Improving quality of care in oncology through healthcare payment reform.

OBJECTIVES: To provide an overview of alternative payment models (APMs) and describe how leading national organizations involved with oncology care and payment are linking quality improvement initiatives and payment reform. STUDY DESIGN: Literature review. METHODS: For this review, we summarized the literature on APMs and their goals of improving healthcare quality while jointly controlling the cost of care. We described the types of APMs that have been examined in the real-world setting, specifically in the area of oncology, and how they have affected the quality of oncology care. RESULTS: Currently, the following types of APMs are actively being explored by public- and private-sector insurers, specifically in oncology: accountable care organizations, bundled payments, clinical pathways, and patient-centered medical homes. To a great extent, the driving force behind implementing APMs tied to quality can be attributed to the initiatives of several leading national organizations, including the National Academy of Medicine, the American Society of Clinical Oncology, the National Committee for Quality Assurance, HHS, and CMS. Real-world evidence of APMs shows that progress is being made toward improving the quality of oncology care in the United States while simultaneously reducing costs. CONCLUSIONS: The effective pairing of quality initiatives with healthcare reimbursement structures will likely be key to the long-term success of such APMs.

Healthcare burden of pulmonary hypertension owing to lung disease and/or hypoxia.

BACKGROUND: Group 3 pulmonary hypertension (PH) encompasses PH owing to lung diseases and/or hypoxia. Treatment patterns, healthcare resource use, and economic burden to US payers of Group 3 PH patients were assessed. METHODS: This retrospective observational study extracted data from July 1, 2010 to June 30, 2013 from two Truven Health Analytics MarketScan databases. Adult Group 3 PH patients were identified based on claims for PH (ICD-9-CM 416.0/416.8), a related lung disease, and an echocardiogram or right heart catheterization (RHC). The index date was the date of the first PH claim; data were collected for 12 months pre- and post-index. A difference-in-difference approach using generalized estimating equations was done to account for baseline differences. RESULTS: Group 3 PH patients (n = 2,236) were matched 1:1 to controls on lung disease. PH patients had higher all-cause resource utilization and annual healthcare costs ($44,732 vs. $7,051) than controls. Costs were driven by inpatient admissions (35.4% of total costs), prescriptions (33.0%), and outpatient care (26.5%). Respiratory-related costs accounted for 11.4% of post-index annual costs for PH patients. PH diagnosis was not confirmed in the majority of PH patients (<7% RHC use) but nevertheless, 22% of PH patients post-index had claims for drugs approved for the treatment of pulmonary arterial hypertension (PAH). CONCLUSIONS: Group 3 PH poses a significant clinical and economic burden. Given the low use of RHC and the prevalence of PAH-indicated prescriptions that are not currently approved for Group 3 PH, this study suggests some Group 3 PH patients may not be receiving guideline-recommended treatment.

A Review of Clinical Trial Endpoints of Patients with Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension and How They Relate to Patient Outcomes in the United States.

Pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) are subgroups of pulmonary hypertension and are considered rare diseases. Understanding how endpoints of clinical trials (and patient registry studies) of patients with PAH and CTEPH are associated with patient outcomes is important in order to address the concerns of patients, health care providers, decision makers, and payers. The purpose of this review was to examine how endpoints used in clinical trials and patient registry studies are associated with outcomes of patients with PAH and CTEPH. A PubMed literature search was conducted to retrieve published studies, including randomized phase III clinical trials and observational studies, from years 2000 to May 2015 that evaluated the associations between change in 6-minute walking distance (6MWD), 6MWD thresholds, change in World Health Organization functional class (WHO-FC), and time to clinical worsening with outcomes of patients with PAH and CTEPH. Based on this review of published literature, a reduction in 6MWD as a criterion for PAH worsening, a deterioration in WHO-FC, and delay in the time to clinical worsening are clinically meaningful trial endpoints and are associated with outcomes of patients with PAH and CTEPH. Utilization and standardization of these endpoints will be useful for comparing interventions of clinical trials and therapies. Hospitalizations are frequent among patients with PAH and CTEPH, and total health care costs are high. From a U.S. payer perspective, clinical worsening is an important composite endpoint in that it includes hospitalization, which can be transformed into a preventative cost value associated with efficacious treatment of patients with PAH and CTEPH. In view of the greater number of medications available to treat PAH, the introduction of the first approved therapy to treat CTEPH, and the increasing use of combination pharmacotherapy, reliable prognostic markers of treatment responsiveness are important to help guide appropriate management. As new clinical trials and observational studies are conducted, it will be important to maintain universal endpoints so that health care providers, decision makers, and payers can better understand the value of targeted pharmacotherapies and combination therapies for the treatment of patients with PAH and CTEPH. DISCLOSURES: Sponsorship for this review and article processing charges were funded by Bayer HealthCare Pharmaceuticals. Divers and Platt are employees of Bayer HealthCare Pharmaceuticals. Wang is an employee of Bayer HealthCare Pharmaceuticals and owns stock in the company. Lin and Lingohr-Smith are employees of Novosys Health, which received research funds from Bayer HealthCare Pharmaceuticals in connection with conducting this review and developing this manuscript. Mathai is a consultant to Bayer HealthCare Pharmaceuticals and also reports consulting fees from Actelion and Gilead. Study concept and design were contributed by Divers, Platt, Lin, and Mathai. Lin and Lingohr-Smith collected the data, and data interpretation was performed by Divers, Platt, Wang, and Matthai. The manuscript was written primarily by Lingohr-Smith, with assistance from the other authors, and revised by Divers, Platt, Wang, and Mathai.

Monitoring for Pulmonary Hypertension Following Pulmonary Embolism: The INFORM Study.

BACKGROUND: Pulmonary hypertension and chronic thromboembolic pulmonary hypertension may develop after a pulmonary embolism event. A ventilation-perfusion scan is recommended as a first-line modality for suspected chronic thromboembolic pulmonary hypertension. In this study, we determined the prevalence of pulmonary hypertension following incident pulmonary embolism and the disease-monitoring patterns in this population. METHODS: We conducted a retrospective claims database analysis of incident pulmonary embolism cases (July 1, 2010 to September 30, 2011) and extracted data for 1 year prior to and 2 years after the incident pulmonary embolism event. Data were analyzed for diagnoses and symptoms related to pulmonary hypertension, claims consistent with other heart or lung diseases, diagnostic imaging tests, and time to first diagnostic imaging test post pulmonary embolism. RESULTS: Of the 7068 incident pulmonary embolism patients that met eligibility criteria, 87% had a claim for a pulmonary hypertension-related symptom and 7.6% had a claim for pulmonary hypertension during follow-up. Only 55% of all pulmonary embolism patients had diagnostic procedural claim(s) post pulmonary embolism: echocardiogram, 47%; computed tomographic angiography, 20%; ventilation-perfusion scan, 6%; and right heart catheterization or pulmonary angiography, <1%. The mean time from pulmonary embolism diagnosis to first screening test was 131 days. CONCLUSIONS: Despite exhibiting pulmonary hypertension-related symptoms, many pulmonary embolism patients did not undergo imaging tests that could diagnose pulmonary hypertension or chronic thromboembolic pulmonary hypertension. This study suggests that physician education about the risk of pulmonary hypertension and chronic thromboembolic pulmonary hypertension after pulmonary embolism may need to be improved.

Budgetary Impact of Adding Riociguat to a US Health Plan for the Treatment of Patients with Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension.

BACKGROUND: Pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) are chronic, debilitating, and life-threatening conditions. Riociguat is the first and only pharmacotherapy approved by the US Food and Drug Administration (FDA) for the treatment of PAH and for CTEPH in patients who are either inoperable or have persistent pulmonary hypertension after surgery. OBJECTIVE: To estimate the budgetary impact of adding riociguat to a US health plan's formulary for the treatment of patients with PAH or CTEPH using a budget impact analytic model. METHODS: A customizable, Microsoft Excel-based decision analytic tool was developed to estimate the impact of riociguat on per-member per-month (PMPM) and per-member per-year (PMPY) bases in Medicare and non-Medicare health plans. The economic impact was calculated based on 1 million insured lives, published prevalence estimates of PAH and CTEPH, pharmacotherapy-eligible patients with PAH or CTEPH, administration costs, and monitoring costs related to pharmacotherapy. The drug costs were based on wholesale acquisition costs, and the medical costs were derived from Truven Health MarketScan claims data and the Medicare 2013 Clinical Diagnostic Laboratory Fee Schedule and Physician Fee Schedule. The market share for approved treatments was based on a tracking study of physicians treating patients with PAH or CTEPH. A sensitivity analysis was used to test the model's robustness. RESULTS: In a hypothetical plan population of 1 million members, the model estimated that 7 patients with PAH and 2 patients with CTEPH would be suitable for pharmacotherapy. Overall, 3 patients (1 with PAH and 2 with CTEPH) were receiving riociguat in a health plan consisting of patients with commercial and with Medicare insurance coverage. The incremental PMPY and PMPM costs for providing insurance coverage for riociguat were $0.27 and $0.02, respectively, for non-Medicare and Medicare health plans. Sensitivity analyses indicated that the budget impact increased by $0.01 PMPM, with a 25% increase in base-case parameter values. CONCLUSION: Riociguat is a first-in-class and the only FDA-approved treatment for patients with PAH or CTEPH-2 debilitating, chronic, and life-threatening conditions with poor prognosis. This drug offers health plans an effective and safe treatment option, with a minimal economic impact. The financial impact to a health plan of providing coverage for riociguat in the first year of treatment was as low as $0.02 PMPM. The real-world budget impact of riociguat needs to be measured using real-world evidence to validate our results.

Employer-based health initiative: impact on employees' cardiovascular outcomes.

BACKGROUND: Cardiovascular disease is the primary cause of mortality among men and women in the United States. The Ready, Set, Goal program was an employer-based initiative designed to identify individuals at risk for cardiovascular disease and to offer an intervention to alter those risk factors. The program involved cardiovascular education, screening, behavior-change incentives, continuing assessment, and follow-up. Pharmacologic treatment was not part of the intervention. OBJECTIVE: To analyze the effects of the Ready, Set, Goal pilot program in 5 employers in the United States on salient cardiovascular end points for employees who completed the program. METHODS: The analysis used a pretest/posttest within-subjects design to compare baseline measurements with measurements for all subjects who completed a second assessment 6 months after baseline measurements. Enrollment began in June 2004 in the first site and in May 2005 in the last site; it ended in January 2006. Patient clinical data from the pilot interventions were aggregated to assess the effects of the intervention on salient cardiovascular end points for individuals who completed the Ready, Set, Goal program. Changes in short-term cardiovascular risk factors were evaluated. Descriptive measures with paired t-tests (α = 0.05) were calculated at the aggregate level for each dependent variable. Range checks were conducted on all variables for clinical validity. RESULTS: A total of 589 subjects from 5 employer group pilot interventions completed the program. Of these, 43% were men, 60% were white, 9% were African-American, 11% were Hispanic, and 20% were categorized as "other." After the intervention, mean blood pressure, total cholesterol, and low-density lipoprotein cholesterol levels were significantly lower (P <.05) compared with baseline measurements. On average, systolic blood pressure declined by 1.9 mm Hg; diastolic blood pressure by 1.3 mm Hg; total cholesterol decreased by 5.2 mg/dL and low-density lipoprotein cholesterol by 3.4 mg/dL. Triglyceride levels increased and high-density lipoprotein levels decreased, although these changes were not significant, and neither were the mean increases in body weight. But increases in body mass index were significant. CONCLUSIONS: A worksite cardiovascular health program can have positive effects on salient cardiovascular end points for employees. The increases in triglyceridnes and body mass index should be further explored.

Evaluating the efficiency of treatment in the allergic rhinitis market.

BACKGROUND: In the present era of increasing health care expenditures, economic comparisons of therapeutic products play an important role in ensuring that limited health care resources are used appropriately. OBJECTIVE: To provide a model for the comparative analysis of alternative treatments, in terms of both cost and efficacy, in allergic rhinitis that will provide decision makers in a managed care environment an additional tool to help maximize health care benefit per dollar spent. We also review current treatments in the allergic rhinitis market and their impact on cost, availability, and utilization. SUMMARY: Efficacy estimates were derived from published reviews, meta-analyses, and guidelines, and cost data are based on average wholesale prices. Our results indicate that when cost and efficacy data are plotted on a cost-effectiveness plane, the intranasal corticosteroids appear to be the most efficient use of health care resources. Moreover, budesonide aqueous nasal spray was found to be the most efficient treatment for allergic rhinitis when compared with 3 other leading intranasal corticosteroids used at their recommended starting doses, the less-sedating/nonsedating antihistamines, and a leukotriene receptor antagonist. CONCLUSION: Evaluating products on an efficiency frontier platform, which integrates both the effectiveness and cost of products, will allow health plan decision makers to ensure the appropriate allocation of health care resources.