Subject: Antiobesity Agents Aetna ONLY for Specific States PA with Limit 5098-C UDR 08-2023 v6

Drug

ANTI-OBESITY AGENTS (SPECIFIC STATES)

ADIPEX-P  (phentermine)

benzphetamine

CONTRAVE  (naltrexone/bupropion extended-release)

diethylpropion

LOMAIRA  (phentermine)

phendimetrazine

phentermine

QSYMIA  (phentermine/topiramate extended-release)

SAXENDA  (liraglutide)

WEGOVY  (semaglutide)

XENICAL  (orlistat)

ZEPBOUND  (tirzepatide)

Note: *Drugs that are listed in the target drug box include both brand and generic and all dosage forms and strengths unless otherwise stated. OTC products are not included unless otherwise stated.

Policy:

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, USP 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, USP 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 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 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 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 comorbidity
          such as hypertension, type 2 diabetes mellitus, or dyslipidemia
•   Pediatric patients aged 12 years and older with an initial BMI in the 95^th percentile or greater
     standardized for age and sex.

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.

Limitation 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 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 (obesity) or
     •   27 kg/m² or greater (overweight) in the presence of at least one weight-related comorbid
          condition (e.g., hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea,
          or cardiovascular disease).

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.
     •   The safety and efficacy of Zepbound in combination with other products intended for weight
          management, including prescription drugs, over-the-counter drugs, and herbal preparations,
          have not been established.
     •   Zepbound has not been studied in patients with a history of pancreatitis.


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 prescribed 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) [ACTION REQUIRED: Documentation is required for
          approval.]
     •   The patient has a baseline body mass index (BMI) greater than or equal to 27 kg/m2 [ACTION
          REQUIRED: Documentation is required for approval.]
     •   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 OR the patient has clinical reason not to be treated with GDMT for
          cardiovascular disease (e.g., lipid-lowering agent, antiplatelet, beta-blocker, renin-angiotensin
          inhibitor, etc.) [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 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 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 escalated to Qsymia 11.25 mg/69 mg
                                   AND will follow the appropriate dose escalation schedule
               °   The patient’s dose has been escalated to Qsymia 11.25 mg/69 mg AND will follow the
                    appropriate 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 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 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 escalated to Qsymia 11.25 mg/69 mg
                                   AND will follow the appropriate dose escalation schedule
                    °   The patient’s dose has been escalated to Qsymia 11.25 mg/69 mg AND will follow the
                         appropriate 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 prescribed 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.
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
	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
	105 mg ER	30 capsules / 25 days	90 capsules / 75 days
Phentermine	15 mg	60 capsules / 25 days	180 capsules / 75 days
	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
	7.5 mg/46 mg
	11.25 mg/69 mg
	15 mg/92 mg
Saxenda (liraglutide)	18 mg/3 mL (provides      variable dosing)	15 mL (1 package of 5 3mL      pens) / 25 days	45 mL (3 packages of 5 3mL      pens each) / 75 days
Wegovy (semaglutide)	0.25 mg/0.5 mL	2 mL (1 package of 4 pens each)      / 21 days**	6 mL (3 packages of 4 pens each)      / 63 days**
	0.5 mg/0.5 mL
	1 mg/0.5 mL
	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**
	2.4 mg/0.75 mL
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**
	5 mg/0.5 mL
	7.5 mg/0.5 mL
	10 mg/0.5 mL
	12.5 mg/0.5 mL
	15 mg/0.5 mL
*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 a 84-day fill period to allow time for refill processing.

 

DURATION OF APPROVAL (DOA)
     •   5098-C:
          °   Adipex-P, benzphetamine, diethylpropion, Lomaira, phendimetrazine, phentermine: DOA: 3 months
          °   Contrave, Qsymia, Saxenda, Wegovy, Xenical: Initial therapy DOA: 7 months; Continuation of therapy DOA: 12 months
          °   Zepbound: Initial therapy DOA: 8 months; Continuation of therapy DOA; 12 months

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Adipex-P [package insert]. Parsippany, NJ: Teva Pharmaceuticals USA, Inc.; September 2020.
2. Benzphetamine [package insert]. Newtown, PA: KVK-Tech, INC.; June 2022.
3. Contrave Extended-Release [package insert]. Brentwood, TN: Currax Pharmaceuticals LLC; December 2022.
4. Diethylpropion hydrochloride [package insert]. Congers, NY: Chartwell RX, LLC.; March 2023.
5. Diethylpropion hydrochloride ER [package insert]. Congers, NY: Chartwell RX, LLC.; March 2023.
6. Lomaira [package insert]. Newtown, PA: KVK-Tech, Inc.; December 2018.
7. Phendimetrazine [package insert]. Newtown, PA: KVK-TECH, INC.; September 2019.
8. Phendimetrazine extended-release [package insert]. Langhorne, PA: Virtus Pharmaceuticals, LLC; March 2021.
9. Phentermine [package insert]. Rahway, NJ: Sunrise Pharmaceutical, Inc.; April 2022.
10. Qsymia [package insert]. Campbell, CA: VIVUS LLC; June 2022.
11. Saxenda [package insert]. Plainsboro, NJ: Novo Nordisk Inc.; April 2023.
12. Wegovy [package insert]. Plainsboro, NJ: Novo Nordisk Inc.; March 2024.
13. Xenical [package insert]. Montgomery, AL: H2-Pharma, LLC; November 2022.
14. Zepbound [package insert]. Indianapolis, IN: Lilly USA, LLC; March 2024.
15. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2023. https://online.lexi.com. Accessed May 10, 2023.
16. Lexicomp Online, Lexi-Drugs Online. Waltham, MA: UpToDate, Inc.; 2023. https://online.lexi.com. Accessed May 10, 2023.
17. Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 05/10/2023).
18. National Heart, Lung, and Blood Institute. Classification of Overweight and Obesity by BMI, Waist Circumference, and Associated Disease Risks. Available at: https://www.nhlbi.nih.gov/health/educational/lose_wt/BMI/bmi_dis.htm. Accessed April 2, 2024.

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.

August 08, 2024