Journal of managed care & specialty pharmacy最新文献

Background: Trastuzumab is an antihuman epidermal growth factor receptor 2 monoclonal antibody used to treat breast and other cancers. Trastuzumab biosimilars were approved in the United States beginning in 2017. Utilization information on these biosimilars is limited.

Objective: To examine utilization patterns and characteristics of patients treated with trastuzumab (biosimilars and reference) and other human epidermal growth factor receptor 2 products.

Methods: We evaluated health care claims data from the Biologics and Biosimilars Collective Intelligence Consortium distributed research network, representing a large, geographically diverse US population of commercially insured individuals. We queried 4 distributed research network health plan partners to capture product usage data and patient information from October 1, 2016, to October 31, 2022. Patients were required to be continuously enrolled in their health plan for at least 365 days before their first observed trastuzumab utilization date in this study period. Data were aggregated across data partners.

Results: More than 16 million eligible health plan members representing more than 31 million person-years of data were evaluated. We identified 5,984 incident treatment episodes; 3,878 (64.8%) episodes were with the reference trastuzumab. The mean ages were consistent across trastuzumab products (60.2 to 65.1 years) and at least 80% of the episodes were among female patients. The mean comorbidity index score was 1.2 (SD = 1.9) among users of the reference vs the biosimilars (range 1.2-2.5). Other clinical characteristics (eg, diabetes, hypertension) were comparable across products. The proportion of total incident episodes of the reference trastuzumab decreased substantially over time (96% in 2016 vs 28% in 2021) as utilization of the biosimilars increased (eg, use of trastuzumab-anns increased from 2% [2019] to 36% [2021]). Similar utilization trends were seen among patients with and without metastatic breast cancer.

Conclusions: Trastuzumab biosimilars utilization has grown since their introduction to the US market. Exploration of these biosimilars' comparative effectiveness and safety to their reference product is warranted.

Background: Because of concerns of cost-effectiveness and low utilization, in 2018, manufacturers initiated a 60% price reduction for PCSK9 inhibitors, reducing the list price from more than $14,000 to $5,850. The goal of the reduction was to increase access and lower patient cost sharing for PCSK9 inhibitors.

Objective: To determine whether list price reductions resulted in a statistically significant decrease in patient cost sharing for PCSK9 inhibitors. The secondary objective is to quantify the change in monthly out-of-pocket (OOP) cost in the years following the price reduction policies.

Methods: This analysis uses a cross-sectional quasi-experimental design, with 2 time periods, to estimate the change in monthly OOP cost. A 2-stage cost model was used to quantify the difference in mean monthly OOP cost between the preprice and postprice reduction periods. This analysis was completed using IQVIA PharMetrics Plus for Academics health plan claims for PSCK9 inhibitors between January 2016 and December 2021 for commercially insured individuals in the United States. The primary exposure of interest is a manufacturer-initiated list price reduction in October 2018. The primary outcome of interest is the difference in the predicted monthly OOP cost between the prereduction and postreduction periods.

Results: There was a 50% decrease in the predicted monthly OOP cost, from $235.22 (SD = $241) in the prereduction period to $116.75 (SD = $152) in the postreduction period.

Conclusions: This claims level analysis used robust statistical modeling techniques to quantify the effect of manufacturer-initiated price reductions on monthly OOP cost. This unique manufacturer decision resulted in a statistically significant decrease in the monthly OOP cost for beneficiaries using PCSK9 inhibitors. Manufacturer-initiated price reductions could be a strategy to reduce the cost for other therapies with access and cost concerns. Further research is needed on the downstream patient-level effects of cost reductions, particularly among individuals who experience multiple barriers to care.

Background: A tubeless, disposable insulin pump (Omnipod DASH Insulin Management System, Insulet Corporation) has demonstrated improved glycemic outcomes for people with diabetes who require insulin. The impact of the system on downstream health care events has not been studied.

Objective: To assess health care resource utilization for a Medicare population before and after starting tubeless, disposable insulin pump therapy.

Methods: This retrospective, observational analysis used data from the Centers for Medicare & Medicaid Services 100% Research Identifiable Files. Study outcomes included change in event rates for diabetes-related emergency department (DRED) visits, all-cause emergency department (ACED) visits, diabetes-related inpatient (DRIP) admissions, and all-cause inpatient (ACIP) admissions among Medicare beneficiaries who started the tubeless, disposable insulin pump in 2020 (postpump observation period) as compared with the same duration and calendar period in 2019 (prepump observation period) with no pump use. Subgroup analyses were performed based on Medicare entitlement reason, diabetes type, and diagnosis status for depressive disorder.

Results: A total of 811 users met the criteria for analysis: 46.2% had type 2 diabetes, a majority (59.2%) were aged 65 years or older, and 37.0% had a diagnosis for depressive disorder. Significant reductions were observed for DRED of -46.9% (95% CI = -63% to -23%); ACED of -29.0% (95% CI = -37% to -20%); ACIP of -19.9% (95% CI = -32% to -6%). DRIP rates declined notably (-36.6%; 95% CI = -61% to 4%). Event rates observed across subgroups demonstrated consistent downward trends; however, not all were statistically significant.

Conclusions: These findings demonstrate that use of the tubeless, disposable insulin pump was associated with reductions in DRED, ACED, and ACIP. Our results provide real-world evidence to support the use of the tubeless, disposable insulin pump among Medicare beneficiaries who require insulin, regardless of diabetes type or Medicare entitlement reason. Additional studies are recommended to further evaluate the effect of insulin pumps on health care utilization among the Medicare population and other insurance populations.

Value-based diabetes care is a proactive approach to providing quality care to individuals with diabetes. This approach focuses on improving clinical outcomes rather than the volume of services provided. Implementation of value-based diabetes care requires an established set of standardized quality measures against which all stakeholders can assess and benchmark their performance. The National Committee for Quality Assurance recently added the Glucose Management Indicator to its Healthcare Effectiveness Data and Information Set. The Glucose Management Indicator can be used as a measure of glucose control. This article discusses the benefits of value-based care, the importance of diabetes quality measures, and how the rapidly increasing adoption of continuous glucose monitoring is impacting these measures while improving the lives of individuals with diabetes.

Background: With the rising costs for knee arthroplasty, therapies that allow patients to avoid or delay surgery following knee osteoarthritis (KOA) may help in reducing overall health care costs. Multiple intraarticular hyaluronic acid (HA) products are available on the market, varying by formulation, molecular weight, and number of injections, but clinical and economic benefits may differ by product. OBJECTIVES: To evaluate the all-cause and KOA-related health care resource utilization (HCRU) and costs among newly diagnosed patients with KOA treated with multi-injection HA.

Methods: A retrospective cohort study using a large commercial claims database (Merative MarketScan database) to identify patients with KOA treated with high molecular weight (HMW) (n = 11,200), medium molecular weight (MMW) (n = 10,225), or low molecular weight (LMW) HAs (n = 8,473) between 2016 and 2019. KOA-related and all-cause HCRU and costs were compared within 12 months after the index HA treatment date. The association between outcomes and HA treatments was evaluated using a doubly robust method to adjust for confounding factors. HCRU and costs among the propensity score-weighted HA groups were compared using generalized linear models.

Results: HMW HA patients were found to have lower adjusted KOA-related medical costs by $265.37 (P < 0.001) and pharmacy costs by $19.90 (P < 0.001) compared with LMW HA patients, as well as lower all-cause total medical costs by $130.42 (P = 0.013) and pharmacy costs by $63.33 (P < 0.001). HMW HA patients also had a lower adjusted KOA-related medical cost by $205.74 (P < 0.001) and pharmacy cost by $14.39 (P < 0.001) compared with MMW HA patients, as well as lower all-cause medical by $1,195.66 (P < 0.001) and pharmacy by $196.99 (P < 0.001). Three-injection treatment patients (HMW HA, 84%; MMW HA, 82%) had high completion rate, compared with the 5-injection treatment cohort (LMW HA, 48%).

Conclusions: HMW HA patients had statistically significantly lower adjusted all-cause and KOA-related medical and pharmacy costs at 1 year follow-up compared with MMW HA and LMW HA patients. It is unclear if this is related to differences in molecular weight or specific mechanism of actions.

Numerous studies have demonstrated that use of continuous glucose monitoring (CGM) significantly improves overall glycemic control and reduces the frequency and severity of hypoglycemic events in individuals treated with intensive insulin, nonintensive insulin, and noninsulin therapies, with reductions in both all-cause and diabetes-related health care resource utilization and lower costs. However, implementation of CGM including prescribing and assessment of the ambulatory glucose profile to make clinical decisions in primary care settings is low. A recent pilot program was initiated at MetroHealth System (Cleveland, Ohio) to implement a CGM integration program for primary care offices throughout the system. Based on the experience and successes from this health system as well as current literature, rationale will be discussed to support the expansion of CGM to individuals enrolled in all Medicaid programs.

Biologic therapies play a critical role in modern medical practice but also present challenges for payers, patients, and other stakeholders because of their high cost. Biosimilars can mitigate the cost pressures of reference biologic therapy because they are typically priced at least 25% lower, providing a means to administer cutting-edge biologic therapy while also managing cost of care. In fact, the US health care system has saved an estimated $23.6 billion from use of biosimilars. However, the market is still in a nascent phase of development, and early cost-saving successes are not guaranteed to persist unless sustainable market conditions are established. To better understand the perspectives of stakeholders about opportunities and threats to the sustainability of the US biosimilar market, a multistakeholder roundtable discussion was convened in December of 2023 and included health care payers, providers, self-insured employers, a manufacturer, and a biosimilar research and advocacy organization. The objective of this commentary, authored by the roundtable participants, is to posit specific opportunities and threats that stakeholders should consider to better facilitate sustainable biosimilar market conditions in the United States. We highlight key points, including (1) biosimilar price volatility with large quarter-on-quarter declines for most products; (2) perverse economic incentives that encourage providers to use more expensive reference products because reimbursement dynamics make them more profitable; (3) complex rebate structures that create barriers to biosimilar access; and (4) ongoing changes to the legal and regulatory environment, including evidence requirements to gain "interchangeable" status. We conclude with an overview of potential policy solutions to address the sustainability opportunities and threats. The authors welcome the opportunity to advance this dialogue toward action and encourage additional stakeholders to join the effort. We are optimistic that, through informed decision-making and compromise, we can collectively achieve a robust and sustainable US biosimilars market that appropriately benefits all stakeholders.