Journal of managed care & specialty pharmacy最新文献

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.

Background: Non-small cell lung cancer (NSCLC) presents a formidable global health challenge owing to significant morbidity, high mortality rates, and substantial economic burden. Recent advances in targeted therapies and immunotherapies have transformed NSCLC treatment, but efficacy varies across patients. Tailoring treatment to patients can improve outcomes and potentially improve cost-effectiveness (ie, value for money) as well. For NSCLC, cost-effectiveness must often be estimated using economic modeling, and estimates are only as good as the models. Existing cost-effectiveness models are not necessarily suitable for evaluating personalized medicines.

Objective: To identify and assess cost-effectiveness models of NSCLC.

Methods: We searched for studies indexed in PubMed and Embase from 2012 to October 2023 that described cost-effectiveness models of NSCLC. Study details were extracted, summarized, and evaluated for adherence to the Consolidated Health Economic Evaluation Reporting Standards.

Results: We identified 237 unique models, 40% of which were published in 2022 or 2023. Despite cross-model heterogeneity, most models used the same 3 health states (progression-free survival, progressive disease, and death) combined with time-to-event equations that characterize risks. Thirty models included a diagnostic component, most of which considered guiding treatment selection using biomarkers. Adherence to the overall Consolidated Health Economic Evaluation Reporting Standards checklist was generally incomplete, and adherence to a subset of model-related questions even more so.

Conclusions: The large number of models that were found, almost half of which were published since 2022, underscores the importance of cost-effectiveness analysis in NSCLC. Variable adherence to best practices suggests opportunities for improvement, however, and making high-quality, open-source models available to researchers may be valuable.

Background: Heart failure is a prevalent disease state associated with limitations in function, hospitalization, and death. The 2022 American Heart Association/American College of Cardiology/Heart Failure Society of America guidelines recommend medications including sacubitril/valsartan to decrease morbidity and mortality in patients with heart failure. However, if patients are nonadherent to treatment or experience barriers to care, they will forgo these benefits.

Objective: To assess the pharmacy staff compliance rate to a workflow protocol for sacubitril/valsartan prescriptions received by Cleveland Clinic Home Delivery (HD) and Adherence Pharmacy (AP) and determine the nonclinical benefits experienced by the patients enrolled in the protocol.

Methods: At Cleveland Clinic, there are 2 mail-order pharmacies: HD and AP. Both pharmacies offer a variety of benefits and adherence services, with each pharmacy having their own unique services offered. With numerous adherence services provided by both pharmacies, it is likely that patients with heart failure would see clinical and nonclinical benefits, such as cost savings. This project created a triage protocol for patients deemed to experience the most benefit from services offered through AP. The primary endpoint of this project was determining the feasibility of a medication-specific workflow protocol for sacubitril/valsartan prescriptions at HD and AP.

Results: There were 114 qualifying prescriptions per the protocol, and 98 of those prescriptions were appropriately screened by the pharmacy staff, equating to an 86% compliance rate for the primary outcome. Of the 98 patients included in the workflow protocol, prior authorization was completed by pharmacy staff for 41 patients (41.8%), manufacturer copay card was applied for 13 patients (13.3%), 17 patients (17.3%) were enrolled in grant funding programs, and patient assistance program enrollment was initiated for 9 patients (9.2%).

Conclusions: Medication-specific workflows may be a feasible option to implement for pharmacies to ensure the offering of adherence services to patients with high-risk disease states using treatment with expensive, branded medications.