Journal of managed care & specialty pharmacy最新文献

Background: Geographic atrophy (GA) is a form of advanced age-related macular degeneration (AMD) that can cause irreversible vision impairment and is responsible for approximately 20% of legal blindness in the United States. There is limited real-world evidence assessing health outcomes and health care resource use (HCRU) among individuals with GA.

Objective: To examine the progression from GA without subfoveal involvement (SFI) to GA with SFI, progression to irreversible blindness, and HCRU among older individuals with GA enrolled in Medicare Advantage Prescription Drug (MAPD) plans.

Methods: This retrospective study used claims data for MAPD-plan enrollees aged at least 65 years with an AMD diagnosis between 2018 and 2021. To assess progression of GA, development of blindness, and HCRU, propensity score matched cohorts of individuals with GA and without GA were identified and compared. For GA progression analysis, at least 12 months of follow-up was required, and patients were followed until the end of either follow-up or study period.

Results: Total 9,511 individuals with GA were matched 1:1 to individuals without GA. Among individuals with GA, initial diagnosis was primarily by an ophthalmologist (58.6%) followed by an optometrist (30.9%). The most common diagnostic imaging procedure at index was optical coherence tomography (53.0%). Mean follow-up time was 2.3 years. At index, 4,781 (50.3%) individuals had GA without SFI and 4,697 (49.4%) had GA with SFI. Among individuals with GA without SFI at index, 479 (10.2%) progressed to GA with SFI during the 12-month follow-up. Among individuals with GA without SFI at index, 173 (3.6%) developed irreversible blindness, compared to 312 (6.6%) of those with SFI, and 51 (0.5%) individuals without GA. Kaplan-Meier analysis indicated fastest progression to irreversible blindness among individuals with GA with SFI, followed by those without SFI (log-rank test P < 0.001). Both diagnosis of GA without SFI (hazard ratio [HR] [CI] = 6.77 [4.98-9.35], P < 0.001) and diagnosis of GA with SFI (HR [CI] = 12.59 [9.43-17.16], P < 0.001) were strongly associated with increased risk of developing irreversible blindness. Significant predictors of progression to GA with SFI were wet AMD at baseline (HR [CI] = 5.70 [4.63-6.99], P < 0.001), Elixhauser comorbidity score of 4-5 (HR [CI] = 1.46 [1.12-1.91], P = 0.006), and more than 5 (HR [CI] = 1.40 [1.02-1.89], P = 0.035).

Conclusions: GA with or without SFI was associated with progression to irreversible blindness in an MAPD-plan population. Patients with GA with SFI progressed to irreversible blindness faster than patients with GA without SFI. With the recent approval of GA treatments, future research is needed to assess the impacts on disease progression, including blindness.

Background: The introduction of cyclin-dependent kinases 4 and 6 inhibitors (CDK4/6is) has transformed the treatment landscape for patients with hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer (MBC). To our knowledge, no studies have quantified health care resource utilization (HRU) or economic burden following CDK4/6i initiation in the Medicare population.

Objective: To describe HRU and quantify health care costs among Medicare-enrolled patients with HR+ HER2- MBC treated with CDK4/6is in the first-line setting.

Methods: We conducted a retrospective cohort study on Medicare-enrolled patients with HR+ HER2- MBC who initiated a CDK4/6i in the first-line setting between February 2, 2016, and December 31, 2022, using claims from the Merative MarketScan database. We examined all-cause HRU by summarizing the number of inpatient (IP), outpatient (OP), and emergency department (ED) visits as well as the length of stay during the 6 months following CDK4/6i initiation. Additionally, we assessed all-cause health care costs, including IP, OP, ED, and pharmacy, over the 1 year following CDK4/6i initiation using the Kaplan-Meier sample average estimator to account for censoring. We reported total health care costs as the sum of IP, OP, ED, and pharmacy costs.

Results: 901 patients met the inclusion criteria with a mean age of 74 years (SD = 6.84). Nearly 24% (n = 214) had an IP admission in the 6 months following CDK4/6i initiation. Among patients with an IP admission, the mean number of admissions per patient was 1.65 (SD = 0.98) with a mean length of stay per admission of 5.98 (SD = 6.25) days. Roughly 30% (n = 271) of patients had an ED visit, with a mean of 2.1 (SD = 1.54) visits per patient among those who had a visit. Most patients (n = 868, 96.44%) had an OP service, and among those with an OP service, the mean number of days with OP services was 19.96 (SD = 12.29). Mean total health care costs over the 1-year period following CDK4/6is were $62,228 (95% CI = 52,281-73,029) per patient with the main drivers being OP services ($31,686 [95% CI = 27,168-36,925]) and pharmacy costs ($22,727 [95% CI = 19,273-25,931]).

Conclusions: There are numerous sources of HRU and cost in patients following CDK4/6i initiation in the Medicare population. Patients with HR+ HER2- MBC incur high HRU, providing insights for health care decision-makers to optimize treatment strategies and resource allocation for this population.

Background: Disparities in mental health care access and health outcomes based on sociodemographic factors in the United States have been extensively documented. However, there is limited knowledge regarding these socioeconomic factors with respect to initiation of esketamine nasal spray, a novel therapy for treatment-resistant depression (TRD).

Objective: To evaluate the association of socioeconomic factors with the initiation of esketamine nasal spray.

Methods: Adults with TRD and commercial or Medicare Advantage (MA) insurance (Commercial-MA cohort) were included from Optum's deidentified Clinformatics Data Mart Database (January 2016-June 2022) and adults with Medicaid insurance (Medicaid cohort) were included from Merative MarketScan Multi-State Medicaid Database (January 2016-June 2022). The baseline period spanned 12 months before the index date (latter of evidence of TRD or US esketamine approval date); follow-up period spanned the index date until the end of health plan eligibility/data availability. Multivariate Cox proportional hazard models were used, separately for each cohort, to evaluate the association of characteristics with time to esketamine initiation; patients who did not initiate esketamine were censored at the end of follow-up.

Results: In the Commercial-MA cohort, 201,937 patients were included (75.0% female, mean age 62.3 years, 80.9% White, 82.8% having less than a bachelor's degree, 60.3% with a household income less than $75,000). Having both an education of less than a bachelor's degree and a household income less than $75,000 reduced the chance of esketamine initiation by 37% (hazard ratio [HR] = 0.63, P < 0.001). In the Medicaid cohort, 51,206 patients were included (77.8% female, mean age 43.2 years, 78.6% White). In both cohorts, chances of initiation trended to be lower in females (Commercial-MA: HR = 0.63, P < 0.001; Medicaid: HR = 0.68, P = 0.088), whereas racial or ethnic minorities had similar chances of initiation to White patients (Commercial-MA: HR = 1.23, P = 0.104; Medicaid: HR = 0.79, P = 0.376).

Conclusions: Disparities in esketamine nasal spray initiation were observed based on education, income, and gender highlighting a potential health equity gap.

Background: Geographic atrophy (GA) is an advanced form of dry age-related macular degeneration (AMD) that can lead to visual impairment. Published studies estimate approximately 1 million people in the United States have GA in at least 1 eye. There is a lack of real-world evidence from the US payer perspective on the prevalence of AMD and GA among Medicare Advantage prescription drug (MAPD) plan enrollees.

Objective: To estimate the annual prevalence of GA, wet AMD, and co-occurring GA and wet AMD among MAPD plan enrollees from 2018 through 2021.

Methods: This retrospective, cross-sectional study estimated the prevalence of GA and AMD based on Medicare Advantage enrollee claims data. Individuals aged 65 years and older who had continuous enrollment throughout each calendar year constituted the denominator for each annual prevalence calculation. Enrollees with at least 1 medical claim with a diagnosis code for GA or wet AMD during each year were identified to estimate annual prevalence for that respective calendar year.

Results: The total number of patients in the denominator was 2,175,803 (2018); 2,445,163 (2019); 2,680,322 (2020); and 2,905,366 (2021). The annual prevalence of GA was 0.56% (2018), 0.55% (2019), 0.48% (2020), and 0.51% (2021). The annual prevalence of wet AMD was 1.2% (2018), 1.3% (2019), 1.2% (2020), and 1.3% (2021). The prevalence of GA was highest among individuals classified as White race (annual range 0.61% to 0.71%) and among patients with GA aged 75 years and older (range 0.95% to 1.11%). The proportion of patients with GA with co-occurring wet AMD was 25.6% to 28.0%. The annual prevalence of advanced AMD (GA or wet AMD) was 1.6% to 1.7%.

Conclusions: In the Medicare populations, the prevalence of GA was greatest among patients aged 75 years and older and individuals classified as White race. A substantial proportion of individuals with GA had evidence of co-occurring wet AMD. MAPD plans should evaluate how their membership may be impacted by the recently approved medications for the treatment of GA.

Objective: To examine the real-world impact of continuous glucose monitoring (CGM) use on glycemic management and health care resource utilization (HCRU) in people with diabetes in a large US-insured population.

Methods: This retrospective observational study used Aetna administrative claims data from a cohort of fully insured commercial and Medicare Advantage beneficiaries with diabetes and with coverage for medical and pharmacy benefits. The index date was the first CGM pharmacy or medical claim observed between January 1, 2019, and December 31, 2021. Change in hemoglobin A1c was calculated using values from 3 months before and the latest values 10-12 months after the index date. HCRU was measured 12 months before and after the index date. Data were analyzed by the following patient groups: type 1 diabetes, type 2 diabetes (T2D) on intensive insulin therapy, T2D on basal-only insulin therapy, and T2D not on insulin therapy.

Results: Data from 7,336 patients (74% T2D, mean age 57 years, 42% Medicare-insured, 54% male, 56% White) were analyzed. Beneficiaries with available A1c data (n = 1,063) showed a significant improvement in A1c after CGM initiation (-0.7%, P < 0.0001), including -0.9% change in the T2D not on insulin group (n = 264). For the overall cohort, the number of patients with diabetes-related hospitalizations and emergency department visits decreased significantly by 67% and 40%, respectively (P < 0.0001 for both).

Conclusions: This study showed that CGM use was associated with clinically meaningful improvements in A1c and reduced HCRU, suggesting potential for population-level clinical benefits, especially for patients not using insulin.