The Relative Value of Anti-Obesity Medications Compared to Similar Therapies.

Purpose: To demonstrate a need for improved health insurance coverage for anti-obesity medications (AOMs) by comparing clinical and economic benefits of obesity treatments to covered medications for selected therapeutic areas. Methods: Using a grey literature search, we identified and prioritized therapeutic areas and treatment analogues for comparison to obesity. A targeted literature review identified clinical and economic outcomes research across the therapeutic area analogues. Associated comorbidities, clinical evidence, indirect costs (ie, absenteeism and productivity loss), and direct medical costs were evaluated to determine the relative value of treating obesity. Results: Four therapeutic areas/treatment analogues were selected for comparison to obesity: smoking cessation (varenicline), daytime sleepiness (modafinil), migraines (erenumab), and fibromyalgia (pregabalin). Obesity was associated with 17 comorbidities, more than migraine (9), smoking (8), daytime sleepiness (5), and fibromyalgia (2). Economic burden was greatest for obesity, followed by smoking, with yearly indirect and direct medical costs totaling $676 and $345 billion, respectively. AOMs resulted in cost savings of $2586 in direct medical costs per patient per year (PPPY), greater than that for varenicline at $930 PPPY, modafinil at $1045 PPPY, and erenumab at $468 PPPY; pregabalin utilization increased costs by $924 PPPY. AOMs were covered by 10-16% of United States health insurance plans, compared to 45-59% for the four comparators. Conclusion: Compared to four therapeutic analogues, obesity represented the highest economic burden and was associated with more comorbidities. AOMs provide greater cost savings compared to selected analogues. However, AOMs have limited formulary coverage. Improved coverage of AOMs may increase access to these treatments and may help address the clinical and economic burden associated with obesity and its comorbidities.

Cost-effectiveness analysis of semaglutide 2.4 mg for the treatment of adult patients with overweight and obesity in the United States.

BACKGROUND: The rising prevalence and associated public health burden of obesity has led to advancements in pharmaceuticals for weight management. Semaglutide 2.4 mg, an anti-obesity medication (AOM) recently approved by the US Food and Drug Administration, has demonstrated clinically relevant weight loss in its phase 3 clinical trials. Economic evaluation comparing semaglutide 2.4 mg with other available weight management therapies is essential to inform payers for decision-making. OBJECTIVES: To assess the cost-effectiveness of semaglutide 2.4 mg in the treatment of adult patients with obesity (ie, body mass index [BMI] ≥ 30) and adult patients who are overweight (ie, BMI 27-29.9) with 1 or more weight-related comorbidities from a US third-party payer perspective. METHODS: A cohort Markov model was constructed to compare semaglutide 2.4 mg with the following comparators: no treatment, diet and exercise (D&E), and 3 branded AOMs (liraglutide 3 mg, phentermine-topiramate, and naltrexone-bupropion). All AOMs, including semaglutide 2.4 mg, were assumed to be taken in conjunction with D&E. Changes in BMI, blood pressure, cholesterol level, experience of acute and chronic obesity-related complications, costs, and quality-adjusted life years (QALYs) were simulated over 30 years based on pivotal trials of the AOMs and other relevant literature. Drug and health care prices reflect 2021 standardized values. Cost-effectiveness was examined with a willingness-to-pay (WTP) threshold of $150,000 per QALY gained. Sensitivity analyses were conducted to test the robustness of the cost-effectiveness results to plausible variation in model inputs. RESULTS: In the base-case analysis, treatment with semaglutide 2.4 mg was estimated to improve QALYs by 0.138 to 0.925 and incur higher costs by $3,254 to $25,086 over the 30-year time horizon vs comparators. Semaglutide 2.4 mg is cost-effective against all comparators at the prespecified WTP threshold, with the incremental cost per QALY gained ranging from $23,556 to $144,296 per QALY gained. In the sensitivity analysis, extended maximum treatment duration, types of subsequent treatment following therapy discontinuation, and weight-rebound rates were identified as key drivers for model results. The estimated probability of semaglutide 2.4 mg being cost-effective compared with comparators ranged from 67% to 100% when varying model parameters and assumptions. CONCLUSIONS: As a long-term weight management therapy, semaglutide 2.4 mg was estimated to be cost-effective compared with no treatment, D&E alone, and all other branded AOM comparators under a WTP threshold of $150,000 per QALY gained over a 30-year time horizon. DISCLOSURES: Financial support for this research was provided by Novo Nordisk Inc. The study sponsor was involved in several aspects of the research, including the study design, the interpretation of data, the writing of the manuscript, and the decision to submit the manuscript for publication. Dr Kim and Ms Ramasamy are employees of Novo Nordisk Inc. Ms Kumar and Dr Burudpakdee were employees of Novo Nordisk Inc at the time this study was conducted. Dr Sullivan received research support from Novo Nordisk Inc for this study. Drs Wang, Song, Wu, Ms Xie, and Ms Sun are employees of Analysis Group, Inc, who received consultancy fees from Novo Nordisk Inc in connection with this study.

Effects of sustained weight loss on outcomes associated with obesity comorbidities and healthcare resource utilization.

OBJECTIVE: Determine the impact of long-term non-surgical weight loss maintenance on clinical relevance for osteoarthritis, cancer, opioid use, and depression/anxiety and healthcare resource utilization. METHODS: A cohort of adults receiving primary care within Geisinger Health System between 2001-2017 was retrospectively studied. Patients with ≥3 weight measurements in the two-year index period and obesity at baseline (BMI ≥30 kg/m2) were categorized: Obesity Maintainers (reference group) maintained weight within +/-3%; Weight Loss Rebounders lost ≥5% body weight in year one, regaining ≥20% of weight loss in year two; Weight Loss Maintainers lost ≥5% body weight in year one, maintaining ≥80% of weight loss. Association with development of osteoarthritis, cancer, opioid use, and depression/anxiety, was assessed; healthcare resource utilization was quantified. Magnitude of weight loss among maintainers was evaluated for impact on health outcomes. RESULTS: In total, 63,567 patients were analyzed including 67% Obesity Maintainers, 19% Weight Loss Rebounders, and 14% Weight Loss Maintainers; median follow-up was 9.7 years. Time until osteoarthritis onset was delayed for Weight Loss Maintainers compared to Obesity Maintainers (Logrank test p <0.0001). Female Weight Loss Maintainers had a 19% and 24% lower risk of developing any cancer (p = 0.0022) or obesity-related cancer (p = 0.0021), respectively. No significant trends were observed for opioid use. Weight loss Rebounders and Maintainers had increased risk (14% and 25%) of future treatment for anxiety/depression (both <0.0001). Weight loss maintenance of >15% weight loss was associated with the greatest decrease in incident osteoarthritis. Healthcare resource utilization was significantly higher for Weight Loss Rebounders and Maintainers compared to Obesity Maintainers. Increased weight loss among Weight Loss Maintainers trended with lower overall healthcare resource utilization, except for hospitalizations. CONCLUSIONS: In people with obesity, sustained weight loss was associated with greater clinical benefits than regained short-term weight loss and obesity maintenance. Higher weight loss magnitudes were associated with delayed onset of osteoarthritis and led to decreased healthcare utilization.

Simulating the Fiscal Impact of Anti-Obesity Medications as an Obesity Reduction Strategy.

While substantial public health investment in anti-smoking initiatives has had demonstrated benefits on health and fiscal outcomes, similar investment in reducing obesity has not been undertaken, despite the substantial burden obesity places on society. Anti-obesity medications (AOMs) are poorly prescribed despite evidence that weight loss is not sustained using other strategies alone.We used a simulation model to estimate the potential impact of 100% uptake of AOMs on Medicare and Medicaid spending, disability payments, and taxes collected relative to status quo with negligible AOM use. Relative to status quo, AOM use simulation would result in Medicare and Medicaid savings of $231.5 billion and $188.8 billion respectively over 75 years. Government tax revenues would increase by $452.8 billion. Overall, the net benefit would be $746.6 billion. Anti-smoking efforts have had substantial benefits for society. A similar investment in obesity reduction, including broad use of AOMs, should be considered.

Complication-specific direct medical costs by body mass index for 13 obesity-related complications: a retrospective database study.

BACKGROUND: Obesity, a multifactorial disease associated with many severe complications, affects more than 40% of adults in the United States. OBJECTIVE: To quantify the cost burden of 13 obesity-related complications (ORCs), overall and by body mass index (BMI) class. METHODS: Adult patients (aged ≥ 18 years) with ≥ 1 medical claim with an ICD-9/10 diagnosis code for the ORC of interest were identified using linked data from IQVIA's Ambulatory Electronic Medical Records and PharMetrics Plus. Thirteen ORCs were separately assessed (asthma, dyslipidemia, gastroesophageal reflux disease [GERD], heart failure with preserved ejection fraction [HFpEF], hypertension, musculoskeletal pain, obstructive sleep apnea [OSA], osteoarthritis [OA] of the knee, polycystic ovary syndrome [PCOS], prediabetes, psoriasis, type 2 diabetes mellitus [T2DM], and urinary incontinence); ORC cohorts were not mutually exclusive. For each ORC, the first claim identified for the ORC from January 2010-December 2016 was termed the index date. Patients had continuous enrollment in the 1-year pre-index (without a diagnosis code of the specific ORC under study) and the 1-year post-index, with ≥ 1 BMI value in the 6-months pre-index. Patients with underweight (BMI < 18.5 kg/m2) and those with cancer or pregnancy were excluded. Complication-specific costs were identified as claims with a diagnosis code for the ORC (primary position only for hospitalizations) or ORC-specific medications or procedures. Baseline demographic/clinical characteristics and complication-specific costs over the 1-year follow-up were assessed for each ORC cohort, overall and by BMI class (18.5-24.9; 25.0-29.9; 30.0-34.9; 35.0-39.9; ≥ 40 kg/m2). The association between total complication-specific costs and BMI class was assessed by generalized linear regression model for each ORC, adjusting for baseline characteristics. RESULTS: The total number of patients that comprised the ORC cohorts ranged from 1,275 (HFpEF) to 101,784 (musculoskeletal pain). Across ORC cohorts, 41.6% (musculoskeletal pain) to 73.5% (OSA) had obesity (BMI ≥ 30 kg/m2). For 4 ORC cohorts, more than one fifth of patients had class III obesity (BMI ≥ 40 kg/m2): T2DM, OSA, PCOS, and HFpEF. Baseline mean Charlson Comorbidity Index score increased with increasing BMI class for most ORC cohorts. The most costly ORCs overall based on mean total 1-year cost were: OA of the knee ($3,697 [range from normal weight (BMI: 18.5-24.9 kg/m2) to class III obesity: $2,453-$4,518]), HFpEF ($3,586 [range: $3,402-$4,685]), OSA ($2,768 [$2,442-$2,974]), and psoriasis ($2,711 [$2,131-$3,292]). The highest cost differences (≥20%) were observed among those with class III obesity versus those with normal weight for these aforementioned ORCs, as well as for GERD ($1,719 [$1,484-$1,893]) and asthma ($1,531 [$1,361-$1,780]). Following adjustment, most cost comparisons by BMI class were significantly higher versus those for normal weight for 6 ORCs. CONCLUSIONS: ORCs are important drivers of the economic burden of obesity, indicating an unmet need for the treatment of obesity. Appropriate weight management may reduce ORC-associated costs. DISCLOSURES: This study and its publication were supported by Novo Nordisk. Divino, Anupindi, and DeKoven are employed by IQVIA, which received funding from Novo Nordisk for this study. Ramasamy, Eriksen, Olsen, and Meincke are employed by and shareholders of Novo Nordisk. Material reported in this manuscript was presented in an abstract accepted by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2020, to be published in Value in Health. There was no presentation at ISPOR 2020.

Economic value of nonsurgical weight loss in adults with obesity.

BACKGROUND: Obesity imposes a substantial economic burden on the United States. The short-term value of nonsurgical weight loss (WL) and nonsurgical sustained WL (i.e., WL not resulting from bariatric surgery) is poorly understood. OBJECTIVES: To assess short-term (1 year) effect of nonsurgical WL and sustained nonsurgical WL (i.e., approximately 2 years) on per-patient-per-month (PPPM) total all-cause health care costs among adults with obesity in the United States. METHODS: In this retrospective cohort study, we analyzed data from the IBM MarketScan Explorys Claims-EMR Data Set from January 1, 2012, through June 30, 2018. Adults aged 18-64 years with a body mass index (BMI) measurement ≥ 30 kg/m2 on the index date and BMI measurements at 12, 24, and 36 months were classified into weight-gain (≥ 3%), no-weight-change (within ± 3%), and WL (≥ 3%-≤ 5%, > 5%-≤ 10%, and > 10%-≤ 20%) cohorts based on the change from first to second BMI measurements (baseline), and sustained nonsurgical WL based on WL during baseline and < 3% weight gain from second to third BMI measurement. PPPM all-cause health care costs were calculated for baseline, first year, and second year of follow-up. Generalized linear models were used to examine if PPPM all-cause health care cost change (ΔPPPM) from baseline to follow-up differed significantly between nonsurgical WL/sustained WL and no-weight-change cohorts. Analyses were stratified by index obesity class (class 1: BMI 30- < 34.9 kg/m2, class 2: BMI 35- < 39.9 kg/m2, class 3: BMI ≥ 40 kg/m2). Specific nonsurgical WL treatments used by individuals in the study were not studied. RESULTS: The sample included 20,488 adults who were grouped as follows: weight-gain cohort (24.8%), no-weight-change cohort (56.6%), ≥ 3%- ≤ 5% WL cohort (8.2%), > 5%- ≤ 10% WL cohort (7.7%), and > 10%- ≤ 20% WL cohort (2.8%). Compared with the no-weight-change cohort, adjusted mean ΔPPPM all-cause health care cost from baseline to first year of follow-up was lower in all WL cohorts (≥ 3%- ≤ 5% WL: -$57.36, > 5%- ≤ 10% WL: -$135.35 [P < 0.05], > 10%- ≤ 20% WL: -$193.54 [P < 0.05]). In the second year of follow-up (n = 15,307), the cohorts were weight-gain (43.4%), no-weight-change (59.4%), ≥ 3%- ≤ 5% sustained WL (7.3%), ≥ 5%- ≤ 10% sustained WL (6.3%), and > 10%- ≤ 20% sustained WL (1.8%). Adjusted mean ΔPPPM all-cause health care cost was lower in all sustained WL groups (-$26.38, -$157.41 [P < 0.05], and -$185.41 for ≥ 3%- ≤ 5%, ≥ 5%- ≤ 10%, and > 10%- ≤ 20% WL, respectively). Greater nonsurgical WL and sustained nonsurgical WL were generally associated with larger reduction in short-term all-cause health care costs. Results stratified by index obesity class were mixed, due to small samples. CONCLUSIONS: Substantial all-cause health care cost savings were observed 1 year after nonsurgical WL and after sustained (on average for 2 years) nonsurgical WL in adults with obesity, with greater nonsurgical WL and sustained nonsurgical WL associated with greater cost savings. Comprehensive solutions to chronic weight management, including improved access to antiobesity medications in combination with lifestyle interventions, could be valuable to patients, employers, and payers. DISCLOSURES: This study was sponsored by Novo Nordisk, which also purchased the data. Blanchette is an employee of Novo Nordisk. Smolarz and Ramasamy are employees of Novo Nordisk and hold equity in Novo Nordisk. Ding, Fan, and Weng were employees of Novo Nordisk at the time this study was conducted. The findings from this study were previously presented at Obesity Week 2019; November 3-7, 2019; Las Vegas, NV.