Journal of managed care & specialty pharmacy最新文献

Background: Although advancements in antiretroviral therapy (ART) have significantly improved outcomes for people with HIV (PWH), there remains a subset of PWH who are heavily treatment experienced (HTE) and at increased risk for poor outcomes, including AIDS-related complications and mortality.

Objective: To describe the clinical characteristics, treatment patterns, health care utilization, and costs associated with HTE among PWH.

Methods: Treatment-experienced PWH who had at least 2 ART lines of therapy (LOTs) between January 1, 2015, and December 31, 2022, were identified from the Veradigm Network electronic health record (EHR)-linked claims database. HTE PWH met at least 1 of 4 HTE-defining criteria based on ART indication and exposure, evidence of viremia, and/or ART resistance (index date = earliest criterion met). Patients were eligible for study inclusion if they were aged 18 years or older, had a prior HIV diagnosis, and had continuous claims enrollment and EHR activity for at least 6 months before and after the index date. A matched comparator group of treatment-experienced non-HTE PWH was also identified. Treatment patterns were measured for HTE PWH in a variable follow-up period lasting until the end of continuous enrollment or December 31, 2022. HIV-related clinical measures in the 6-month follow-up, and health care resource utilization and costs in the variable-length follow-up, were measured for both HTE PWH and non-HTE PWH.

Results: Among the 19,221 HTE PWH identified in the Veradigm dataset, 2,507 met all remaining study criteria. On average, HTE PWH were aged 50.6 years and predominantly male (63.3%), Black (43.6%), and insured through Medicaid (56.7%). Over a mean 3 years of follow-up, more than 50% of HTE PWH had ART on hand for at least 75% of the follow-up period (median percentage of days = 75.4%); however, treatment modifications were common, as 58.1% had at least 3 LOTs during follow-up. Although the majority of HTE PWH avoided gaps in ART, 26.5% to 32.5% of people in each LOT experienced a gap in ART of at least 45 days. Mean (SD) annualized all-cause and HIV-related health care costs for HTE PWH vs non-HTE PWH were $69,529 ($156,077) vs $51,726 ($89,179) (P < 0.001) and $40,082 ($91,703) vs $30,717 ($66,926) (P < 0.001), respectively. Pharmacy costs and outpatient costs were the largest factors contributing to increased costs for HTE PWH.

Conclusions: HTE PWH experienced frequent changes to their ART regimens, and they had higher disease burden, health care utilization, and health care costs compared with PWH who do not meet the criteria of HTE, suggesting an unmet need in this population.

Background: In 2016, the Safe & Effective Management of Pain (SEMP) organization created guidelines regarding how to safely and effectively ensure patients were being treated with opioids. Two insurance companies in West Virginia used the SEMP guidelines to create a prior authorization (PA) form. This form requires extensive information about the patient to be submitted and then reviewed, including those with cancer or being treated with palliative intent.

Objective: To evaluate the potential delay in accessing opioid prescriptions for patients with cancer or in palliative care who are required to use a specific PA form.

Methods: This retrospective chart review used pharmacy claims for opioid prescriptions that were prescribed from the Edwards Cancer Institute and filled at Marshall Pharmacy beginning on January 1, 2022, to June 30, 2024. Prescriptions were stratified into 2 groups, those who had an approved claim by an SEMP-PA adherent insurance and those who were approved by another insurance that may or may not have required a different PA (non-SEMP). Turnaround time was evaluated from the moment the prescription was entered into Marshall Pharmacy's software to the moment it was ready to be dispensed to the patient.

Results: A total of 62 (45%) prescriptions were in the SEMP-PA group, and 77 (55%) did not require an SEMP-PA. The mean average turnaround time for the SEMP-PA group was 32.9 (SD = 67.6) hours and in the non-SEMP group was 6.23 (SD = 18.3) hours. The difference in turnaround time between both groups is 26.7 hours (P = 0.0012; 95% CI = 10.7-42.5).

Conclusions: The SEMP-PA, after completion and approval, was associated with a significant increase in turnaround time for patients with cancer or for those being treated with palliative intent.

Critical evidence for the evaluation and implementation of managed care strategies relies on researchers examining the health outcomes and costs associated with various pharmacological and nonpharmacological treatments and interventions. These studies usually leverage secondary data sources, such as administrative claims or electronic health records, and it is customary for researchers to design studies that explicitly exclude study participants that may be lost to follow-up. These exclusion criteria can be commonly referred to as continuous enrollment requirements and are ubiquitous in health outcomes research because such criteria are straightforward to implement and justify. However, requiring study participants to be continuously enrolled after the start of follow-up may lead to time-related biases, which can lead to lack of validity in study results. This article illustrates a type of time-related bias known as immortal time bias and explains how requirements for continuous enrollment during follow-up can contribute to this and other time-related biases. We examine the reasons individuals are usually lost to follow-up-death, insurance termination, or switching of insurance-and consider the various mechanisms by which these events can bias study estimates. We then delineate various considerations for evaluating the impact of attrition on various studies and conclude with a brief discussion of methods for avoiding time-related biases. We discuss recommendations for researchers to report useful attrition tables, reevaluate their study designs, and take steps to limit susceptibility to time-related biases. Additionally, resources for redesigning studies vulnerable to bias are presented along with some analytical strategies.

The price of a prescription drug can be difficult to determine in the United States. Pricing benchmarks are reference points used to determine acquisition costs as drugs are physically moved through the supply chain, to reimburse pharmacies, to calculate rebates, and to determine patient payments. Public health insurance programs, including Medicare and Medicaid, leverage different pricing benchmarks to pay for drugs for their beneficiaries, and the same drug can vary in price by program. The goal of this primer is to explain the most commonly used drug pricing benchmarks and their current contexts for use.

Background: The use of cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6is) in treating hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer (MBC) have been shown to be effective in prolonging progression-free survival with manageable safety profiles. However, the impact of CDK4/6is on health-related quality of life (HRQoL) is unclear.

Objective: To comprehensively assess the association of CDK4/6is with HRQoL outcomes in patients with MBC.

Methods: We searched PubMed, Embase, and ClinicalTrials.gov to identify relevant randomized controlled trials (RCTs) of CDK4/6is on HRQoL outcomes in MBC. The CDK4/6is included in this study were palbociclib, ribociclib, and abemaciclib. Heterogeneity among studies was evaluated via the I² statistic.

Results: Of the 18 included RCTs, HRQoL outcomes were most widely measured with the general European Organization for Research and Treatment of Cancer QoL Questionnaire Core 30 (EORTC QLQ-C30) (72%) and the EuroQol-5 Dimension (EQ-5D) (39%). There were no statistically significant differences between CDK4/6is and non-CDK4/6is in the EORTC QLQ-C30 global health status and EQ-5D index scores. Although CDK4/6is were associated with statistically significant worse outcomes in appetite loss, diarrhea, systemic side effects, and upset by hair loss, only the mean difference values for EORTC QLQ-C30 diarrhea of 8.56 (95% CI = 1.05-16.06; P = 0.03; I² = 98%) and EORTC breast cancer-specific upset by hair loss of 10.24 (95% CI = 8.88-11.59; P < 0.00001; I² = 0%) were greater than the published minimum clinically important difference values (EORTC QLQ-C30 diarrhea = 6; EORTC breast cancer-specific upset by hair loss=5).

Conclusions: Treatment with CDK4/6is was not generally associated with worsening HRQoL among patients with MBC, except for the symptom-related, patient-reported measures of diarrhea and upset by hair loss. Understanding HRQoL impacts can help support health care decisions and treatment using CDK4/6is for patients with MBC.

Background: Glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications are efficacious in improving health outcomes in patients with type 2 diabetes mellitus (T2DM). As demand and costs have increased, questions have arisen around socioeconomic and geographic differences in adherence.

Objective: To understand these differences, pharmacy claims data were used to examine medication fills across urban and rural areas and Census tract-level income and racial make-up.

Methods: Data obtained from the Wisconsin Health Information Organization database included adults (aged ≥18 years) diagnosed with T2DM, with a prescription fill for a GLP-1 RA medication between January 1, 2020, and September 30, 2022. Adherence was defined as proportion of prescription days covered of 80% or greater for 1 year from first fill. Unadjusted and adjusted logistic regression was performed. Adherence was compared across urban and rural residence and Census tract-level median household income quintiles and race (majority Black residents vs nonmajority, majority Hispanic residents vs nonmajority, and majority White residents vs nonmajority). Adjusted models included age, sex, insurance provider, and number of comorbidities.

Results: Patients (N = 7,265) were 56.3% female with a mean age of 55.3 (SD = 12.1) years. Place-based variables showed 38.2% lived in rural areas, 5.8% lived in areas with majority Black population, 2.0% with majority Hispanic population, and 87.9% with majority White population. Overall, 40.1% of patients were adherent 1 year following first prescription fill. Adjusted models showed that patients in tracts with the lowest incomes had lower odds of adherence compared with those living in the highest income tracts (odds ratio [OR] = 0.76; 95% CI = 0.59-0.98). Patients in areas with majority Black residents had lower odds of adherence (OR = 0.67; 95% CI = 0.52-0.85) than areas with less than a majority of Black residents, whereas patients living in areas with majority White residents had higher odds of adherence (OR = 1.31; 95% CI = 1.11-1.56) than areas with less than a majority of White residents.

Conclusions: This analysis highlights geographic differences in medication adherence in patients with T2DM. Patients living in high-income areas and areas with higher percentages of White residents had higher odds of adherence to GLP-1 RA medications. As demand for GLP-1 RA medications grow, future work that identifies reasons for disparities in adherence and potential strategies to improve adherence is critical.

Background: Chimeric antigen receptor T-cell (CAR T) therapies have transformed the management of relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Receiving CAR T infusion in the hospital may be limited by constrained capacity of hospitals. Emerging data have demonstrated the safety and feasibility of outpatient CAR T administration. There are limited real-world data on economic outcomes for inpatient and outpatient CAR T administration among patients with DLBCL.

Objective: To describe all-cause health care resource utilization (HRU) and costs of patients with DLBCL receiving CAR T infusion in the outpatient setting relative to those infused in the inpatient setting within a commercially insured population within the United States.

Methods: A retrospective cohort study was conducted leveraging IQVIA PharMetrics Plus Health Plans Claims database between January 2017 and March 2024. Patients with DLBCL who received a CAR T infusion were identified and indexed on the date of the earliest CAR T infusion observed. Patients with clinical trial participation or invalid CAR T cost data (30-day post-index all-cause or CAR T-related costs of <$250,000) were excluded. All-cause HRU and costs (including CAR T product costs) within 30 days following the index CAR T infusion were described, stratified by the index infusion setting of care. Subgroup analyses were performed for patients receiving axicabtagene ciloleucel (axi-cel).

Results: There were 508 patients receiving CAR T infusion and meeting all selection criteria. 442 patients had CAR T administered in the inpatient setting, and 66 had it in the outpatient setting. Axi-cel was the most observed DLBCL-specific CAR T product (n = 223), and 10.3% received it in the outpatient setting (n = 23). Within 30 days following CAR T infusion, 48.5% of the outpatient cohort and 60.9% of patients receiving axi-cel in the outpatient setting had an inpatient stay, with lower rates of intensive care unit admissions (overall: 18.2% vs 43.9%; axi-cel: 39.1% vs 43.5%) and shorter median inpatient stays (overall: 9.0 vs 15.0 days; axi-cel: 11.0 vs 15.0 days) than the inpatient cohort. The mean total 30-day costs appeared lower in the outpatient cohort, overall ($643,902 vs $691,771) and for axi-cel ($695,904 vs $741,449).

Conclusions: DLBCL CAR T products were administered predominantly in the inpatient setting. For overall CAR T products for DLBCL and axi-cel, patients receiving CAR T administration in the outpatient setting tended to have lower inpatient service utilizations and lower costs relative to those receiving it in the inpatient setting, suggesting that outpatient CAR T administration may help address capacity constraint and economic burden of CAR T delivery.

Background: The phase 3 PERSEUS trial demonstrated superior efficacy of daratumumab (D), bortezomib (V), lenalidomide (R), and dexamethasone (d) induction/consolidation followed by DR maintenance (DVRd/DR) vs VRd induction/consolidation followed by R maintenance (VRd/R) in transplant-eligible patients with newly diagnosed multiple myeloma.

Objective: To assess the economic value associated with achieving and sustaining minimal residual disease (MRD)-negative status with DVRd/DR vs VRd/R.

Methods: A model of cost per patient with MRD-negative status was developed from a US mixed-payer perspective (60% Medicare, 40% commercial) using PERSEUS trial data. Model inputs included costs for first-line (1L) and second-line (2L) treatment, autologous stem cell transplant, medical care, adverse event management, and MRD testing. Outcomes included the cost per MRD-negative patient, calculated using the cost per treated patient and cumulative proportion of patients achieving MRD-negative status at 48 months after randomization, and cost per patient sustaining MRD negativity for at least 12 months during maintenance, calculated using maintenance treatment costs and the proportion of patients who converted from MRD-positive at the end of consolidation to achieving sustained MRD-negative status during maintenance. Costs were reported in 2025 US dollars.

Results: At 48 months, the total cost per patient with MRD-negative status was lower with DVRd/DR compared with VRd/R ($519,999 less). Key drivers of these cost savings included the lower maintenance treatment costs per MRD-negative patient ($106,707 less) and the lower 2L treatment costs per MRD-negative patient ($434,184 less) with DVRd/DR compared with VRd/R. The lower maintenance treatment costs with DVRd/DR were attributable to the higher proportion of patients achieving MRD-negative status. The lower 2L treatment costs with DVRd/DR were attributable to the lower proportion of patients initiating 2L (9.4%) compared with VRd/R (26.8%). Among patients who were MRD-positive at the end of consolidation, the cost per patient achieving sustained MRD-negative status was lower with DVRd/DR vs VRd/R, resulting in savings of $961,880. This was primarily attributable to a higher proportion of patients achieving sustained MRD-negative status with DVRd/DR (44.2%) than with VRd/R (22.6%) during the maintenance phase.

Conclusions: The cost per MRD-negative patient and the cost per patient achieving sustained MRD negativity during maintenance were lower with DVRd/DR compared with VRd/R. These findings demonstrate the cost savings associated with the use of DVRd induction/consolidation followed by DR maintenance for transplant-eligible patients with newly diagnosed multiple myeloma, supplementing the superior efficacy benefits relative to VRd induction/consolidation demonstrated in the PERSEUS trial.