Treatment of Chronic Hepatitis C Infection with Sofosbuvir-Based Regimens in a Commercially Insured Patient Population.

BACKGROUND: The response to treatment with direct-acting antiviral agents in patients with chronic hepatitis C virus (HCV) is not well-characterized in the real-world setting. OBJECTIVE: To describe patients' response to 3 sofosbuvir-based treatment regimens among commercially insured patients with chronic HCV. METHODS: In this observational study, we identified patients with HCV who started sofosbuvir treatment with 1 of 3 sofosbuvir-based regimens between December 1, 2013, and April 30, 2014, in the HealthCore Integrated Research Database, a large managed care repository. All patients were aged ≥18 years and had ≥1 RNA viral load tests after starting treatment. Pharmacy and medical claims, laboratory results, and patient medical records were integrated for information on HCV genotype, treatment regimen, RNA viral load, and other clinical and demographic characteristics. The primary outcome was the response to HCV treatment during and after treatment completion, which was defined as an HCV RNA viral load of <25 IU/mL. The 3 HCV treatment regimens included sofosbuvir plus peginterferon alfa and ribavirin; sofosbuvir plus ribavirin; and sofosbuvir plus simeprevir, with or without ribavirin in patients with HCV genotypes 1 to 3. The secondary outcome was the number of patients who had a treatment response in the first 4, 6, and 8 weeks of therapy to determine whether a lack of early response to treatment is suggestive of a posttreatment lack of response. Relapse was defined as regression from response during treatment, with a detectable viral load of ≥25 IU/mL in the most recent test after treatment completion. RESULTS: Among 249 patients with ≥1 documented viral load tests after treatment initiation, 200 (80%) patients had ≥1 tests after the end of treatment. The posttreatment response rate for all 3 regimens was 88% (95% confidence interval, 84%-93%), ranging from 81% to 93%. In the largest category-patients with genotype 1 HCV (N = 130)-the response rate was between 83% and 92% across the 3 regimens. During treatment, 34% of the patients with any viral load test results by week 4 did not respond; however, 81% of those patients had a response after week 12. Of the patients who responded during treatment, 8% had relapsed disease after the end of treatment. CONCLUSION: The response rate to the sofosbuvir-based regimens included in this study was similar to those seen in published randomized clinical trials. Although 34% of the patients with any viral load test result by week 4 of treatment had viral loads of ≥25 IU/mL, persistent treatment was associated with response in the majority of those patients. This supports the effectiveness of sofosbuvir treatment and the need for treatment persistence. The rapid emergence of new treatments in this field presents exciting opportunities for additional research, and holds important clinical and economic implications for patients and their families, healthcare providers, and critically, for payers, who have to accommodate the new pricing models associated with these treatments.

Determinants of high cost in multiple sclerosis patients: a claims and chart review study.

OBJECTIVE: To identify factors associated with high cost multiple sclerosis (MS) patients using integrated administrative claims and medical charts data. METHODS: This study identified newly diagnosed MS patients (≥18 years) in a large United States managed care claims database between 1 January 2007 and 30 April 2011 using the ICD-9-CM code (340.xx). Mean annualized MS-related costs higher than the third quartile were categorized as high cost, lower than the first quartile as low, and the rest as medium. Patients were compared across cohorts with descriptive and inferential statistics. Baseline high cost factors were identified with multivariable logistic regression models. RESULTS: Administrative claims (n = 4342) and medical chart records (n = 400) data was evaluated. Mean (SD) annualized MS-related costs were $6313 ($14,177) for patients overall and $18,398 ($24,483) for high cost patients. Inpatient costs accounted for the largest proportion (49.69%) of MS-related costs among high cost patients. MS relapses and MS-related comorbidities were more prevalent in the high cost patients. In the multivariable analyses, patients with baseline use of antidepressants or corticosteroids, baseline muscle weakness, and initial treatment from a non-neurologist were likelier to be high cost MS patients. LIMITATIONS: MS-related clinical information was not completely available from medical chart data. The specificity of true MS-related costs may have been limited and the definition of the cost-based cohort segmentations was arbitrary. CONCLUSIONS: Overall, baseline use of MS-related medications, the presence of baseline MS-related comorbidities, MS relapses, and MS-related hospitalizations were significantly associated with high cost patients. Future comparative effectiveness studies of currently approved disease modifying therapies for MS may help to identify best strategies for individual patients to minimize clinical events that are associated with high disease related costs.

Cost and consequences of noncompliance to oral bisphosphonate treatment.

BACKGROUND: Despite the favorable efficacy, safety, and cost-effectiveness profile of bisphosphonate (BIS) treatment for osteoporosis (OP), patient compliance remains suboptimal. A longer follow-up period could help to better characterize patient behavior as well as the predictors of noncompliance because of the extended durations of osteoporosis and time to a fracture. OBJECTIVE: To determine health care outcomes associated with compliance and noncompliance to BIS therapy in women diagnosed with OP. METHODS: This retrospective claims study focused on women with OP, who were aged 55 years and older and using oral BIS treatment. Patients were identified within the HealthCore Integrated Research Environment (HIRE) between January 1, 2007, through June 30, 2010. Patients were required to have ≥ 12 months of pre-index eligibility and ≥ 24 months of post-index health plan eligibility. Post-index eligibility was split into 2 periods: (1) the compliance time period (the first 12-month post-index period, in which compliance was determined) and (2) the cost and consequences time period (13- to 24-month post-index period during which time health care resource utilization, cost, and outcomes were assessed). Noncompliance was defined as medical possession ratio (MPR) less than 70%. Descriptive statistics described outcome variables for the study population. A logistic regression model determined variables predictive of compliance. Further, a generalized linear model was used to examine associations between all-cause or OP-related medical/total costs and to estimate health care utilization. RESULTS: Of patients overall (N = 27,905), 59% were noncompliant, and 62% discontinued medication. Among noncompliant patients, 6.7% switched BIS therapy (after 64 days average); 97% discontinued (87 days average); and 21% restarted medication (218 days average). Of noncompliant patients, 14% had greater than 1 inpatient visits; 16% had greater than 1 emergency room visits; 94% had greater than 1 outpatient visits; and 95% had greater than 1 office visits. Logistic regression results indicated that under aged 65 years (P = 0.012) predicted noncompliance. Relative to the compliant group, noncompliant patients had higher fracture rates at post-index second year, 3.3% vs. 2.4%, and combined second and third years, 6.0% vs. 4.8%, respectively. Compared with noncompliant patients, compliant patients had 9% (P = 0.007) lower OP-related costs, 3% lower all-cause costs during the second post-index year, and 11% (P = 0.016) lower OP-related costs. Mean 13- to 24-month post-index period all-cause costs were $7,237 for noncompliant patients versus $6,758 for compliant patients (P = 0.008). CONCLUSIONS: These results indicate high noncompliance rates in this population of older females. OP medication compliance was associated with lower fracture rates, OP- and all-cause costs, and health care utilization. These findings highlight the financial implications and treatment outcomes of BIS medication noncompliance within a female osteoporotic population.