The effects of patient out-of-pocket costs on insulin use among people with type 1 and type 2 diabetes with Medicare Advantage insurance-2014-2018.

OBJECTIVE: To identify the association between insulin out-of-pocket costs (OOPC) and adherence to insulin in Medicare Advantage (MA) patients. DATA SOURCES AND STUDY SETTING: The study is based on Optum Labs Data Warehouse, a longitudinal, real-world data asset with de-identified administrative claims and electronic health record data. STUDY DESIGN: Using descriptive and multivariable logistic regression analyses, we identified the likelihood of patients with diabetes having ≥60 consecutive days between an expected insulin fill date and the actual fill date (refill lapse) by OOPC, categorized by $0, >$0-$20 (reference), >$20-$35, >$35-$50, and > $50 per 30-day supply. DATA COLLECTION/EXTRACTION METHODS: The study included MA enrollees with type 1 or type 2 diabetes and prescription claims for insulin between 2014 and 2018. PRINCIPAL FINDINGS: Those with average insulin OOPC per 30-day supply >$35 or $0 were more likely to have an insulin refill lapse versus OOPC of >$0 to $20, with odds ratios ranging 1.18 (95% CI 1.13-1.22) to 1.74 (95% CI 1.66-1.83) depending on OOPC group and diabetes type. CONCLUSIONS: Capping average insulin OOPC at $35 per 30-day supply may help avoid cost-related insulin non-adherence in MA patients; efforts to address non-cost barriers to medication adherence remain important.

Impact of home blood pressure monitors on self-monitoring and control of blood pressure in vulnerable adults.

To evaluate associations between home blood pressure monitoring (HBPM) and blood pressure (BP) in vulnerable adults during the COVID-19 pandemic, when access to in-person care was restricted. A retrospective cohort study was conducted in adults with hypertension or elevated BP given a home BP monitor vs. usual care. Change in BP from baseline to follow-up was compared between groups, controlling for potential confounders. Subgroup analyses of BP outcomes were also assessed in patients age >50 years. There was no difference in SBP reduction between n = 82 HBPM patients (-11.7/-2.9 mmHg) and n = 280 usual care patients (-12.5/-5.8 mmHg; P > 0.05). Results were similar in multivariable analysis controlling for potential confounders [coefficient 0.44, 95% confidence interval (CI) -3.98 to 4.87]. However, in the subgroup of patients aged>50 years, there was a significant association between SBP reduction and HBPM in the multivariable analyses (coefficient -7.2, 95% CI -13.8 to -0.62, P = 0.032). HBPM use was not associated with BP reduction in vulnerable adults overall during high telehealth use. An association between SBP reduction and HBPM was observed in those aged>50 years. Targeting limited HBPM resources to those aged >50 years old may have the most impact on BP.

Pharmacist impact on evidence-based prescribing of diabetes medications in patients with clinical atherosclerotic cardiovascular disease.

BACKGROUND: Including pharmacists on care teams of patients with type 2 diabetes (T2D) has been shown to promote guideline-based prescribing and improve glycemic control, lowering risks of adverse cardiovascular outcomes. Evidence is lacking regarding whether including pharmacists on the care team is associated with the prescribing of GLP-1 receptor agonists (GLP-1 RA) and SGLT-2 inhibitors (SGLT-2i) recommended for use in patients with T2D and atherosclerotic cardiovascular disease (ASCVD). OBJECTIVE: To assess the association between having a pharmacist on the primary care team of patients with T2D and ASCVD and being prescribed a guideline-recommended GLP-1 RA or SGLT-2i. METHODS: A cross-sectional analysis of patients with T2D and ASCVD seen by primary care providers at an academic medical center between June 2019 and May 2020 was completed. Patients with prescriptions for GLP-1 RA or SGLT-2i with evidence of cardiovascular benefit were identified and compared between those with pharmacist care vs usual care using multivariable log-binominal regression analyses. RESULTS: Of 1,497 included patients, 1,283 (85.7%) were in the usual care group (mean age 68.9 years, hemoglobin A1c 7.6%) and 214 (14.3%) in the pharmacist care group (mean age 64.5 years, A1c 9.0%). Of the pharmacist care group, 50.5% were prescribed a GLP-1 RA or SGLT-2i with cardiovascular benefit vs 17.9% in the usual care group (P < 0.001). In multivariable analyses controlling for A1c and other potential confounders, those in the pharmacist care group were 2.15 times as likely to have been prescribed a GLP-1 RA or SGLT-2i than those in the usual care group (adjusted risk ratio 2.15, 95% CI = 1.83-2.52; P < 0.001). CONCLUSIONS: These data provide preliminary evidence that integrating pharmacists into patient care teams is associated with increased prescribing of guideline-recommended treatment with GLP-1 RA and SGLT-2i in patients with T2D and ASCVD, yet there is room for improvement in prescribing these agents to patients with T2D and ASCVD.

Influence of prior authorization requirements on provider clinical decision-making.

OBJECTIVES: Prior authorization (PA) aims to promote the safe and effective use of medications and to control costs. However, PA-related administrative tasks can contribute to burden on health care providers. This study examines how such tasks affect treatment decisions. STUDY DESIGN: Cross-sectional, online survey. METHODS: We conducted an online survey of US medical providers in 2020 based on a convenience sample of 100,000 providers. Multivariate path analysis was used to examine associations among provider practice characteristics, step therapy and other health plan requirements, perceived burdens of PA, communication issues with insurers, and prescribing behaviors (prescribing a different medication than planned, avoiding prescribing of newer medications even if evidence-based guideline recommendations are met, and modifying a diagnosis). Weighted analyses were conducted to assess nonresponse bias. RESULTS: A total of 1173 respondents (1.2% response rate) provided 1147 usable surveys. Step therapy requirements had the largest effect on clinical decision-making. Other significant effects on clinical decision-making included perceived PA likelihood, communication issues, and health plan requirements (eg, clinical documentation). Weighted analyses showed that the study conclusions were unlikely to have been biased by nonresponse. CONCLUSIONS: Respondents report that they may alter clinical decisions to avoid PA requirements and related burdens, even in cases in which use of the PA medication was clinically appropriate. Processes that reduce the administrative burden of PA through improved communication and transparency as well as standardized documentation may help ensure that PA more seamlessly achieves its goals of safe and effective use of medications.

Patient-centered medical home pharmacists' impact on composite quality care measures for patients with uncontrolled type 2 diabetes.

BACKGROUND: Patients with uncontrolled diabetes are at risk for developing complications. Many health care systems have implemented multidisciplinary care models including pharmacists to help achieve quality care measures to reduce complications. OBJECTIVE: This study aimed to evaluate whether patients with uncontrolled type 2 diabetes mellitus (T2D) seen at patient-centered medical home (PCMH) clinics affiliated with an academic medical center are more likely to meet a composite of diabetes quality care measures with a pharmacist on their care team than usual care patients without a pharmacist on their care team. METHODS: This is a cross-sectional study. The setting included PCMH primary care clinics affiliated with an academic medical center from January 2017 to December 2020. Included were adults aged 18 to 75 years with a diagnosis of T2D, hemoglobin A1C (A1C) more than 9%, and established with a PCMH provider. The intervention is inclusion of PCMH pharmacist on the patient's care team for management of T2D per a collaborative practice agreement. The main outcome measures included A1C ≤9% per last recorded value during observation period, a composite A1C ≤9% and completion of yearly laboratory tests, and a composite A1C ≤9%, completion of yearly laboratory tests, and statin prescription for adults aged 40-75 years. RESULTS: Identified were 1807 patients in the usual care cohort with mean baseline A1C of 10.7% and 207 patients in the pharmacist cohort with mean baseline A1C of 11.1%. The pharmacist cohort was more likely to have an A1C of ≤9% at the end of the observation period (70.1% vs. 45.4%; P < 0.001), a composite of measures met (28.5% vs. 16.8%; P < 0.001), and a composite of measures met for patients aged 40-75 years (27.2% vs. 13.7%; P < 0.001). CONCLUSION: Pharmacist involvement in the multidisciplinary management of uncontrolled T2D is associated with a higher attainment of a composite of quality care measures at the population health level.

Assessment of medication adherence after enrollment in a health system funded medication assistance program for patients with diabetes.

BACKGROUND: High costs for patients' medications decrease medication access and adherence which contributes to poor clinical outcomes. Numerous medication assistance programs exist, but many patients needing assistance, particularly insured patients, do not receive assistance due to eligibility criteria. OBJECTIVE: To determine if there is an association between medication adherence to antihyperglycemic therapy and patient access to Nebraska Medicine Charity Care (NMCC). PRACTICE DESCRIPTION: NMCC covers up to 100% of medication out-of-pocket costs for patients in financial need who do not qualify for other programs. PRACTICE INNOVATION: There is no published information about a long-term health system-led financial medication assistance program being utilized to improve patient medication adherence and clinical outcomes. EVALUATION METHODS: A retrospective cohort analysis was conducted to assess adherence in patients who initiated NMCC between July 1, 2018 and June 30, 2020, with a focus on diabetes for feasibility. Adherence was assessed using a modified medication possession ratio (mMPR) for 6 months after initiating NMCC based on health system dispensing data. Overall population adherence analyses were conducted in all available data, while pre-post analyses were conducted in those with antihyperglycemic medication fills during the prior 6 months. RESULTS: Of 2758 unique patients receiving NMCC support, 656 patients with diabetes medication use were included. Of these, 71% had prescription insurance and 28% had prescription fills in the baseline period. Mean (SD) adherence to noninsulin antihyperglycemic medications in the follow-up period was 0.80 (0.25) with 63% adherent per mMPR ≥0.80. In the prepost analysis, mMPR was significantly higher during the follow-up period at 0.83 (0.23) than during the preindex period at 0.34 (0.17), as was the proportion who were adherent (66% vs. 2%) (P < 0.001). CONCLUSION: This practice innovation observed an improvement in adherence and A1C outcomes in patients with diabetes who received medication financial assistance through a health system.

In-Person and Telehealth Provider Access and Glycemic Control for People With Diabetes During the COVID-19 Pandemic.

BACKGROUND: Ambulatory care underwent rapid changes at the onset of the COVID-19 pandemic. Care for people with diabetes shifted from an almost exclusively in-person model to a hybrid model consisting of in-person visits, telehealth visits, phone calls, and asynchronous messaging. METHODS: We analyzed data for all patients with diabetes and established with a provider at a large academic medical center to identify in-person and telehealth ambulatory provider visits over two periods of time (a "pre-COVID" and "COVID" period). RESULTS: While the number of people with diabetes and any ambulatory provider visit decreased during the COVID period, telehealth saw massive growth. Per Hemoglobin A1c, glycemic control remained stable from the pre-COVID to COVID time periods. CONCLUSIONS: Findings support continued use of telehealth, and we anticipate hybrid models of care will be utilized for people with diabetes beyond the pandemic.

Short-term cost-effectiveness analysis of tirzepatide for the treatment of type 2 diabetes in the United States.

BACKGROUND: Tirzepatide is a novel once-a-week dual glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist that is used as an addition to diet and exercise to improve blood glucose in adults with type 2 diabetes. It is the first dual glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide receptor agonist that has been approved by the US Food and Drug Administration. The SURPASS-2 clinical trial demonstrated superiority of tirzepatide 10 mg and 15 mg over semaglutide 1 mg in glycated hemoglobin A1c reduction and weight loss from baseline to week 40. Economic analyses to support coverage and access decision-making for tirzepatide are limited. OBJECTIVES: To evaluate the cost-effectiveness of tirzepatide 10 mg vs semaglutide 1 mg injection over 52 weeks of treatment regarding A1c reduction and weight loss from the perspective of the US health care payer. METHODS: A decision tree model over a 52-week time horizon was developed to identify incremental treatment-related costs of once-weekly tirzepatide 10 mg vs semaglutide 1 mg injection. Costs were divided by mean reduction in A1c and change in body weight from baseline to week 52 observed in the SURPASS-2 clinical trial. In addition to efficacy, probabilities of adverse events, discontinuation, and need for rescue therapy were derived from the SURPASS-2 study. Drug costs in 2022 US dollars were based on wholesale acquisition cost. Costs associated with adverse events were sourced from the published literature. One-way sensitivity analyses were conducted. RESULTS: Treatment with once-weekly tirzepatide 10 mg injection was associated with a higher cost and larger reduction in A1c and body weight after 52 weeks, compared with once-weekly semaglutide 1 mg injection. The incremental cost-effectiveness ratio for tirzepatide vs semaglutide was $2,247 per 1% reduction in A1c and $237 per 1 kg weight loss. One-way sensitivity analysis suggested that incremental cost-effectiveness ratios were most sensitive to the drug costs and treatment effect on A1c and weight. CONCLUSIONS: Once-weekly tirzepatide 10 mg was associated with higher cost and greater reduction in A1c and weight vs semaglutide. Tirzepatide 10 mg is cost-effective compared with semaglutide 1 mg if payers' willingness-to-pay threshold exceeds $2,247 for 1% reduction in A1c level and $237 for 1 kg weight loss.

Telemedicine and health access inequalities during the COVID-19 pandemic.

Background: During the COVID-19 pandemic, health systems rapidly introduced in-home telehealth to maintain access to care. Evidence is evolving regarding telehealth's impact on health disparities. Our objective was to evaluate associations between socioeconomic factors and rurality with access to ambulatory care and telehealth use during the COVID-19 pandemic. Methods: We conducted a retrospective study at an academic medical centre in midwestern United States. We included established and new patients who received care during a one-year COVID-19 period vs pre-COVID-19 baseline cohorts. The primary outcome was the occurrence of in-person or telehealth visits during the pandemic. Multivariable analyses identified factors associated with having a health care provider visit during the COVID-19 vs pre-COVID-19 period, as well as having at least one telehealth visit during the COVID-19 period. Results: All patient visit types were lower during the COVID-19 vs the pre-COVID-19 period. During the COVID-19 period, 125 855 of 255 742 established patients and 53 973 new patients had at least one health care provider visit, with 41.1% of established and 23.5% of new patients having at least one telehealth visit. Controlling for demographic and clinical characteristics, established patients had 30% lower odds of having any health care provider visit during COVID-19 vs pre-COVID-19 (adjusted odds ratio (aOR) = 0.71, 95% confidence interval (CI) = 0.698-0.71) period. Factors associated with lower odds of having a telehealth visit during COVID-19 period for established patients included older age, self-pay or other insurance vs commercial insurance, Black or Asian vs White race and non-English preferred languages. Female patients, patients with Medicare or Medicaid coverage, and those living in lower income zip codes were more likely to have a telehealth visit. Living in a zip code with higher average internet access was associated with telehealth use but living in a rural zip code was not. Factors affecting telehealth visit during the COVID-19 period for new patients were similar, although new patients living in more rural areas had a higher odds of telehealth use. Conclusion: Healthcare inequities existed during the COVID-19 pandemic, despite the availability of in-home telehealth. Patient-level solutions targeted at improving digital literacy, interpretive services, as well as increasing access to stable high-speed internet are needed to promote equitable health care access.

Perceptions of prior authorization by use of electronic prior authorization software: A survey of providers in the United States.

BACKGROUND: Given provider, patient, and health plan administrative burden, there is consensus that the medication prior authorization (PA) process needs to be streamlined and standardized. This includes broader adoption of electronic PA (ePA) solutions, including real-time clinical benefit determination. Insight into provider experiences with ePA will help health plans and pharmacy benefit managers (PBMs) prioritize efforts and investments in PA process improvement. OBJECTIVE: To identify provider experiences with PA by their use of ePA technology in a national sample of providers from the United States. METHODS: An online, nationwide survey was sent to licensed providers in 2020. The survey obtained information on provider experiences with PA, including PA workload, time to the communication of a PA decision, and other PA-related interactions with plans/PBMs. Provider characteristics and survey responses by provider use of ePA were compared using analysis of variance tests for items based on ordinal scales and a chi-square test statistic for nominal variables. Multivariable regression analyses identified associations between ePA use and PA experience variables, controlling for provider characteristics. RESULTS: Of 1,147 providers submitting usable surveys, 58% reported personally using ePA for at least some of their PA submissions, 88% submit at least 1 PA in a typical week, and most (82%) spend up to 5 hours a week on PA submissions. A majority (58.5%) reported that manual PA is often required. Those using ePA submitted a higher volume of PAs (P < 0.001) and spent more time on PA submissions (P = 0.003) than providers not using ePA software, but the duration of time from start to finish for a PA submission did not differ (P = 0.211). Providers who use ePA reported more difficulty identifying step therapy requirements (P = 0.005) and more frequently needing to submit additional documentation (P = 0.022). PA-related communication failures did not differ. Those using ePA reported a shorter time to PA decision (P = 0.004) than those not using ePA. Univariate descriptive findings were supported by multivariable analyses. CONCLUSIONS: This large, nationwide survey identified that a provider's use of ePA was not associated with less provider time or fewer challenges in preparing and submitting PA requests. However, the use of ePA was associated with a reported shorter PA decision time. Efforts to standardize PA requirements, support of real-time benefits check functionality, and better integration of ePA processes into provider workflows may help reduce PA burden and treatment delays. DISCLOSURES: Funding provided by the National Institutes of Health (NIMH #1R41MH124600-01).

Addressing healthcare disparities and managed care considerations with continuous glucose monitoring.

About 37 million people in the United States have diabetes. Diabetes-related complications are costly and associated with substantial morbidity. By improving glucose control, continuous glucose monitoring (CGM) can reduce costs due to diabetes-related hospitalizations, hypoglycemia, and diabetic ketoacidosis. However, people of color and low socioeconomic status, populations with disproportionately high prevalence of diabetes, face significant inequity in accessing CGM technology. Potential reasons for CGM inequity include implicit bias and differences in coverage between commercial and government insurance. Recent changes to Medicare CGM eligibility criteria have eliminated blood glucose monitoring requirements. However, cost and CGM coverage requirements remain as barriers to the recommended use of this technology as defined in current clinical practice guidelines. Coverage expansion from durable medical equipment to the pharmacy benefit may improve access. Other strategies to optimize CGM utility overall include integrating CGM data directly into electronic health records for population health management and diabetes control performance measures based on CGM data in value-based contracts (VBCs). VBCs may encourage real-world data generation which in turn may bolster stakeholder support for the equitable use and coverage of CGM in diabetes management.

Healthcare costs and resource utilization associated with renal cell carcinoma among older Americans: A longitudinal case-control study using the SEER-Medicare data.

OBJECTIVES: To determine 1-year and 5-year total healthcare costs and healthcare resource (HRU) associated with renal cell carcinoma (RCC) in older Americans, from a healthcare sector perspective. MATERIALS AND METHODS: This was a longitudinal, retrospective cohort study using the Surveillance, Epidemiology and End Results-Medicare linked data (2006-2014), which included older (≥66 years) patients with primary RCC and 1:5 matched noncancer controls. Patients/controls were followed from diagnosis (pseudo-diagnosis for controls) until death or up to loss-to-follow-up (censored). Per-patient average 1-year and 5-year cumulative total and incremental total healthcare costs and HRU were reported. RESULTS: A total of 11,228 RCC patients were matched to 56,140 controls. Per-patient cumulative average 1-year (incremental = $38,291 [$36,417-$40,165]; $57,588 vs. $19,297) and 5-year (incremental = $68,004 [$55,123-$80,885]; $183,550 vs. $115,547) total costs (excluding prescription drug costs) were 3 and 1.6 times higher for RCC vs. controls. These estimates were 3.6 and 1.7 times higher for RCC vs. controls when prescription costs were included in total costs. Prescription drug costs accounted for 8.4% (incremental = $3,715) and 18.1% (incremental = $15,375) of the 1-year and 5-year incremental total costs, respectively. RCC patients had greater cumulative number of hospitalizations, emergency department visits and prescriptions in 1- and 5-years, compared to controls. CONCLUSIONS: Average first year total cost for a patient with incident diagnosis of RCC is substantially higher than that for controls and it varies depending on the stage at diagnosis. Study findings could help in planning future resource allocation and in determining research and unmet needs in this patient population.

Pharmacist-led drug therapy management for hepatitis C at a federally qualified health care center.

BACKGROUND: Chronic hepatitis C (HCV) infection is challenging to address in patients with barriers to accessing care, including those from underserved populations. Linking at-risk patients through the HCV cascade of care can address such disparities by leveraging existing patient-provider relationships to identify and treat HCV. Pharmacists are ideal clinical team members to provide direct-acting antiviral (DAA) management, given their expertise in pharmacotherapy and medication access. However, literature describing pharmacist-led DAA management at federally qualified health centers (FQHCs) is limited. OBJECTIVE(S): To describe HCV screening, DAA prescribing and treatment initiation, post-treatment sustained virologic response (SVR) assessment, and treatment outcomes in an FQHC with pharmacist-led DAA management. METHODS: This study describes HCV screening rates in adults with select HCV risk factors receiving primary care at a Midwest FQHC over a 4-year period. In patients with a detectible HCV viral load, DAA prescription orders for patients referred to pharmacist-led DAA management was evaluated in comparison with usual care. Treatment completion and SVR results were assessed in patients referred to pharmacists. RESULTS: HCV screening in patients with identifiable risk factors increased from 8.0% to 67.5% over 4 years, driven by a clinical reminder for HCV screening in the birth year cohort. Of patients with positive HCV viral load results, 9.9% in the usual care group received an order for DAA therapy versus 57.1% (P < 0.001) in the pharmacist-led DAA management group. Of 162 patients referred to pharmacist-led DAA management, 61 (37.7%) initiated therapy. Of patients who initiated treatment, 57 (94.7%) had post-treatment viral load testing, with 46 (80.7% of treated patients) having SVR results and 45 (97.8% of SVR tested patients) testing negative. No usual care patients had subsequent negative HCV viral load results. CONCLUSION: Pharmacist-led DAA management is an effective intervention to improve the treatment of patients with HCV in the FQHC setting.

The effects of patient out-of-pocket costs for insulin on medication adherence and health care utilization in patients with commercial insurance; 2007-2018.

BACKGROUND: High out-of-pocket costs (OOPCs) for insulin can lead to cost-related nonadherence and poor outcomes, prompting payers to limit insulin OOPCs. However, data are scarce on whether insulin OOPCs at policy-relevant levels is associated with improved adherence and outcomes. OBJECTIVE: To identify associations between insulin OOPCs and insulin adherence, noninsulin antihyperglycemic (AHG) medication adherence, and diabetes-related emergency department (ED) visits and hospitalizations. METHODS: This retrospective cohort study was conducted using OptumLabs Data Warehouse, a longitudinal, real-world data asset with deidentified administrative claims and electronic health record data. Individuals with type 1 diabetes (T1D) or type 2 diabetes (T2D), insulin use on January 1 of a study year (index date: 2007-2018), continuous commercial health plan eligibility 12 months pre-index and post-index date, and at least 1 insulin claim during the 12-month follow-up period were included. Average insulin OOPCs per 30-day supply in the follow-up period was identified and categorized ($0, > $0-$20 [referent group], > $20-$35, > $35-$50, and > $50). The proportion of patients with a gap in insulin supply of 60 or more continuous days, AHG nonadherence per modified proportion of days covered less than 0.80, and a diabetes-related ED visit or hospitalization were identified and compared by insulin OOPC category vs more than $0 to $20 using pairwise chi-square tests and multivariable logistic regression. RESULTS: The study included 21,085 individuals with T1D and 72,512 with T2D. Patients with average OOPCs more than $50 were more likely to have a gap in insulin supply vs those with OOPCs more than $0 to $20, with an odds ratio (OR) of 1.14 (95% CI =1.05-1.24) and 1.38 (95% CI = 1.32-1.45) for T1D and T2D, respectively. Those with T2D and OOPCs more than $35 were also more likely to have a 60-day gap in insulin supply (OR 1.17; 95% CI = 1.11-1.23). Odds of having a diabetes-related hospitalization or ED visit did not increase with higher OOPCs; rather, associations tended to be inverse. Nonadherence to AHG medications in the T2D cohort was higher with insulin OOPCs more than $20 vs those more than $0-$20 (P < 0.05 for all). CONCLUSIONS: Individuals with T2D were more likely to have a 60-day gap in insulin supply when the OOPC was more than $35 per 30-day supply and with the OOPC more than $50 in those with T1D. These findings suggest that health plans can facilitate adherence to insulin therapy and possibly to noninsulin AHG medications by protecting patients with diabetes from experiencing high insulin OOPC. A study with a longer follow-up period is warranted to fully assess ED and hospitalization outcomes. DISCLOSURES: This study was funded by the Robert Wood Johnson Foundation, Health Data for Action Research Program. The study sponsor played no role in the design or conduct of this study. The views expressed here do not necessarily reflect the views of the Foundation.

Association of Health-Related Quality of Life with Overall Survival in Older Americans with Kidney Cancer: A Population-Based Cohort Study.

BACKGROUND: Our purpose was to evaluate associations between health-related quality of life (HRQoL) and overall survival (OS) in a population-based sample of kidney cancer (KC) patients in the US. METHODS: We analyzed a longitudinal cohort (n = 188) using the Surveillance, Epidemiology, and End Results (SEER) database linked with the Medicare Health Outcomes Survey (MHOS; 1998-2014). We included KC patients aged ≥65 years, with a completed MHOS during baseline (pre-diagnosis) and another during follow-up (post-diagnosis). We reported HRQoL as physical component summary (PCS) and mental component summary (MCS) scores and OS as number of months from diagnosis to death/end-of-follow-up. Findings were reported as adjusted hazard ratios (aHRs (95% CI)) from Cox Proportional Hazard models. RESULTS: The aHRs associated with a 3-point lower average (baseline and follow-up) or a 3-point within-patient decline (change) in HRQoL with OS were: (a) baseline: PCS (1.08 (1.01-1.16)) and MCS (1.09 (1.01-1.18)); (b) follow-up: PCS (1.21 (1.12-1.31)) and MCS (1.11 (1.04-1.19)); and (c) change: PCS (1.10 (1.02-1.18)) and MCS (1.02 (0.95-1.10)). CONCLUSIONS: Reduced HRQoL was associated with worse OS and this association was strongest for post-diagnosis PCS, followed by change in PCS and pre-diagnosis PCS. Findings highlight the prognostic value of HRQoL on OS, emphasize the importance of monitoring PCS in evaluating KC prognosis, and contribute additional evidence to support the implementation of patient-reported outcomes in clinical settings.

Short-term cost-effectiveness of oral semaglutide for the treatment of type 2 diabetes mellitus in the United States.

BACKGROUND: Oral semaglutide is the first orally administered glucagon-like peptide-1 receptor agonist (GLP-1RA) approved by the FDA. Clinical trials found that oral semaglutide 14 mg had a greater reduction in hemoglobin A1c (A1c) compared with empagliflozin 25 mg and sitagliptin 100 mg and was noninferior to liraglutide 1.8 mg. However, US cost-effectiveness data for oral semaglutide are limited and do not consider the costs of adverse events. OBJECTIVE: To assess the short-term cost-effectiveness of oral semaglutide compared with empagliflozin, sitagliptin, and liraglutide in patients with type 2 diabetes. METHODS: A decision analysis over a 52-week time horizon was used to evaluate the incremental cost-effectiveness of oral semaglutide vs empagliflozin, sitagliptin, and liraglutide from a US health care payer's perspective. Data on efficacy, adverse events, and discontinuation were derived from 52-week data from phase 3, head-to-head clinical trials (PIONEER 2, 3, and 4). Costs included drug and administration cost and treatment of gastrointestinal adverse events. Incremental cost-effectiveness ratios (ICERs) were calculated as the difference in cost over the difference in A1c reduction between oral semaglutide and comparators. RESULTS: In the base-case analysis, 52-week treatment costs with oral semaglutide were $2,660 and $3,104 higher and $2,337 less than empagliflozin, sitagliptin, and liraglutide, respectively. Incremental (greater) A1c reductions were seen with oral semaglutide at 0.40%, 0.50%, and 0.30% vs empagliflozin, sitagliptin, and liraglutide, respectively. ICERs per 1% reduction in A1c for oral semaglutide were $6,650 and $6,207 vs empagliflozin and sitagliptin, respectively. Oral semaglutide was dominant vs liraglutide (ICER of -$7,790). CONCLUSIONS: Oral semaglutide was dominant relative to liraglutide, offering a cost-saving GLP-1RA oral alternative. While there is not a recognized willingness-to-pay threshold for a 1% reduction in A1c, oral semaglutide may be cost-effective relative to empagliflozin and sitagliptin if a decision maker's willingness-to-pay threshold exceeds $6,650 and $6,207, respectively. DISCLOSURES: No outside funding supported this study. The authors have no conflicts of interest to declare.

A historical cohort study of glycemic control in patients with concurrent type 2 diabetes and substance use disorder treated in a primary care setting.

BACKGROUND: Substance use disorder (SUD) is a known barrier to patient-self-management, which can hinder efforts to achieve treatment goals in type 2 diabetes (T2D) when the conditions coexist. OBJECTIVE: Identify the association between SUD and glycemic control in patients with T2D treated in a primary care setting. METHODS: This retrospective cohort study included patients with T2D treated by providers at family medicine clinics at an academic medical center and its affiliated regional sites from January 2014 to October 2019. Study index date was the first A1c recorded when T2D and SUD diagnoses had both been documented in the medical record. Glycemic control, measured by hemoglobin A1c (A1c), was identified at baseline and over a 12-month follow-up period and was compared between SUD and non-SUD patients. RESULTS: Of 9568 included patients with T2D, 468 (4.9%) had a SUD diagnosis. In 237 SUD and 4334 non-SUD patients with A1c data, mean (SD) baseline A1c was 8.2% (2.5) and 7.9% (2.1), respectively (P = 0.043). A1c reduction was statistically greater in SUD patients than non-SUD patients (-0.31% versus -0.06%, respectively; P = 0.015), although the clinical significance is modest. In a multivariable linear regression analysis, follow-up A1c was lower in the SUD versus non-SUD patients (coefficient -0.184, 95% CI -0.358, -0.010; P = 0.038). CONCLUSIONS: Patients with T2D and SUD had higher baseline A1c but this difference was minimized over a 12-month follow-up period. Additional research is warranted to determine long-term glycemic control and barriers to attaining and maintaining glycemic control in patients with T2D and SUD.

Using projective exercises to identify patient perspectives of living with comorbid type 2 diabetes and asthma.

OBJECTIVE: Patient self-management of a single chronic condition can be challenging, but few studies have examined the emotional impact of living with comorbid conditions and how that differs from a single chronic condition. This study examined patient perspectives of the emotional impact of living with asthma or asthma with comorbid type 2 diabetes (asthma+diabetes). METHODS: Data were collected from 41 adults (asthma only n = 22, asthma+diabetes n = 19) using semi-structured interviews on two separate online bulletin boards. Respondents engaged in discussions that leveraged two projective exercises: describing their health condition(s) as an animal, and selecting one of eight images that best illustrated how they were living with and managing their health condition(s). RESULTS: Respondents described physical and emotional challenges related to managing asthma or asthma+diabetes. Animal- and image- projective exercises were categorized by response and health condition. Thematic analysis across both projective exercises identified four themes: (1) frustrations with dual diagnosis, (2) juggling the dual diagnosis, (3) anticipating the future, and (4) unpredictability. DISCUSSION: Projective exercises are one way to elicit feelings about living with chronic conditions. Healthcare providers can improve support for patients with more than one health condition by providing education on how to manage comorbid conditions.