State Coverage and Reimbursement of Antiobesity Medications in Medicaid.

This study examines state Medicaid coverage policies for antiobesity medications and their trends in Medicaid reimbursement from 2011 to 2022.

Economic outcomes of antiobesity medication use among adults in the United States: A retrospective cohort study.

BACKGROUND: Obesity prevalence exceeds 40% in the US adult population, posing a substantial burden on the health care system. Antiobesity medication (AOM) is recommended for obesity management. However, little evidence exists estimating the economic impact of AOMs on health care costs over time. OBJECTIVE: To estimate the impact of AOMs indicated for long-term therapy on shortterm direct medical costs, by obesity class, in a commercially insured population. METHODS: For this retrospective cohort study, we used the IBM MarketScan Commercial Claims and Encounters Database to capture health care utilization between January 1, 2015, and December 31, 2019. Adults aged 18-63 years with a body mass index greater than or equal to 30 kg/m2 were categorized into 2 cohorts based on new AOM usage at cohort entry. New AOM users were taking 1 of 4 AOMs currently approved by the US Food and Drug Administration for long-term therapy, with greater than 112 days supply of medicine within 12 months after treatment initiation. AOM nonusers were those not taking an AOM indicated for long-term therapy during the baseline or follow-up period. We used difference-in-differences estimation to calculate the change in average annual total health care costs and cost of medications (excluding AOMs) over a 2-year follow-up period using inverse probability of treatment-weighted estimates. RESULTS: The study population included 219,971 patients, 1,405 AOM users and 218,566 AOM nonusers. Over 2 years, patients on treatment were more than twice as likely to be classified into a lower obesity class than AOM nonusers. Although the average yearly direct cost of care increased for both treatment groups in the first year of follow-up, by year 2, costs for untreated patients continued to rise while costs for patients on therapy remained stable or declined. The difference-in-differences of medication cost (excluding AOMs) and total health care cost (excluding AOMs) across all 3 obesity classes in year 2 ranged from $1,321 to $1,952 and $1,323 to $2,766, respectively, indicating a cost savings. Total cost of care, inclusive of AOMs, followed a similar trend. CONCLUSIONS: Use of AOMs is associated with the odds of moving to a lower obesity class and a general stabilization or reduction in health care costs in year 2 of follow-up. When considering change in health care costs over time, use of AOMs may be an effective strategy to mitigate the rising health care costs associated with obesity. DISCLOSURES: Dr Toliver is an employee of Novo Nordisk, Inc. Dr Watkins, Dr Kim, and Ms Whitmire were employees of Novo Nordisk at the time the study was conducted. Dr Garvey has served as a volunteer consultant on advisory committees for Jazz Pharmaceuticals, Boehringer Ingelheim, Eli Lilly, Novo Nordisk, and Pfizer; in each instance, he received no financial compensation, nor was there a financial relationship. He also has served as site principal investigator for clinical trials sponsored by his university and funded by Eli Lilly, Novo Nordisk, Epitomee, and Pfizer. Novo Nordisk funded the study and had a role in the study design, data collection, analysis, and interpretation of data, as well as writing support of the manuscript.

Role of community pharmacists in weight management: results of a national study in Lebanon.

BACKGROUND: Ideally situated within the community, pharmacists can be involved in a broad range of health promotion campaigns including prevention of obesity. Limited evidence is available regarding their involvement in weight management in Lebanon, a country with escalating prevalence rate of obesity. OBJECTIVE: To examine the role of community pharmacists in weight management in Lebanon, specifically studying their beliefs, current practices, services, and knowledge. METHODS: Using a stratified random sampling approach, a cross sectional national survey of community pharmacists was conducted (n = 341, response rate 89%). At the pharmacy, and through a face-to-face interview, pharmacists completed a multi-component questionnaire that addressed, in addition to socio-demographic and work characteristics, their beliefs, practices, knowledge in relation to weight management. Frequencies and proportions were used to describe the data. Simple and multiple linear regression analyses were used to examine the determinants of knowledge in the study population. RESULTS: Over 80% of study participants agreed that they have an important role to play in weight management. However, 50% of pharmacists did not agree that weight loss products are well regulated and 81.1% thought that companies marketing weight loss products are making false promises. The majority of pharmacists always/often sold weight loss products (84.7%) and counseled their patients for diet (86.3%) and physical activity (91.7%). Despite taking weight and height measurements, 50% of pharmacists rarely/never calculated BMI. Among the pharmacists who reported side effects of weight loss products (46.5%), the majority (91.3%) did so to the pharmaceutical company. The knowledge of pharmacists was better for the use of weight loss products as opposed to their side effects and interactions. Significant predictors of knowledge were holding a Masters/ PhD degree in Pharmacy, graduating from a university inside Lebanon, obtaining weight management training within the academic degree, and receiving inquiries about weight management in the pharmacy more than once daily. CONCLUSIONS: The results of the study provided important insights on the beliefs, practices and knowledge of community pharmacists in weight management in Lebanon. These findings could be used to inform the development of future evidence-based community pharmacists led weight management service provision nationally and internationally.

The Societal Value of Broader Access to Antiobesity Medications.

OBJECTIVE: Obesity and its complications place an enormous burden on society. Yet antiobesity medications (AOM) are prescribed to only 2% of the eligible population, even though few individuals can sustain weight loss using other strategies alone. This study estimated the societal value of greater access to AOM. METHODS: By using a well-established simulation model (The Health Economics Medical Innovation Simulation), the societal value of AOM for the cohort of Americans aged ≥ 25 years in 2019 was quantified. Four scenarios with differential uptake among the eligible population (15% and 30%) were modeled, with efficacy from current and next-generation AOM. Societal value was measured as monetized quality of life, productivity gains, and savings in medical spending, subtracting the costs of AOM. RESULTS: For the 217 million Americans aged ≥ 25 years, AOM generated $1.2 trillion in lifetime societal value under a conservative scenario (15% annual uptake using currently available AOM). The introduction of next-generation AOM increased societal value to $1.9 to $2.5 trillion, depending on uptake. Finally, societal value was higher for younger individuals and Black and Hispanic individuals compared with White individuals. CONCLUSIONS: This study suggests that AOM provide substantial gains to patients and society. Policies promoting broader clinical access to and use of AOM warrant consideration to reach national goals to reduce obesity.

Incremental cost-effectiveness of evidence-based non-surgical weight loss strategies.

Recent medical advancements have led to new modes of treatment for non-surgical weight loss, including several new medications. Our aim was to conduct an incremental cost-effectiveness analysis for all commercially available, evidence-based non-surgical weight loss interventions for people with excess weight. We identified interventions through a systematic review of randomized controlled trials that reported weight loss 12 months from baseline. We then meta-analysed the results, sourced costs and performed an incremental cost-effectiveness analysis from the payer perspective. Cost-effectiveness was presented in terms of cost per kilogram lost and quality-adjusted life years (QALY) gained. We further performed sensitivity analyses on costs and duration of benefits, and a probabilistic sensitivity analysis. Ten interventions were identified for inclusion: six pharmaceutical products (Alli, Xenical, Qsymia, Contrave, Belviq and Saxenda), two lifestyle modification programmes (Weight Watchers Meetings and Online), one food replacement and lifestyle programme (Jenny Craig) and one intragastric balloon system (Orbera). At an incremental cost-effectiveness ratio of $30 071 per additional QALY gained, only Weight Watchers Meetings was cost-effective. Sensitivity analyses revealed that for the medications to become incrementally cost-effective, costs would have to decrease by as much as 91%. Results are highly dependent on duration that benefits are maintained. Despite several newly available interventions, Weight Watchers Meetings is currently the only evidence-based, commercially available, cost-effective option for non-surgical weight loss. Other interventions, specifically medications, are more effective but priced too high to be cost-effective.

Determination of macro, micro, trace essential, and toxic elements in Garcinia cambogia fruit and its anti-obesity commercial products.

BACKGROUND: Garcinia (Clusiaceae) species are traditionally used as flavoring agents in curries and to cure several human health complications. This study investigated 31 macro, micro, and trace elements in microwave-assisted digested samples of Garcinia cambogia fruit and its anti-obesity commercial products by inductively coupled plasma-optical emission spectroscopy (ICP-OES) and inductively coupled plasma-mass spectrometric (ICP-MS) techniques. The methods were also validated using the coefficient of determination (R2 ), limits of detection and quantification (LOD, LOQ), precision (CV%), analysis of certified reference materials, spiking recovery experiments, and participation in an accredited laboratory proficiency test organized by Food Analysis Performance Assessment Scheme (FAPAS). RESULTS: Quality assurance confirmed that the methods were efficient and in accordance with criteria set by the Association of Official Analytical Chemists (AOAC). In the elemental analysis, the analyzed macro, micro, and trace essential elements were present in appreciable concentrations, which could meet the human nutritional requirements. Traces of toxic elements were within safe limits. CONCLUSION: From the results of the current study, the fruit and its commercial products could be considered potential sources of mineral elements without posing any threats to consumers. © 2018 Society of Chemical Industry.

Switching from sitagliptin to liraglutide to manage patients with type 2 diabetes in the UK: A long-term cost-effectiveness analysis.

AIMS: The recent LIRA-SWITCH trial showed that switching from sitagliptin 100 mg to liraglutide 1.8 mg led to statistically significant and clinically relevant improvements in glycated haemoglobin (HbA1C) and body mass index (BMI). Based on these findings, the aim of the present study was to assess the long-term cost-effectiveness of switching from sitagliptin to liraglutide in patients with type 2 diabetes in the UK. MATERIALS AND METHODS: The IQVIA CORE Diabetes Model Version 8.5+ was used to project costs and clinical outcomes over patients' lifetimes. Baseline cohort characteristics and treatment effects were derived from the LIRA-SWITCH trial. Future costs and clinical benefits were discounted at 3.5% annually. Costs were accounted in pounds sterling (GBP) and expressed in 2016 values. One-way and probabilistic sensitivity analyses were performed. RESULTS: Model projections showed improved quality-adjusted life expectancy for patients with poorly controlled HbA1c upon switching from sitagliptin to liraglutide, compared with continuing sitagliptin treatment (9.18 vs 9.02 quality-adjusted life years [QALYs]). Treatment switching was associated with increased overall costs (GBP 24737 vs GBP 22362). Higher pharmacy costs were partially offset by reduced diabetes-related complication costs in patients who switched to liraglutide. Switching to liraglutide was associated with an incremental cost-effectiveness ratio of GBP 15423 per QALY gained vs continuing with sitagliptin treatment. CONCLUSIONS: Switching from sitagliptin 100 mg to liraglutide 1.8 mg in patients with poor glycaemic control was projected to improve clinical outcomes and is likely to be considered cost-effective in the UK setting and, therefore, a good use of limited NHS resources.

US health policy and prescription drug coverage of FDA-approved medications for the treatment of obesity.

OBJECTIVE: Obesity is now the most prevalent chronic disease in the United States, which amounts to an estimated $147 billion in health care spending annually. The Affordable Care Act (ACA) enacted in 2010 included provisions for private and public health insurance plans that expanded coverage for lifestyle/behavior modification and bariatric surgery for the treatment of obesity. Pharmacotherapy, however, has not been included despite their evidence-based efficacy. We set out to investigate the coverage of Food and Drug Administration-approved medications for obesity within Medicare, Medicaid and ACA-established marketplace health insurance plans. METHODS: We examined coverage for phentermine, diethylpropion, phendimetrazine, Benzphentamine, Lorcaserin, Phentermine/Topiramate (Qysmia), Liraglutide (Saxenda) and Buproprion/Naltrexone (Contrave) among Medicare, Medicaid and marketplace insurance plans in 34 states. RESULTS: Among 136 marketplace health insurance plans, 11% had some coverage for the specified drugs in only nine states. Medicare policy strictly excludes drug therapy for obesity. Only seven state Medicaid programs have drug coverage. CONCLUSIONS: Obesity requires an integrated approach to combat its public health threat. Broader coverage of pharmacotherapy can make a significant contribution to fighting this complex and chronic disease.

Yellow Oleander Seed, or "Codo de Fraile" (Thevetia spp.): A Review of Its Potential Toxicity as a Purported Weight-Loss Supplement.

The Dietary Supplements and Health Education Act (DSHEA), passed by the United States Congress in October of 1994, defines herbal products as nutritional supplements, not medications. This opened the market for diverse products made from plants, including teas, extracts, essential oils, and syrups. Mexico and the United States share an extensive border, where diverse herbal products are available to the public without a medical prescription. Research undertaken in the neighboring cities of Ciudad Juarez, Mexico, and El Paso, Texas, USA, shows the use of herbs is higher in this border area compared to the rest of the United States. A portion of the population is still under the erroneous impression that "natural" products are completely safe to use and therefore lack side effects. We review the dangers of ingesting the toxic seed of Thevetia spp. (family Apocynaceae), commonly known as "yellow oleander" or "codo de fraile," misleadingly advertised on the Internet as an effective and safe dietary supplement for weight loss. Lack of proper quality control regarding herbs generates a great variability in the quantity and quality of the products' content. Herb-drug interactions occur between some herbal products and certain prescription pharmaceuticals. Certain herbs recently introduced into the U.S. market may not have been previously tested adequately for purity, safety, and efficacy. Due to the lack of reliable clinical data regarding the safe use of various herbal products currently available, the public should be made aware regarding the possible health hazards of using certain herbs for therapeutic purposes. The potentially fatal toxicity of yellow oleander seed is confirmed by cases reported from various countries, while the purported benefits of using it for weight loss have not been evaluated by any known clinical trials. For this reason, the use of yellow oleander seed as a dietary supplement should be avoided.

Exploring the relationship between online buyers and sellers of image and performance enhancing drugs (IPEDs): Quality issues, trust and self-regulation.

BACKGROUND: Online drug markets are expanding the boundaries of drug supply including the sale and purchase of image and performance enhancing drugs (IPEDs). However, the role of the internet in IPED markets, and in particular the ways in which these substances are supplied via the surface web, has rarely been considered. This article examines the online IPED market in order to inform drug policy and to provide a nuanced understanding of retailers involved, particularly exploring the relationship between buyers and sellers. METHODS: This paper is based on two extensive research projects conducted in the Netherlands and Belgium. The first project focuses on muscle drugs and is based on 64 IPED dealing cases, semi-structured interviews with authorities (N=32), and dealers (N=15), along with an analysis of 10 steroid-selling websites. The second research project primarily focuses on weight loss drugs and sexual enhancers in the Netherlands, and relies on interviews with authorities (N=38), suppliers (N=30), and consumers (N=10), analysis of 69 criminal case files, and an online analysis. RESULTS: In the literature, the illicit online sale of IPEDs is generally associated with illegal online pharmacies that try to mislead buyers. While confirmed in our research, we also illustrate that there are online suppliers who invest in customer relationships and services, and that users are aware of the illegal nature of their business. These e-vendors incorporate a 'social supply business model' by providing the best possible service to their customers and attempting to minimise risks in order to attract, satisfy and maintain customers. CONCLUSION: As it is likely that users will continue to make use of the internet to order IPEDs, regardless of closing down selling websites, it is first of all important to counteract these online sources by educating all types of consumers and providing harm reduction services.

Past, present and future of pharmacotherapy for obesity. / Pasado, presente y futuro de la farmacoterapia para la obesidad.

Conventional treatment for obesity with diet, exercise and bariatric surgery has limitations; thus, it is necessary to have pharmacological tools. In the past, different drugs were marketed that were withdrawn due to safety problems. There are currently 3 drugs approved by the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) for obesity therapy (orlistat, combination of bupropion and delayed-release naltrexone and liraglutide) and two more only authorized by FDA (lorcaserin and the combination of phentermine and extended release topiramate). It is recommended to use as a second therapeutic line and its choice should be individualized taking into account multiple aspects such as expected weight loss, route of administration, safety profile and cost. Currently there are several drugs under development that act on different therapeutic targets.

Cost and Health Care Utilization Implications of Bariatric Surgery Versus Intensive Lifestyle and Medical Intervention for Type 2 Diabetes.

OBJECTIVE: The aim of this study was to compare the cost and health care utilization of patients with obesity and type 2 diabetes mellitus (T2DM) randomized into either Roux-en-Y gastric bypass (RYGB) surgery or an intensive lifestyle and medical intervention (ILMI). METHODS: This analysis (N = 745) is based on 2-year follow-up of a small randomized controlled trial (RCT); adult patients with obesity and T2DM were recruited between 2011 and 2012 from Kaiser Permanente Washington. Comparisons were made for patients randomized into either RYGB (N = 15) or ILMI (N = 17). RESULTS: There were no significant cost savings for RYGB versus ILMI patients through the follow-up years. Pharmacy cost was lower for RYGB versus ILMI patients by about $900 in year 2 versus year 0; however, inpatient and emergency room costs were higher for surgery patients in follow-up years relative to year 0. Median total cost for nonrandomized patients was higher in year 0 and in year 2 compared to randomized patients. CONCLUSIONS: Bariatric surgery is not cost saving in the short term. Moreover, the costs of patients who enter into RCTs of RYGB may differ from the costs of those who do not enter RCTs, suggesting use of caution when using such data to draw inferences about the general population with obesity.

Estimated Costs of Clinical and Surgical Treatment of Severe Obesity in the Brazilian Public Health System.

BACKGROUND: Obesity is a major global epidemic and a burden to society and health systems. This study aimed to estimate and compare the anual costs of clinical and surgical treatment of severe obesity from the perspective of the Brazilian Public Health System. METHODS: An observational and cross-sectional study was performed in three reference centers. Data collection on health resources utilization and productivity loss was carried out through an online questionnaire. Participants were divided in clinical (waiting list for a bariatric surgery) and surgical groups (open Roux-en-Y gastric bypass), and then allocated by the time of surgery (up to 1 year; 1-2 years; 2-3 years; and >3 years). Costs of visits, medications, exams, and surgeries were obtained from government sources. Data on non-medical costs, such as transportation, special diets, and caregivers, were also colleted. Productivity loss was estimated using self-reported income. Costs in local currency (Real) were converted to international dollars (Int$ 2015). RESULTS: Two hundred and seventy-four patients, 140 in surgical group and 134 in clinical group were included. In first postoperative year, the surgical group had higher costs than clinical group (Int$6005.47 [5000.18-8262.36] versus 2148.14 [1412.2-3506.8]; p = 0.0002); however, from the second year, the costs decreased progressively. In the same way, indirect costs decreased significantly after surgery (259.08 [163.63-662.72] versus 368.17 [163.62-687.27]; p = 0.06). CONCLUSION: Total costs were higher in the surgical group in the first 2 years after surgery. However, from the third year on, the costs were lower than in the clinical group.

Dietary fish protein hydrolysates containing bioactive motifs affect serum and adipose tissue fatty acid compositions, serum lipids, postprandial glucose regulation and growth in obese Zucker fa/fa rats.

The world's fisheries and aquaculture industries produce vast amounts of protein-containing by-products that can be enzymatically hydrolysed to smaller peptides and possibly be used as additives to functional foods and nutraceuticals targeted for patients with obesity-related metabolic disorders. To investigate the effects of fish protein hydrolysates on markers of metabolic disorders, obese Zucker fa/fa rats consumed diets with 75 % of protein from casein/whey (CAS) and 25 % from herring (HER) or salmon (SAL) protein hydrolysate from rest raw material, or 100 % protein from CAS for 4 weeks. The fatty acid compositions were similar in the experimental diets, and none of them contained any long-chain n-3 PUFA. Ratios of lysine:arginine and methionine:glycine were lower in HER and SAL diets when compared with CAS, and taurine was detected only in fish protein hydrolysate diets. Motifs with reported hypocholesterolemic or antidiabetic activities were identified in both fish protein hydrolysates. Rats fed HER diet had lower serum HDL-cholesterol and LDL-cholesterol, and higher serum TAG, MUFA and n-3:n-6 PUFA ratio compared with CAS-fed rats. SAL rats gained more weight and had better postprandial glucose regulation compared with CAS rats. Serum lipids and fatty acids were only marginally affected by SAL, but adipose tissue contained less total SFA and more total n-3 PUFA when compared with CAS. To conclude, diets containing hydrolysed rest raw material from herring or salmon proteins may affect growth, lipid metabolism, postprandial glucose regulation and fatty acid composition in serum and adipose tissue in obese Zucker rats.

Topiramate-Associated Weight Loss in a Veteran Population.

OBJECTIVE: This study aims to see whether patients in a real-world setting taking topiramate for varied indications experience significant weight loss. METHODS: This was a retrospective cohort study from the Veterans Affairs San Diego Healthcare System. Patients were new topiramate users between January 1, 2000 and December 31, 2013 with body mass index > 25 kg/m(2) and medication possession ratio > 0.5. Primary outcome determined if topiramate users experienced significant changes in weight and body mass index. Secondary outcome analyzed predictive factors associated with 5% weight loss using logistic regression models. Patients were followed up 1 year post index date. RESULTS: A total of 767 patients were included in the final analysis. Patients lost an average of 5.6 lbs (216.1 lbs preweight vs. 210.5 lbs postweight) at an average follow-up of 7.8 months. A total of 43.2% (92/213) of females lost 5% of their body weight compared to 29.4% (163/554) of males. Females (odds ratio 1.73; 95% confidence interval 1.21-2.48; p = 0.003), topiramate indication other than headache, and adherent patients (odds ratio 1.78; 95% confidence interval 1.28-2.49; p = 0.001) were more likely to lose 5% of body weight. CONCLUSION: Topiramate should be considered with higher priority in overweight and obese patients for nonweight loss indications for dual benefit.

A Review of Potential Marine-derived Hypotensive and Anti-obesity Peptides.

Bioactive peptides are food derived components, usually consisting of 3-20 amino acids, which are inactive when incorporated within their parent protein. Once liberated by enzymatic or chemical hydrolysis, during food processing and gastrointestinal transit, they can potentially provide an array of health benefits to the human body. Owing to an unprecedented increase in the worldwide incidence of obesity and hypertension, medical researchers are focusing on the hypotensive and anti-obesity properties of nutritionally derived bioactive peptides. The role of the renin-angiotensin system has long been established in the aetiology of metabolic diseases and hypertension. Targeting the renin-angiotensin system by inhibiting the activity of angiotensin-converting enzyme (ACE) and preventing the formation of angiotensin II can be a potential therapeutic approach to the treatment of hypertension and obesity. Fish-derived proteins and peptides can potentially be excellent sources of bioactive components, mainly as a source of ACE inhibitors. However, increased use of marine sources, poses an unsustainable burden on particular fish stocks, so, the underutilized fish species and by-products can be exploited for this purpose. This paper provides an overview of the techniques involved in the production, isolation, purification, and characterization of bioactive peptides from marine sources, as well as the evaluation of the ACE inhibitory (ACE-I) activity and bioavailability.