Journal of managed care & specialty pharmacy最新文献

Background: The benefits of urate-lowering therapies (ULTs) for the long-term management of gout are well established. However, suboptimal adherence remains a significant challenge, resulting in increased gout flares and higher health care utilization. The proportion of days covered (PDC) is commonly used to assess adherence but provides only a single value that fails to distinguish among individuals with differing and dynamic adherence patterns over time. Understanding fluctuations in adherence and their associated characteristics can inform interventions aimed at improving adherence.

Objective: To identify distinct trajectories of ULT adherence in a commercially insured population and determine the sociodemographic and clinical factors associated with each trajectory.

Methods: This retrospective cohort study used a 25% random sample from the IQVIA PharMetrics Plus database and included a commercially insured population who had a first index ULT prescription between 2017 and 2020, had at least 1 inpatient or 2 outpatient visits on different dates for gout in the year prior to the index ULT, and maintained continuous medical and prescription coverage for 1 year before and after the index ULT. A group-based trajectory model identified distinct adherence patterns and a multinomial logistic regression identified factors that were associated with adherence trajectory group membership.

Results: A total of 9,404 beneficiaries in the analytic sample were categorized into 4 ULT adherence trajectory groups: early decline (PDC = 0 by month 6, 14.97%), high-then-low (PDC = 0 by month 10, 7.95%), intermediate (PDC 0.4-0.6, 16.57%), and continuously high (PDC ≥ 0.8, 60.51%). In general, groups showing intermediate or declining adherence were more likely to be younger than 46 years, be female, reside outside the Eastern United States, have conditions such as peripheral vascular disease or dementia, and be prescribed medications for gout flares in the baseline period compared with the continuously high adherence group. These adherence groups were also less likely to have documented cardiometabolic comorbidities or other arthritic conditions relative to the continuously high adherence group.

Conclusions: Nearly 40% of beneficiaries were nonadherent to ULTs during the 1-year follow-up period. Adherence trajectory groups have unique characteristics that could help to target interventions and improve patient care.

Background: Psoriatic arthritis (PsA) is a chronic, immune-mediated inflammatory arthropathy presenting with multiple manifestations, including peripheral arthritis, enthesitis, and skin psoriasis (PSO). Immunosuppressive/immunomodulatory therapies, including biologic/targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARD), are common effective treatments for PsA; however, discontinuation is reported and contributing factors remain unclear.

Objective: To describe the probability of persistence and time to discontinuation (including switch) of b/tsDMARD therapy in both b/tsDMARD-naive and -experienced patients with PsA within 12 months following initiation of a new b/tsDMARD. Secondary objectives included (1) describing the factors associated with b/tsDMARD persistence or nonpersistence and (2) assessing maintenance dose changes among patients with PsA initiating the anti-IL17A agents secukinumab (SEC) or ixekizumab (IXE). SEC and IXE were of particular focus owing to the variability in their dosage recommendation guidelines at the time of this study.

Methods: This observational cohort study used Merative MarketScan data and included patients initiating a new prescription of b/tsDMARD treatment for PsA, with a diagnosis of PsA between January 1, 2017, and June 30, 2021. The primary outcome was persistence, defined as days of b/tsDMARD therapy use from index date to 12 months of continuous index treatment, or first occurrence of b/tsDMARD discontinuation/switch. Associations between patient characteristics and outcomes were explored using Cox regressions, with descriptive dose analyses exploring proportions of patients with specific starting/maintenance b/tsDMARD doses.

Results: 7,037 adult patients with PsA were included: 26.7% with PsA only and 73.3% with PsA+PSO at baseline. The 12-month probability for persistence of b/tsDMARD treatment was 51.2% (95% CI, 49.5%-52.9%), with an 8.3-month mean length of persistence. Treatment persistence probability at 12 months was 52.7% (50.8%-57.7%) for patients with PsA+PSO and 47.0% (43.7%-50.3%) for patients with PsA only. Treatment persistence probability at 12 months was 51.4% (49.6%-53.2%) for the b/tsDMARD-naive subgroup and 49.8% (45.5%-54.1%) for the b/tsDMARD-experienced group. Female sex and a baseline codiagnosis of fatigue were associated with an increased probability of nonpersistence, whereas codiagnosis of PSO was associated with decreased probability of nonpersistence. In the dosing analysis, of the patients initiating SEC therapy included in the analysis, 60.4% were prescribed a starting maintenance dose of 300 mg every 4 weeks (Q4W) and 34.1% were prescribed a starting maintenance dose of 150 mg Q4W. Of patients initiating IXE therapy included in the analysis, 84.4% were prescribed an 80-mg Q4W starting maintenance dose and 10.4% were prescribed a 160-mg Q4W starting maintenance dose.

Background: Ustekinumab, approved for the treatment of moderate to severe Crohn disease (CD) and ulcerative colitis (UC), requires a clinic-administered intravenous (IV) induction infusion (loading dose) followed by transition to self-administered, subcutaneous (SC) injection for maintenance every 8 weeks. Many patients need subsequent dose escalations to obtain or maintain effectiveness. As an increasing number of CD and UC therapies require a similar dosing and escalation strategy, research evaluating care coordination requirements and clinical outcomes for patients prescribed ustekinumab can help guide best practices.

Objective: To describe the care coordination process and response to therapy from decision to treat with ustekinumab through the first 12 months of initiating SC injection and evaluate differences in SC shipment timing between patients filling at a health-system specialty pharmacy (HSSP) compared with a non-HSSP.

Methods: A single-center, retrospective cohort study was conducted. Patients prescribed ustekinumab for CD or UC between November 1, 2021, and March 31, 2022, were included. Patients were excluded if they never received an infusion or SC dose, received the SC dose at an infusion center, or became lost to follow-up. Outcomes included time between clinical events (decision to treat to IV infusion, prior authorization [PA] submission, PA approval, and SC shipment), the occurrence of SC shipments between 4 and 8 weeks after infusion (most appropriate time frame to prevent waste), and the occurrence of a dose escalation within the first 12 months of therapy. The occurrence of SC shipments within the 4- to 8-week window were analyzed using a multiple logistic regression with the following covariates: age, insurance type, and filling pharmacy type.

Results: In the 70 included patients, the median age was 36 (IQR, 28-44) years. Most patients had commercial insurance (79%), and approximately half filled SC doses external to the HSSP (53%). Median time between events was as follows: decision to treat to PA submission: 3 days (IQR, 1-8); decision to treat to PA approval: 6 days (IQR, 3-14); decision to treat to infusion date: 20 days (IQR, 13-25); and PA approval to medication shipment: 49 days (IQR, 34-73). In the 70 SC doses shipped, 64% (n = 45) occurred within the 4- to 8-week window. Prescriptions filled with the HSSP had 2.5 times higher odds of being shipped in the appropriate window compared with non-HSSP prescriptions (95% CI, 0.8-7.8; P = 0.126). Thirty-nine patients (56%) had dose escalations.

Conclusions: Ustekinumab initiation and escalation within the first year can be a complex process requiring a high level of care coordination to ensure patients receive timely therapy while reducing potential waste.

Background: Heart failure with preserved ejection fraction (HFpEF) represents half of all HF diagnoses and is a growing public health concern. Despite therapeutic advancements, HFpEF contributes to substantial health care resource utilization (HCRU) and costs. Characterizing these measures and identifying potential associations in HFpEF is needed.

Objective: To characterize the HCRU and costs among the bottom 10th and top 90th percentiles of total health care cost, examine associations of belonging to the 90th percentile, and analyze trends over time.

Methods: We conducted a retrospective cohort study using the Merative MarketScan database to examine commercially insured adults diagnosed with HFpEF from 2014 to 2021. HCRU and costs were estimated using a Cox proportional hazards model and Kaplan-Meier sample average techniques, bootstrapping was applied to generate credible intervals. Predictors of high HCRU were identified using a multivariable logistic regression model.

Results: We had 24,071 eligible participants. The HCRU among the 90th percentile possessed an annual incremental average of 13 emergency department/urgent care visits, 3 inpatient admissions, and 30 days in the hospital. Total health care costs of the 90th percentile were $378,880 higher on average than the 10th percentile. Both cohorts experienced the highest HCRU and costs the first month after diagnosis. Credible intervals of total costs from bootstrapping overlapped from 2014 to 2021. Baseline characteristics associated with the 90th percentile included female sex (odds ratio [OR] = 1.13; 95% CI = 1.1-1.2), a Charlson comorbidity index (CCI) score of 2 (OR = 3.28; 95% CI = 3.0-3.6), and a CCI score greater than 2 (OR = 18.81; 95% CI = 16.9-20.9). Comorbidities associated with the 90th percentile included atrial fibrillation (OR = 3.51; 95% CI = 2.8-4.4), loop diuretics (OR = 2.18; 95% CI = 2.0-2.4), angiotensin receptor-neprilysin inhibitor (OR = 1.89; 95% CI = 1.1-3.2), and sodium-glucose cotransporter-2 inhibitors (OR = 4.48; 95% CI = 3.0-6.7). Comorbidities associated with the 10th percentile included diabetes (OR = 0.53; 95% CI = 0.4-0.7), hypertension (OR = 0.71; 95% CI = 0.6-0.8), and chronic kidney disease (OR = 0.63; 95% CI = 0.4-0.9). Interactions indicating multiple comorbidities were significant.

Conclusions: Significant differences in HCRU exist between high- and low-cost patients with HFpEF. However, both groups experienced their highest utilization the first month after diagnosis. Total costs remained consistent from 2014 to 2022. Strategies to reduce the risk of HFpEF onset are essential for lowering health care expenditures. Future research is needed to examine the impact of access to newer therapies.

Background: Mild cognitive impairment (MCI) is a transitional stage before Alzheimer disease and related dementias (ADRD). The link between AD and increased health care resource utilization (HCRU) and costs is well established but not the economic burden of MCI.

Objective: To estimate the incremental economic burden of individuals with MCI in the United States.

Methods: This was a retrospective cohort study that derived data from the MarketScan Commercial and Medicare Supplemental Databases. The observation period was from January 1, 2014, through December 31, 2019. Included individuals were (1) aged at least 50 years, (2) had at least 2 years of pre-index (ie, date of their first MCI diagnosis) continuous health plan enrollment, and (3) had at least 1 year of post-index continuous health plan enrollment. Individuals were excluded if they had (1) at least 1 claim with a diagnosis of Parkinson disease at any time during the study period, (2) at least 1 claim with a diagnosis of ADRD at any time before the index date, or (3) at least 1 pharmacy claim for an ADRD medication (donepezil, memantine, memantine/donepezil, galantamine, or rivastigmine) at any time before the index date. Outcomes included all-cause HCRU and health care costs for incident MCI individuals (MCI cohort) and matched individuals without MCI or dementia (control cohort) during the 12-month follow-up period. Controls were matched at a 3:1 ratio by age, sex, region, and index year.

Results: In total, 5,185 individuals met the criteria for the MCI cohort and 15,555 for the control cohort. Mean age at baseline was 67 years and 57.7% were female in both cohorts. The MCI cohort had a higher comorbidity burden compared with the control cohort (1.5 vs 1.0 and 2.6 vs 1.8, respectively; P < 0.0001) All comorbidities assessed at baseline were more prevalent in the MCI cohort than in the control. Adjusted all-cause HCRU for all points of service and adjusted all-cause mean costs in total ($32,318 vs $13,894; mean ratio [MR] = 2.33, 95% CI = 2.23-2.43), for emergency department ($4,460 vs $3,849; MR = 1.16, 95% CI = 1.08-1.25), outpatient ($16,054 vs $7,265; MR = 2.21, 95% CI = 2.12-2.30), and pharmacy ($5,503 vs $2,933; MR = 1.88, 95% CI = 1.78-1.97) (all P < 0.0001) were significantly higher for the MCI cohort.

Conclusions: The economic burden of MCI was more than double that for similar individuals without MCI or dementia. Timely diagnosis and intervention are key to delaying progression to AD and reducing associated costs.

Multiple sclerosis (MS) is an immune-mediated disease of the central nervous system (CNS) and is associated with significant clinical and economic burden. Advancements in the understanding of the underlying biology of MS have important implications for both diagnosis and treatment. To discuss the impact of continuing developments in MS on managed care, AMCP Market Insights virtually convened an expert panel of managed care stakeholders in December 2024. Key insights from the discussion related to supporting patient needs in MS, advancing understanding of MS, emerging treatments in MS, using real-world evidence in MS coverage decision-making, and addressing continued challenges in MS. Suggested payer best practices in MS also emerged from the discussion.

Background: For individuals living with type 2 diabetes (T2D) requiring insulin therapy, the use of real-time continuous glucose monitoring (rt-CGM) yields significant clinical benefits relative to self-monitoring of blood glucose (SMBG).

Objective: To determine the cost-utility of rt-CGM vs SMBG in a US setting, for a simulated cohort of individuals with T2D receiving insulin therapy.

Methods: The IQVIA CORE Diabetes Model version 10 was employed for this analysis, which was conducted over a remaining lifetime horizon. Clinical effectiveness data were sourced from a large-scale, retrospective cohort study set in the United States. Direct medical costs were obtained from a range of published studies for the Medicare setting and by using relevant Healthcare Common Procedure Coding System codes for Medicare. A willingness- to-pay (WTP) threshold of $50,000 per quality-adjusted life-year (QALY) was used, with future effects and costs discounted at 3% per annum. The base case was conducted from a Medicare perspective. One-way and probabilistic sensitivity analyses were performed.

Results: From a Medicare perspective, the use of rt-CGM yielded mean total direct medical costs of $107,215, alongside 7.584 QALYs over a time horizon of 50 years. Comparatively, SMBG was associated with lower mean total direct medical costs of $100,116 while yielding only 6.818 QALYs. The final incremental cost-utility ratio was $9,265 per QALY gained, showing that at a WTP threshold of $50,000 per QALY gained, rt-CGM was cost-effective relative to SMBG. Results from the 1-way sensitivity analysis showed rt-CGM to be dominant when a commercial plan perspective was adopted and more cost-effective for 100% Black, Native American, and Hispanic cohorts when compared with a 100% White cohort.

Conclusions: In a simulated cohort representative of individuals living with T2D and receiving insulin therapy, rt-CGM may be cost-effective compared with SMBG from a Medicare perspective. Therefore, rt-CGM plausibly possesses the potential to address existing racial and ethnic disparities in diabetes-related outcomes for patients within the United States.

Background: Acute leukemias (ALs), including acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL), are heterogeneous diseases characterized by different phenotypic, genetic, and molecular alterations that can guide treatment decisions. ALs harboring lysine methyltransferase 2A gene translocation (KMT2t), previously known as mixed-lineage leukemia, are associated with high rates of relapsed or refractory (R/R) disease. Revumenib, a first-in-class oral menin inhibitor, has shown improved clinical outcomes in patients with R/R KMT2At ALs.

Objective: To estimate, using a budget impact model (BIM), the financial impact of introducing revumenib for the treatment of adult patients with R/R KMT2At ALs on the formulary of a hypothetical US 1-million-member commercial health plan.

Methods: The BIM compared scenarios with or without revumenib and the resulting impact on commercial US third-party payers over a 3-year time horizon. Although no other therapies specifically targeted for R/R KMT2At ALs were approved during BIM development, 11 additional pharmacotherapies for R/R ALs (5 for AML and 6 for ALL, not including revumenib) were included as treatment options in the model. Clinical data included adverse event (AE) rates, duration of treatment, time to subsequent treatment, and survival outcomes. Cost inputs (USD 2024) included in the model comprised drug acquisition and administration, grade 3 or greater AEs, treatment-related supportive care and monitoring, subsequent treatment, and end-of-life costs. The differential cost per member per month (PMPM) was estimated. One-way sensitivity analyses varying the costs of drug acquisition and toxicity by ±20% and scenario analyses varying uptake of revumenib and epidemiology inputs, as well as excluding costs related to supportive care and posttreatment discontinuation, were performed.

Results: An estimated 1.7 adult patients (AML, 1.1; ALL, 0.6) were treatment eligible annually. Estimated 3-year total plan costs without and with revumenib were $2,146,564 and $2,126,919, respectively, for savings of -$19,646. Including revumenib was estimated to yield a differential PMPM cost of -$0.0005 over 3 years. The total number of grade 3 or greater AEs was lower over 3 years (10.82 vs 10.99, respectively) in the plan with revumenib vs without. Sensitivity and scenario analyses validated the robustness of the model.

Conclusions: The BIM demonstrated that including revumenib in a formulary for adult patients with R/R KMT2At ALs was approximately cost neutral, offering patients access to a targeted treatment with potential for improved clinical outcomes.

This article commemorates the 30th anniversary of the Journal of Managed Care & Specialty Pharmacy (JMCP), reflecting on its evolution to a central voice in managed care pharmacy. Launched in 1995, JMCP has chronicled the profession's growth while shaping the national conversation around value, access, and outcomes. The journal's early content addressed educational gaps and shared practical insights from the field, developing over time to feature rigorous health economics and outcomes research studies. JMCP and its authors played a pivotal role in elevating real-world evidence, as well as guiding stakeholders through transformative policy shifts like Medicare Part D and the Inflation Reduction Act. Over the years, JMCP has delved into complex topics such as management of high-cost drugs, value assessment, equity, and access. Acknowledging its most influential contributors and publications, this article illustrates how JMCP has remained a dynamic forum for scholarly dialogue. With an enduring legacy of connecting researchers, practitioners, and policymakers, JMCP remains poised to guide managed care pharmacy through future challenges in pursuit of improved patient health through evidence-based decision-making.

Background: Glucagon-like peptide-1 receptor agonists (GLP-1 RA) or sodium-glucose cotransporter-2 inhibitors (SGLT2i) are recommended as first-line therapy for glycemic management for adults with type 2 diabetes and specific comorbidities. It is unknown whether there are meaningful differences in how GLP-1 RA vs SGLT2i therapy may affect health care resource utilization and medical costs.

Objective: To compare health care resource utilization and costs in adults with type 2 diabetes newly initiating GLP-1 RA vs SGLT2i therapy.

Methods: We used the Humana Healthcare Research database and a retrospective cohort study design to identify patients with type 2 diabetes, enrolled in a Medicare Advantage Prescription Drug plan from January 1, 2018, to June 30, 2022. Eligible patients had at least 2 pharmacy claims for a GLP-1 RA or SGLT2i drug and had at least 12 months of continuous enrollment prior to and after the first prescription claim. Propensity score matching adjusted for population differences between GLP-1 RA and SGLT2i groups. Subgroup analyses included patients with baseline atherosclerotic cardiovascular disease and obesity. Main outcomes included inpatient stays, emergency department visits, and all-cause health care costs in the 12-month follow-up period.

Results: The 1:1 matched cohort consisted of 22,167 individuals each treated with SGLT2i or GLP-1 RA, had a mean age of 68.2 years, and was 52.2% female, 73.4% White, and 18.6% Black. There were no significant differences in all-cause or diabetes-related inpatient stays or emergency department visits between GLP-1 RA and SGLT2i users for overall and subgroup analyses. Compared with SGLT2i patients, those on GLP-1 RA had 3.1% (95% CI = 0.9%-5.3%) higher medical costs in the overall cohort but 2.9% (95% CI = -5.5% to -0.2%) lower medical costs in the obesity subgroup. Pharmacy costs for patients on GLP-1 RA were 6% to 9% higher for overall and subgroup analyses, resulting in 4% to 6% higher total health care costs for GLP-1 RA users relative to SGLT2i users.

Conclusions: There were no significant differences in health care resource utilization in the overall cohort between patients taking GLP-1 RA vs those taking SGLT2i, and pharmacy and total health care costs were higher in the GLP-1 RA group. In the obesity subgroup, GLP-1 RA initiators had lower medical costs.