Associated With Diabetes Complications in Medicare Beneficiaries Aged 65 Years or Older With Type 1 Diabetes.

OBJECTIVE: To estimate medical costs associated with 17 diabetes complications and treatment procedures among Medicare beneficiaries aged ≥65 years with type 1 diabetes. RESEARCH DESIGN AND METHODS: With use of the 2006-2017 100% Medicare claims database for beneficiaries enrolled in fee-for-service plans and Part D, we estimated the annual cost of 17 diabetes complications and treatment procedures. Type 1 diabetes and its complications and procedures were identified using ICD-9/ICD-10, procedure, and diagnosis-related group codes. Individuals with type 1 diabetes were followed from the year when their diabetes was initially identified in Medicare (2006-2015) until death, discontinuing plan coverage, or 31 December 2017. Fixed-effects regression was used to estimate costs in the complication occurrence year and subsequent years. The cost proportion of a complication was equal to the total cost of the complication, calculated by multiplying prevalence by the per-person cost divided by the total cost for all complications. All costs were standardized to 2017 U.S. dollars. RESULTS: Our study included 114,879 people with type 1 diabetes with lengths of follow-up from 3 to 10 years. The costliest complications per person were kidney failure treated by transplant ($77,809 in the occurrence year and $13,556 in subsequent years), kidney failure treated by dialysis ($56,469 and $41,429), and neuropathy treated by lower-extremity amputation ($40,698 and $7,380). Sixteen percent of the total medical cost for diabetes complications was for treating congestive heart failure. CONCLUSIONS: Costs of diabetes complications were large and varied by complications. Our results can assist in cost-effectiveness analysis of treatments and interventions for preventing or delaying diabetes complications in Medicare beneficiaries aged ≥65 years with type 1 diabetes.

Medical Costs Associated With Diabetes Complications in Medicare Beneficiaries Aged 65 Years or Older With Type 2 Diabetes.

OBJECTIVE: To estimate medical costs associated with 17 major diabetes-related complications and treatment procedures among Medicare beneficiaries aged ≥65 years with type 2 diabetes. RESEARCH DESIGN AND METHODS: Claims data from 100% of Medicare beneficiaries enrolled in fee-for-service plans from 2006 to 2017 were analyzed. Records with type 2 diabetes and complications were identified using ICD-9, ICD-10, and diagnosis-related group codes. The index year was the year when a person was first identified as having diabetes with an inpatient claim or an outpatient claim plus another inpatient/outpatient claim in the 2 years following the first claim in Medicare. Included individuals were followed from index years until death, discontinuation of plan coverage, or 31 December 2017. Fixed-effects regression was used to estimate the cost in years when the complication event occurred and in subsequent years. The total cost for each complication was calculated for 2017 by multiplying the complication prevalence by the cost estimate. All costs were standardized to 2017 U.S. dollars. RESULTS: Our study included 10,982,900 beneficiaries with type 2 diabetes. Follow-up ranged from 3 to 10 years. The three costliest complications were kidney failure treated by transplant (occurring year $79,045, subsequent years $17,303), kidney failure treated by dialysis ($54,394, $38,670), and lower-extremity amputation ($38,982, $8,084). Congestive heart failure accounted for the largest share (18%) of total complication costs. CONCLUSIONS: Costs associated with diabetes complications were substantial. Our cost estimates provide essential information needed for conducting economic evaluation of treatment and programs to prevent and delay diabetes complications in Medicare beneficiaries.

Cost-Effectiveness of iGlarLixi Versus Premix BIAsp 30 in People with Type 2 Diabetes Suboptimally Controlled by Basal Insulin in the US.

INTRODUCTION: Many people with type 2 diabetes mellitus (T2DM) experience suboptimal glycemic control and require therapy advancement. This cost-effectiveness analysis was conducted to compare iGlarLixi (insulin glargine 100 U/mL plus lixisenatide) versus BIAsp 30 (biphasic insulin aspart 30) in people with T2DM suboptimally controlled with basal insulin. METHODS: The IQVIA Core Diabetes Model was used to estimate lifetime costs and outcomes for people with T2DM from a US healthcare payer perspective. Initial clinical data were based on the phase 3 randomized, open-label, active-controlled SoliMix clinical study, which compared the efficacy and safety of once-daily iGlarLixi with twice-daily BIAsp 30. Lifetime costs (US$) and quality-adjusted life-years (QALYs) were predicted, and the incremental cost-effectiveness ratio (ICER) for iGlarLixi versus BIAsp 30 was estimated; the willingness-to-pay threshold was considered to be $50,000. A subgroup analysis considered people with T2DM aged ≥ 65 years. RESULTS: Estimated QALYs gained were slightly higher with iGlarLixi compared with BIAsp 30 (9.3 vs. 9.2), with lower costs for iGlarLixi ($117,854 vs. $120,109); the ICER for iGlarLixi was therefore considered dominant over BIAsp 30 in the base case. Key drivers for cost savings were the higher dose and twice-daily administration for BIAsp 30 versus once-daily administration for iGlarLixi. The robustness of the base-case results was confirmed by sensitivity and scenario analyses. Results were similar in a subgroup of people with T2DM aged ≥ 65 years. CONCLUSION: In people with T2DM with suboptimal glycemic control on basal insulin, iGlarLixi confers improved QALYs and reduced costs compared with BIAsp 30.