Pharmacy Policy Bulletin
Anti-Obesity - Commercial and Healthcare Reform
Number: J-0184 Category: Prior Authorization
Line(s) of Business:

Commercial
Healthcare Reform
Medicare

Benefit(s):

Commercial:

Prior Authorization (1. and 2.):

1.  Anti-Obesity = Yes

2.  Other Managed Prior Authorization = Yes w/ Prior Authorization

 

Healthcare Reform: Not Applicable
Region(s):

All
Delaware
New York
Pennsylvania
West Virginia

Additional Restriction(s):

None


Drugs Products
  • Belviq (lorcaserin)
  • Belviq XR (lorcaserin extended-release)
  • Qsymia (phentermine and topiramate extended-release)
  • Contrave (bupropion and naltrexone)
  • Saxenda (liraglutide)
  • Xenical (orlistat)
FDA-Approved Indications:
  • Chronic weight management, as an adjunct to a reduced-calorie diet and increased physical activity in adults who are obese (BMI ≥30 kg/m2) or overweight (BMI ≥27 kg/m2) in the presence of at least  one weight-related comorbidity (e.g., hypertension, dyslipidemia, type 2 diabetes)
  • Reduce the risk for weight regain after prior weight loss (Xenical only)


Background:
  • Belviq and Beliviq XR contain lorcaserin which is a serotonin 2C (5-HT2C) receptor agonist and is believed to decrease food consumption and promote satiety by selectively activating 5-HT2C receptors on anorexigenic pro-opiomelanocortin neurons located in the hypothalamus.
  • Qsymia is a combination medication containing phentermine and topiramate extended release. Phentermine is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, amphetamine. The effect of phentermine on chronic weight management is likely mediated by release of catecholamines in the hypothalamus, resulting in reduced appetite and decreased food consumption, but other metabolic effects may be also be involved. The exact mechanism of action of topiramate on chronic weight management is unknown. Topiramate may have an effect on chronic weight management due to its effects on both appetite suppression and satiety enhancement, induced by a combination of pharmacologic effects including augmentation of the activity of the neurotransmitter GABA, modulation of voltage-gated ion channels, inhibition of the AMPA/kainite excitatory glutamate receptors, or inhibition of carbonic anhydrase.
  • Contrave works by addressing behavioral and physiological aspects of obesity. It regulates energy balance and decreases appetite by working in the hypothalamus (appetite regulatory center) and the mesolimbic dopamine circuit (the reward system).
  • Saxenda is an acylated human glucagon-like pepetide-1 (GLP-1) receptor agonist which binds to the GLP-1 receptor ultimately leading to a decrease in caloric intake resulting in lower body weight.  Saxenda does not increase 24-hour energy expenditure.
  • Xenical is a reversible inhibitor of gastrointestinal lipases.  Xenical forms a covalent bond with the serine residue site of gastric acid and pancreatic lipases, thus rendering pancreatic lipase from hydrolyzing dietary fat into absorbable free fatty acids (FFA) and monoglycerides.  As undigested FFA and monoglycerides are not absorbed, the resulting caloric deficit may have a positive effect on weight control.
  • Initiation refers to members who are new to therapy. Continuation refers to the period after the initiation phase (7 months for Qsymia, 4 months for all others). Maintenance refers to a member that has been using the chronic weight loss agent for more than 12 months.
  • Members that have a gap in therapy should be evaluated using the initiation criteria.
  • For Saxenda, the step-therapy includes therapeutic failure or intolerance to two medications or contraindication to all three medications. Contraindication to only two medications does not qualify for approval of Saxenda.
  • Saxenda has a warning for serious hypoglycemia when used with a sulfonylurea or insulin. The dose of anti-diabetic drugs should be reduced to lower the risk of hypoglycemia when Saxenda is given with a sulfonylurea or insulin.


Approval Criteria

I.      Chronic Weight Management

A.     Belviq, Belviq XR, Contrave, Qsymia or Xenical

1.     Initiation

·         0 to < 4 months previous therapy for Belviq, Belviq XR and Contrave

·         0 to < 6 months previous therapy for Xenical

·         0 to < 7 months previous therapy for Qsymia

When a benefit, initiation of Belviq, Belviq XR, Contrave, Qsymia or Xenical for chronic weight management will be approved when all of the following criteria are met (a., b., and c.):

a.     If the request is for Belviq/Belviq RX, Contrave or Qsymia, the member is 18 years of age or older

b.     If the request is for Xenical, the member is 12 years of age or older.

c.     The prescriber submits documentation substantiating all of the following (i., ii., and iii.):

                         i.           Documentation of baseline height, weight and BMI

                        ii.           The member meets (1) one of the following (A. or B.):

A.    The member has a BMI ≥ 30 kg/m2

B.    The member meets both of the following (1. and 2.):

1.     The member has a BMI ≥ 27 kg/m2

2.     The member has one of the following weight-related comorbidities (a. through g.):

a.     Hypertension

b.    Dyslipidemia

c.     Type 2 diabetes mellitus

d.    Obstructive sleep apnea

e.     Symptomatic arthritis of the lower extremities

f.      Gastroesophageal reflux disease

g.    Coronary artery disease

                      iii.              The member will be using the product in combination with all of the following healthy lifestyle modifications (A. and B.):

 A.    Reduced calorie diet

 B.    Exercise regimen

 

2.     Continuation

·         4 to < 12 months previous therapy for Belviq, Belviq XR and Contrave

·         6 to < 12 months previous therapy for Xenical

·         7 to < 12 months previous therapy for Qsymia

When a benefit, a continuation of therapy for Belviq, Belviq XR, Contrave, Qsymia or Xenical for chronic weight management will be approved if all of the following criteria are met (a., b., c., and d.):

a.     If the request is for Belviq/Belviq XR, Contrave or Qsymia, the member is 18 years of age or older.

b.    If the request is for Xenical, the member is 12 years of age or older.

c.     The prescriber submits documentation substantiating all of the following (i., i., and iii.):

                         i.            Documentation of baseline and current height, weight and BMI

                        ii.            The member meets one of the following (A. or B.):

A.    The member’s baseline BMI was ≥ 30 kg/m2

B.    The member meets both of the following (1. and 2.):

1.     The member’s baseline BMI was ≥ 27 kg/m2

2.     The member has one (1) of the following weight-related comorbidities (a. through g.):

a.     Hypertension

b.    Dyslipidemia

c.     Type 2 diabetes mellitus

d.     Obstructive sleep apnea

e.      Symptomatic arthritis of the lower extremities

f.      Gastroesophageal reflux disease

g.    Coronary artery disease

                      iii.            The member will be using the product in combination with all of the following healthy lifestyle modifications (A. and B.):

A.    Reduced calorie diet

B.    Exercise regimen

d.    The member has experienced ≥ 5% weight loss from baseline

 

3.     Maintenance

·         ≥ 12 months previous therapy

When a benefit, maintenance therapy for Belviq, Belviq XR, Contrave, Qsymia or Xenical for chronic weight management will be approved if all of the following criteria are met (a., b., and c.):

a.     If the request is for Belviq/Belviq XR, Contrave or Qsymia, the member is 18 years of age or older

b.    If the request is for Xenical, the member is 12 years or older.

c.     The prescriber submits documentation substantiating all of the following (i. through iv.):

                         i.             Documentation of baseline and current height, weight and BMI

                        ii.             Documentation of height, weight and BMI from 12 months previously

                       iii.             The member meets one (1) of the following criteria (A. or B.):

 A.    The member’s baseline BMI was ≥ 30 kg/m2

 B.    The member meets both of the following (1. and 2.):

1.     The member’s baseline BMI was ≥ 27 kg/m2

2.     The member had one of the following weight-related comorbidities at baseline (a. through g.):

a.     Hypertension

b.    Dyslipidemia

c.     Type 2 diabetes mellitus

d.    Obstructive sleep apnea

e.     Symptomatic arthritis of the lower extremities

f.      Gastroesophageal reflux disease

g.    Coronary artery disease

                       iv.            The member will be using the product in combination with all of the following healthy lifestyle modifications (A. and B.):

 A.    Reduced calorie diet

 B.    Exercise regimen

d.    The member has maintained weight loss from baseline

 

B.    Saxenda

1.      Initiation

·         0 to < 4 months previous therapy

When a benefit, initiation of Saxenda for chronic weight management will be approved if all of the following criteria are met (a. through d.):

a.       The member is 18 years of age or older.

b.        The prescriber submits documentation substantiating all of the following (i., ii., and iii.):

                   i.          Documentation of baseline height, weight and BMI

                   ii.         The member meets one (1) of the following (A. or B.):

 A.    The member has a BMI ≥ 30 kg/m2

 B.    The member meets both of the following criteria (1. and 2.):

1.     The member has a BMI ≥ 27 kg/m2

2.     The member has one (1) of the following weight-related comorbidities (a. through g.):

a.     Hypertension

b.    Dyslipidemia

c.     Type 2 diabetes mellitus

d.    Obstructive sleep apnea

e.     Symptomatic arthritis of the lower extremities

f.      Gastroesophageal reflux disease

g.    Coronary artery disease

                 iii.         The member will be using the product in combination with all of the following healthy lifestyle modifications (A. and B.):

A.    Reduced calorie diet

B.    Exercise regimen

c.     The member has experienced therapeutic failure, or intolerance to two (2) of the following medications or all are contraindicated (i. through iii.):

                         i.        Contrave

                        ii.        Qsymia

                        iii.        Xenical

d.      The member will not be using Saxenda in combination with any of the following products (i.  and ii.):

                         i.        GLP-receptor agonist (i.e., Bydureon, Byetta, Trulicity, Victoza, Adlyxin, Ozempic)

                        ii.        Insulin/GLP-receptor agonist combinations (i.e., Soliqua, Xultophy)

 

2.     Continuation

·         4 to < 12 months previous therapy

When a benefit, a continuation of therapy of Saxenda for chronic weight management will be approved if all of the following criteria are met (a. through e.):

a.       The member is 18 years of age or older

b.       The prescriber submits documentation substantiating all of the following (i., ii., and iii.):

                         i.            Documentation of baseline and current height, weight and BMI

                        ii.            The member meets one (1) of the following criteria (A. or B.):

A.    The member’s baseline BMI was ≥ 30 kg/m2

B.    The member meets both of the following criteria (1. and 2.):

1.     The member’s baseline BMI was ≥ 27 kg/m2

2.     The member had one of the following weight-related comorbidities at baseline (a. through g.):

a.     Hypertension

b.    Dyslipidemia

c.     Type 2 diabetes mellitus

d.    Obstructive sleep apnea

e.     Symptomatic arthritis of the lower extremities

f.      Gastroesophageal reflux disease

g.    Coronary artery disease

                      iii.            The member will be using the product in combination with all of the following healthy lifestyle modifications (A. and B.):

A.    Reduced calorie diet

B.    Exercise regimen

c.      The member has experienced ≥ 4% weight loss from baseline

d.      The member has experienced therapeutic failure, or intolerance to two (2) of the following medications or all are contraindicated (i. through iii.):

                         i.        Contrave

                        ii.        Qsymia

                       iii.        Xenical

e.       The member will not be using Saxenda with any of the following products (i. and ii.):

                         i.        GLP-receptor agonist (i.e., Bydureon, Byetta, Trulicity, Victoza, Adlyxin, Ozempic)

                        ii.        Insulin/GLP-receptor agonist combinations (i.e., Soliqua, Xultophy)

 

3.     Maintenance

·         ≥ 12 months previous therapy

When a benefit, maintenance therapy of Saxenda for chronic weight management will be approved if all of the following criteria are met (a. through e.):

a.      The member is 18 years of age or older

b.      The prescriber submits documentation substantiating all of the following (i. through iv.):

                         i.           Documentation of baseline and current height, weight and BMI

                        ii.           Documentation of height, weight and BMI from 12 months previously

                        iii.          The member meets one (1) of the following criteria (A. or B.):

A.    The member’s baseline BMI was ≥ 30 kg/m2

B.    The member meets both of the following criteria (1. and 2.):

1.     The member’s baseline BMI was ≥ 27 kg/m2

2.     The member had one of the following weight-related comorbidities at baseline (a. through g.):

a.     Hypertension

b.    Dyslipidemia

c.     Type 2 diabetes mellitus

d.    Obstructive sleep apnea

e.     Symptomatic arthritis of the lower extremities

f.      Gastroesophageal reflux disease

g.    Coronary artery disease

                 iv.          The member will be using the product in combination with all of the following healthy lifestyle modifications (A. and B.):

A.    Reduced calorie diet

B.    Exercise regimen

c.       The member has experienced maintained weight loss from baseline.

d.      The member has experienced therapeutic failure, or intolerance to two (2) of the following medications or all are contraindicated (i. through iii.):

                  i.        Contrave

                 ii.        Qsymia

                 iii.        Xenical

e.      The member will not be using Saxenda with any of the following products (i. and ii.):

                 i.        GLP-receptor agonist (i.e., Bydureon, Byetta, Trulicity, Victoza, Adlyxin, Ozempic)

                 ii.        Insulin/GLP-receptor agonist combinations (i.e., Soliqua, Xultophy)

 

II.    Reduce Risk of Weight Regain after Weight Loss

A.    Xenical

1.     Initiation

·         < 12 months previous therapy

When a benefit, initiation of Xenical to reduce the risk of weight regain will be approved if all of the following are met (a. through e.):

a.     The member is 12 years of age or older.

b.    The prescriber documents that the member will be using Xenical to reduce the risk of weight regain after initial weight loss.

c.     The prescriber submits documentation substantiating all of the following (i. and ii.):

i.            Documentation of baseline and current height, weight and BMI

ii.           The member meets one (1) of the following criteria (A. or B.):

A.    The member's baseline BMI was > 30 kg/m2

B.    The member meets both of the following criteria (1. and 2.):

1.     The member's baseline BMI was > 27 kg/m2

2.     The member has or had one (1) of the weight-related comorbidities at baseline (a. through g.):

a.     Hypertension

b.    Dyslipidemia

c.     Type 2 diabetes mellitus

d.    Obstructive sleep apnea

e.     Symptomatic arthritis of the lower extremities

f.      Gastroesophageal reflux disease

g.    Coronary artery disease

d.      The member will continue using the product in combination with all of the following healthy lifestyle modifications (i. and ii.):

                         i.       Reduced calorie diet

                        ii.        Exercise regimen

e.     The member has experienced at least an 8% weight loss without use of pharmacologic weight loss therapy

 

2.     Maintenance

·         > 12 months previous therapy

When a benefit, initiation of Xenical to reduce the risk of weight regain will be approved if all of the following are met (a. through e.):

a.     The member is 12 years of age or older.

b.    The prescriber documents that the member will be using Xenical to reduce the risk of weight regain after initial weight loss.

c.     The prescriber submits documentation substantiating all of the following (i. and ii.):

                         i.           Documentation of baseline and current height, weight and BMI

                        ii.           The member meets one (1) of the following criteria (A. or B.):

A.    The member's baseline BMI was > 30 kg/m2

B.    The member meets both of the following criteria (1. and 2.):

1.     The member's baseline BMI was > 27 kg/m2

2.     The member has or had one (1) of the weight-related comorbidities at baseline (a. through g.):

a.     Hypertension

b.    Dyslipidemia

c.     Type 2 diabetes mellitus

d.    Obstructive sleep apnea

e.     Symptomatic arthritis of the lower extremities

f.      Gastroesophageal reflux disease

g.    Coronary artery disease

d.    The member will continue using the product in combination with all of the following healthy lifestyle modifications (i. and ii.):

                         i.        Reduced calorie diet

                        ii.        Exercise regimen

The member has maintained weight loss from baseline.

III.   An exception to some or all of the criteria above may be granted for select members and/or circumstances based on state and/or federal regulations


Limitations of Coverage

I.      Use of anti-obesity agents for disease states outside of its FDA-approved indications should be denied based on the lack of clinical data to support its effectiveness and safety in other conditions.

II.    For Commercial or HCR members with a closed formulary, a non-formulary product will only be approved if the member meets the criteria for a formulary exception in addition to the criteria outlined within this policy.


Authorization Duration

If approved, a duration of authorization may be granted as follows:

I.      Initiation

A.    Belviq, Belviq XR, Contrave, Saxenda – 4 months

B.    Qsymia – 7 months

C.    Xenical - 6 months

 

II.    Continuation – 12 months

 

III.   Maintenance – 12 months

 

IV.   Discontinuation

A.    1 week of additional coverage of Belviq or Contrave will be granted for discontinuation of the product

 


Automatic Approval Criteria
  1. Belviq/Belviq XR [package insert]. Woodcliff Lake, NJ: Eisai Inc.; May 2017.
  2. Qsymia [package insert]. Campbell, CA: Vivus, Inc.; March 2018.
  3. Contrave [package insert]. La Jolla, CA: Orexigen; June 2018.
  4. Saxenda [package insert]. Plainsboro, NJ: Novo Nordisk; March 2020.
  5. Xenical [package insert]. South San Francisco, CA: Genentech, Inc.; August 2015.
  6. DRUGDEX System (Micromedex 2.0). Greenwood Village, CO: Truven Health Analytics; 2020.
  7. Guidelines for the Management of Overweight and Obesity in Adults (2013). Accessed April 20, 2019.
  8. Garvey WT, Mechanick JI, Brett EM, et al. American Association of Clinical Endocrinologists and American College of Endocrinology Clinical Practice Guidelines for Comprehensive Medical Care of Patients with Obesity-Executive Summary. American Association of Clinical Endocrinologists. Published July 1, 2016. Accessed June 05, 2019.
  9. Jensen MD, Ryan DH, Apovian CM, et al. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. J Am Coll Cardiol. 2014;63(25 Pt B):2985-3023. 
  10. Seger JC, Horn DB, Westman EC, et al. Obesity Algorithm, presented by the American Society of Bariatric Physicians. Obesity Medicine Association. 2015. Accessed April 20, 2020. 
  11. Apovian CM, Aronne LJ, Bessesen DH, et al. Endocrine Society. Pharmacological management of obesity: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2015;100 (2):342-362.

 

 

 


Version: J-0184-016
Effective Date Begin: 07/06/2020
Effective End Begin: 10/19/2020
Original Date: 09/04/2013
Review Date: 06/03/2020




Pharmacy policies do not constitute medical advice, nor are they intended to govern physicians' prescribing or the practice of medicine. They are intended to reflect Highmark's coverage and reimbursement guidelines. Coverage may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its pharmacy policy at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the pharmacy policies is prohibited; however, limited copying of pharmacy policies is permitted for individual use.