The Coming Obesity Rx Cost Crisis

New treatments have been approved by the US Food & Drug Administration (FDA) for the treatment of obesity but payers covering these patient populations must now determine how to provide coverage and that begins with understanding the latest results. This article examines  recent data regarding new treatments for patients with obesity and what the future may bring.

In June, the FDA approved a new drug for the treatment of obesity. Semaglutide is now the second drug, along with liraglutide, in a class of drugs called GLP-1 agonists approved for weight reduction. Originally developed for the treatment of type 2 diabetes, the GLP-1 agonists are emerging as a promising class of drugs for the treatment of obesity.

By year’s end, another GLP-1 agonist, tirzepatide, is expected to be submitted for FDA approval for obesity and by 2026 another five new generation GLP-1 agonists, some long-lasting, are expected to hit the market, according to Chantell Reagan, PharmD, director, National Pharmacy Practice Clinical Lead at Willis Towers Watson, a global advisory, broking, and solutions company, citing a report by GlobalData that documents a growing portfolio of over 250 obesity drugs at various stages of investigation in the drug pipeline.^1,2

In the June webinar³, “Is America’s Future Obesity Free?” hosted by Virta Health, Dr Reagan joined a panel of experts discussing the impact of pharmacologic treatment of obesity on payers given the high cost of these drugs. The webinar specifically addressed the concerns of health plan leaders and benefits leaders over the expected acceleration of costly drugs coming to market, and recommendations for health plans and payers when considering coverage for treatment strategies.

Semaglutide comes with an expected yearly cost of $15,800 before rebates and may cost more if needed for an ongoing basis, said Dr Reagan, emphasizing that the growth in these new drugs will introduce new spend for employers. “For an employer that covers weight loss drugs with 10,000 lives, if 2% to 5% of the population considered obese uses the drug, an extra $3.1 million to $7.8 million annually would be added to drug costs before rebates,” said Dr Reagan.

Similar to other areas of health care with promising pharmaceuticals coming to market—some with the potential to significantly impact the lives of patient populations—the high cost of drugs like semaglutide place an enormous burden on individuals and payers alike, mandating a close scrutiny on the short-term cost-effectiveness of drugs as well as their long-term cost savings.

In weighing issues of cost, payers must attend to all the cascading effects of obesity on an individual’s life and by extension the burden on the health care system as a whole. With an estimated prevalence of 42.4% in the United States and growing, obesity presents a host of problems to individuals affected and a health care system charged with providing care. Among these problems are the many obesity-related conditions afflicting people who are overweight and reducing their quality of life and, for many, their overall lifespan.

For providers and payers, helping people to both lose weight and maintain a healthy weight is a high priority. A recent report⁴ by the Milkin Institute estimated a total cost of obesity in 2018 at $1.39 trillion, or 6.76 of GDP in the United States;
these costs included $370 billion in direct costs for medical treatment per condition related to obesity and indirect costs of $1.02 trillion for lost workdays. The report found hypertension, type 2 diabetes, chronic back pain, and osteoarthritis comprised 77% of the total costs (or $1.07 trillion), with 68% of the deaths attributed to obesity from coronary heart disease, type 2 diabetes, Alzheimer disease or vascular dementia, and stroke.

Given what is at stake, the lives of millions of people, preventing obesity is a major public health focus and treatment an ongoing challenge to achieve substantial weight reduction and, crucially, sustained weight loss.

Multifactorial Chronic Disease

Underlying the enormity of what many call an obesity epidemic is the multifactorial causes of obesity that include social, environmental, genetic, and behavioral factors.⁴ While prevention and management ultimately require strong partnership with public health agencies to address all these factors, providers and payers also need to first understand the complexity of obesity in order to appreciate the management strategies required.

“We need to stop thinking about obesity as a short-term problem and understand it as the long-term lifelong chronic disease that it is,” said Angela Fitch, MD, MD, associate director, Massachusetts General Hospital Weight Center, Boston, MA. “Living healthier and longer with less disease and better quality will have a cost associated with it; we tend to only see the immediate cost and not focus on the long-term positive benefits.”

For Dr Fitch, who did not participate in the webinar but asked to comment on these new drugs, having good tools to help people manage obesity is important, and she thinks a drug like semaglutide is a good tool. “Prior to semaglutide, only about 15% of people attained a 20% weight loss with medical intervention,” she said, explaining that research shows that a person needs a 15% to 20% sustained weight loss to reverse type 2 diabetes. “With semaglutide, that number goes up to close to 40% of patients that can get a 20% weight loss.”

Evidence from the Semaglutide Treatment Effect in People with Obesity (STEP) trials5, specifically STEP 1, showed that patients without diabetes treated with semaglutide 2.4 mg plus a lifestyle intervention over 68 weeks lost on average 34 lbs or experienced a 15% change in body weight compared to an average weight loss of just under 6 lbs or 2.4% change in body weight in the placebo group.⁶

In STEP 3, which compared the effects of adding a more intensive behavioral therapy with an initial low-calorie diet for the first 8 weeks of treatment to patients treated with once-weekly semaglutide and those randomized to the placebo group, patients in the treatment group also lost significantly more weight than the placebo group (16.0% vs 5.7% reduction, respectively; P<.001) at week 68. Patients in the treatment group also achieved significantly greater weight loss compared to the placebo group of at least 10% (75.3% vs 27.0%, P<.001) or 15% (55.8% vs 13.2%, P<.001).⁷

Sami Inkinen, MSc, MBA, CEO, and cofounder of Virta Health, a company founded in 2014 to reverse type 2 diabetes in people through a nutritionally based lifestyle intervention and sponsor of the webinar, emphasized that historically, drugs for obesity have not solved the obesity problem in part because most carry massive side effects. He acknowledged that the side effects with semaglutide are better tolerated, which will likely increase the number of people taking them. The most common side effects of semaglutide are nausea, diarrhea, and vomiting, which subsided in most patients and mitigated through a slow titration.

Given the efficacy and better side-effect profile and anticipated number of people who may want the drug, a key question remaining unanswered by current data that will be important to health plans is how long treatment will be needed. “Is this a short-term treatment that will deliver long-term results or is it a lifelong treatment?” he said. Although no data is yet available to answer that question, Mr Inkinen suspects that patients may potentially have to be on these drugs (GLP-1 agonists) long-term to maintain weight reduction.

For health plans trying to navigate the cost-effectiveness of the various weight reduction options, including bariatric surgery, pharmaceutical options, and lifestyle/behavioral strategies, Mr Inkinen underscored the need to weigh all factors in making that decision including weight loss effect, side effects, weight gain over time, length of treatment, and cost to payer. “One size fits all is not the option,” he said. “Consider plan design changes to drive adoption of the most cost-effective weight loss solutions first.”

In discussing lifestyle/behavioral strategies, Mr Inkinen focused on a proprietary medical nutrition therapy program developed by Virta used to manage patients with type 2 diabetes with weight loss as an integral goal. Along with the significant and substantial initial weight loss achieved with the program, sustained weight loss was achieved at the follow up of 3.5 years.^8,9

Hassan Azar, JD, MBA, vice president of global benefits, Jones Lange LaSalle, presented a case study of the efficacy of the nutritionally based program used for type 2 diabetes management for employees in the global real estate firm. Along with reversing the progression of type 2 diabetes by reducing A1c levels, 77% of employees on medications were able to eliminate at least one medication and 68% of diabetes-specific prescriptions were eliminated after being on the program for 1 year. At 2 years, the company saved $6466 in drug and medical costs per participant (per patient cost with the nutrition program was $12,965 vs $19,431 without the program).³

Given the good results with the nutrition-based program, Mr Inkinen recommends that employers and health plans help their employees lose weight nutritionally as the first-line therapy before using pharmaceuticals that may have significant side effects and be more expensive. “It is very important when there are multiple options, different outcomes, and different cost levels to really reconsider the plan design so that you are driving and promoting the most effective solution first,” he said, during the webinar. “Plan design becomes even more important when you have these massively expensive options developed in the marketplace.”

Dr Reagan also recommended that plans review their current benefit design, ensure drugs if used are being used for appropriate populations, and develop a comprehensive obesity/diabetes prevention strategy. Although she said the GLP-1 agonists are extremely effective, she underscored the need for payers to ensure effective obesity management programs are in place if covering these drugs. “Addressing the root cause of obesity through diet and lifestyle is critical when developing strategies to mitigate the cost of obesity,” she said. “Employers should use engaging programs using these foundational tools that have been proven effective, usually combining behavioral support through coaching or through other mechanisms.”

Dr Fitch also recommends a tailored approach to obesity management, based on shared decision-making between physician and patient on what strategy has the best chance for success with the least risk and is most cost-effective. From her clinical perspective, many patients will need a more intensive approach to effectively lose weight.

“We know that lifestyle alone helps about 5% of people achieve that 20% weight loss,” she said. “If someone has multiple disease comorbidities already and lifestyle, though less expensive, will produce the desired result in only 5% of the time, then it is likely that a patient should increase the intensity of treatment to have a better chance at a successful outcome.”

For employers and payers wanting information on how much money they will save by covering effective obesity treatments, she refers them to NovoNordisk website (www.novonordiskworks.com). 

References:

1. Obesity: Competitive Landscape to 2026. Global Data. October 2018. Accessed July 15, 2021. https://store.globaldata.com/report/gdhc017cl--obesity-competitive-landscape-to-2026/
2. Six new obesity drugs set to launch by 2026. Global Data. November 12, 2018. Accessed July 15, 2021 https://www.globaldata.com/six-new-obesity-drugs-set-launch-2026/
3. Sell C, Inkinen S, Hassan A. Is America’s Future Obesity Free. YouTube page. Accessed June 17, 2021. https://www.youtube.com/watch?v=lNdgVW0gPgY
4. Lopez A, Bendix J, Sagynbekov K. Weighing down America: 2020 update; a community approach against obesity. Milken Institute. 2020. Accessed July 15, 2021. https://milkeninstitute.org/sites/default/files/reports-pdf/Weighing%20Down%20America%20v12.3.20_0.pdf
5. Kushner RF, Calanna S, Davies M, et al. Semaglutide 2.4 mg for the treatment of obesity: key elements of the STEP trials 1 to 5. Obesity. 2020;28(6):1050-1061. https://doi.org/10.1002/oby.22794
6. Wilding JPH, Batterham RL, Calanna S, et al. Once-weekly semaglutide in adults with overweight or obesity. N Engl J Med 2021;384:989-1002. doi:10.1056/NEJMoa2032183
7. Wadden TA, Bailey TS, Billings LK. Effect of subcutaneous semaglutide vs placebo as an adjunct to intensive behavioral therapy on body weight in adults with over-weight or obesity. the step 3 randomized clinical trial. JAMA. 2021;325(14):1403-1413. doi:10.1001/jama.2021.1831
8. Hallberg SJ, McKenzie AL, Williams PT, et al. Effectiveness and safety of a novel care model for the management of type 2 diabetes at 1 year: an open-label, non-randomized, controlled study. Diabetes Ther. 2018;9(2):583-612. doi:10.1007/s13300-018-0373-9
9. McKenzie A, Athinarayanan S, Adams R, Volek J, Phinney S, Hallberg S. A continuous remote care intervention utilizing carbohydrate restriction including nutritional ketosis improves markers of metabolic risk and reduces diabetes medication use in patients with type 2 diabetes over 3.5 years. J Endocr Soc. 2020;4(suppl1):SUN-L113.B.. doi:10.1210/jendso/bvaa046.2302