Diabetes Medications for Management of Obesity

Coverage considerations for payors

BRIEFING
August 19, 2021
Senior Vice President, CVS Health and Chief Medical Officer, CVS Caremark

In early June, the U.S. Food and Drug Administration approved semaglutide 2.4 mg (Wegovy) for chronic management of obesity and for those with a body mass index (BMI)* of 27 or greater in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes, or dyslipidemia).https://www.cdc.gov/obesity/adult/defining.html Semaglutide is a member of the glucagon-like peptide 1 (GLP-1) receptor agonist class, which has mainly been used to control type 2 diabetes. GLP-1s, which also include liraglutide, simulate a hormone that stimulates insulin secretion in response to eating.https://www.nejm.org/doi/full/10.1056/NEJMoa2032183 They also slow gastric emptying to decrease hunger, making the treatment of diabetes their primary indication. The approval is a notable part of a larger trend of using GLP-1s for weight management in people both with and without diabetes.

Guidelines for the management of obesity

Obesity is a growing, costly challenge in the United States.

~1 in 5 children
struggle with obesity
1 in 3 adults
struggle with obesity
~Half of adults
will be obese or severely obese by 2030https://www.nejm.org/doi/10.1056/NEJMsa1909301
~1 in 5 children
struggle with obesity
1 in 3 adults
struggle with obesity
~Half of adults
will be obese or severely obese by 20303

The decision to initiate drug therapy must weigh the risks and benefits of all treatment options for obesity. Initial treatment usually includes nutrition management, exercise and other behavior modifications. Subsequent therapy may include pharmacotherapy, devices and/or bariatric surgery. In this discussion, we are focusing on the subset of patients who may benefit from pharmacotherapy as part of a larger set of interventions.

Several medical professional societies recommend pharmacotherapy as an adjunct to a reduced-calorie diet and increased physical activity for patients with a BMI of more than 27 kg/m2 with at least one weight-related comorbidity; or a BMI of more than 30 kg/m.American Diabetes Association (2021), American Gastroenterological Association (2017), American Association of Clinical Endocrinologists/American College of Endocrinology (2016), Endocrine Society Clinical Practice Guidelines (2015)Clin Gastroenterol Hepatol. 2017;15(5):631-649; Diabetes Care. 2021;44(Suppl. 1):S100–S110; Endocr Pract. 2016;22(suppl 3):1-203; J Clin Endocrinol Metab. 2015;100(2):342-362 [from internal Obesity Agents deck]

The role of diabetes medications in weight loss

For obese patients for whom pharmacotherapy is appropriate, liraglutide (Saxenda) and semaglutide (Wegovy) are the most promising. Semaglutide, which is given as a weekly subcutaneous injection, is more efficacious** than liraglutide, which is administered daily. This difference in efficacy and administration may lead patients to change therapies.

Result liraglutide semaglutide

Patients w >5% weight loss

49% to 62.3%

67.4% to 84.8%

Patients w >10% weight loss

22.4% to 33.9%

44.5% to 73%

For these drugs that are mainly used to control diabetes, many insurers require prior authorization for patients without diabetes. Patients who do not lose 5 percent of their body weight in the first 12 weeks on the drug may be switched to another therapy.

Both agents carry safety concerns, including risk of thyroid C-cell tumors, acute pancreatitis, acute gallbladder disease, increased heart rate, and suicidal behavior and ideation. Patients on semaglutide (1 mg.) experience high rates of gastrointestinal adverse events, including nausea (20.3% vs. 6.1% for placebo), diarrhea (8.8% vs. 1.9% for placebo), abdominal pain (5.7% vs. 4.6% for placebo) and constipation (3.1% vs. 1.5% for placebo), and vomiting (9.2% vs. 2.3% for placebo).https://www.rxlist.com/ozempic-side-effects-drug-center.htm Prevalence of these side effects with liraglutide is also greater than 5 percent.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5358074/

Wegovy and Saxenda are manufactured by Novo Nordisk which, as of 2020, had 56 percent of the global obesity prescription drug market.https://www.fiercebiotech.com/research/insights-into-how-novo-nordisk-s-saxenda-reduces-food-cravings-may-inspire-new-obesity Looking forward, more diabetes drugs are expected to be approved for obesity indications. Eli Lilly is developing a new product, tirzepatide, a weekly subcutaneous injection that is still in early stage trials for weight loss in obese patients with and without diabetes.https://www.healthcaredive.com/news/novo-new-obesity-drug-approved-wegovy/601391/ The primary outcome measure is body weight reduction of more than 5 percent.https://clinicaltrials.gov/ct2/show/NCT04657016?term=tirzepatide&phase=2&draw=2&rank=4 A 2022 launch is planned.

Other drugs in the pipeline include new molecular entities by Boehringer Ingelheim/Zealand Pharma and Hanmi Pharmaceutical/Merck and a new biologic from Novo Nordisk, in addition to the new oral formulation of semaglutide.

Considerations for payors

~$3,500
increased health care costs for an obese adult each year
$342.2 billion
Total medical costs for obese adults in the United States (2013)
28.2%
Share of total health care spending devoted to treating obesity-related illness
~$3,500
increased health care costs for an obese adult each year
$342.2 billion
Total medical costs for obese adults in the United States (2013)
28.2%
Share of total health care spending devoted to treating obesity-related illness

Determining the impact of weight loss on overall medical costs is difficult to determine due to its broad impact on overall health and the heterogeneity of the population. However, given the significant numerous comorbidities (high blood pressure, diabetes, osteoarthritis, sleep apnea, atrial fibrillation, etc.) associated with obesity, there is benefit to health and health care costs from weight loss. For example, in one model, annual medical costs for obese people rise with the degree of obesity and are greatest in those with a BMI greater than 35. The investigators demonstrated reductions in medical costs were proportionate to the patients' starting BMI.Cawley et al. Savings in Medical Expenditures Associated with Reductions in Body Mass Index Among US Adults with Obesity, by Diabetes Status. PharmacoEconomics (2015) 33:707–722. doi 10.1007/s40273-014-0230-2

Savings with BMI Reduction of 10 Percent

Starting BMI

Reduction in annual medical cost

44

$10,992

40

$3,402

35

$583

<35

Not statistically significant

Savings with BMI Reduction of 10 Percent

Starting BMI

Reduction in annual medical cost

44

$10,992

40

$3,402

35

$583

<35

Not statistically significant

Of course, this is only one model. The list price for these drugs currently averages $1,200 per month. They may be right clinically for some patients, but cost effectiveness is clearer in those who are more obese or have one or more comorbidities such as diabetes. In obese people with diabetes, a 10 percent drop in BMI results in medical cost savings ranging from $1,000 in people with a BMI of 30, up to approximately $7,000 in people with a BMI of 45 — a sevenfold difference compared to the 3.5x difference seen in people without diabetes.Cawley et al. Savings in Medical Expenditures Associated with Reductions in Body Mass Index Among US Adults with Obesity, by Diabetes Status. PharmacoEconomics (2015) 33:707–722. doi 10.1007/s40273-014-0230-2

As the prevalence of obesity continues to increase, so does the drug pipeline, providing more options for managing this condition. Increased competition will continue to make these drugs more cost-effective. Ensuring appropriate utilization and the lowest net cost for these drugs is the best way to ensure improved health outcomes for patients with lower medical cost savings for plan sponsors.

Plan sponsors should consider the benefit of covering these drugs for their plan members, especially in light of comorbidities and potential downstream health care costs. Of course, every client must decide how to spend their health care dollars, striking a balance between clinical impact, access and cost. In the past, some payors chose not to include weight loss coverage in their prescription drug benefit. Today, some are choosing to include it but want cost management via prior authorization; others have more open access for obesity drug options.

There are also non-medication weight management options available to members through through the MinuteClinic Weight Loss Program and the vendors we have carefully selected for our Point Solutions Management portfolio.

Learn more about coverage considerations for weight management drugs and other management strategies. Ask Us
BRIEFING
August 19, 2021
Senior Vice President, CVS Health and Chief Medical Officer, CVS Caremark

* BMI is a person’s weight in kilograms divided by the square of height in meters — https://www.cdc.gov/obesity/adult/defining.html

** Per product inserts

† compared to their normal-weight peers

The source for data in this document is CVS Health Enterprise Analytics, unless otherwise noted.

This document contains references to brand-name prescription drugs that are trademarks or registered trademarks of pharmaceutical manufacturers not affiliated with CVS Health.

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