American Health and Drug Benefits最新文献

Background: The treatment of rheumatoid arthritis is based on the use of disease-modifying antirheumatic drugs (DMARDs). Tocilizumab can be used as monotherapy or in combination with conventional synthetic DMARDs for the treatment of moderate-to-severe active rheumatoid arthritis. Subcutaneous (SC) and intravenous forms of the drug are available, but the SC form is more widely used.

Objective: To understand the real-world dose modification patterns of SC tocilizumab in the treatment of patients with rheumatoid arthritis in the United States.

Methods: Data were obtained from the Truven (now IBM) MarketScan and Optum Clinformatics databases. Patients were included if they had ≥1 pharmacy claims for SC tocilizumab and met other inclusion criteria. The mean, standard deviation, and median values were reported for the continuous variables, and frequency was reported for the categorical variables. Kaplan-Meier analysis was used to analyze the time to first dose modification. Logistic regression modeling was used to identify predictors of the likelihood of dose modification.

Results: The study included 1266 patients in the Truven database and 512 patients in the Optum database who had commercial or Medicare Advantage or supplemental insurance. Of the patients who started treatment with biweekly SC tocilizumab (48% each in the Truven and Optum databases), 37% in Truven and 40% in Optum had dose escalation to a weekly dose. Of those who started weekly SC tocilizumab (43% in the Truven and 49% in the Optum databases), 3% (Truven) and 4% (Optum) had dose reduction. The remaining patients started alternative SC tocilizumab doses. Overall, 60% and 68% of patients in the Truven and Optum cohorts, respectively, initiated or escalated to the higher weekly dose of tocilizumab; the mean time to dose escalation was 126 days and 112 days, respectively. In the Truven cohort, corticosteroid use, age, and anemia were the main predictors for dose escalation. In the Optum cohort, female patients had increased odds of dose escalation compared with male patients.

Conclusion: The dosing trends observed in this study show that physicians have taken advantage of the option to increase SC tocilizumab dosing, but only a few providers chose to reduce the dose. This trend in dose modification may increase the costs related to SC tocilizumab therapy.

Background: In therapeutic areas with uncertainty regarding clinical outcomes that are dependent on high-cost specialty medications, outcomes-based contracts can be a tool to reduce financial risk for payers and for drug manufacturers. With a high treatment cost, large number of therapy choices, and variability of responses to therapy across patients, multiple sclerosis is a compelling therapeutic area to support outcomes-based contracts.

Objective: To identify the necessary conditions to support the widespread adoption of outcomes-based contracts for high-cost drug therapy, with a focus on disease-modifying therapies for multiple sclerosis.

Methods: We conducted a series of in-depth, semi-structured phone interviews during fall 2018 with 17 healthcare stakeholders representing payers, manufacturers, and industry consultants, all of whom had some involvement in outcomes-based contract development or evaluation. The qualitative data management program from QSR International, N-VIVO 11, was used to store, organize, categorize, analyze, and produce visualization tools to explore, map ideas, and understand themes from the data.

Results: Overall, payers and manufacturers agreed that outcomes-based contracts are an effective vehicle to mitigate financial risk and deliver value for disease-modifying therapies for multiple sclerosis, but they noted that the widespread adoption of outcomes-based contracts was tempered by 5 broad categories of challenges, including data-related issues, outcome measurement and confounding factors, regulatory barriers, levels of risk mitigation, and patient adherence. The majority of participants were receptive to using blood-based clinical biomarkers as outcomes-based contract end points, as long as the biomarkers are validated, accurately predict clinical outcomes, are well-established in the therapeutic area, and are readily accessible to various stakeholders.

Conclusion: Our findings indicate there is general support from payers and drug manufacturers to adopt outcomes-based contracts for disease-modifying therapies for multiple sclerosis. However, some conditions need to be met to allow their widespread adoption, including resolving data issues, ensuring patient adherence to therapy, having a level of risk mitigation that is significant for both parties to make the endeavor economically worthwhile, and fostering a supportive regulatory environment. Blood-based clinical biomarkers that meet certain criteria could be viable end points in outcomes-based contract for disease-modifying therapies for multiple sclerosis and can address many of the necessary conditions regarding data issues, including timeliness.

Background: Hyperkalemia, defined as a serum potassium level >5 mEq/L that results from multiple mechanisms, is a serious medical condition that can lead to life-threatening arrhythmias and sudden cardiac death. The coexistence of cardiac and renal diseases (ie, cardiorenal syndrome) significantly increases the complexity of care, but its economic impact is not well-characterized in this understudied Medicaid managed care population with hyperkalemia.

Objective: To calculate the economic impact of hyperkalemia on patients with cardiorenal syndrome in a Medicaid managed care population in the United States using real-world data.

Methods: In this retrospective cohort study, we used a proprietary Medicaid managed care database from 1 southern state. The total study population included 3563 patients, including 973 patients with hyperkalemia and 2590 controls (without hyperkalemia), who were matched based on age, comorbidities, and Medicaid eligibility status and duration, during a 30-month period between 2013 and 2016. The inclusion criteria for the hyperkalemia cohort were age ≥18 years, Medicaid-only insurance status, coded cardiorenal diagnosis, and a claim for hyperkalemia during the study period. The cost was determined using paid claims data.

Results: The mean healthcare costs (medical and pharmacy per member per year [PMPY] for patients with hyperkalemia was higher than that for the control cohort without hyperkalemia ($56,002 vs $23,653, respectively). These cost differences were driven by medical costs accrued in the hyperkalemia and in the control cohorts ($49,648 and $18,399 PMPY, respectively). Two of the largest drivers of the medical cost variance were inpatient costs ($33,116 vs $10,629 PMPY for the hyperkalemia and control cohorts, respectively) and dialysis costs ($2716 vs $810 PMPY, respectively). The medical loss ratios were 552% for the hyperkalemia cohort and 260% for the control cohort. Both cohorts had revenue deficits to the health plan, but the hyperkalemia cohort had double the medical loss ratio compared with the control cohort.

Conclusions: The findings from this Medicaid managed care population suggest that hyperkalemia increases healthcare utilization and costs, which were primarily driven by the costs associated with inpatient care and dialysis. Our findings demonstrate that the Medicaid beneficiaries who have cardiorenal comorbidities accrue high costs to the Medicaid health plan, and these costs are even higher if a hyperkalemia diagnosis is present. The very high medical loss ratio for the hyperkalemia cohort in our analysis indicates that enhanced monitoring and management of patients with hyperkalemia should be considered.

Background: Imatinib, a first-generation tyrosine kinase inhibitor (TKI), and the newer second-generation TKIs have dramatically improved outcomes for patients with chronic myelogenous leukemia (CML). A previous model estimated the potential cost-savings over the next 2 years after the loss of patent exclusivity for imatinib in the United States in 2016 and its availability in a generic form. Payers have indeed realized meaningful savings, but it took 2 years for the prices of generic imatinib to decline substantially.

Objective: To quantify the cost-savings for a US health plan from the passive substitution of generic imatinib and the impact of step-edit therapy with the use of generic imatinib before coverage of a second-generation TKI.

Methods: We updated the previously published model utilizing hypothetical 1-million-member commercial and Medicare plans to include current TKI use and pricing combined with recent epidemiologic data. Regression models were used to project utilization to 5 years after the loss of imatinib's patent exclusivity. We compared generic imatinib costs with a scenario in which generic imatinib was not available. The impact of a step-edit therapy restriction was explored for patients with incident CML. The analyses were repeated for the entire US population based on national census data.

Results: The 1-million-member commercial plan saved $0.5 million (3%) from pharmacy spending on TKIs in year 1 and $3.9 million (19%) in year 2 after the loss of patent exclusivity. The projected savings significantly increased to $7.8 million (37%), $8.3 million (39%), and $8.6 million (40%) in years 3, 4, and 5, respectively. Step-edits strategies were projected to result in small incremental savings of $0.3 million (1.5%) annually in years 3 to 5. The 1-million-member Medicare plan saved $1.7 million (3%) in year 1 and $14.1 million (19%) in year 2. The projected savings were $27.8 million (37%), $29.5 million (39%), and $30.8 million (40%), with step-edit estimated to add only $0.9 million (1.2%) annually in years 3 to 5. Generic imatinib saved US payers $2.5 billion (13% of the total spending on TKIs) in years 1 and 2. In years 3 to 5, the cumulative projected savings totaled $12.2 billion, and the savings were expected to grow to 39% as a result of passive generic imatinib substitution, with only 1.7% additional savings from step-edit restriction.

Conclusions: As a result of a lower price for generic imatinib relative to the brand-name version of the drug, substantial cost-savings to US payers over the next 3 years are expected without step-edit formulary management restrictions. Cost-saving strategies, including formulary management restrictions, should adhere to evidence-based guidelines to ensure the appropriate use of generic imatinib and all available TKIs, with the objective to maintain positive outcomes and, in tur

Background: The increasing prevalence of chronic disease states, such as hypertension and dyslipidemia, in the United States has placed a growing economic burden on the nation's healthcare system, and incentives for cost reductions have been used by various private health insurers.

Objective: To analyze the clinical outcomes of pharmacy department-managed, employer-sponsored wellness programs for dyslipidemia and hypertension in a 2-hospital health system.

Methods: Using a retrospective chart review, we evaluated outcomes of employees and their spouses who were enrolled in our dyslipidemia and hypertension Wellpath programs between November 2015 and April 2017. Employees or their spouses were referred to these programs, which were coordinated by the pharmacy department. Enrollees completed in-person appointments and telephone interviews with a pharmacist or an advanced practice nurse, who provided evidence-based lifestyle and pharmacologic recommendations. The primary outcomes were lipid changes in the dyslipidemia program, and changes in systolic or diastolic blood pressure in the hypertension program. The secondary outcome was the total number of pharmacologic interventions. Paired sample t-tests were used to assess the results.

Results: A total of 138 enrollees met the study inclusion criteria. The mean difference in systolic and diastolic blood pressure between baseline and completion of the program was -8.33 mm Hg (P = .001; 95% confidence interval [CI], 3.58-13.09) and -3.67 mm Hg (P = .015; 95% CI, 0.75-6.58), respectively. The mean differences in total cholesterol, low-density lipoprotein, and triglycerides from baseline were -27.67 mg/dL (P <.001; 95% CI, 19.36-35.99), -23.16 mg/dL (P <.001; 95% CI, 15.41-30.92), and -67.62 mg/dL (P <.001; 95% CI, 30.73-104.52), respectively. In all, 46 (46.9%) of the 98 enrollees in the dyslipidemia program required a pharmacologic intervention. In the hypertension program, 18 (31.6%) of 57 enrollees required a pharmacologic intervention.

Conclusion: Our findings demonstrate that the use of a pharmacy department-managed, employer-sponsored wellness program that is managed by pharmacists and an advanced practice nurse could lead to significant reductions in blood pressure and lipid levels for employees and for their spouses who are enrolled in the program.