Treatment Patterns and Economic Burden by Lines of Therapy Among Patients with Advanced Hepatocellular Carcinoma Treated with Systemic Cancer Therapy.

PURPOSE: This study examined clinical and economic outcomes among patients with advanced hepatocellular carcinoma (HCC) treated with systemic agents by line of therapy. METHODS: Adults with ≥ 2 medical claims for primary diagnosed HCC (from January 1, 2008, through September 30, 2015) and ≥ 1 claim for systemic HCC-related therapy were identified in the IBM MarketScan® Research Databases. Continuous enrollment was required 6 months before and 1 month after diagnosis. Patients were categorized into first- (1L) and second-line (2L) treatment cohorts; those receiving sorafenib as 1L were evaluated. Treatment patterns, healthcare resource utilization, costs, and survival during 1L and 2L therapy were measured. Survival was assessed for patients linked to the Social Security Administration Master Death File. RESULTS: 1459 patients, 758 with death data, met the 1L cohort criteria; 163 patients, 87 with death data, later received 2L therapy. 77.1% had 1L sorafenib, alone or in combination. Median 1L treatment duration was 3.0 months; median survival time from start of 1L to death or censor was 6.8 months. There was no predominant 2L agent. Median 2L treatment duration was 3.0 months; median survival time from start of 2L was 9.3 months. Median total healthcare costs per patient per month were $13,297 for 1L (all), $13,471 for 1L (sorafenib), and $11,786 for 2L. CONCLUSIONS: Findings confirm high 1-year mortality for advanced HCC, suggesting a high cost burden. While no 2L therapy was available during this analysis, recently approved 2L agents have the potential to improve survival after sorafenib failure or intolerance.

Cost-effectiveness of combination daclatasvir-sofosbuvir for treatment of genotype 3 chronic hepatitis C infection in the United States.

BACKGROUND: A phase III trial evaluated the efficacy and safety of Daklinza (daclatasvir or DCV) in combination with sofosbuvir (SOF) for treatment of genotype (GT) 3 hepatitis C virus (HCV) patients. AIM: This study evaluated the cost-effectiveness of DCV + SOF vs SOF in combination with ribavirin (RBV) over a 20-year time horizon from the perspective of a United States (US) payer. METHODS: A published Markov model was adapted to reflect US demographic characteristics, treatment patterns, costs of drug acquisition, monitoring, disease and adverse event management, and mortality risks. Clinical inputs came from the ALLY-3 and VALENCE trials. The primary outcome was the incremental cost-utility ratio. Life-years, incidence of complications, number of patients achieving sustained virological response (SVR), and the total cost per SVR were secondary outcomes. Costs (2014 USD) and quality-adjusted life years (QALYs) were discounted at 3% per year. Deterministic, probabilistic, and scenario sensitivity analyses were conducted. RESULTS: DCV + SOF was associated with lower costs and better effectiveness than SOF + RBV in the base case and in almost all scenarios (i.e. treatment-experienced, non-cirrhotic, time horizons of 5, 10, and 80 years). DCV + SOF was less costly, but also slightly less effective than SOF + RBV in the cirrhotic and treatment-naïve population scenarios. Results were sensitive to variations in the probability of achieving SVR for both treatment arms. DCV + SOF costs less than $50,000 per QALY gained in 79% of all probabilistic iterations compared with SOF + RBV. CONCLUSION: DCV + SOF is a dominant option compared with SOF + RBV in the US for the overall GT 3 HCV patient population.

Prescribing Patterns for Outpatient Treatment of Constipation, Irritable Bowel Syndrome-Related Constipation, and Opioid-Induced Constipation: A Retrospective Cross-Sectional Study.

BACKGROUND: Despite national recommendations for treatment of constipation, prescribing patterns for treatment are inconsistent, and health care utilization has increased. OBJECTIVE: To identify patterns in pharmacologic and nonpharmacologic treatment of constipation and associations between treatment and other variables across age groups. METHODS: This was a retrospective cross-sectional study that used the National Ambulatory Medical Care Survey (NAMCS) to compare prescribing from 2000 to 2004 and from 2005 to 2009. Treatment patterns for constipation, irritable bowel syndrome-related constipation (IBS-C), and opioid-induced constipation were considered. RESULTS: From 2000 to 2009, there were 89.6 million office visits related to constipation: 63.4 million for constipation alone, 28.2 million for IBS-C alone, and 3.7 million for opioid-induced constipation. For constipation, there was an overall decrease in the prescription of combination therapy (17% vs. 11%, P less than 0.05); an increase in the prescription of medication monotherapy (21% vs. 29%, P less than 0.05); decreases in the use of lubricants (9% vs. 2%, P less than 0.05) and saline (7% vs. 1%, P less than 0.001) among patients aged less than 18 years; a decrease in combination therapy (31% vs. 17%, P less than 0.05); and age group differences in the prescription of specific medications. For IBS-C and opioid-induced constipation, there were no changes in major treatment category or specific medication. Age, gender, race, ethnicity, payer source, physician specialty, and region were all found to be associated with treatment choice. CONCLUSIONS: Health care utilization for constipation increased, and prescribing patterns shifted significantly from 2000 to 2009 for constipation and IBS-C. Patterns in treatment were significantly influenced by many factors, including age, gender, and race. Changes in treatment categories over time included a decrease in combination therapy for patients aged less than 18 years and an increase in medication monotherapy for all ages, which are in contrast to national recommendations.

Prescribing trends for the outpatient treatment of adolescents and young adults with type 2 diabetes mellitus.

BACKGROUND: Little is known about U.S. outpatient prescribing trends for type 2 diabetes (T2DM) in adolescents and young adults. OBJECTIVES: To determine (a) trends in the outpatient prescribing of pharmacological and nonpharmacological therapies and (b) factors influencing prescribing trends for adolescents and young adults with T2DM. METHODS: A retrospective, cross-sectional analysis was conducted on office visits of adolescents (12-17 years) and young adults (18-39 years) with T2DM or impaired glucose tolerance (IGT), using the National Ambulatory Medical Care Survey (NAMCS) from 1996-2005. Logistic regression was used to test for prescribing trends over time. RESULTS: There were an estimated 1.6 million (93.7% T2DM; 4.4% T2DM + IGT; 1.9% IGT) and 22.2 million (88.1% T2DM; 11.9% IGT) office visits for adolescents (0.4% of all adolescent visits) and young adults (1.2% of all young adult visits) associated with T2DM based on ICD-9-CM codes, respectively. In young adults, diabetes drug mentions increased significantly from 39% of visits with T2DM to 61% in 2004-2005 (P = 0.04). Oral diabetes medication mentions increased from 20% to 49% (P = 0.001). However, reports of nonpharmacological therapy decreased from 53% in 1996-1997 to 37% in 2004-2005 (P = 0.14). CONCLUSIONS: The prescribing of pharmacological treatment for T2DM increased with emphasis on oral agents, while reports of nonpharmacological therapy for T2DM decreased over the 9-year study period with increased use of oral medications in both adolescents and young adults. Health care providers should consistently consider both treatment approaches when prescribing patient care as recommended by treatment guidelines.