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)
  • 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:
  • 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. However, the exact mechanism is unknown.
  • 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.
  • Lorcaserin 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. However, the exact mechanism is unknown.
  • Bupropion/naltrexone 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 (liraglutide) 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 (liraglutide) does not increase 24-hour energy expenditure.
  • Orlistat is a reversible inhibitor of gastrointestinal lipases.  Orlistat 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.


Approval Criteria

I.        Chronic Weight Management

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

·         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 if all of the following criteria are met (1. and 2.):

1.     The member is 18 years of age or older (Xenical: 12 years and older).

2.     The prescriber submits documentation (i.e. chart notes) substantiating all of the following (a., b., and c.):

a.     Documentation of baseline height, weight and BMI.

b.    The member meets one of the following (i. or ii.):

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

ii.    The member meets both of the following (A and B):

A)    The member has a BMI ≥ 27 kg/m2

B)    The member has one of the following weight-related comorbidities (1 through 7):

1)     Hypertension

2)     Dyslipidemia

3)     Type 2 diabetes mellitus

4)     Obstructive sleep apnea

5)     Symptomatic arthritis of the lower extremities

6)     Gastroesophageal reflux disease

7)     Coronary artery disease

c.     The member will be using the product in adjunct to all of the following healthy lifestyle modifications (i. and ii.):

i.      Reduced calorie diet

ii.    Exercise regimen

 

·         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 (1. through 3.):

1.     The member is 18 years of age or older (Xenical: 12 years and older).

2.     The prescriber submits documentation (i.e. chart notes) substantiating all of the following (a., b, and c.):

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

b.    The member meets one of the following (i. or ii.):

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

ii.    The member meets both of the following (A and B):

A)    The member’s baseline BMI was ≥ 27 kg/m2

B)    The member had one of the following weight-related comorbidities at baseline (1 through 7):

1)     Hypertension

2)     Dyslipidemia

3)     Type 2 diabetes mellitus

4)     Obstructive sleep apnea

5)     Symptomatic arthritis of the lower extremities

6)     Gastroesophageal reflux disease

7)     Coronary artery disease

c.     The member will be using the product in adjunct to all of the following healthy lifestyle modifications (i. and ii.):

i.      Reduced calorie diet

ii.    Exercise regimen

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

 

·         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 (1., 2, and 3.):

1.     The member is 18 years of age or older (Xenical: 12 years and older).

2.     The prescriber submits documentation (i.e. chart notes) substantiating all of the following (a. through d.):

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

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

c.     The member meets one of the following (i. or ii.):

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

ii.    The member meets both of the following (A and B):

A)    The member’s baseline BMI was ≥ 27 kg/m2

B)    The member had one of the following weight-related comorbidities at baseline (1 through 7):

1)     Hypertension

2)     Dyslipidemia

3)     Type 2 diabetes mellitus

4)     Obstructive sleep apnea

5)     Symptomatic arthritis of the lower extremities

6)     Gastroesophageal reflux disease

7)     Coronary artery disease

d.    The member will be using the product in adjunct to all of the following healthy lifestyle modifications (i. and ii.):

i.      Reduced calorie diet

ii.    Exercise regimen

3.     The member has experienced continued weight loss in the past 12 months.

 

B.    Saxenda

·         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 (1. through 4.):

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

2.     The prescriber submits documentation (i.e. chart notes) substantiating all of the following (a., b, and c.):

a.     Documentation of baseline height, weight and BMI.

b.    The member meets one of the following (i. or ii.):

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

ii.    The member meets both of the following (A and B):

A)    The member has a BMI ≥ 27 kg/m2

B)    The member has one of the following weight-related comorbidities (1 through 7):

1)     Hypertension

2)     Dyslipidemia

3)     Type 2 diabetes mellitus

4)     Obstructive sleep apnea

5)     Symptomatic arthritis of the lower extremities

6)     Gastroesophageal reflux disease

7)     Coronary artery disease

c.     The member will be using the product in adjunct to all of the following healthy lifestyle modifications (i. and ii.):

i.      Reduced calorie diet

ii.    Exercise regimen

3.     The member has tried and failed two of the following medications or all are contraindicated (a. through d.):

a.     Belviq/Belviq XR

b.    Contrave

c.     Qsymia

d.    Xenical

4.     The member will not be using Saxenda with any of the following products (a., b., and c.):

a.     Insulin

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

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

 

·         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 (1. through 5.):

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

2.     The prescriber submits documentation (i.e. chart notes) substantiating all of the following (a., b, and c.):

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

b.    The member meets one of the following (i. or ii.):

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

ii.    The member meets both of the following (A and B):

A)    The member’s baseline BMI was ≥ 27 kg/m2

B)    The member had one of the following weight-related comorbidities at baseline (1 through 7):

1)     Hypertension

2)     Dyslipidemia

3)     Type 2 diabetes mellitus

4)     Obstructive sleep apnea

5)     Symptomatic arthritis of the lower extremities

6)     Gastroesophageal reflux disease

7)     Coronary artery disease

c.     The member will be using the product in adjunct to all of the following healthy lifestyle modifications (i. and ii.):

i.      Reduced calorie diet

ii.    Exercise regimen

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

4.     The member has tried and failed two of the following medications or all are contraindicated (a. through d.):

a.     Belviq/Belviq XR

b.    Contrave

c.     Qsymia

d.    Xenical

5.     The member will not be using Saxenda with any of the following products (a., b., and c.):

a.     Insulin

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

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

 

·         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 (1. through 5.):

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

2.     The prescriber submits documentation (i.e. chart notes) substantiating all of the following (a. through d.):

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

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

c.     The member meets one of the following (i. or ii.):

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

ii.    The member meets both of the following (A and B):

A)    The member’s baseline BMI was ≥ 27 kg/m2

B)    The member had one of the following weight-related comorbidities at baseline (1 through 7):

1)     Hypertension

2)     Dyslipidemia

3)     Type 2 diabetes mellitus

4)     Obstructive sleep apnea

5)     Symptomatic arthritis of the lower extremities

6)     Gastroesophageal reflux disease

7)     Coronary artery disease

d.    The member will be using the product in adjunct to all of the following healthy lifestyle modifications (i. and ii.):

i.      Reduced calorie diet

ii.    Exercise regimen

3.     The member has experienced continued weight loss in the past 12 months.

4.     The member has tried and failed two of the following medications or all are contraindicated (a. through d.):

a.     Belviq/Belviq XR

b.    Contrave

c.     Qsymia

d.    Xenical

5.     The member will not be using Saxenda with any of the following products (a., b, and c.):

a.     Insulin

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

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

 

II.        Reduce Risk of Weight Regain after Weight Loss

A.    Xenical

·         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 (1. through 5.)

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

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

3.     The prescriber submits documentation (i.e. chart notes) substantiating all of the following (a. and b.)

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

b.       The member meets one of the following (i. or ii.)

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

ii.       The member meets both of the following (A and B)

A)     The member's baseline BMI was > 27 kg/m2

B)     The member has or had one of the weight-related comorbidities at baseline (1 through 7)

1)     Hypertension

2)    Dyslipidemia

3)     Type 2 diabetes mellitus

4)    Obstructive sleep apnea

5)     Symptomatic arthritis of the lower extremities

6)      Gastroesophageal reflux disease

7)    Coronary artery disease

4.    The member will continue using the product in adjunct to all of the following healthy lifestyle modifications (a. and b.)

a.        Reduced calorie diet

b.        Exercise regimen

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

 

·         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 (1. through 6.)

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

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

3.     The prescriber submits documentation (i.e. chart notes) substantiating all of the following (a. and b.)

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

b.    The member meets one of the following (i. or ii.)

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

ii.      The member meets both of the following (A and B)

A)     The member's baseline BMI was > 27 kg/m2

B)     The member has or had one of the weight-related comorbidities at baseline (1 through 7)

1)     Hypertension

2)    Dyslipidemia

3)     Type 2 diabetes mellitus

4)    Obstructive sleep apnea

5)     Symptomatic arthritis of the lower extremities

6)      Gastroesophageal reflux disease

7)    Coronary artery disease

4.    The member will continue using the product in adjunct to all of the following healthy lifestyle modifications (a. and b.)

a.    Reduced calorie diet

b.    Exercise regimen

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

6.      The member has not experienced weight regain of > 35% from initiation of Xenical. 

 

III.  For Commercial and Healthcare Reform members enrolled in a West Virginia Plan, an exception to the step therapy within this policy may be made base on Policy J-513 – West Virginia – Step Therapy Override Exception – Commercial and Healthcare Reform.


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 will 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

None


Version: J-0184-010
Effective Date Begin: 01/01/2018
Effective End Begin: 08/08/2019
Original Date: 09/04/2013
Review Date: 08/01/2018


References:

  1. Belviq/Belviq XR [package insert]. Eisai Inc., Woodcliff Lake, NJ. May 2017.
  2. Qsymia [package insert]. Vivus, Inc., Campbell, CA. March 2018.
  3. Contrave [package insert]. Orexigen, La Jolla, CA. June 2018.
  4. Saxenda [package insert]. Novo Nordisk: Plainsboro, NJ; May 2017.
  5. Xenical [package insert]. Genentech, Inc: South San Francisco, CA; August 2015.
  6. DRUGDEX System (Micromedex 2.0). Greenwood Village, CO: Truven Health Analytics; 2018. Accessed July 27, 2018.
  7. Guidelines for the Management of Overweight and Obesity in Adults (2013). http://onlinelibrary.wiley.com/doi/10.1002/oby.20660/pdf (accessed 06/30/2017)
  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. https://www.aace.com/files/guidelines/ObesityExecutiveSummary.pdf. Published July 1, 2016. Accessed July 12, 2017.
  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. [EL 4; NE]
  10. Seger JC, Horn DB, Westman EC, et al. Obesity Algorithm, presented by the American Society of Bariatric Physicians. Available at: www.obesityalgorithm.org. Obesity Medicine Association. 2015. Accessed October 25, 2015. [EL 4; NE]
  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. [EL 4; NE]




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.