Pharmacy Clinical Policy Bulletins Aetna Non-Medicare Prescription Drug Plan
Subject: Antiobesity Agents Aetna ONLY for Specific States PA with Limit 5098-C P08-2024_R
Drug
Anti-Obesity Agents (Specific States)
ADIPEX-P(phentermine)
benzphetamine (all brands)
CONTRAVE(naltrexone/bupropion extended-release)
diethylpropion (all brands)
LOMARIA(phentermine)
phendimetrazine (all brands)
phentermine (all brands)
QSYMIA(phentermine/topiramate extended-release)
SAXENDA(liraglutide)
WEGOVY(semaglutide)
XENICAL(orlistat)
ZEPBOUND(tirzepatide)
Policy:
Indications
FDA-approved Indications
Adipex-P (phentermine), Lomaira (phentermine), Phentermine Phentermine is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater than or equal to 30 kg/m2, or greater than or equal to 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). The limited usefulness of agents of this class should be measured against possible risk factors inherent in their use.
Benzphetamine Benzphetamine Hydrochloride Tablets are indicated in the management of exogenous obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. The limited usefulness of agents of this class should be weighed against possible risks inherent in their use.
Benzphetamine Hydrochloride Tablets are indicated for use as monotherapy only.
Contrave (naltrexone/bupropion extended-release) Contrave is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:
30 kg/m2 or greater (obese) or
27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia).
Limitations of Use
The effect of Contrave on cardiovascular morbidity and mortality has not been established.
The safety and effectiveness of Contrave in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.
Diethylpropion (extended and immediate release) Diethylpropion hydrochloride is indicated in the management of exogenous obesity as a short-term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m2 or higher and who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. The usefulness of agents of this class should be measured against possible risk factors inherent in their use. Diethylpropion hydrochloride is indicated for use as monotherapy only.
Phendimetrazine (extended release) Phendimetrazine tartrate is indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of greater than or equal to 30 kg/m2 or greater than or equal to 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia) who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. The usefulness of agents of this class should be measured against possible risk factors inherent in their use. Phendimetrazine tartrate is indicated for use as monotherapy only.
Phendimetrazine (immediate release) Phendimetrazine tartrate is indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone.
Phendimetrazine tartrate is indicated for use as monotherapy only.
Qsymia (phentermine/topiramate extended-release)
Qsymia is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in:
Adults and pediatric patients aged 12 years and older with obesity
Adults with overweight in the presence of at least one weight-related comorbid condition
Limitations of Use
The effect of Qsymia on cardiovascular morbidity and mortality has not been established.
The safety and effectiveness of Qsymia in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.
Saxenda (liraglutide) Saxenda is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in:
Adult patients with an initial body mass index (BMI) of:
30 kg/m2 or greater (obese), or
27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia)
Pediatric patients aged 12 years and older with:
body weight above 60 kg and
an initial BMI corresponding to 30 kg/m2 or greater for adults (obese) by international cut-offs (Cole Criteria)
Limitations of Use
Saxenda contains liraglutide and should not be coadministered with other liraglutide-containing products or with any other GLP-1 receptor agonist.
The safety and effectiveness of Saxenda in pediatric patients with type 2 diabetes have not been established.
The safety and effectiveness of Saxenda in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.
Wegovy (semaglutide) Wegovy is indicated in combination with a reduced calorie diet and increased physical activity:
to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight.
to reduce excess body weight and maintain weight reduction long term in:
Adults and pediatric patients aged 12 years and older with obesity
Adults with overweight in the presence of at least one weight-related comorbid condition.
Limitations of Use
Wegovy contains semaglutide. Coadministration with other semaglutide-containing products or with any other GLP-1 receptor agonist is not recommended.
Xenical (orlistat) Xenical is indicated for obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet. Xenical is also indicated to reduce the risk for weight regain after prior weight loss. Xenical is indicated for obese patients with an initial body mass index (BMI) greater than or equal to 30 kg/m2 or greater than or equal to 27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, dyslipidemia).
Zepbound (tirzepatide)
Zepbound is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.
Limitations of Use
Zepbound contains tirzepatide. Coadministration with other tirzepatide-containing products or with any glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended.
Coverage Criteria
Morbid Obesity (Adult) Authorization may be granted for the requested drug when ALL of the following criteria are met:
There is documentation that the patient is actively enrolled in a weight loss program that involves a reduced-calorie diet AND increased physical activity adjunct to therapy
The patient’s age is appropriate according to FDA labeling of the requested drug
The patient is NOT receiving TWO drugs for weight loss at the same time
The patient does NOT have ANY contraindications to the requested drug
The requested drug is being used for an FDA approved indication
The patient is 18 years of age or older
The patient meets ONE of the following:
The patient has a documented diagnosis of morbid obesity defined by a current body mass index (BMI) of greater than or equal to 40 kg/m2
The patient has a documented diagnosis of morbid obesity defined by a current BMI of greater than or equal to 35 kg/m2 and the following criteria is met:
The patient has one or more comorbid conditions (i.e., cardiovascular disease, hypertension, dyslipidemia, diabetes, elevated waist circumference) OR other obesity-related medical condition (e.g., sleep apnea)
If the request is for Adipex-P (phentermine), benzphetamine, diethylpropion, Lomaira (phentermine), phendimetrazine, or phentermine, then the following criteria is met:
The patient has NOT received 3 months of therapy or more with the requested drug in the past 365 days
Obesity (Pediatric) Authorization may be granted for the requested drug when ALL of the following criteria are met:
There is documentation that the patient is actively enrolled in a weight loss program that involves a reduced-calorie diet AND increased physical activity adjunct to therapy
The patient’s age is appropriate according to FDA labeling of the requested drug
The patient is NOT receiving TWO drugs for weight loss at the same time
The patient does NOT have ANY contraindications to the requested drug
The requested drug is being used for an FDA approved indication
The patient is 12 to 17 years of age
If the request is for Qsymia (phentermine/topiramate extended-release), then the following criteria is met:
The patient has an initial body mass index (BMI) in the 95th percentile or greater standardized for age and sex
If the request is for Saxenda (liraglutide), then ALL of the following criteria are met:
The patient has a body weight above 60 kg
The patient has an initial BMI corresponding to 30 kg/m2 or greater for adults (obese) by international cut-offs (Cole Criteria)
If the request is for Wegovy (semaglutide), then the following criteria is met:
The patient has an initial BMI in the 95th percentile or greater standardized for age and sex
Risk Reduction of Major Adverse Cardiovascular Events (Adult) Authorization may be granted when the requested drug is being used to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction (MI), or non-fatal stroke) in an adult with established cardiovascular disease AND either obesity or overweight when ALL of the following criteria are met:
The request is for Wegovy (semaglutide)
The requested drug is being used with a reduced-calorie diet AND increased physical activity
The patient has established cardiovascular disease with a history of ONE of the following: [ACTION REQUIRED: Documentation is required for approval.]
Previous MI
Previous stroke
Symptomatic peripheral arterial disease (PAD), as evidenced by intermittent claudication with ankle-brachial index (ABI) less than 0.85 (at rest), peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease
Prior history of revascularization (coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), or angioplasty)
The patient has a baseline body mass index (BMI) greater than or equal to 27 kg/m2 [ACTION REQUIRED: Documentation is required for approval.] [NOTE: If the patient is transitioning from another drug therapy for weight loss, please consider their baseline BMI at the start of any drug therapy.]
The patient does NOT have type 2 diabetes [NOTE: Ozempic is indicated to reduce the risk of major cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease. Patients with type 2 diabetes may be treated for risk reduction of cardiovascular events with Ozempic.]
The patient is currently receiving guideline-directed management and therapy (GDMT) for cardiovascular disease (e.g., lipid-lowering agent, antiplatelet, beta-blocker, renin-angiotensin inhibitor, etc.) OR the patient has clinical reason not to be treated with GDMT for cardiovascular disease [ACTION REQUIRED: Documentation is required for approval.]
Continuation of Therapy
Morbid Obesity (Adult) Authorization may be granted for the requested drug when ALL of the following criteria are met:
There is documentation that the patient is actively enrolled in a weight loss program that involves a reduced-calorie diet AND increased physical activity adjunct to therapy
The patient’s age is appropriate according to FDA labeling of the requested drug
The patient is NOT receiving TWO drugs for weight loss at the same time
The patient does NOT have ANY contraindications to the requested drug
The requested drug is being used for an FDA approved indication
The patient is 18 years of age or older
If the request is for Adipex-P (phentermine), benzphetamine, diethylpropion, Lomaira (phentermine), phendimetrazine, or phentermine, then ALL of the following criteria are met:
The patient has NOT received 3 months of therapy or more with the requested drug in the past 365 days
The patient has evidence of weight loss from baseline
If the request is for Contrave (naltrexone/bupropion extended-release), then the following criteria is met:
The patient has lost at least 5 percent of baseline body weight after 12 weeks of therapy at a stable maintenance dose OR the patient continues to maintain their initial 5 percent weight loss
If the request is for Qsymia (phentermine/topiramate extended-release), then ONE of the following criteria are met:
The patient has completed at least 12 weeks of Qsymia (phentermine/topiramate extended-release) 15 mg/92 mg therapy and the following criteria is met:
The patient has lost at least 5 percent of baseline body weight OR the patient continues to maintain their initial 5 percent weight loss
The patient has completed at least 12 weeks of Qsymia (phentermine/topiramate extended-release) 7.5 mg/46 mg therapy and the following criteria is met:
The patient meets ONE of the following: the patient has lost at least 3 percent of baseline body weight, the patient continues to maintain their initial 3 percent weight loss, the patient’s dose has been increased to Qsymia (phentermine/topiramate extended-release) 11.25 mg/69 mg AND will follow the recommended dose escalation schedule
If the request is for Saxenda (liraglutide), then the following criteria is met:
The patient has lost at least 4 percent of baseline body weight after 16 weeks of therapy at a stable maintenance dose OR the patient continues to maintain their initial 4 percent weight loss
If the request is for Wegovy (semaglutide), then the following criteria is met:
The patient has lost at least 5 percent of baseline body weight after 12 weeks of therapy at a stable maintenance dose OR the patient continues to maintain their initial 5 percent weight loss
If the request is for Xenical (orlistat), then the following criteria is met:
The patient has lost at least 5 percent of initial body weight after 6 months of therapy OR the patient continues to maintain their initial 5 percent weight loss
If the request is for Zepbound (tirzepatide), then the following criteria is met:
The patient has lost at least 5 percent of baseline body weight after 12 weeks of therapy at a stable maintenance dose OR the patient continues to maintain their initial 5 percent weight loss
Obesity (Pediatric) Authorization may be granted for the requested drug when ALL of the following criteria are met:
There is documentation that the patient is actively enrolled in a weight loss program that involves a reduced-calorie diet AND increased physical activity adjunct to therapy
The patient’s age is appropriate according to FDA labeling of the requested drug
The patient is NOT receiving TWO drugs for weight loss at the same time
The patient does NOT have ANY contraindications to the requested drug
The requested drug is being used for an FDA approved indication
The patient is 12 to 17 years of age
If the request is for Qsymia (phentermine/topiramate extended-release), then ONE of the following criteria are met:
The patient has completed at least 12 weeks of Qsymia (phentermine/topiramate extended-release) 15 mg/92 mg therapy and the following criteria is met:
The patient has lost at least 5 percent of baseline body mass index (BMI) OR the patient continues to maintain their initial 5 percent BMI reduction
The patient has completed at least 12 weeks of Qsymia (phentermine/topiramate extended-release) 7.5 mg/46 mg therapy and the following criteria is met:
The patient meets ONE of the following: the patient has lost at least 3 percent of baseline BMI, the patient continues to maintain their initial 3 percent BMI reduction, the patient’s dose has been increased to Qsymia (phentermine/topiramate extended-release) 11.25 mg/69 mg AND will follow the recommended dose escalation schedule
If the request is for Saxenda (liraglutide), then the following criteria is met:
The patient has lost at least 1 percent of baseline BMI after 12 weeks of therapy at a stable maintenance dose OR the patient continues to maintain their initial 1 percent BMI reduction
If the request is for Wegovy (semaglutide), then the following criteria is met:
The patient has a reduction in their baseline BMI after successfully titrating to a stable maintenance dose OR the patient continues to maintain their initial BMI reduction
Risk Reduction of Major Adverse Cardiovascular Events (Adult) Authorization may be granted when the requested drug is being used to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction (MI), or non-fatal stroke) in an adult with established cardiovascular disease AND either obesity or overweight when ALL of the following criteria are met:
The request is for Wegovy (semaglutide)
The requested drug is being used with a reduced-calorie diet AND increased physical activity
The patient has established cardiovascular disease with a history of ONE of the following:
Previous MI
Previous stroke
Symptomatic peripheral arterial disease (PAD), as evidenced by intermittent claudication with ankle-brachial index (ABI) less than 0.85 (at rest), peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease
Prior history of revascularization (coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), or angioplasty)
The patient is being treated with a maintenance dosage of the requested drug
Quantity Limits Apply
Quantity Limit Limits should accumulate across all drugs and strengths up to highest quantity listed depending on the order the claims are processed.
The duration of 25 days is used for a 30-day fill period and 75 days is used for a 90-day fill period to allow time for refill processing.
The duration of 21 days is used for a 28-day fill period and 63 days is used for an 84-day fill period to allow time for refill processing.
Drug
Dosage
1 Month Limit
3 Month Limit
Adipex-P (phentermine)
37.5 mg
30 units / 25 days
90 units / 75 days
Benzphetamine
50 mg
90 tablets / 25 days
270 tablets / 75 days
Contrave (naltrexone/bupropion extended-release)
8 mg / 90 mg
120 tablets / 25 days
360 tablets / 75 days
Diethylpropion
25 mg IR
90 tablets / 25 days
270 tablets / 75 days
Diethylpropion
75 mg ER
30 tablets / 25 days
90 tablets / 75 days
Lomaira (phentermine)
8 mg
90 tablets / 25 days
270 tablets / 75 days
Phendimetrazine
35 mg IR
180 tablets / 25 days
540 tablets / 75 days
Phendimetrazine
105 mg ER
30 capsules / 25 days
90 capsules / 75 days
Phentermine
15 mg
60 capsules / 25 days
180 capsules / 75 days
Phentermine
30 mg
30 capsules / 25 days
90 capsules / 75 days
Qsymia (phentermine/topiramate extended-release)
3.75 mg / 23 mg
30 capsules / 25 days
90 capsules / 75 days
Qsymia (phentermine/topiramate extended-release)
7.5 mg / 46 mg
30 capsules / 25 days
90 capsules / 75 days
Qsymia (phentermine/topiramate extended-release)
11.25 mg / 69 mg
30 capsules / 25 days
90 capsules / 75 days
Qsymia (phentermine/topiramate extended-release)
15 mg / 92 mg
30 capsules / 25 days
90 capsules / 75 days
Saxenda (liraglutide)
18 mg / 3 mL (provides variable dosing)
15 mL (1 package of 5 3 mL pens) / 25 days
45 mL (3 packages of 5 3 mL pens each) / 75 days
Wegovy (semaglutide)
0.25 mg / 0.5 mL
2 mL (1 package of 4 pens each)Z / 21 days
6 mL (3 packages of 4 pens each) / 63 days
Wegovy (semaglutide)
0.5 mg / 0.5 mL
2 mL (1 package of 4 pens each) / 21 days
6 mL (3 packages of 4 pens each) / 63 days
Wegovy (semaglutide)
1 mg / 0.5 mL
2 mL (1 package of 4 pens each) / 21 days
6 mL (3 packages of 4 pens each) / 63 days
Wegovy (semaglutide)
1.7 mg / 0.75 mL
3 mL (1 package of 4 pens each) / 21 days
9 mL (3 packages of 4 pens each) / 63 days
Wegovy (semaglutide)
2.4 mg / 0.75 mL
3 mL (1 package of 4 pens each) / 21 days
9 mL (3 packages of 4 pens each) / 63 days
Xenical (orlistat)
120 mg
90 capsules / 25 days
270 capsules / 75 days
Zepbound (tirzepatide)
2.5 mg / 0.5 mL
2 mL (1 package of 4 pens each or 4 single-dose vials) / 21 days
6 mL (3 packages of 4 pens each or 12 single-dose vials) / 63 days
Zepbound (tirzepatide)
5 mg / 0.5 mL
2 mL (1 package of 4 pens each or 4 single-dose vials) / 21 days
6 mL (3 packages of 4 pens each or 12 single-dose vials) / 63 days
Zepbound (tirzepatide)
7.5 mg / 0.5 mL
2 mL (1 package of 4 pens each or 4 single-dose vials) / 21 days
6 mL (3 packages of 4 pens each or 12 single-dose vials) / 63 days
Zepbound (tirzepatide)
10 mg / 0.5 mL
2 mL (1 package of 4 pens each or 4 single-dose vials) / 21 days
6 mL (3 packages of 4 pens each or 12 single-dose vials) / 63 days
Zepbound (tirzepatide)
12.5 mg / 0.5 mL
2 mL (1 package of 4 pens each or 4 single-dose vials) / 21 days
6 mL (3 packages of 4 pens each or 12 single-dose vials) / 63 days
Zepbound (tirzepatide)
15 mg / 0.5 mL
2 mL (1 package of 4 pens each or 4 single-dose vials) / 21 days
6 mL (3 packages of 4 pens each or 12 single-dose vials) / 63 days
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
