Formulary Coverage of Brand-Name Adalimumab and Biosimilars Across Medicare Part D Plans.

This study examines formulary coverage of brand-name adalimumab and biosimilars across Medicare Part D plans.

Bariatric surgery for nonalcoholic steatohepatitis: A clinical and cost-effectiveness analysis.

Nonalcoholic steatohepatitis (NASH) affects 2%-3% of the US population and is expected to become the leading indication for liver transplantation in the next decade. Bariatric surgery may be an effective but expensive treatment for NASH. Using a state-transition model, our analysis assessed the effectiveness and cost-effectiveness of surgery to manage NASH. We simulated the benefits and harms of laparoscopic Roux-en-Y gastric bypass surgery in patients defined by weight class (overweight, mild obesity, moderate obesity, and severe obesity) and fibrosis stage (F0-F3). Comparators included intensive lifestyle intervention (ILI) and no treatment. Quality-adjusted life years (QALYs), costs, and incremental cost-effectiveness ratios were calculated. Our results showed that surgery and ILI in obese patients (with F0-F3) increased QALYs by 0.678-2.152 and 0.452-0.618, respectively, compared with no treatment. Incremental cost-effectiveness ratios for surgery in all F0-F3 patients with mild, moderate, or severe obesity were $48,836/QALY, $24,949/QALY, and $19,222/QALY, respectively. In overweight patients (with F0-F3), surgery increased QALYs by 0.050-0.824 and ILI increased QALYs by 0.031-0.164. In overweight patients, it was cost-effective to reserve treatment only for F3 patients; the incremental cost-effectiveness ratios for providing surgery or ILI only to F3 patients were $30,484/QALY and $25,367/QALY, respectively. CONCLUSIONS: Surgery was both effective and cost-effective for obese patients with NASH, regardless of fibrosis stage; in overweight patients, surgery increased QALYs for all patients regardless of fibrosis stage, but was cost-effective only for patients with F3 fibrosis; our results highlight the promise of bariatric surgery for treating NASH and underscore the need for clinical trials in this area. (Hepatology 2017;65:1156-1164).

Long-term clinical impact and cost-effectiveness of obeticholic acid for the treatment of primary biliary cholangitis.

Primary biliary cholangitis (PBC) is a chronic, progressive autoimmune liver disease that mainly affects middle-aged women. Obeticholic acid (OCA), which was recently approved by the Food and Drug Administration for PBC treatment, has demonstrated positive effects on biochemical markers of liver function. Our objective was to evaluate the long-term clinical impact and cost-effectiveness of OCA as a second-line treatment for PBC in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA. We developed a mathematical model to simulate the lifetime course of PBC patients treated with OCA+UDCA versus UDCA alone. Efficacy data were derived from the phase 3 PBC OCA International Study of Efficacy trial, and the natural history of PBC was informed by published clinical studies. Model outcomes were validated using the PBC Global Study. We found that in comparison with UDCA, OCA+UDCA could decrease the 15-year cumulative incidences of decompensated cirrhosis from 12.2% to 4.5%, hepatocellular carcinoma from 9.1% to 4.0%, liver transplants from 4.5% to 1.2%, and liver-related deaths from 16.2% to 5.7% and increase 15-year transplant-free survival from 61.1% to 72.9%. The lifetime cost of PBC treatment would increase from $63,000 to $902,000 (1,330% increment). The discounted quality-adjusted life years with UDCA and OCA+UDCA were 10.74 and 11.78, respectively, and the corresponding costs were $142,300 and $633,900, resulting in an incremental cost-effectiveness ratio of $473,400/quality-adjusted life year gained. The results were most sensitive to the cost of OCA. CONCLUSION: OCA is a promising new therapy to substantially improve the long-term outcomes of PBC patients, but at its current annual price of $69,350, it is not cost-effective using a willingness-to-pay threshold of $100,000/quality-adjusted life year; pricing below $18,450/year is needed to make OCA cost-effective. (Hepatology 2017;65:920-928).

Screening for Nonalcoholic Steatohepatitis in Individuals with Type 2 Diabetes: A Cost-Effectiveness Analysis.

BACKGROUND AND AIM: Individuals with type 2 diabetes are at heightened risk for nonalcoholic fatty liver disease, which gives rise to nonalcoholic steatohepatitis (NASH) and cirrhosis. Yet, current guidelines do not recommend screening for NASH among these high-risk patients. Using a simulation model, we assessed the effectiveness and cost-effectiveness of screening diabetic patients for NASH. METHODS: A Markov model was constructed to compare two management strategies for 50-year-olds with diabetes. In the No Screening strategy, patients do not undergo screening, although NASH may be diagnosed incidentally over their lifetime. In the NASH Screening strategy, all patients receive a one-time screening ultrasound. Individuals with fatty infiltration on ultrasound then have a liver biopsy, and those found to have NASH receive medical therapy, which decreases progression to cirrhosis. Endpoints evaluated included quality-adjusted life years (QALYs) gained, costs, and incremental cost-effectiveness ratios (ICERs). RESULTS: Screening for NASH decreased the number of individuals who developed cirrhosis by 12.9 % and resulted in an 11.9 % decrease in liver-related deaths. However, screening resulted in 0.02 fewer QALYs, due to the disutility associated with treatment, and was therefore dominated by the No Screening strategy. When the model excluded this quality-of-life decrement, screening became cost-effective, at an ICER of $42,134 per QALY. CONCLUSIONS: Screening for NASH may improve liver-related outcomes, but is not cost-effective at present, due to side effects of therapy. As better tolerated treatments for NASH become available, even with modest efficacy, screening for NASH will become cost-effective.

The cost-effectiveness of pharmacotherapy and lifestyle intervention in the treatment of obesity.

BACKGROUND: The Food and Drug Administration has approved several pharmacotherapies for the treatment of obesity. This study assesses the cost-effectiveness of six pharmacotherapies and lifestyle intervention for people with mild obesity (body mass indices [BMIs] 30 to 35). METHODS: A microsimulation model was constructed to compare seven weight loss strategies plus no treatment: intensive lifestyle intervention, orlistat, phentermine, phentermine/topiramate, lorcaserin, liraglutide, and semaglutide. Weight loss, quality-of-life scores, and costs were estimated using clinical trials and other published literature. Endpoints included costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) with a willingness-to-pay (WTP) threshold of $100 000/QALY. Results were analysed at 1-, 3-, and 5-year time horizons. RESULTS: At each of the three follow-up periods, phentermine was the cost-effective strategy, with ICERs of $46 258/QALY, $20 157/QALY, and $17 880/QALY after 1, 3, and 5 years, respectively. Semaglutide was the most effective strategy in the 3- and 5-year time horizons, with total QALYs of 2.224 and 3.711, respectively. However, the ICERs were prohibitively high at $1 437 340/QALY after 3 years and $576 931/QALY after 5 years. Deterministic and probabilistic sensitivity analyses indicated these results were robust. CONCLUSIONS: Phentermine is the cost-effective pharmacologic weight-loss strategy. Although semaglutide is the most effective, it is not cost-effective because of its high price.

Cost-effectiveness Analysis of Bariatric Surgery for Patients With Nonalcoholic Steatohepatitis Cirrhosis.

Importance: Obesity is the most common risk factor for nonalcoholic steatohepatitis (NASH), the progressive form of nonalcoholic fatty liver disease that can lead to cirrhosis and hepatocellular carcinoma. Weight loss can be an effective treatment for obesity and may slow the progression of advanced liver disease. Objective: To assess the cost-effectiveness of bariatric surgery in patients with NASH and compensated cirrhosis. Design, Setting, and Participants: This economic evaluation study used a Markov-based state-transition model to simulate the benefits and risks of laparoscopic sleeve gastrectomy (SG), laparoscopic Roux-en-Y gastric bypass (GB), and intensive lifestyle intervention (ILI) compared with usual care in patients with NASH and compensated cirrhosis and varying baseline weight (overweight, mild obesity, moderate obesity, and severe obesity). Patients faced varied risks of perioperative mortality and complications depending on the type of surgery they underwent. Data were collected on March 22, 2017. Main Outcomes and Measures: Life-years, quality-adjusted life-years (QALYs), costs (in 2017 $US), and incremental cost-effectiveness ratios (ICERs) were calculated. Results: Demographic characteristics of the patient population were based on a previously published prospective study (n = 161). Patients in the model were 41.0% female, and the base case age was 54 years. Compared with usual care, SG was associated with an increase in QALYs of 0.263 to 1.180 (bounds of ranges represent overweight to severe obesity); GB, 0.263 to 1.207; and ILI, 0.004 to 0.216. Sleeve gastrectomy was also associated with an increase in life-years of 0.693 to 1.930; GB, 0.694 to 1.947; and ILI, 0.012 to 0.114. With usual care, expected life-years in overweight, mild obesity, moderate obesity, and severe obesity were 12.939, 11.949, 10.976, and 10.095, respectively. With usual care, QALY in overweight was 6.418; mild obesity, 5.790; moderate obesity, 5.186; and severe obesity, 4.577. Sleeve gastrectomy was the most cost-effective option for patients across all weight classes assessed: ICER for SG in patients with overweight was $66 119 per QALY; mild obesity, $18 716 per QALY; moderate obesity, $10 274 per QALY; and severe obesity, $6563 per QALY. A threshold analysis on the procedure cost of GB found that for GB to be cost-effective, the cost of the surgery must be decreased from its baseline value of $28 734 by $4889 for mild obesity, by $3189 for moderate obesity, and by $2289 for severe obesity. In overweight patients, GB involved fewer QALYs than SG, and thus decreasing the cost of surgery would not result in cost-effectiveness. Conclusions and Relevance: Bariatric surgery could be highly cost-effective in patients with NASH compensated cirrhosis and obesity or overweight. The findings from this analysis suggest that it can inform clinical trials evaluating the effect of bariatric procedures in patients with NASH cirrhosis, including those with a lower body mass index.

Characteristics of Hospitals Eligible for Rural Emergency Hospital Designation.

This cross-sectional study compares the characteristics, finances, services, and challenges at hospitals that are eligible vs not eligible to become rural emergency hospitals.

Cost-effectiveness of Bariatric Surgery in Adolescents With Obesity.

Importance: Severe obesity affects 4% to 6% of US youth and is increasing in prevalence. Bariatric surgery for the treatment of adolescents with severe obesity is becoming more common, but data on cost-effectiveness are limited. Objective: To assess the cost-effectiveness of bariatric surgery for adolescents with obesity using recently published results from the Teen-Longitudinal Assessment of Bariatric Surgery study. Design, Setting, and Patients: A state-transition model was constructed to compare 2 strategies: no surgery and bariatric surgery. In the no surgery strategy, patients remained at their initial body mass index (calculated as weight in kilograms divided by height in meters squared) over time. In the bariatric surgery strategy, patients were subjected to risks of perioperative mortality and complications as well as initial morbidity but also experienced longer-term quality-of-life improvements associated with weight loss. Cohort demographic information-of the 228 patients included, the mean (SD) age was 17 (1.6) years, the mean (range) body mass index was 53 (34-88), and 171 (75.0%) were female-surgery-related outcomes, and base case time horizon (3 years) were based on data from the Teen-Longitudinal Assessment of Bariatric Surgery study. One-way and probabilistic sensitivity analyses were performed. Main Outcomes and Measures: Quality-adjusted life-years (QALYs), total costs (in US dollars adjusted to 2015-year values using the Consumer Price Index), and incremental cost-effectiveness ratios (ICERs). A willingness-to-pay threshold of $100 000 per QALY was used to assess cost-effectiveness. Results: After 3 years, surgery led to a gain of 0.199 QALYs compared with no surgery at an incremental cost of $30 747, yielding an unfavorable ICER of $154 684 per QALY. When the clinical study results were extrapolated to 4 years, the ICER decreased to $114 078 per QALY and became cost-effective by 5 years with an ICER of $91 032 per QALY. Outcomes were robust in most 1-way and probabilistic sensitivity analyses. Conclusions and Relevance: Bariatric surgery incurs substantial initial cost and morbidity. We found that surgery could be a cost-effective treatment for adolescents with severe obesity if assessed over a time horizon of 5 years. Our study underscores the need for long-term clinical trials in adolescents with at least 5 years of follow-up data that capture financial and quality-of-life end points.

Fibroid morcellation: a shared clinical decision tool for mode of hysterectomy.

OBJECTIVE: To compare risks and benefits of laparoscopic hysterectomy with morcellation versus abdominal hysterectomy without morcellation for large fibroids. STUDY DESIGN: We developed a shared clinical decision tool to communicate risks and benefits of laparoscopic versus abdominal hysterectomy to patients with large fibroids as mandated by the FDA. The decision tool was designed to serve as a framework for providers to counsel patients about mode of hysterectomy to facilitate shared decision-making between patient and provider. Risks and benefits were estimated from the literature, including surgical complications (venous thromboembolism, small bowel obstruction, adhesions, hernia, surgical site infections, and transfusions), uterine sarcoma risks, and quality-of-life endpoints. The shared clinical decision tool was applied to a hypothetical population of 20,000 patients with large uterine fibroids, of which 10,000 underwent laparoscopic hysterectomies and 10,000 had abdominal hysterectomies. RESULTS: Abdominal hysterectomy would result in 50.1% more adhesions, 10.7% more hernias, 4.8% more surgical site infections, 2.8% more bowel obstructions, and 2% more venous thromboembolisms compared to laparoscopic hysterectomy. Abdominal hysterectomy would also result in longer hospital stays (2 days), slower return to work (13.6 days), greater postoperative day 3 narcotic requirements (48%), and lower SF-36 quality-of-life scores (50.4 points lower). 0.28% of fibroid hysterectomy patients would have unsuspected uterine sarcomas. Among these patients, laparoscopic hysterectomy with morcellation would have a 27% reduction in 5-year overall survival rates and a 28.8 month shorter recurrence-free survival period. CONCLUSION: Some evidence suggests laparoscopic hysterectomy with morcellation may result in increased risk of cancer dissemination with worse survival outcomes among uterine sarcoma patients compared to abdominal hysterectomy without morcellation, however, the current data is limited and the exact risks associated specifically with electromechanical morcellation are not conclusive. Data also supports abdominal hysterectomy would lead to a net detriment in other outcomes, with greater risks of venous thromboembolism, obstruction, hernia, adhesions, infection, and blood loss compared to laparoscopic hysterectomy. This shared clinical decision tool may aid the patient and physician in determining an optimal mode of hysterectomy for large uterine fibroids while taking account of risks and benefits as mandated by the FDA.