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
  • Contrave (bupropion and naltrexone)
  • Qsymia (phentermine and topiramate extended-release)
  • Saxenda (liraglutide)
  • Xenical (orlistat)
FDA-Approved Indications:
  • Contrave
    • 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) ≥ 30 kg/m2 or BMI ≥ 27 kg/m2 in the presence of at least one weight-related comorbidity (e.g., hypertension, dyslipidemia, type 2 diabetes)
  • Qsymia
    • As an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial BMI ≥ 30 kg/m2 or BMI ≥ 27 kg/m2 in the presence of at least one weight-related comorbidity (e.g., hypertension, dyslipidemia, type 2 diabetes)
  • Saxenda
    • As an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in:
      • Adults with an initial BMI ≥ 30 kg/m2 or BMI ≥ 27 kg/m2 in the presence of at least one weight-related comorbidity (e.g., hypertension, dyslipidemia, type 2 diabetes)
      • Pediatric patients aged 12 years and older with body weight ≥ 60 kg and an initial BMI corresponding to ≥ 30 kg/m2 or greater for adults (obese) by international cut-offs (Cole Criteria)
  • Xenical
    • For obesity management including weight loss and weight maintenance when used in conjunction with a reduced-caloric diet in adult patients and adolescents 12 years of age and older with an initial BMI ≥ 30 kg/m2 or ≥ 27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, dyslipidemia)
    • To reduce the risk for weight regain after prior weight loss


Background:
  • Initiation refers to members who are new to therapy. Continuation refers to the period after the initiation phase. 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.
  • Contrave
    • Regulates energy balance and decreases appetite by working in the hypothalamus (appetite regulatory center) and the mesolimbic dopamine circuit (the reward system) addressing the behavioral and physiological aspects of obesity.
  • Qsymia
    • 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.
  • Saxenda
    • 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.
    • For Saxenda for the treatment of adult patients, 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.
    • Example GLP-receptor agonists include Bydureon, Byetta, Trulicity, Victoza, Adlyxin, Ozempic, and Rybelsus. Example insulin/GLP-receptor agonist combinations include Soliqua and Xultophy.
    • The Cole Criteria (Table 1) were developed to define internationally acceptable age and sex specific cutoffs for child obesity. This table should be used to determine appropriateness of Saxenda in the treatment of adolescent patients.

 

Table 1. International Obesity Task Force BMI Cut-offs for Obesity by Sex and Age for Pediatric Patients Aged 12 Years and Older (Cole Criteria)

Age (years)

BMI corresponding to adult BMI of 30 kg/m2

Males

Females

12

26.02

26.67

12.5

26.43

27.24

13

26.84

27.76

13.5

27.25

28.20

14

27.63

28.57

14.5

27.98

28.87

15

28.30

29.11

15.5

28.60

29.29

16

28.88

29.43

16.5

29.14

29.56

17

29.41

29.69

17.5

29.70

29.84

 

  • Xenical
    • 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.
  • Prescribing Considerations:
    • While the 3 mg daily dose is the only dose of Saxenda that should be used in adult patients, pediatric patients who do not tolerate 3 mg daily may have their maintenance dose reduced to 2.4 mg daily. Saxenda should be discontinued in adults who do not tolerate 3 mg daily or pediatric patients who do not tolerate 2.4 mg daily.
    • 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.      Contrave, Qsymia or Xenical (for chronic weight management)

A.    Initiation

·         Contrave: 0 to < 4 months of previous therapy

·         Qsymia: 0 to < 7 months of previous therapy

·         Xenical: 0 to < 6 months of previous therapy

When a benefit, initiation of Contrave, Qsymia or Xenical may be approved when all of the following criteria are met (1., 2., and 3.):

1.     The member meets one (1) of the following criteria (a. or b.):

a.     If the request is for 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.

2.     The member is using the requested product for chronic weight management.

3.     The prescriber submits documentation substantiating all of the following (a., b., and c.):

a.     Baseline height, weight, and BMI.

b.    The member meets (1) one of the following (i. or ii.):

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

ii.    The member has a BMI ≥ 27 kg/m2 and has one (1) of the following weight-related comorbidities (A) through G)):

A)    Coronary artery disease

B)    Dyslipidemia

C)    Gastroesophageal reflux disease

D)    Hypertension

E)    Obstructive sleep apnea

F)    Symptomatic arthritis of the lower extremities

G)    Type 2 diabetes mellitus

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

i.      Reduced calorie diet

ii.    Exercise regimen

 

B.    Continuation

·         Contrave: 4 to < 12 months of previous therapy

·         Qsymia: 7 to < 12 months of previous therapy

·         Xenical: 6 to < 12 months of previous therapy

When a benefit, continuation therapy of Contrave, Qsymia or Xenical may be approved when all of the following criteria are met (1. through 4.):

1.     The member meets one (1) of the following criteria (a. or b.):

a.     If the request is for 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.

2.     The member is using the requested product for chronic weight management.

3.     The prescriber submits documentation substantiating all of the following (a. through d.):

a.     Baseline height, weight, and BMI.

b.    Current height, weight, and BMI.

c.     The member meets (1) one of the following (i. or ii.):

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

ii.    The member has a BMI ≥ 27 kg/m2 and has one (1) of the following weight-related comorbidities (A) through G)):

A)    Coronary artery disease

B)    Dyslipidemia

C)    Gastroesophageal reflux disease

D)    Hypertension

E)    Obstructive sleep apnea

F)    Symptomatic arthritis of the lower extremities

G)    Type 2 diabetes mellitus

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

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

 

C.    Maintenance

·         Contrave, Qsymia, or Xenical: ≥ 12 months of previous therapy

When a benefit, maintenance therapy of Contrave, Qsymia or Xenical may be approved when all of the following criteria are met (1. through 4.):

1.     The member meets one (1) of the following criteria (a. or b.):

a.     If the request is for 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.

2.     The member is using the requested product for chronic weight management.

3.     The prescriber submits documentation substantiating all of the following (a. through d.):

a.     Baseline height, weight, and BMI.

b.    Current height, weight, and BMI.

c.     The member meets (1) one of the following (i. or ii.):

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

ii.    The member has a BMI ≥ 27 kg/m2 and has one (1) of the following weight-related comorbidities (A) through G)):

A)    Coronary artery disease

B)    Dyslipidemia

C)    Gastroesophageal reflux disease

D)    Hypertension

E)    Obstructive sleep apnea

F)    Symptomatic arthritis of the lower extremities

G)    Type 2 diabetes mellitus

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

4.     The member has maintained weight loss from baseline.

 

II.    Saxenda for Adolescents

A.    Initiation

·         0 to < 3 months previous therapy

When a benefit, initiation of Saxenda may be approved when all of the following criteria are met (1. through 4.):

1.     The member is 12 to less than 18 years of age.

2.     The member is using Saxenda for chronic weight management.

3.     The prescriber submits documentation substantiating all of the following (a. through d.):

a.     Baseline height, weight, and BMI.

b.    The member has a body weight ≥ 60 kg.

c.     The member has a BMI corresponding to ≥ 30 kg/m2 or greater for adults based on the Cole Criteria (Table 1, above).

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

i.      Reduced calorie diet

ii.    Exercise regimen

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

a.     GLP-receptor agonist.

b.    Insulin/GLP-receptor agonist combinations.

 

B.    Continuation

·         3 to < 12 months previous therapy

When a benefit, continuation therapy of Saxenda may be approved when all of the following criteria are met (1. through 5.):

1.     The member is 12 to less than 18 years of age.

2.     The member is using Saxenda for chronic weight management.

3.     The prescriber submits documentation substantiating all of the following (a. through e.):

a.     Baseline height, weight, and BMI.

b.    Current height, weight, and BMI.

c.     The member has a body weight ≥ 60 kg.

d.    The member has a BMI corresponding to ≥ 30 kg/m2 or greater for adults based on the Cole Criteria (Table 1, above).

e.     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

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

a.     GLP-receptor agonist.

b.    Insulin/GLP-receptor agonist combinations.

5.     The member has experienced ≥ 1% weight loss from baseline

 

C.    Maintenance

·         ≥ 12 months previous therapy

When a benefit, maintenance therapy of Saxenda may be approved when all of the following criteria are met (1. through 5.):

1.     The member is 12 to less than 18 years of age.

2.     The member is using Saxenda for chronic weight management.

3.     The prescriber submits documentation substantiating all of the following (a. through e.):

a.     Baseline height, weight, and BMI.

b.    Current height, weight, and BMI.

c.     The member has a body weight ≥ 60 kg.

d.    The member has a BMI corresponding to ≥ 30 kg/m2 or greater for adults based on the Cole Criteria (Table 1, above).

e.     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

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

a.     GLP-receptor agonist.

b.    Insulin/GLP-receptor agonist combinations.

5.     The member has maintained weight loss from baseline.

 

III.    Saxenda for Adults

A.    Initiation

·         0 to < 4 months previous therapy

When a benefit, initiation of Saxenda may be approved when all of the following criteria are met (1. through 5.):

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

2.     The member is using Saxenda for chronic weight management.

3.     The prescriber submits documentation substantiating all of the following (a., b., and c.):

a.     Baseline height, weight, and BMI.

b.    The member meets (1) one of the following (i., ii., or iii.):

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

ii.    The member has a BMI ≥ 27 kg/m2 and has one (1) of the following weight-related comorbidities (A) through G)):

A)    Coronary artery disease

B)    Dyslipidemia

C)    Gastroesophageal reflux disease

D)    Hypertension

E)    Obstructive sleep apnea

F)    Symptomatic arthritis of the lower extremities

G)    Type 2 diabetes mellitus

iii.   The member meets all of the following criteria (A), B), and C)):

A)    The member was initiated on Saxenda therapy prior to turning 18 years of age.

B)    The member has been on Saxenda for at least 3 months.

C)    The member has experienced ≥ 1% weight loss from baseline.

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

i.      Reduced calorie diet

ii.    Exercise regimen

4.     If the member has not been on Saxenda for at least 3 months as an adolescent, the member has experienced therapeutic failure or intolerance to two (2) of the following medications, or all are contraindicated (a., b., or c.):

a.     Contrave

b.    Qsymia

c.     Xenical

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

a.     GLP-receptor agonist.

b.    Insulin/GLP-receptor agonist combinations.

 

B.    Continuation

·         4 to < 12 months previous therapy

When a benefit, continuation therapy of Saxenda may be approved when all of the following criteria are met (1. through 6.):

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

2.     The member is using Saxenda for chronic weight management.

3.     The prescriber submits documentation substantiating all of the following (a. through d.):

a.     Baseline height, weight, and BMI.

b.    Current height, weight, and BMI.

c.     The member meets (1) one of the following (i., ii., or iii.):

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

ii.    The member has a BMI ≥ 27 kg/m2 and has one (1) of the following weight-related comorbidities (A) through G)):

A)    Coronary artery disease

B)    Dyslipidemia

C)    Gastroesophageal reflux disease

D)    Hypertension

E)    Obstructive sleep apnea

F)    Symptomatic arthritis of the lower extremities

G)    Type 2 diabetes mellitus

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

A)    The member was initiated on Saxenda therapy prior to turning 18 years of age.

B)    The member has experienced ≥ 1% weight loss from baseline.

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

4.     If the member has not been on Saxenda for at least 3 months as an adolescent, the member has experienced therapeutic failure or intolerance to two (2) of the following medications, or all are contraindicated (a., b., or c.):

a.     Contrave

b.    Qsymia

c.     Xenical

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

a.     GLP-receptor agonist.

b.    Insulin/GLP-receptor agonist combinations.

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

 

C.    Maintenance

·         ≥ 12 months previous therapy

When a benefit, maintenance therapy of Saxenda may be approved when all of the following criteria are met (1. through 6.):

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

2.     The member is using Saxenda for chronic weight management.

3.     The prescriber submits documentation substantiating all of the following (a. through d.):

a.     Baseline height, weight, and BMI.

b.    Current height, weight, and BMI.

c.     The member meets (1) one of the following (i., ii., or iii.):

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

ii.    The member has a BMI ≥ 27 kg/m2 and has one (1) of the following weight-related comorbidities (A) through G)):

A)    Coronary artery disease

B)    Dyslipidemia

C)    Gastroesophageal reflux disease

D)    Hypertension

E)    Obstructive sleep apnea

F)    Symptomatic arthritis of the lower extremities

G)    Type 2 diabetes mellitus

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

A)    The member was initiated on Saxenda therapy prior to turning 18 years of age.

B)    The member has experienced ≥ 1% weight loss from baseline.

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

4.     If the member has not been on Saxenda for at least 3 months as an adolescent, the member has experienced therapeutic failure or intolerance to two (2) of the following medications, or all are contraindicated (a., b., or c.):

a.     Contrave

b.    Qsymia

c.     Xenical

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

a.     GLP-receptor agonist.

b.    Insulin/GLP-receptor agonist combinations.

6.     The member has maintained weight loss from baseline.

 

IV.   Xenical (to reduce risk of weight regain after weight loss)

A.    Initiation

·         < 12 months previous therapy

When a benefit, initiation of Xenical may be approved when all of the following are met (1. through 5.):

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

2.     The member is using Xenical to reduce the risk of weight regain after initial weight loss.

3.     The prescriber submits documentation substantiating all of the following (a., b., and c.):

a.     Baseline height, weight, and BMI.

b.    Current height, weight, and BMI.

c.     The member meets one (1) of the following criteria (i. or ii.):

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

ii.    The member has a BMI ≥ 27 kg/m2 and has one (1) of the following weight-related comorbidities (A) through G)):

A)    Coronary artery disease

B)    Dyslipidemia

C)    Gastroesophageal reflux disease

D)    Hypertension

E)    Obstructive sleep apnea

F)    Symptomatic arthritis of the lower extremities

G)    Type 2 diabetes mellitus

4.     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

5.     The member has experienced ≥ 8% weight loss using non-pharmacologic weight loss therapy alone.

 

B.    Maintenance

·         > 12 months previous therapy

When a benefit, initiation of Xenical may be approved when all of the following are met (1. through 5.):

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

2.     The member is using Xenical to reduce the risk of weight regain after initial weight loss.

3.     The prescriber submits documentation substantiating all of the following (a., b., and c.):

a.     Baseline height, weight, and BMI.

b.    Current height, weight, and BMI.

c.     The member meets one (1) of the following criteria (i. or ii.):

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

ii.    The member has a BMI ≥ 27 kg/m2 and has one (1) of the following weight-related comorbidities (A) through G)):

A)    Coronary artery disease

B)    Dyslipidemia

C)    Gastroesophageal reflux disease

D)    Hypertension

E)    Obstructive sleep apnea

F)    Symptomatic arthritis of the lower extremities

G)    Type 2 diabetes mellitus

4.     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

5.     The member has maintained weight loss from baseline.

 

V.    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.      Coverage of drugs addressed in this policy for disease states outside of the FDA-approved indications should be denied based on the lack of clinical data to support effectiveness and safety in other conditions unless otherwise noted in the approval criteria.

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

.      Commercial and HCR Plans: If approved, up to the following authorization duration may be granted.

 

I.     Initiation

A.  Contrave: 4 months

B.  Qsymia: 7 months

C.  Saxenda for adolescents 12 years to less than 18 years of age: 3 months

D.  Saxenda for adults 18 years and older: 4 months

E.  Xenical: 6 months

 

II.    Continuation: 12 months

 

III.  Maintenance: 12 months

 

IV.   Discontinuation

A.  Additional coverage of 1 week for Contrave will be granted for discontinuation of the product.


Automatic Approval Criteria

None


Version: J-0184-018
Effective Date Begin: 02/09/2021
Effective End Begin: 06/13/2021
Original Date: 09/04/2013
Review Date: 01/27/2021


References:

  1. Qsymia [package insert]. Campbell, CA: Vivus, Inc.; March 2018.
  2. Contrave [package insert]. La Jolla, CA: Orexigen; June 2018.
  3. Saxenda [package insert]. Plainsboro, NJ: Novo Nordisk; December 2020.
  4. Xenical [package insert]. South San Francisco, CA: Genentech, Inc.; August 2015.
  5. DRUGDEX System (Micromedex 2.0). Greenwood Village, CO: Truven Health Analytics; 2020.
  6. Guidelines for the Management of Overweight and Obesity in Adults (2013). Accessed April 20, 2019.
  7. Cole TJ, Bellizzi MC, Flegal KM, Dietz WH. Establishing a standard definition for child overweight and obesity worldwide: international survey. BMJ. 2000;320(7244):1240-1243.
  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.

 

 

 




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.