January 09, 2020
What Are They?
The U.S. Food & Drug Administration has approved the use of five medications for the long-term management of overweight or obesity:45
- Xenical (orlistat)* 5
- Belviq (lorcaserin HCI)
- Saxenda (liraglutide)
- Qsymia (phentermine-topiramate)
- Contrave (naltrexone HCl/bupropion HCl)
- Consistent with behavioral treatments for other chronic conditions, maintenance and/or relapse prevention strategies are important aspects of behavior-based interventions.
Xenical, Belviq, Qsymia and Contrave are taken orally; Saxenda is injected.
Among employers that cover at least one FDA-approved weight management medication, more than half cover Belviq (67%), Contrave (63%) and Saxenda (62%). Seventy-nine percent of employers that cover these medications require prior authorization.42
Who Are These Drugs Indicated For?
Medications approved for chronic weight management are indicated for employees with a BMI ≥30 or BMI ≥27 with a weight-related comorbidity.45 They are intended to be used as an adjunct to a reduced-calorie diet and increased physical activity.
Why Should Employers Offer Them?
Many employees cannot achieve clinically-significant weight loss through lifestyle interventions alone. Weight management drugs can be a useful tool to help employees sustain behavioral changes and/or maintain weight loss. People who take weight management medications are 1-4 times more likely to lose 5% of their initial body weight compared to those who don’t.32 They’re also more likely to maintain this weight loss over 12-36 months.32
*A lower dose of the medication (60 mg) is available over the counter under the brand name Alli®
While efficacy varies, the FDA requires all drugs intended for long-term weight management to meet the following minimum criteria in order to be approved for use in the United States:46
- Clinical trials must be underway for at least one year with approximately 3,000 subjects, 1,500 of whom should be randomized to receive the placebo treatment.
- The difference in mean weight loss between the drug and placebo groups is at least 5% and is statistically significant.
- The proportion of subjects who lose ≥5% of baseline body weight in the active product group is at least 35%, is approximately double the proportion in the placebo-treated group, and the difference between the two groups is statistically significant.
- Lifestyle modification programs should be provided as a standard of care for all study subjects. This allows the effectiveness of medications to be directly compared to weight loss that would occur through lifestyle modification alone.
- Effective long-term treatment of obesity requires reduction of the fat mass setpoint toward normal.
Clinical Trial Results of FDA-Approved Weight Management Medications
|Drug Name||Average Percent Weight Loss||Average Percent Weight Loss of Control Group||Percentage of Subjects with 5% Weight Loss||Percentage of Control Subjects with 5% Weight Loss|
|Qsymia® (7.5 mg/46 mg)||7.8%||1.2%||62%||21%|
|Qsymia® (15 mg/92 mg)||9.8%||1.2%||70%||21%|
|Contrave® (32 mg/360 mg)||5.4%||1.3%||42%||17%|
|Saxenda® (3 mg injection)||7.4%||3.0%||62%||34%|
Like medications for other chronic diseases, long-term weight management drugs are intended for sustained use. Just as elevated blood pressure is likely to resume following discontinuation of an ACE inhibitor, employees may regain weight lost following the discontinuation of a weight management drug.
As with any medication, there are risks associated with chronic weight management drugs. Side effects vary by medication but include dizziness, headaches, dry mouth, nausea, diarrhea and constipation.45 All five FDA-approved weight management medications are contraindicated in pregnancy; other contraindications and precautions vary by drug type.45,50
Years after several weight management drugs were withdrawn from the market due serious side effects, concern persists about the safety of newer FDA-approved medications. However, according to a recent research review, serious adverse events associated with chronic weight management drugs are relatively uncommon.32 Post-marketing trials of two medications - Belviq and Saxenda - have shown no increased risk for cardiovascular events, such as stroke, heart attack or death.51,52
Utilization of chronic weight management drugs is low. An analysis of pharmacy claims data from 2012 to 2015 found that the adoption of three new weight management medications (Contrave, Belviq and Qsymia) remained level, while the adoption of new antidiabetes medications (subtype 2 sodium-glucose transport protein inhibitors) increased dramatically. Among weight management drugs prescribed during this timeframe, 74% were for phentermine (a medication indicated for short-term use), while only 18.6% were for Contrave, Belviq and Qsymia.52, 53
Barriers to Utilization
Weight management drug utilization remains low for a number of reasons, including that payers do not cover pharmacotherapy for obesity to the degree that they cover medications for other chronic diseases like diabetes. About half of large employers cover weight management drugs (both short- and long-term medications); CVS Caremark includes Belviq, Belviq XR and Saxenda on its standard and advanced control formularies, OptumRx includes only Contrave and Express Scripts includes Belviq and Saxenda on its preferred national formulary (patients can obtain Qsymia and Contrave through an appeals process).42,55-57 Other contributors to low utilization include the belief that obesity does not require pharmacotherapy and unrealistic weight loss expectations.58
Off-label Use of Medications
Although some benefit designs exclude chronic weight management drugs, lack of coverage may not completely eliminate the use of—and subsequent costs associated with—pharmaceuticals for weight management purposes. There are a number of medications prescribed off-label for chronic weight management, including:
- Medications approved by the FDA to treat other conditions that have a beneficial weight loss side effect; or
- Weight loss drugs that have been approved for short-term use but are used long term.
While the off-label use of medications may aid weight loss, this practice carries risks because these drugs have not been subjected to the efficacy and safety standards put in place by the FDA for the long-term treatment of obesity. Weight loss drugs approved for short-term use have the potential for abuse and evidence indicates only short-term efficacy. Off-label prescribing makes it difficult to utilize pharmacy data to determine appropriate use or the burden of illness associated with specific patient conditions. Finally, while some off-label drugs may be cheaper than FDA-approved medications, others are much more expensive.
Common Drugs Used Off-Label
|Drug-Name||Brand Name||FDA-Approved Use|
|Metformin||Glumetza, Fortamet, Riomet,Glucophage||Diabetes|
|Phentermine||Adipex-P, Suprenza, Ionamin||Short- term weight loss|
|Phendrimetrazine||Bontril||Short- term weight loss|
|Diethylpropion IR or ER||Tenuate, TandiI, Tenuate Dospan||Short- term weight loss|
|Bupropion||Wellbutrin, Zyban, Aplenzin, Buproban, Budeprion||Depression|
|Pramlinitide||SymlinPen and Symlin||Diabetes|
Weight Management Drug Coverage Checklist
- Check your summary plan description(s) to confirm whether your plan(s) include chronic weight management drugs. Verify coverage since the inclusion of these medications on preferred formularies is not standard across PBMs. If you wish to cover medications for chronic weight management, consider including multiple agents on your formulary; while employees with obesity may respond favorably to at least one weight management drug, it may not be the same medication.
- Assess the current use and costs of drugs used off-label for obesity. Determine the costs the company may already be paying for weight management drugs, which may be considered in conversations regarding the coverage of FDA-approved chronic weight management drugs. If you do not wish to cover weight management medications, speak with your PBM regarding strategies to ensure appropriate use of medications being prescribed off-label for weight loss.
- Implement utilization management tools to ensure that weight management drugs are limited to patients for whom they are indicated. Use prior and reauthorization to ensure appropriate use of the medications and prevent unnecessary spending. Prior authorization forms should be designed to: 1) ensure that only individuals for whom the drugs are indicated gain access, and 2) that obesity drugs are being used in conjunction with lifestyle management programs. Reauthorization forms should be designed to determine if individuals are responding to treatment (the FDA recommends that patients either discontinue weight management medications or increase the dose if they do not lose a defined percentage of their body weight after a certain period of time).
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IntroPractical Playbook: Managing Overweight & Obesity
Part 1Managing Overweight and Obesity: Behavior-based Interventions
Part 2Managing Overweight and Obesity: Weight Management Drugs
Part 3Managing Overweight and Obesity: Bariatric Surgery
Part 4Managing Overweight and Obesity: Workplace Culture & Design