Pharmacy Management Drug Policy

SUBJECT: Weight Management Policy

POLICY NUMBER: PHARMACY-03
EFFECTIVE DATE: 02/2012
LAST REVIEW DATE: 12/06/2023
If the member’s subscriber contract excludes coverage for a specific service or prescription drug, it is not covered
under that contract. In such cases, medical or drug policy criteria are not applied. This drug policy applies to the
following line/s of business:
Policy Application
Category: ☒ Commercial Group (e.g., EPO, HMO, POS, PPO) ☐ Medicare Advantage
☒ On Exchange Qualified Health Plans (QHP) ☐ Medicare Part D
☒ Off Exchange Direct Pay ☒ Essential Plan (EP)
☐ Medicaid & Health and Recovery Plans (MMC/HARP) ☒ Child Health Plus (CHP)
☐ Federal Employee Program (FEP) ☐ Ancillary Services
☐ Dual Eligible Special Needs Plan (D-SNP)

DESCRIPTION:

Observational epidemiological studies have established a relationship between obesity and visceral
fat and the risks for cardiovascular disease, type 2 diabetes, certain forms of cancer, gallstones,
certain respiratory disorders, and an increase in overall mortality. These studies suggest that weight
loss, if maintained, may produce health benefits for obese patients who have or are at risk of
developing weight related co-morbidities.

Orlistat, liraglutide, semaglutide, naltrexone/bupropion ER, tirzepatide and

phentermine/topiramate ER are indicated for the management of obesity, including weight loss
and maintenance of weight loss, and should be used in conjunction with a reduced calorie diet.

Xenical (orlistat) is also indicated to reduce the risk of weight regain after prior weight loss. Orlistat
is a reversible inhibitor of lipases. It exerts its therapeutic activity in the lumen of the stomach and
small intestine by forming a covalent bond with the active serine residue site of gastric and
pancreatic lipases. The inactivated enzymes are thus unavailable to hydrolyze dietary fat in the
form of triglycerides into absorbable free fatty acids and monoglycerides. As undigested
triglycerides are not absorbed, the resulting caloric deficit may have a positive effect on weight
control.

Saxenda (liraglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist. GLP-1 is a regulator

of appetite and calorie intake. GLP-1 receptors are present in several areas of the brain involved
with appetite regulation. Liraglutide increases feelings of satiety and decreases hunger.

Wegovy (semaglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist. GLP-1 is a

physiological regulator of appetite and caloric intake, and the GLP-1 receptor is present in several
areas of the brain involved in appetite regulation. Semaglutide increases feelings of satiety and
decreases hunger.

Contrave is a combination of two FDA-approved drugs, naltrexone, and bupropion, in an

extended-release formulation. Naltrexone is approved to treat alcohol and opioid dependence.
Bupropion is approved to treat depression and seasonal affective disorder and as an aid to
smoking cessation treatment.
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Qsymia is a combination of phentermine, a sympathomimetic amine anorectic, and topiramate, an
antiepileptic drug. The exact mechanism of action of these agents is not known. Phentermine
likely releases catecholamines in the hypothalamus, resulting in reduced appetite and decreased
food consumption. Topiramate leads to appetite suppression and satiety enhancement, possibly
induced by a combination of pharmacologic effects.
Zepbound (tirzepatide) glucose-dependent insulinotropic polypeptide (GIP) receptor and
glucagon-like peptide-1 (GLP-1) receptor agonist. GIP and GLP-1 are physiological regulators of
appetite, caloric intake, and insulin secretion and the GLP-1and GIP receptors are present in
several areas of the brain involved in appetite regulation. Tirzepatide increases feelings of satiety
and decreases hunger.
The FDA has approved orlistat, naltrexone/bupropion ER, phentermine/topiramate ER, semaglutide,
tirzepatide and liraglutide as adjuncts to caloric restriction, increased physical activity and behavior
modification in the overall treatment of qualifying obesity. The medications are not approved as the
sole therapeutic modality.
Imcivree is indicated for chronic weight management in adults and pediatric patients ≥ 6 years of
age with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1
(PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing demonstrating variants
in the POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of
uncertain significance.
Imcivree is a melanocortin 4 (MC4) agonist. MC4 receptors in the brain are involved in regulation
of hunger, satiety, and energy expenditure. In patients with obesity due to POMC, PCSK1, and
LEPR deficiency associated with insufficient activation of the MC4 receptor, Imcivree may re-
establish MC4 receptor pathway activity to reduce hunger and promote weight loss through
decreased caloric intake and increased energy expenditure.
General Policy Criteria – For Contrave, Qsymia, Saxenda, Wegovy, Zepbound and
Xenical/Orlistat only. Please refer to drug specific section for ALL Imcivree criteria:
Based upon our review and assessment of peer-reviewed literature, Contrave, Xenical/Orlistat,
Saxenda, Wegovy, Zepbound and Qsymia, have been medically proven to be effective and
therefore medically necessary in the treatment of obesity if all the following criteria are met:
1. For initial reviews, member must fall under one of the following: A, B, or C. (Qsymia,
Wegovy and Saxenda ages 12-17, please refer to drug specific policy below for clinical
criteria for this step) AND
A. Obesity defined as a BMI greater than or equal to 30 kg/m²
OR
B. BMI greater than or equal to 27 kg/m² in the presence of one or more co-morbidities
listed below:
Established Coronary Heart Disease
Other Atherosclerotic Diseases
Dyslipidemia (ex. high LDL, TG, or low HDL)
Hypertension
Type 2 Diabetes
Sleep Apnea
Gynecological abnormalities
Osteoarthritis
Gallstones
Stress Incontinence
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OR
C. BMI greater than or equal to 27 kg/m2 in the presence of two or more risk factors listed
below:
Elevated Blood Pressure (systolic 120-129; diastolic <80)
Smoking
Impaired fasting glucose
Family History of premature CHD
Male > 45 y.o., Female > 55 y.o.
2. Documentation of current enrollment into a qualified comprehensive weight
management program for at least 3 months in addition to counseling in a physician’s
office is required for pharmacotherapy coverage. (Please refer to addendum for
program criteria.) AND

EXAMPLES OF APPROVED PROGRAMS

➢ Provider based counseling that meets guidelines for a comprehensive weight management
program (see addendum at end of policy).
➢ Weight Watchers, Curves Nutrition & Weight Management Program, or other programs that
meet the guidelines for a comprehensive weight management program (see addendum at
end of policy).
➢ Please note: Weight Watchers, Curves Nutrition & Weight Management Program, and
other commercial weight management programs are generally excluded by contract and
therefore, ineligible for coverage under the medical benefit.
Refer to Corporate Medical Policy 11.01.01 regarding Medical/Non-Surgical Weight Management
Programs and Services.
3. For initial approvals - Proof of current and prior participation in a comprehensive
weight management program (such as a receipt or certificate and dietary/exercise logs)
will be required.
4. Recertification of drug approval beyond the initial coverage period will require provider
acknowledgement (via prior authorization form or provider progress note) of continued
comprehensive weight management program enrollment.
5. The safety and efficacy of any anorexiant in combination with other weight loss drugs
(including prescription, OTC, and herbal preparations) has not been established and
therefore, combination therapy will not be approved.
Drug-Specific Policy:

Contrave (naltrexone/bupropion) specific criteria:

1. Member must be 18 years of age or older

2. Initial coverage duration is 4 months. After initial coverage period, recertification will be
required every 6 months.
3. For authorization for additional drug coverage (recertification):
a. For initial recertification, patient must have a physician verified weight loss of 5% of
initial weight by 4 months. Failure to lose 5% of weight at 4 months suggests that
positive health outcome may not be realized, and drug therapy coverage will not be
continued.
b. For continued 6-month recertifications, patient must have maintained initial 5% weight
loss OR has continued to lose weight.
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4. The maximum daily dose is Naltrexone 32 mg/bupropion 360 mg daily (two tablets twice
daily) according to the prescribing information. According to the prescribing information,
titration to this dose occurs over a 4-week period. Response to therapy should be
evaluated after 3 months at the maintenance dosage.

Qsymia (Phentermine/topiramate ER) specific criteria:

For Adults:
1. Member must be 18 years or older
2. Initial coverage duration is 6 months. After the initial coverage period, recertification will be
required every 6 months.
3. For authorization for additional drug coverage (recertification):
a. For initial recertification, patient must have physician verified weight loss of 5% of initial
weight by 6 months.
b. For continued 6-month recertifications, patient must have maintained initial 5% weight
loss OR has continued to lose weight.
4. Please note that the manufacturer recommends the following:
a. Discontinue or increase dose if 3% weight loss is not achieved after 12 weeks on the
7.5/46mg dose.
b. Discontinue Qsymia if 5% weight loss is not achieved after 12 weeks on maximum
daily dose of 15mg/92mg.
c. Discontinue 15/92mg dose gradually to prevent possible seizure.

For Adolescents:
1. Must be 12-17 years of age AND
2. Must have an initial BMI in the 95th percentile or greater standardized for age and sex.
(See CDC website for current BMI for age Growth Charts:
https://www.cdc.gov/healthyweight/assessing/bmi/childrens_bmi/about_childrens_bmi.html)
OR use chart below: AND
3.

4. For authorization for additional drug coverage (recertification):

a. For initial recertification, patient must have a physician verified BMI reduction of 5%
of initial weight by 6 months. Failure to lose 5% of BMI at 6 months suggests that
positive health outcome may not be realized, and drug therapy coverage will not be
continued.
b. For continued 6-month recertifications, patient must have maintained initial 5%
weight loss OR has continued to lose weight.

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5. Please note, the manufacturer recommends the following:
a. Monitor the rate of weight loss in pediatric patients. If weight loss exceeds 2 lbs. (0.9
kg)/week, consider dosage reduction.
b. After 12 weeks of treatment with QSYMIA 7.5 mg/46mg, if a pediatric patient has not
experienced a reduction of at least 3% of baseline BMI, increase the dosage to
QSYMIA 11.25 mg/69 mg (phentermine 11.25 mg/topiramate 69 mg) orally once
daily for 14 days; followed by an increase in the dosage to QSYMIA 15 mg/92 mg.
c. Discontinue QSYMIA 15 mg/92 mg gradually by taking QSYMIA 15 mg/92 mg once
daily every other day for at least 1 week prior to stopping treatment altogether, due
to the possibility of precipitating a seizure

Saxenda (liraglutide) specific criteria:

As of 9/12/23 the following policy criteria will be applicable:

As a result of unexpected demand that far exceeded the manufacturer’s expectations, there is
currently a supply shortage of Saxenda in the marketplace. Novo Nordisk, the manufacturer of
Saxenda, stated there is a shortage of Saxenda, and they will not be able to meet demand for the
medication for an extended period of time. Saxenda is available as a 6 mg/mL strength in a 3 mL
pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg. According to drug labeling,
only the 3mg dose is utilized for maintenance. All other doses are for dose titration only. Due to
the supply issues, titration, and maintenance to 3mg daily cannot be reliably and safely completed
and puts patients at risk for requiring recurrent titration periods which have a lack of weight loss
benefit or continuing maintenance dosing after a large gap in therapy which can lead to adverse
effects. Effective immediately, request for patient's new to therapy with Saxenda will NOT be
granted approval until the supply-chain is restored. A review for an alternative product contained
within this policy can be requested.

When supply of Saxenda is restored to adequate levels, the following criteria will then
become active again for all requests.

For Adults:
1. Member must be 18 years of age or older AND
2. Will not be approved for use in combination with any other GIP and/or GLP-1 receptor
agonist (Adlyxin, Byetta/Bydureon, Victoza, Ozempic, Rybelsus, Trulicity and Mounjaro) AND
3. Initial coverage duration is 4 months. After the initial coverage period, recertification will be
required every 6 months.
4. For authorization for additional drug coverage (recertification):
a. Upon recertification the patient must be utilizing the 3mg dose as maintenance therapy.
b. For initial recertification, patient must have physician verified weight loss of 5% of initial
weight by 4 months.
c. For continued 6-month recertifications, patient must have maintained initial 5% weight
loss OR has continued to lose weight.
5. The maximum daily dose is 3mg subcutaneously once daily according to the prescribing
information.
For Adolescents:
6. Must be 12-17 years of age AND
7. Must have body weight ≥60kg (~132lbs) AND

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8. Must have an initial BMI corresponding to 30 kg/m2 or greater for adults (obese) by
international cut-offs (Cole Criteria; see table) AND

9. Will not be approved for use in combination with any other GIP and/or GLP-1 receptor
agonist (Adlyxin, Byetta/Bydureon, Victoza, Ozempic, Rybelsus, Trulicity and Mounjaro) AND
10. Initial coverage duration is 5 months. After the initial coverage period, recertification will be
required every 6 months.
11. For authorization for additional drug coverage (recertification):
a. Upon recertification the patient must be utilizing the 2.4mg or 3mg dose as
maintenance therapy.
b. For initial recertification, patient must have a physician verified reduction in BMI of at
least 1% by 5 months. Failure to reduce BMI by at least 1% at 5 months suggests that
it is unlikely the patient will achieve and sustain clinically meaningful weight loss, and
therefore coverage will not be continued.
c. For continued 6-month recertifications, patient must have maintained initial 1% weight
loss OR has continued to lose weight.
12. Please note, the manufacturer recommends the following
a. Maintenance dosage of SAXENDA is 3 mg daily. Pediatric patients who do not tolerate
3 mg daily may have their maintenance dose reduced to 2.4 mg daily. Discontinue
SAXENDA if the patient cannot tolerate the 2.4 mg dose.
b. Dose escalation for pediatric patients may take up to 8 weeks.
c. Evaluate the change in BMI after 12 weeks on the maintenance dose.

Wegovy (semaglutide) specific criteria:

As of 5/24/23 the following policy criteria will be applicable.

1. As a result of unexpected demand that far exceeded the manufacturer’s expectations, there
is currently a supply shortage of Wegovy in the marketplace. Novo Nordisk, the
manufacturer of Wegovy, stated they will continue to limit shipments of certain strengths of
Wegovy (0.25 mg, 0.5 mg, and 1 mg) for an extended period of time. Wegovy requires
dose titration with 5 unique strengths to reach the target dose of 1.7 or 2.4mg over a period
of 16 weeks. According to drug labeling, only the 1.7mg or 2.4mg strength is utilized for
maintenance. All other strengths are for dose titration only. Due to the supply issues,
titration to 1.7 or 2.4mg cannot be reliably completed and puts patients at risk for
inappropriate dose titration or “dose jumping” based on available strengths which can lead
to adverse effects or utilization of a lower, titration dose for an extended period as
maintenance therapy. Effective immediately, request for patient's new to therapy requiring
titration to the maintenance dose of Wegovy will NOT be granted approval until the supply-

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chain is restored and all strengths are readily available. A review for an alternative product
contained within this policy can be requested.
2. The quantity limit for all strengths (0.25mg, 0.5mg, 1mg, 1.7mg, 2.4mg) is 4 pens per 28
days. Requests for a quantity outside of these limits will not be approved (i.e., use of
0.25mg x4 pens to make a 1mg dose or use of 0.5mg x2 pens, etc.).

When supply of Wegovy is restored to adequate levels, the following criteria will then
become active again for all requests.
For Adults:
3. The quantity limit for all strengths (0.25mg, 0.5mg, 1mg, 1.7mg, 2.4mg) is 4 pens per 28
days. Requests for a quantity outside of these limits will not be approved (i.e., use of 0.25mg
x 4 pens to make a 1mg dose or use of 0.5mg x2 pens, etc.).
4. Member must be 18 years of age or older AND
5. Will not be approved for use in combination with any other GIP and/or GLP-1 receptor
agonist (Adlyxin, Byetta/Bydureon, Victoza, Ozempic, Rybelsus, Trulicity and Mounjaro) AND
6. Initial coverage duration is 7 months. After the initial coverage period, recertification will be
required every 6 months.
7. For authorization for additional drug coverage (recertification):
a. Upon recertification the patient must be utilizing the 2.4mg OR the 1.7mg dose as
maintenance therapy.
b. For initial recertification, patient must have physician verified weight loss of 5% of initial
weight by 7 months.
c. For continued 6-month recertifications, patient must have maintained initial 5% weight
loss OR has continued to lose weight.
8. The maintenance dose of Wegovy is 2.4mg OR 1.7mg once weekly, and is titrated according
to the following schedule and recommendations:
a. If patients do not tolerate a dose during dose escalation, consider delaying dose
escalation for 4 weeks.
b. Consider treatment response and tolerability when selecting the maintenance dosage.
c. The 0.25 mg, 0.5 mg, and 1 mg once-weekly dosages are initiation and escalation
dosages and are not approved as maintenance dosages for chronic weight
management.

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For Adolescents:
1. Must be 12-17 years of age AND
2. Must have an initial BMI in the 95th percentile or greater standardized for age and sex. (See
CDC website for current BMI for age Growth Charts:
https://www.cdc.gov/healthyweight/assessing/bmi/childrens_bmi/about_childrens_bmi.html)
OR use chart below: AND

3. Will not be approved for use in combination with any other GIP and/or GLP-1 receptor
agonist (Adlyxin, Byetta/Bydureon, Victoza, Ozempic, Rybelsus, Trulicity and Mounjaro) AND
4. Initial coverage duration is 7 months. After the initial coverage period, recertification will be
required every 6 months.
a. For authorization for additional drug coverage (recertification): Upon recertification the
patient must be utilizing the 1.7mg or 2.4mg dose as maintenance therapy.
b. For initial recertification, patient must have a physician verified reduction in BMI of at
least 5% by 7 months. Failure to reduce BMI by at least 5% at 7 months suggests that
it is unlikely the patient will achieve and sustain clinically meaningful weight loss, and
therefore coverage will not be continued.
c. For continued 6-month recertifications, patient must have maintained initial 5% weight
loss OR has continued to lose weight.
5. Please note, the manufacturer recommends the following:
a. Maintenance dosage of WEGOVY is 2.4 mg weekly.
b. Dose escalation for pediatric patients may take up to 16 weeks.

Xenical and generic orlistat specific criteria:

1. Member must be 12 years of age or older

2. Requests for brand Xenical will require documentation of serious side effects or drug failure
with generic orlistat.
3. Initial coverage duration is 6 months. After the initial coverage period, recertification will be
required every 6 months.
4. For authorization for additional drug coverage (recertification):
a. For initial recertification, patient must a physician verified weight loss of 5% of initial
weight by 6 months. Failure to lose 5% of weight at 6 months suggests that positive
health outcome may not be realized, and drug therapy coverage will not be continued.
b. For continued 6-month recertifications, patient must have maintained initial 5% weight
loss OR has continued to lose weight.
5. The maximum daily dose is one 120mg capsule by mouth three times a day with each main
meal containing fat (during or up to 1 hour after the meal) according to the prescribing
information.
6. Quantity Limit of 90 capsules/30 days

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Zepbound (tirzepatide) specific criteria:
1. The quantity limit for all strengths (2.5mg, 5mg, 7.5mg, 10mg, 12.5mg 15mg) is 2ml (4 pens)
per 28 days. Requests for a quantity outside of these limits will not be approved
i. The 2.5mg strength will be limited to 2ml/365 days to allow for titration to maintenance
dosing.
2. Member must be 18 years of age or older AND
3. Will not be approved for use in combination with any other GIP and/or GLP-1 receptor
agonist (Adlyxin, Byetta/Bydureon, Victoza, Ozempic, Rybelsus, Trulicity and Mounjaro) AND
4. Initial coverage duration is 7 months. After the initial coverage period, recertification will be
required every 6 months.
5. For authorization for additional drug coverage (recertification):
a. Upon recertification the patient must be utilizing the 5mg, 7.5mg, 10mg, 12.5mg or
15mg dose as maintenance therapy.
b. For initial recertification, patient must have physician verified weight loss of 5% of
initial weight by 7 months.
c. For continued 6-month recertifications, patient must have maintained initial 5% weight
loss OR has continued to lose weight.
6. Please note, the manufacturer recommends the following:
a. The maximum dose is 15mg subcutaneously once weekly according to the
prescribing information.
b. The recommended starting dosage is 2.5 mg once weekly for 4 weeks. The 2.5 mg
dosage is for treatment initiation and is not intended for chronic weight management.
c. The recommended maintenance dosages are 5 mg, 10 mg, or 15 mg injected
subcutaneously once weekly.
d. If patients do not tolerate a maintenance dosage, consider a lower maintenance
dosage.

Imcivree (setmelanotide) specific criteria (NOTE: Comprehensive Weight Management

Program criteria do not apply to this drug):

Based upon our review and assessment of peer-reviewed literature, Imcivree, has been medically
proven to be effective and therefore medically necessary in the treatment of obesity due to variants
in the POMC, PCSK1, or LEPR genes that are interpreted as ‘pathogenic, likely pathogenic, or of
uncertain significance (VUS),’ if ALL the following criteria are met:
1. Must be prescribed by an expert in rare genetic disorders of obesity or a medical geneticist AND
2. Must be ≥ 6 years of age or older AND
3. Must have a creatinine clearance (CrCl) ≥ 15 mL/min
4. Must have one of the following diagnoses (a or b):
a. Must have a diagnosis of obesity due to POMC, PCSK1, and LEPR deficiencies that
includes ALL the following (i-iv)
i. A diagnosis of Obesity is defined as:
1. Adult patients with a BMI of ≥ 30 kg/m2 OR
2. Pediatric patients (6-17 years): For diagnosis of POMC, PCSK1, and LEPR
deficiencies with body weight ≥ 95th percentile for age using growth chart
assessments AND
ii. Documentation of a recent (within the past month) height measurement, weight
measurement, BMI, and growth chart (for pediatric patients) must be submitted for
each review (initial and recertifications) AND
iii. Obesity must be due to a homozygous or presumed compound heterozygous variant
in at least one of the following genes, confirmed by genetic testing, AND:
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1. Proopiomelanocortin (POMC)
2. Proprotein convertase subtilisin/kexin type 1 (PCSK1)
3. Leptin receptor (LEPR)
iv. Documentation of genetic testing demonstrating that the variants in POMC, PCSK1,
or LEPR genes are interpreted as ‘pathogenic’, ‘likely pathogenic’, OR ‘of
uncertain significance (VUS)’ must be submitted. Coverage will not be provided
for variants identified as ‘benign’ or ‘likely benign.’ Please note, direct to
consumer (DTC) testing will not be accepted as these tests do not determine if the
gene variant is disease-causing. OR
b. Must have a diagnosis of monogenic or syndromic obesity due to Bardet-Biedl syndrome
(BBS) that includes the following (i-iii):
i. A diagnosis of Obesity is defined as:
1. Adult patients with a BMI of ≥ 30 kg/m2
2. Pediatric patients (6-17 years): For diagnosis of BBS ≥97th percentile using
growth chart assessments AND
ii. Documentation of a recent (within the past month) height measurement, weight
measurement, BMI, and growth chart (for pediatric patients) must be submitted for
each review (initial and recertifications) AND
iii. Patient has either 4 primary features OR 3 primary and 2 secondary features of BBS:
1. Primary features: Rod-cone dystrophy, Polydactyly, Obesity, Learning
disabilities, Hypogonadism in males, Renal anomalies
2. Secondary features: Speech disorder/delay, Strabismus/cataracts/astigmatism,
Brachydactyly/syndactyly, Developmental delay, Polyuria/polydipsia
(nephrogenic diabetes insipidus), Ataxia/poor coordination/imbalance, Mild
spasticity (especially lower limbs), Diabetes mellitus, Dental crowding/
hypodontia/small roots/high arched palate, left ventricular hypertrophy/congenital
heart disease, Hepatic fibrosis AND
3. Initial approval will be for 12 months.
a. Recertification for obesity due to variants in the POMC, PCSK1, or LEPR genes
after the initial approval of 4 months will require documentation of a ≥5% decrease of
baseline body weight, or a ≥5% decrease of baseline body mass index (BMI) for
patients with continued growth potential (pediatric patients). If the patient meets for
recertification, approval will be for 8 months.
Recertification at the 1-year mark will require documentation that the patient achieved a
≥ 10% decrease of baseline body weight or a ≥ 10% decrease of BMI for patients with
continued growth potential (pediatric patients). If the patient meets for recertification,
approval will be for 1 year.
Recertifications thereafter will require documentation that the patient maintains a
weight loss of ≥ 10% decrease of baseline body weight or a ≥ 10% decrease of BMI for
patients with continued growth potential (pediatric patients). If the patient meets for
recertification, approval will be for 1 year.
Recertification for obesity due to Bardet-Biedl syndrome (BBS) after the initial
approval of 12 months will require documentation of a ≥5% decrease of baseline body
weight, or a ≥5% decrease of baseline body mass index (BMI) for patients with
continued growth potential (pediatric patients). If the patient meets for recertification,
approval will be for 1 year.

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Recertifications thereafter will require documentation that the patient maintains a
weight loss of ≥ 5% decrease of baseline body weight or a ≥ 5% decrease of BMI for
patients with continued growth potential (pediatric patients). If the patient meets for
recertification, approval will be for 1 year.
b. Each recertification will require that the patient has a creatinine clearance of at least 15
mL/min.
5. Recommended Dose:
a. The maximum daily dose is 3 mg (0.3 mL) for adults and pediatric patients
b. Adult Patients: Starting dose: 2 mg injected subcutaneously (SC) once daily for 2
weeks. If the starting dose is not tolerated, reduce to 1 mg once daily. If the 1-mg once-
daily dose is tolerated and additional weight loss is desired, titrate to 2 mg once daily. If
the 2-mg daily dose is tolerated, increase the dose to 3 mg once daily. If the 3-mg
once-daily dose is not tolerated, maintain administration of 2 mg once daily.
c. Pediatric Patients: Starting dose: 1 mg injected SC once daily for 2 weeks. If the
starting dose is not tolerated, reduce to 0.5 mg once daily. If the 0.5-mg once-daily
dose is tolerated and additional weight loss is desired, titrate to 1 mg once daily. If the
1-mg dose is tolerated, increase the dose to 2 mg once daily. If the 2-mg once-daily
dose is not tolerated, reduce to 1 mg once daily. If the 2-mg once-daily dose is
tolerated and additional weight loss is desired, the dose may be increased to 3 mg
once daily.
6. Quantity Limit of 9 milliliters (9 vials) per 30 days.
7. Imcivree will not be covered in the following circumstances:
a. Non-FDA approved genetic conditions that can cause obesity (such as: Alström
syndrome, Prader-Willi syndrome [PWS], etc.)
b. A lifetime history of suicide attempt or any suicidal behavior within the last month
c. Prior gastric bypass surgery resulting in >10% weight loss durably maintained from the
baseline pre-operative weight, with no evidence of weight regain

POLICY GUIDELINES:

1. Utilization Management are contract dependent and coverage criteria may be dependent on the
contract renewal date. Additionally, coverage of drugs listed in this policy are contract
dependent. Refer to specific contract/benefit language for exclusions.
2. This policy is applicable to drugs that are included on a specific drug formulary. If a drug
referenced in this policy is non-formulary, please reference the Coverage Exception Evaluation
Policy for All Lines of Business Formularies policy for review guidelines.
3. Organic causes of obesity such as hypothyroidism should be excluded before prescribing weight
loss medications.
4. Victoza (liraglutide) will not be authorized at a dose of greater than 1.8mg once daily, as there is
an active formulation of liraglutide (Saxenda) that is FDA approved for chronic weight
management. Ozempic (semaglutide) will not be authorized at a dose greater than 2mg once
weekly, as there is an active formulation of semaglutide that is FDA approved for chronic weight
management.
5. Upon recertification, maintenance dosing per FDA labeling will be required for continued use of
Wegovy, Zepbound and Saxenda. Dosing below FDA approved maintenance dosing will not be
allowed after adequate dose titration (per medication package insert) has occurred.

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Pharmacy Management Drug Policy
Weight Management Policy
UPDATES:

Date: Revision:
12/06/2023 Revised
11/29/2023 Revised
10/25/2023 Revised
10/10/2023 Revised
9/12/2023 Revised
9/5/2023 Revised
8/24/2023 P&T Committee Approval
8/15/2023 Revised
6/28/2023 Revised
6/21/2023 Revised
5/24/2023 Revised
04/01/2023 Revised
1/2023 Revised
10/2022 Revised
8/2022 Revised
07/14/2022 Reviewed & Approved P&T Committee
7/2022 Revised
1/2022 Revised
9/2021 Revised
7/2021 Revised/P&T Committee Approval
6/21 Revised
2/21 Revised
12/20 Revised
11/2020 Revised
9/16/2020 P&T Committee Approval
8/2020 Revised
03/20 Revised
02/20 Revised
9/19 P&T Committee Approval
08/19 Revised
06/19 Reviewed
08/18 Revised
06/18 Revised
8/17 Revised
9/16 Revised
12/15 Revised
4/15 Revised
9/14 Revised
7/14 Revised
2/14 Revised
6/13 Revised
1/13 Revised
10/12 Revised
7/12 Revised
5/99 Created

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Pharmacy Management Drug Policy
Weight Management Policy
REFERENCES:

1. US Food and Drug Administration. CDER Report to Nation: 2003. Found in

http://www.fda.gov/cder/reports/rtn/2003/rtn2003-1.HTM
2. Fitchet M, et al. Meta-analysis of weight loss in three dose ranging studies [abstract],Int J Obes
1996; 20:156. .
3. Xenical Prescribing information. Cheplapharm; revised 08/2017. Accessed online 05/31/19.
4. Clinical Guidelines on the Indication, Evaluation, and Treatment of Overweight and Obesity in
Adults. National Institute of Health. National Heart, Lung & Blood Institute 1998
5. Heshka S, et al. Weight Loss with Self-help Compared with a Structured Commercial Program:
A Randomized Trial, JAMA April 9, 2003;289(14): 1792-1798
6. Diet, Drugs and Surgery for Weight Loss, Treatment Guidelines from The Medical Letter,
December 2003; Vol1 (Issue 16):101-106
7. Ogden C, et al. Prevalence of Overweight and Obesity in the United States 1999-2004 JAMA
April 5, 2006; 295: 1549-1555
8. Issued by Leade Health Inc: RadosevichT, VossD. Excellus Outcomes Report --Weight
Management Program September 2001 through March 2003; Leade Health Inc, Ann Arbor,
Michigan May 2003
9. Christakis NA, Fowler JH The Spread of Obesity in a Large Social Network over 32 Years JAMA
July 26, 2007 357:370-379
10. Redmon, JB, et al Two-Year outcome of a Combination of Weight Loss Therapies for Type 2
Diabetes Care 2005,28(6):1311-1315
11. Snow V; Barry P; Fitterman N; Qaseem A; Weiss K Pharmacologic and surgical management of
obesity in primary care: a clinical practice guideline from the American College of Physicians
Ann Intern Med 2005 Apr 5;142(7):525-31
12. USPSTF Screening for Obesity Release date Dec 2003 Accessed at
www.ahrq.gov/clinic/uspstfix.htm
13. www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm19
8221.htm - 31k - 2010-01-21
14. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/
ucm228830.htm
15. Wadden TA, et al A two-year randomized trial of obesity treatment in primary care practice N
Engl J Med. 2011 Nov 24;365(21):1969-79. Epub 2011 Nov 14.
16. Garcia Diaz E et al Systematic review of the clinical efficacy of sibutramine and orlistat in weight
loss, quality of life and its adverse effects in obese adolescents Nutr Hosp. 2011 Jun;26(3):451-7.
17. Thomas EL Pragmatic study of orlistat 60 mg on abdominal obesity Eur J Clin Nutr. 2011
Nov;65(11):1256-62. doi: 10.1038/ejcn.2011.108. Epub 2011 Jun 22.
18. Chanoine JP et al Early weight loss and outcome at one year in obese adolescents treated with
orlistat or placebo Int J Pediatr Obes. 2011 Apr;6(2):95-101. Epub 2010 Sep 22.
19. CDC website http://www.cdc.gov/obesity/data/trends.html accessed 4/17/12
20. Saxenda prescribing information. Novo Nordisk; Revised 12/2020. Accessed online 12/23/2020.
21. Contrave prescribing information. Orexigen Therapeutics, Inc.; Revised 04/2019. Accessed
online: 05/31/19.
22. Qsymia prescribing information. Vivus, Inc.; Revised 06/2022. Accessed online: 08/09/2022.
23. U.S. Department of Health and Human Services, National Institutes of Health, National Heart,
Lung, and Blood Institute. (2000). The Practical Guide. Identification, Evaluation, and Treatment
of Overweight and Obesity in Adults. NIH Publication No. 00-4084. Retrieved from:
https://www.nhlbi.nih.gov/files/docs/guidelines/prctgd_c.pdf
24. Michael D. Jensen, Donna H. Ryan, Caroline M. Apovian, Jamy D. Ard, Anthony G. Comuzzie,
Karen A. Donato, Frank B. Hu, Van S. Hubbard, John M. Jakicic, Robert F. Kushner, Catherine
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Weight Management Policy
M. Loria, Barbara E. Millen, Cathy A. Nonas, F. Xavier Pi-Sunyer, June Stevens, Victor J.
Stevens, Thomas A. Wadden, Bruce M. Wolfe and Susan Z. Yanovski; 2013 AHA/ACC/TOS
Guideline for the Management of Overweight and Obesity in Adults, Circulation, 12 November
2013, http://circ.ahajournals.org/content/early/2013/11/11/01.cir.0000437739.71477.ee
25. Caroline M. Apovian, Louis J. Aronne, Daniel H. Bessesen, Marie E. McDonnell, M. Hassan
Murad, Uberto Pagotto, Donna H. Ryan, Christopher D. Still, Pharmacological Management of
Obesity: An Endocrine Society Clinical Practice Guideline, The Journal of Clinical Endocrinology
& Metabolism, Volume 100, Issue 2, 1 February 2015, Pages 342–362,
https://doi.org/10.1210/jc.2014-3415
26. W. Timothy Garvey, MD, FACE; Jeffrey I. Mechanick, MD, FACP, FACE, FACN, ECNU; Elise M.
Brett, MD, FACE, CNSC, ECNU; Alan J. Garber, MD, PhD, FACE; Daniel L. Hurley, MD,
FACE5; Ania M. Jastreboff, MD, PhD; Karl Nadolsky, DO;Rachel Pessah-Pollack, MD; Raymond
Plodkowski, MD; and Reviewers of the AACE/ACE Obesity Clinical Practice Guidelines;
American Association Of Clinical Endocrinologists And American College Of Endocrinology
Comprehensive Clinical Practice Guidelines For Medical Care Of Patients With Obesity;
Endocrine Practice, Volume 22 (Suppl 3) July 2016. https://www.aace.com/files/final-
appendix.pdf
27. Imcivree™ subcutaneous injection [prescribing information]. Boston, MA: Rhythm
Pharmaceuticals; June, 2022.
28. Wegovy™ subcutaneous injection [prescribing information]. Novo Nordisk; Revised 6/2022.
Accessed online: 1/3/2023.
29. Beales PL, Elcioglu N, Woolf AS, et al New criteria for improved diagnosis of Bardet-Biedl
syndrome: results of a population survey Journal of Medical Genetics 1999;36:437-446.
30. Grunvald E, Shah R, Hernaez R, et al. AGA Clinical Practice Guideline on Pharmacological
Interventions for Adults with Obesity Gastroenterology 2022; 163,5:1198-1225.
31. Zepbound™ subcutaneous injection, tirzepatide subcutaneous injection. Eli Lilly and Company
(per FDA), Indianapolis, IN, 2023. Accessed online November 2023

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Weight Management Policy
Addendum:
Guidelines for Comprehensive Weight Management Program
This document outlines the minimum standards that will be applied in the evaluation of a
comprehensive Weight Management Program.
Purpose
The proliferation and availability of weight management support programs without widespread
evidence of value provides a challenge to our members and health care programs. The availability of
the internet, with unlimited and untested offerings, numerous alternative health care approaches as
well as a multitude of self-professed “experts”, demands establishment of a set of standards that can
be applied consistently in the evaluation of these programs. This document describes the standards
that will be applied in the evaluation of a comprehensive Weight Management Program for weight
loss medications Wegovy, Xenical, Orlistat, Contrave, Saxenda, and Qsymia.
Weight Management Programs
The Weight management program guidelines combine coverage of medication with participation in a
“comprehensive weight management program” in addition to the counseling offered through the
primary care physician office. The comprehensive program includes nutritional counseling, behavior
modification and the importance of lifestyle changes, including exercise. The program provides
individual assessment, coaching, and information and helps to develop an action plan and establish
goals and process to achieve sustained and significant weight loss.
Minimum Standards for a Weight Management program:
The comprehensive weight management program must:
• Include diet modification, meal-planning and/or a nutrition education component
• Include an exercise component (at a minimum documentation of oversight/education to increase
physical activity)
• Address Behavior modifications
• Provide intensive individual coaching or group sessions on an ongoing basis and regularly
scheduled sessions. (Monthly minimum)
• Have the capability to provide verification of program enrollment and individual session
attendance/participation.
• Weight management programs conducted via the internet or telehealth will be given
consideration. However, these programs must still comply with the required components of a
qualified comprehensive weight management program as described above.
Programs not qualifying:
• Stand-alone Internet based programs (such as calorie or step tracking apps; ex. myfitnesspal).
Internet programs/apps can be used to supplement a qualifying comprehensive program as above.
• Isolated dietician visits or referrals.
• Exercise only based programs.
• Programs that offer only weekly enrollment commitments
• Nutritional supplement-oriented programs (e.g., Optifast).
Review process
• All programs will be reviewed against these criteria.
• The clinical team will contact the program and obtain information if needed
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