Journal of managed care & specialty pharmacy最新文献

Background: Bipolar I disorder (BP-I) is a chronic and recurrent mental health disorder, broadly characterized by patients who alternate between the extremes of the mood spectrum: mania or hypomania; and depression. In 2015, the total estimated annual cost of BP-I in the United States reached more than $200 billion, approximately 2.5 times higher than the general population, largely driven by the increased use of acute health care services. Long-acting injectable antipsychotics such as aripiprazole were developed to significantly reduce patient burden for treatment adherence compared with oral formulations, to allow consistent dosing and improved outcomes. Previous real-world evidence studies have shown the benefits of starting aripiprazole once-monthly injection (AOM) at an early stage in patients diagnosed with schizophrenia; however, the effect of early initiation in the BP-I population remains unknown.

Objective: To evaluate the impact of initiating AOM 400 mg (AOM 400) in adults at an early stage (<180 days) following a diagnosis of BP-I compared with late initiation (>365 days) in a real-world setting, via a retrospective analysis using claims data from the MarketScan Medicaid database.

Methods: Study outcomes included the numbers of emergency department, hospitalization, outpatient, and pharmacy visits, together with the associated costs over a 1-year time horizon. A generalized linear model was used to compare the annualized costs associated with early, intermediate, and late initiators of treatment, using late initiators as the main reference group.

Results: Among 866 patients diagnosed with BP-I (median age, 36 years), 161 early initiators had significantly lower risks of emergency department visits (incidence rate ratio = 0.76; 95% CI, 0.61-0.94) and outpatient pharmacy visits (incidence rate ratio = 0.82; 95% CI, 0.73-0.93) compared with 591 late initiators. Early initiators also incurred lower pharmacy visit costs ($18,787 vs $23,503; P = 0.03) and lower medical costs ($13,898 vs $18,277; P = 0.01). Overall, early initiators incurred much lower total health care costs than late initiators during the follow-up ($31,086 vs $40,599, respectively; P < 0.001). Early initiators also incurred significantly lower total health care costs than intermediate initiators ($31,086 vs $40,892; P = 0.01).

Conclusions: This real-world study demonstrates that early initiation of AOM 400 among patients living with BP-I may offer a significant advantage of lower health care resource utilization and associated costs when compared with late initiation.

Background: The Medicare Part D Medication Therapy Management (MTM) program uses comprehensive medication reviews (CMRs) and targeted medication reviews to address medication-related problems in older adults. One such problem is central nervous system (CNS)-active polypharmacy, which is associated with impaired cognition and falls in older adults. To date, little is known about the prevalence of CNS-active polypharmacy among MTM enrollees and how they might differ from MTM enrollees without CNS-active polypharmacy; such insights would be helpful to MTM programs developing interventions to reduce CNS-active polypharmacy.

Objective: To (1) estimate the prevalence of MTM enrollees with CNS-active polypharmacy in a nationwide cohort and (2) compare patient characteristics and MTM service use of MTM enrollees with CNS-active polypharmacy vs without.

Methods: Cross-sectional, observational study of 2019-2021 Medicare 5% fee-for-service data linked to 2020-2021 MTM data. Patient characteristics and MTM use were compared between MTM enrollees with and without CNS-active polypharmacy.

Results: Among 38,733 MTM enrollees in 2021, 4,144 (10.7%) experienced CNS-active polypharmacy. Compared with those without CNS-active polypharmacy, the CNS-active polypharmacy cohort was more likely to be male (72% vs 55%, standardized mean difference [SMD] = 34.7%), be dually enrolled in Medicaid (42% vs 24%, SMD = 41.1%), and have greater comorbidity burden (Charlson Comorbidity Score of 6.0 vs 5.0, SMD = 13.2%). The CNS-active polypharmacy cohort also had more prior-year health care utilization, such as being more likely to have an inpatient stay (37.5% vs 29.0%, SMD = 18.1%) or emergency department visit (53.7% vs 43.0%, SMD = 21.6%), as well as number of outpatient visits (7.0 vs 5.0, SMD = 20.8%) and number of unique prescription drugs (21.0 vs 15.0, SMD = 91.9%). The number of targeted medication reviews received was greater in the CNS-active polypharmacy cohort, but a lower proportion (35% vs 39%) participated in a CMR.

Conclusions: More than 1 in 10 MTM enrollees experience CNS-active polypharmacy, which is higher than the general Medicare fee-for-service beneficiary population. MTM enrollees with CNS-active polypharmacy are more likely to be male, dually enrolled in Medicaid, and with greater comorbidity burden and prior-year use of health care and medications, suggesting that interventions for this population may need to account for additional clinical and socioeconomic needs. Despite being at greater risk of adverse drug events including impaired cognition and falls, just over one-third of MTM enrollees with CNS-active polypharmacy participate in a CMR, suggesting opportunity for more targeted outreach and intervention by MTM programs, Part D plan sponsors, and Centers for Medicare & Medicaid Services.

Background: Sickle cell disease (SCD) is one of the most common chronic blood diseases found among individuals of African heritage. Hydroxyurea (HU) has remained the mainstay pharmacological therapy for SCD, given its disease-modifying effects. Still, its use is limited by a lack of adherence, particularly among adolescents and young adults. Telemedicine has been beneficial in addressing patient nonadherence to chronic conditions but underexplored in the SCD population.

Objective: To assess the impact of telehealth-based interventions on HU adherence and clinical outcomes in patients with SCD.

Methods: We conducted a comprehensive literature search from January 2014 to March 2025 across PubMed, Web of Science, PsycINFO, and Embase. The included studies were randomized controlled trials and quasi-experimental studies assessing the effect of telemedicine intervention on SCD and clinical outcomes. A random effects model was used to conduct the meta-analysis in R Statistical Software, version 4.4.2.

Results: Five studies (n = 353 participants) met the inclusion criteria: 1 cluster randomized controlled trial and 4 quasi-experimental designs. The pooled effect of telehealth for HU adherence (standardized mean difference, 0.91; 95% CI, 0.62-1.20) with moderate heterogeneity (17.8%) was observed alongside increased mean corpuscular volume and fetal hemoglobin in some studies.

Conclusions: Telehealth programs improved HU adherence in the SCD population. However, findings should be interpreted cautiously, given the small number of studies and reliance on quasi-experimental studies. Prospective investigations to evaluate the effect of these telehealth interventions on the diverse SCD genotypes are needed to individualize and optimize strategies to improve HU adherence.

Trial registration: PROSPERO International Prospective Register of Systematic Reviews CRD420251037623.

Background: Trastuzumab-based regimens are the historical standard first-line (1L) treatments for HER2+ advanced gastric/gastroesophageal junction (GEJ) adenocarcinoma. With pembrolizumab recently approved in combination with trastuzumab and chemotherapy as 1L treatment for patients with a programmed death-ligand 1 combined positive score of 1 or higher, establishing real-world benchmarks for patients' real-world outcomes from the preimmunotherapy era is essential.

Objective: To assess the real-world treatment patterns and the clinical and economic impact of 1L trastuzumab-based regimens among patients with HER2+ advanced gastric/GEJ adenocarcinoma.

Methods: This retrospective study used the Surveillance, Epidemiology, and End Results-Medicare linked database (January 1, 2011, to December 31, 2019) to identify patients with HER2+ advanced gastric/GEJ adenocarcinoma who initiated a 1L trastuzumab-containing regimen (index date). Outcomes during follow-up (from index to death/data end) included health care resource utilization (HCRU), health care costs (2022 US dollars), 1L to 3L treatments, real-world overall survival (rwOS), and real-world time to next treatment or death (rwTNTD). All-cause and cancer-related HCRU and costs were assessed during preprogression, postprogression, and terminal care periods. rwOS and rwTNTD were assessed in the overall cohort and in subgroups by 1L therapy.

Results: Among 315 included patients (mean age 73.9 ± 5.9 years; 77.1% male; 84.1% stage IV at initial diagnosis; 58.7% gastric adenocarcinoma), the most common 1L regimen was trastuzumab + chemotherapy doublet (57.8%), with the mean time to 1L initiation being 2.2 ± 3.3 months. Nearly half (49.5%) received 2L and, among them, 46.8% proceeded to 3L. Cancer-related inpatient admissions occurred among 52.9%, 64.2%, and 46.6% of patients during the preprogression, postprogression, and terminal care periods, with mean lengths of stay of 1.1, 1.1, and 3.9 days/person-month, respectively. The mean monthly all-cause total health care costs were $12,356, $13,545, and $19,085 during the above periods, respectively. In the overall cohort, median rwOS and rwTNTD were 15.3 (95% CI = 13.2-16.9) and 8.3 (6.7- 8.9) months, respectively, which varied across subgroups by 1L regimen. The trastuzumab + chemo-monotherapy subgroup was older (mean age 78 years) with median rwOS of 12.0 (95% CI = 8.3-14.9) months.

Conclusions: Prior to the advent of immuno-oncology agents for HER2+ advanced gastric/GEJ adenocarcinoma (2011-2019), the economic burden was substantial throughout patients' treatment journey, whereas OS ranged from 12.0 to 15.3 months. During this period, trastuzumab with chemo-monotherapy backbones was often used in older patients. These real-world benchmarks offer valuable context for evaluating the impact of newer therapies in this population.

Background: Many dermatologic medications are available as expensive combination products, though their lower-cost, generic components are available. Underutilization of these cheaper replacements is common and influenced by several factors, including prescriber's knowledge and disease severity.

Objective: To characterize differences in prescribing patterns for high- vs lower-cost dermatologic agents for acne between dermatologists and primary care physicians (PCPs).

Methods: Using an administrative insurance claims database, IQVIA PharMetrics Plus for Academics, we identified medication claims between January 01, 2017, and June 30, 2022. Inclusion criteria were claims for high-cost medications and lower-cost alternatives for patients diagnosed with acne. We excluded patients without continuous insurance enrollment for the previous year. Data collected included patient, prescriber, and prescription characteristics. Distribution of costs to payers and patients were compared using the Wilcoxon rank sum test.

Results: We identified 7,843 patients with medication claims meeting inclusion and exclusion criteria. High- vs low-cost acne medications cost insurers a median $480.6 (IQR: 377.2-535.2) vs $81.8 (IQR: 30.3-162.3), respectively, whereas patient burden was $60.0 (IQR: 40.0-182.4) vs $15.0 (IQR: 10.0-35.4). Dermatologists prescribed the largest number of acne medications, 7,648 of 9,791 (78.1%), and a higher proportion of high-cost medications (7.8% vs 1.3% for PCPs, P < 0.001). Median insurer cost was lower among dermatologists ($86.9, IQR: 33.6-184.5) than PCPs ($87.3, IQR: 87.3, P = 0.008), but means were higher (mean ± SD: $144.3 ± 169.9 vs $119.5 ± 126.9, respectively). Median patient cost was higher for dermatologists ($20.0, IQR: 10.0-40.0) than PCPs ($15.0, IQR: 10.0-25.0, P < 0.001). The mean costs were similarly higher (mean ± SD: $49.8 ± 105.6 vs $34.0 ± 60.9, respectively).

Conclusions: Dermatologists prescribed a higher percentage of high-cost medications for acne. These differences resulted in a slightly higher distribution of costs to the patient but lower for the insurer, as median is a better indicator of the cost distribution. System processes to identify high-cost combination medications and provide low-cost alternatives may further reduce costs.

Background: US payers are interested in incorporating real-world evidence (RWE) into their pharmaceutical coverage and reimbursement decisions. One barrier to using RWE to inform decisions is the lack of standards for RWE assessment and interpretation specific to US payer needs.

Objective: To develop RWE standards supporting US payer decision-making through a framework outlining study types and potential endpoints important to US payers throughout a product's life cycle and a set of criteria, tailored to US payer needs, for assessing and applying RWE.

Methods: The Academy of Managed Care Pharmacy (AMCP) Research Institute, in partnership with IQVIA, convened a multistakeholder group of RWE experts to complete a survey and participate in a series of workshops with the goal of developing RWE standards tailored to payer decision-making needs. Informed by a targeted literature search, we created an initial list of RWE assessment criteria relevant to payers and refined by consensus and a framework describing RWE appropriate to different product life cycle stages from pre- to postapproval.

Results: A total of 36 payers completed the survey, and few (18%) reported regularly using RWE as part of their decision process; however, most (80%) were interested in using it. There was consensus on the need for a set of payer-specific standards. Through 2 focus groups and an AMCP Partnership Forum, participants vetted, refined, and finalized this payer-specific framework and developed a checklist that comprised a total of 29 RWE assessment criteria across 6 categories. This framework and set of criteria became the final AMCP RWE standards.

Conclusions: The AMCP RWE standards provide a tool to facilitate payer-specific assessments of RWE and guidance for designing RWE studies and communicating results that will be most impactful for payer formulary and coverage decisions.