Weight Loss Medications - Cigna
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Pharmacy Benefit Coverage Criteria
Effective Date ............................................ 6/1/2021
Next Review Date… ..................................... 6/1/2022
Coverage Policy Number ................................ P0104
Weight Loss Medications
Table of Contents Related Coverage Resources
Medical Necessity Criteria ...................................1
FDA Approved Indications ...................................3
Recommended Dosing ........................................5
Background ..........................................................7
References ..........................................................9
INSTRUCTIONS FOR USE
The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of
business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan
language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting
certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document
[Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may
differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan
document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit
plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage
mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific
instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable
laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular
situation. Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for
treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support
medical necessity and other coverage determinations.
Medical Necessity Criteria
Weight Loss Medications includes the following products:
• Adipex-P® (phentermine hydrochloride)
• Contrave® (naltrexone HCl and bupropion HCl)
• Qsymia® (phentermine and topiramate extended-release)
• Saxenda® (liraglutide)
• Xenical® (orlistat)
For Employer Group Standard, Performance, Value, Advantage, and Legacy Drug List Plans: Coverage
for Weight Loss Medications may require the use of preferred or generic products according to the
customer’s benefit plan. Refer to the customer’s benefit plan document for coverage details.
I. Adipex-P (phentermine hydrochloride) is considered medically necessary when ALL of the following
criteria are met:
• Individual is 16 years of age or older
• Individual currently has a BMI ≥ 30 kg/m2, or a BMI ≥ 27 kg/m2 for those with risk factors besides obesity
(for example, diabetes mellitus, impaired glucose tolerance, dyslipidemia, hypertension, coronary heart
disease, sleep apnea)
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Pharmacy Benefit Clinical Criteria: P0104• Individual has engaged in a trial of behavioral modification and dietary restriction for at least 3 months
and has failed to achieve the desired weight loss
• Individual is currently engaged in behavioral modification and on a reduced calorie diet
• For Employer Group Standard, Performance, Value, Advantage, and Legacy Drug List Plans:
o Documented intolerance to generic phentermine
II. Contrave (naltrexone HCl and bupropion HCl) or Qsymia (phentermine and topiramate extended-
release) are considered medically necessary when ALL of the following criteria are met:
• Individual is 18 years of age or older
• Individual currently has a BMI ≥ 30 kg/m2, or a BMI ≥ 27 kg/m2 for those with risk factors besides obesity
(for example, diabetes mellitus, impaired glucose tolerance, dyslipidemia, hypertension, coronary heart
disease, sleep apnea)
• Individual has engaged in a trial of behavioral modification and dietary restriction for at least 3 months
and has failed to achieve the desired weight loss
• Individual is currently engaged in behavioral modification and on a reduced calorie diet
III. Saxenda (liraglutide) is considered medically necessary when ONE of the following are met:
• Individual is 18 years of age or older and ALL of the following:
o Individual currently has a BMI ≥ 30 kg/m 2, or a BMI ≥ 27 kg/m2 for those with risk factors besides
obesity (for example, diabetes mellitus, impaired glucose tolerance, dyslipidemia, hypertension,
coronary heart disease, sleep apnea)
o Individual has engaged in a trial of behavioral modification and dietary restriction for at least 3
months and has failed to achieve the desired weight loss
o Individual is currently engaged in behavioral modification and on a reduced calorie diet
• Individual is ≥ 12 years of age to less than 18 years of age and ALL of the following:
o Individual currently has a BMI of ≥ 95th percentile for age and sex, or in ≥ 85th percentile but <
95th percentile for age and sex and has at least one comorbidity (for example, type 2 diabetes
mellitus, cardiovascular disease, dyslipidemia) or has a strong family history of type 2 diabetes
or premature cardiovascular disease (CVD)
o Individual has engaged in a trial of behavioral modification and dietary restriction for at least 3
months and has failed to limit weight gain or to modify comorbidities
o Individual is currently engaged in behavioral modification and participating in improved dietary
choices
Coverage for brand Saxenda (liraglutide) varies across plans and may require the use of Preferred
Covered Alternatives in addition to the medical necessity criteria listed above. Refer to the
customer’s benefit plan document for coverage details.
When coverage requires the use of preferred products, there is documentation of ONE of the following:
A. The individual has had inadequate efficacy to the ONE of covered alternatives:
a. For individuals 18 years of age or older: Contrave†, Qsymia†, or Xenical†
b. For individuals ≥ 12 years of age to less than 18 years of age: Xenical†
OR
B. The individual has a contraindication according to FDA label, significant intolerance, or is not a
candidate* for the covered alternatives:
a. For individuals 18 years of age or older: Contrave†, Qsymia†, or Xenical†
b. For individuals ≥ 12 years of age to less than 18 years of age: Xenical†
*Note: Not a candidate due to being subject to a warning per the prescribing information (labeling),
having a disease characteristic, individual clinical factor[s], other attributes/conditions, or is unable to
administer and requires this dosage formulation)
† Coverage of these weight loss medications may require prior authorization.
Page 2 of 10
Pharmacy Benefit Clinical Criteria: P0104IV. Xenical (orlistat) is considered medically necessary when ALL of the following criteria are met:
• Individual is 12 years of age or older
• Individual currently has a BMI ≥ 30 kg/m2, or a BMI ≥ 27 kg/m2 for those with risk factors besides obesity
(for example, diabetes mellitus, impaired glucose tolerance, dyslipidemia, hypertension, coronary heart
disease, sleep apnea)
• Individual has engaged in a trial of behavioral modification and dietary restriction for at least 3 months
and has failed to achieve the desired weight loss
• Individual is currently engaged in behavioral modification and on a reduced calorie diet
Initial authorization is up to 4 months.
Weight Loss Medications are considered medically necessary for continued use when ALL of the
following are met:
• Individual had an initial BMI per above criteria
• Individual is currently engaged in behavioral modification and on a reduced calorie diet
• Individual has lost at least 4% of baseline body weight (only required once)
Reauthorization for up to 12 months.
When coverage is available and medically necessary, the dosage, frequency, duration of therapy, and
site of care should be reasonable, clinically appropriate, and supported by evidence-based literature and
adjusted based upon severity, alternative available treatments, and previous response to therapy.
Weight Loss Medications are considered experimental, investigational or unproven for ANY other use
including the following:
• Combination appetite suppressant therapy
• Simultaneous use of Xenical with benzphetamine, diethylpropion, phendimetrazine tartrate, or
phentermine hydrochloride or resin, Contrave, Saxenda or Qsymia
• Treatment of hyperlipidemia in non-obese individuals
• Treatment of binge-eating disorder in non-obese individuals (BMI < 30 kg/m 2 or < 27 kg/m2 for those with
risk factors)
• Prevention of diabetes in individuals with BMI < 30 kg/m2
• Nonalcoholic fatty liver disease
Note: Receipt of sample product does not satisfy any criteria requirements for coverage.
*If you’re a Cigna provider, please log in to the Cigna for Health Care Professionals website and search for
specific patients to view their covered medications.
FDA Approved Indications
FDA Approved Indication
Product FDA Approved Indication
Adipex-P Adipex-P is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction
(phentermine based on exercise, behavioral modification and caloric restriction in the management of
hydrochloride) exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in
the presence of other risk factors (for example, controlled hypertension, diabetes,
hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and
weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the
patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 =
kg; inches x 0.0254 = meters.
BODY MASS INDEX (BMI), kg/m2
Page 3 of 10
Pharmacy Benefit Clinical Criteria: P0104Height (feet, inches)
Weight 5’0” 5’3” 5’6” 5’9” 6’0” 6’3”
(pounds)
140 27 25 23 21 19 18
150 29 27 24 22 20 19
160 31 28 26 24 22 20
170 33 30 28 25 23 21
180 35 32 29 27 25 23
190 37 34 31 28 26 24
200 39 36 32 30 27 25
210 41 37 34 31 29 26
220 43 39 36 33 30 28
230 45 41 37 34 31 29
240 47 43 39 36 33 30
250 49 44 40 37 34 31
The limited usefulness of agents of this class, including Adipex-P should be measured
possible risk factors inherent in their use such.
Contrave Contrave is indicated as an adjunct to a reduced-calorie diet and increased physical activity
(naltrexone for chronic weight management in adults with an initial body mass index (BMI) of:
HCl and • 30 kg/m2 or greater (obese) or
bupropion • 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid
HCl) condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia).
Limitations of Use:
• The effect of Contrave on cardiovascular morbidity and mortality has not been
established.
• The safety and effectiveness of Contrave in combination with other products intended for
weight loss, including prescription drugs, over-the-counter drugs, and herbal
preparations, have not been established.
Qsymia Qsymia is indicated as an adjunct to a reduced-calorie diet and increased physical activity for
(phentermine chronic weight management in adult patients with an initial body mass index (BMI) of
and • 30 kg/m2 or greater (obese), or
topiramate • 27 kg/m2 or greater (overweight) in the presence of at least one weight related
extended- comorbidity such as hypertension, type 2 diabetes mellitus, or dyslipidemia
release)
Limitations of Use:
• The effect of Qsymia on cardiovascular morbidity and mortality has not been established.
• The safety and effectiveness of Qsymia in combination with other products intended for
weight loss, including prescription and over-the-counter drugs and herbal preparations
have not been established.
Saxenda SAXENDA is indicated as an adjunct to a reduced-calorie diet and increased physical
(liraglutide) activity for chronic weight management in:
Adult patients with an initial body mass index (BMI) of:
2
o 30 kg/m or greater (obese), or
2
o 27 kg/m or greater (overweight) in the presence of at least one weight-
related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or
dyslipidemia)
Pediatric patients aged 12 years and older with:
o body weight above 60 kg and
2
o an initial BMI corresponding to 30 kg/m or greater for adults (obese) by
international cut-offs (Cole Criteria, Table 2) [see Dosage and Administration
(2.1)]
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Pharmacy Benefit Clinical Criteria: P0104Limitations of Use
o SAXENDA contains liraglutide and should not be coadministered with other liraglutide-
containing products or with any other GLP-1 receptor agonist.
o The safety and effectiveness of SAXENDA in pediatric patients with type 2 diabetes have
not been established.
o The safety and effectiveness of SAXENDA in combination with other products intended
for weight loss, including prescription drugs, over-the-counter drugs, and herbal
preparations, have not been established.
Xenical Xenical is indicated for obesity management including weight loss and weight maintenance
(orlistat) when used in conjunction with a reduced-calorie diet. Xenical is also indicated to reduce the
risk for weight regain after prior weight loss. Xenical is indicated for obese patients with an
initial body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 in the presence of other risk factors (for
example, hypertension, diabetes, dyslipidemia).
The BMI is calculated by dividing weight in kilograms by height in meters squared.
Recommended Dosing
FDA Recommended Dosing
Adipex-P Exogenous Obesity
(phentermine Dosage should be individualized to obtain an adequate response with the lowest effective
hydrochloride) dose.
The usual adult dose is one capsule (37.5 mg) daily as prescribed by the physician,
administered before breakfast or 1 to 2 hours after breakfast for appetite control.
The usual adult dose is one tablet (37.5 mg) daily as prescribed by the physician,
administered before breakfast or 1 to 2 hours after breakfast. The dosage may be adjusted to
the patient’s need. For some patients, half tablet (18.75 mg) daily may be adequate, while in
some cases it may be desirable to give half tablets (18.75 mg) two times a day.
Adipex-P® is not recommended for use in pediatric patients less than or equal to 16 years of
age.
Late evening medication should be avoided because of the possibility of resulting insomnia.
Contrave Contrave dosing should be escalated according to the following schedule:
(naltrexone
HCl and Morning Dose Evening Dose
bupropion Week 1 1 tablet None
HCl) Week 2 1 tablet 1 tablet
Week 3 2 tablets 1 tablet
Week 4 - Onward 2 tablets 2 tablets
A total daily dosage of two Contrave 8 mg/90 mg tablets twice daily (32 mg/360 mg) is
reached at the start of Week 4.
Contrave should be taken by mouth in the morning and in the evening. The tablets should
not be cut, chewed, or crushed. Total daily doses greater than 32 mg/360 mg per day (two
tablets twice daily) are not recommended. In clinical trials, Contrave was administered with
meals. However, Contrave should not be taken with a high-fat meal because of a resulting
significant increase in bupropion and naltrexone systemic exposure.
Patients may develop elevated blood pressure or heart rate during Contrave treatment; the
risk may be greater during the initial three months of therapy. Because patients with
Page 5 of 10
Pharmacy Benefit Clinical Criteria: P0104hypertension may be at increased risk for developing blood pressure elevations, such
patients should be monitored for this potential effect when initiating treatment with Contrave.
Response to therapy should be evaluated after 12 weeks at the maintenance dosage. If a
patient has not lost at least 5% of baseline body weight, discontinue Contrave, as it is
unlikely that the patient will achieve and sustain clinically meaningful weight loss with
continued treatment.
BMI is calculated by dividing weight (in kg) by height (in meters) squared.
Qsymia Determine the patient's BMI. BMI is calculated by dividing weight (in kilograms) by height (in
(phentermine meters) squared.
and
topiramate In adults with an initial BMI of 30 kg/m2 or greater or 27 kg/m2 or greater when accompanied
extended- by weight-related co-morbidities such as hypertension, type 2 diabetes mellitus, or
release) dyslipidemia prescribe Qsymia as follows:
• Take Qsymia once daily in the morning with or without food. Avoid dosing with Qsymia in
the evening due to the possibility of insomnia.
• Start treatment with Qsymia 3.75 mg/23 mg (phentermine 3.75 mg/topiramate 23 mg
extended-release) daily for 14 days; after 14 days increase to the recommended dose of
Qsymia 7.5 mg/46 mg (phentermine 7.5 mg/topiramate 46 mg extended-release) once
daily.
• Evaluate weight loss after 12 weeks of treatment with Qsymia 7.5 mg/46 mg.
If a patient has not lost at least 3% of baseline body weight on Qsymia 7.5 mg/46 mg,
discontinue Qsymia or escalate the dose, as it is unlikely that the patient will achieve and
sustain clinically meaningful weight loss at the Qsymia 7.5 mg/46 mg dose.
To escalate the dose: Increase to Qsymia 11.25 mg/69 mg (phentermine 11.25
mg/topiramate 69 mg extended-release) daily for 14 days; followed by dosing Qsymia 15
mg/92 mg (phentermine 15 mg/topiramate 92 mg extended-release) once daily.
• Evaluate weight loss following dose escalation to Qsymia 15 mg/92 mg after an
additional 12 weeks of treatment.
If a patient has not lost at least 5% of baseline body weight on Qsymia 15 mg/92 mg,
discontinue Qsymia as directed, as it is unlikely that the patient will achieve and sustain
clinically meaningful weight loss with continued treatment.
• Qsymia 3.75 mg/23 mg and Qsymia 11.25 mg/69 mg are for titration purposes only.
Discontinuing Qsymia
• Discontinue Qsymia 15 mg/92 mg gradually by taking a dose every other day for at least
1 week prior to stopping treatment altogether, due to the possibility of precipitating a
seizure.
Saxenda Patient Selection
(liraglutide) Select patients for SAXENDA treatment as an adjunct to a reduced-calorie diet and
increased physical activity for chronic weight management based on the BMI values provided
in the Saxenda Prescribing Information.
Xenical The recommended dose of Xenical is one 120-mg capsule three times a day with each main
(orlistat) meal containing fat (during or up to 1 hour after the meal).
The patient should be on a nutritionally balanced, reduced-calorie diet that contains
approximately 30% of calories from fat. The daily intake of fat, carbohydrate, and protein
should be distributed over three main meals. If a meal is occasionally missed or contains no
fat, the dose of Xenical can be omitted.
Because Xenical has been shown to reduce the absorption of some fat-soluble vitamins and
beta-carotene, patients should be counseled to take a multivitamin containing fat-soluble
vitamins to ensure adequate nutrition. The vitamin supplement should be taken at least 2
hours before or after the administration of Xenical, such as at bedtime.
Page 6 of 10
Pharmacy Benefit Clinical Criteria: P0104For patients receiving both Xenical and cyclosporine therapy, administer cyclosporine 3
hours after Xenical.
For patients receiving both Xenical and levothyroxine therapy, administer levothyroxine and
Xenical at least 4 hours apart. Patients treated concomitantly with Xenical and levothyroxine
should be monitored for changes in thyroid function.
Doses above 120 mg three times a day have not been shown to provide additional benefit.
Based on fecal fat measurements, the effect of Xenical is seen as soon as 24 to 48 hours
after dosing. Upon discontinuation of therapy, fecal fat content usually returns to
pretreatment levels within 48 to 72 hours.
Drug Availability
Adipex-P Supplied as tablets and capsules containing 37.5 mg phentermine hydrochloride (equivalent
(phentermine to 30 mg phentermine base).
hydrochloride)
Contrave Supplied as 8 mg/90 mg (naltrexone HCl 8 mg and buproprion HCl 90 mg) extended-release
(naltrexone tablets.
HCl and
bupropion
HCl)
Qsymia Supplied as 3.75 mg/23 mg, 7.5 mg/46 mg, 11.25 mg/69 mg and 15 mg/92 mg (phentermine
(phentermine hydrochloride [expressed as the weight of the free base]/topiramate) extended-release
and capsules.
topiramate
extended-
release)
Saxenda Supplied as disposable, pre-filled, multi-dose pens, each delivering doses of 0.6 mg, 1.2 mg,
(liraglutide) 1.8 mg, 2.4 mg or 3 mg.
Xenical Supplied as 120 mg orlistat capsules.
(orlistat)
Background
Professional Societies/Organizations
The Endocrine Society published a clinical practice guideline (2015) for the pharmacological management of
obesity. (Apovian, 2015) The guidelines recommend that pharmacotherapy be employed for patients with BMI ≥
27 kg/m2 with comorbidity (or BMI > 40 kg/m2) as adjuncts to behavioral modification to reduce food intake and
increase physical activity when possible. The Society states that patients who have a history of being unable to
successfully lose and maintain weight and who meet label indications are candidates for weight-loss medication.
Safety and efficacy is recommended to be assessed monthly for the first three months, and then at least every 3
months in all patients prescribed medications for weight loss. If a patient has an adequate response to weight
loss medication (weight loss ≥ 5% at 3 months), medication is recommended to be continued. If deemed to be
ineffective (weight loss < 5% at 3 months) or if there are safety or tolerability issues at any time, it is
recommended that medication be discontinued and alternative medications or referral for alternative treatment
approaches be considered.
The American Association of Clinical Endocrinology (AACE)/American College of Endocrinology (ACE) guidelines
for medical care of patients with obesity (2016) recommend pharmacotherapy for overweight and obese patients
only as an adjunct to lifestyle therapy. (Garvey, 2016) Pharmacotherapy should be offered to patients who are
obese when the potential benefits outweigh the risks, for the chronic treatment of obesity. Short-term (3 to 6
months) use of weight-loss medications has not been demonstrated to produce longer-term health benefits and
cannot be generally recommended.
Page 7 of 10
Pharmacy Benefit Clinical Criteria: P0104Guidelines in Pediatric Obesity A 2008 Endocrine Society practice guideline on pediatric obesity recommends pharmacotherapy in combination with lifestyle modification be considered in the following population: 1) obese children only after failure of a formal program of intensive lifestyle [dietary, physical activity and behavioral] modification; and 2) overweight children only if severe co-morbidities persist despite intensive lifestyle modification, particularly in children with a strong family history of type 2 diabetes or premature cardiovascular disease. (August, 2008) Patients with a genetic syndrome etiology should be referred to a geneticist. Pharmacotherapy should be provided only by clinicians who are experienced in the use of antiobesity agents and aware of the potential for adverse events. These guidelines recommend limited use of pharmacotherapy because pediatric obesity should be managed preferably as a serious lifestyle condition with important lifelong consequences. The Endocrine Society defines overweight as BMI in at least the 85th percentile but less than the 95th percentile, and obesity as BMI in at least the 95th percentile for age and sex against routine endocrine studies, unless the height velocity is attenuated or inappropriate for the family background or stage of puberty. (August, 2008) The Centers for Disease Control (CDC) derived normative percentiles are recommended as the appropriate method for determining the BMI in children. (National, 2017; CDC 2015) Off Label Uses Combination Appetite Suppressant Therapy Appetite suppressants (benzphetamine, diethylpropion, phendimetrazine tartrate, phentermine hydrochloride or resin, Qsymia, Contrave, Saxenda) are indicated only as monotherapy and should not be used in combination with other appetite suppressant drugs. Simultaneous Use of Xenical with Any of the Following: benzphetamine, diethylpropion, phendimetrazine tartrate, or phentermine hydrochloride or resin, Contrave, Saxenda or Qsymia Limited information from published well-controlled studies is available on the combination use of Xenical with any of the following: benzphetamine, diethylpropion, phendimetrazine tartrate, or phentermine hydrochloride or resin, Contrave, Saxenda or Qsymia. Using weight loss drugs one at a time and starting with the lowest effective doses can decrease the chance of adverse effects. (National, 2013) Unproven combination therapy is not recommended. (Yanovski, 2002) Treatment of Hyperlipidemia in Non-Obese Patients Short-term use of Xenical has slightly decreased total and low density lipoprotein (LDL) cholesterol in patients with increased total and LDL cholesterol levels and normal triglyceride levels who were not obese (BMI 19 to 28.7 kg/m2). (Tonstad, 1994) Triglycerides were unchanged and high density lipoprotein (HDL) cholesterol tended to decrease. Although not directly compared with other drugs, Xenical’s effects on total and LDL cholesterol were less than those observed with hydroxy-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors (HMGs) and low dose cholestyramine. Treatment of Binge-Eating Disorder in Non-Obese Patients (BMI < 30 kg/m2 or < 27 kg/m2 for Those with Risk Factors) In a short term (12 or 24 week) placebo-controlled trial in obese patients (BMI ≥ 30 kg/m2) with binge eating disorder, Xenical has been effective in producing weight loss. (Golay, 2005; Grilo, 2005) Patients with binge- eating disorder are usually obese and should be reviewed for weight loss therapy using the medical necessity criteria for Xenical. Prevention of Diabetes in Patients with BMI < 30 kg/m2 In a large (n = 3,305) 4-year study, Xenical, in addition to lifestyle changes, led to a 37% risk reduction in the development of type 2 diabetes in obese (BMI ≥ 30 kg/m2) patients compared with placebo. (National, 2017) However, those most affected had impaired glucose tolerance at baseline and these patients achieved a more pronounced weight reduction. Qsymia in addition to lifestyle modification reduced the progression to type 2 diabetes in overweight/obese patients (BMI 27 to 45 kg/m2) plus at least two weight-related comorbidities with pre-existing prediabetes and/or metabolic syndrome in a 108-week study compared with placebo (n = 475). Page 8 of 10 Pharmacy Benefit Clinical Criteria: P0104
However, the magnitude of effect for prevention of type 2 diabetes was related to the degree of weight loss achieved in this sub-analysis. Nonalcoholic Fatty Liver Disease In a single-center trial, 52 patients with nonalcoholic fatty liver disease were randomized to Xenical 120 mg three times daily or placebo. (Zelber-Sagi, 2006) Mean BMI was 33 kg/m2. All patients were in a behavioral weight loss program. Forty-four patients completed 6 months and their results were analyzed. Patients were not well- matched for baseline characteristics (e.g., BMI, waist circumference, glucose and insulin levels were significantly different between groups at baseline). The authors concluded that Xenical improves serum alanine aminotransferase (ALT) and steatosis on ultrasound in these patients beyond its effect on weight reduction. Long-term, well-designed trials in a large number of patients are needed to determine if Xenical has a place in therapy for nonalcoholic fatty liver disease. There is very little good quality evidence to support or refute the use of weight reduction as a treatment for nonalcoholic fatty liver disease. (Clark, 2006) Therapeutic Alternatives An individual must document the failure of or intolerance to any Covered Alternative Drug(s) before coverage will be approved for the identified drug. A “Covered Alternative Drug” is a drug in the same therapeutic class that can be expected to have equivalent clinical efficacy and safety when administered to patients under the conditions specified in the FDA-approved product information (Label). The number of Covered Alternative Drugs may vary by employer group plan and Prescription Drug Lists (e.g. “closed” versus “open” formulary plan designs). Generics The FDA’s generic drug approval process does not require the drug sponsor to repeat costly animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness. Generic drugs must establish the following for approval: • contain the same active ingredients as the innovator drug (inactive ingredients may vary) • be identical in strength, dosage form, and route of administration • have the same use indications • be bioequivalent • meet the same batch requirements for identity, strength, purity, and quality • be manufactured under the same strict standards of FDA's good manufacturing practice regulations required for innovator products A generic drug is the same as a brand-name drug in dosage, safety, strength, quality, the way it works, the way it is taken and the way it should be used. FDA requires generic drugs have the same high quality, strength, purity and stability as brand-name drugs. Not every brand-name drug has a generic drug. When new drugs are first made they have drug patents. Most drug patents are protected for 20 years. The patent, which protects the company that made the drug first, doesn't allow anyone else to make and sell the drug. When the patent expires, other drug companies can start selling a generic version of the drug. But, first, they must test the drug and the FDA must approve it. References 1. Adipex-P tablets and capsules [prescribing information]. Horsham, PA: Teva Pharmaceuticals; March 2017. 2. Apovian CM, Aronne LJ, Bessesen DH, et al. Pharmacological management of obesity: An endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2015;100(2):342-362. Available at: http://press.endocrine.org/doi/pdf/10.1210/jc.2014-3415. Accessed on August 14, 2019. 3. August GP, Caprio S, Fennoy I, et al; Endocrine Society. Prevention and treatment of pediatric obesity: an endocrine society clinical practice guideline based on expert opinion. J Clin Endocrinol Metab. 2008;93:4576- 4599. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6048599/. Accessed on August 14, 2019. 4. Centers for Disease Control and Prevention. About BMI for children and teens. Updated May 15, 2015. Available at: http://www.cdc.gov/healthyweight/assessing/bmi/childrens_bmi/about_childrens_bmi.html. Accessed on August 14, 2019. 5. Clark JM. Weight loss as a treatment for nonalcoholic fatty liver disease. J Clin Gastroenterol. 2006;40 (3 Suppl 1):S39-43. Page 9 of 10 Pharmacy Benefit Clinical Criteria: P0104
6. Contrave tablets [prescribing information]. La Jolla, CA: Orexigen Therapeutics; May 2017.
7. Garvey WT, Mechanick JI, Brett EM, et al; 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 Pract. 2016;22(Suppl 3);1-203.
Available at: https://www.aace.com/files/final-appendix.pdf. Accessed on August 14, 2019.
8. Golay A, Laurent-Jaccard A, Habicht F, et al. Effect of orlistat in obese patients with binge eating disorder.
Obes Res. 2005;13:1701-1708.
9. Grilo CM, Masheb RM, Salant SL. Cognitive behavioral therapy guided self-help and orlistat for the treatment
of binge eating disorder: a randomized, double-blind, placebo-controlled trial. Biol Psychiatry. 2005;57:1193-
1201.
10. National Center for Health Statistics. Clinical Growth Charts. Updated June 16, 2017. Available at:
http://www.cdc.gov/growthcharts/clinical_charts.htm. Accessed on August 14, 2019. Access set 1. BMI-for-
age charts for boys and girls ages 2 to 20 years are recommended to assess weight in relation to stature.
11. National Institutes of Health National Heart, Lung, and Blood Institute. Managing overweight and obesity in
adults. Systematic evidence review from the obesity expert panel, 2013. Available at:
https://www.nhlbi.nih.gov/health-topics/managing-overweight-obesity-in-adults. Accessed on August 14,
2019.
12. Qsymia capsules [prescribing information]. Mountain View, CA: Vivus, Inc.; March 2018.
13. Saxenda tablets [prescribing information]. Plainsboro, NJ: NovoNordisk; April 2017.
14. Tonstad S, Pometta D, Erkelens DW, et al. The effect of the gastrointestinal lipase inhibitor, orlistat, on serum
lipids and lipoproteins in patients with primary hyperlipidemia. Eur J Clin Pharmacol. 1994;46:405-410.
15. Xenical capsules [prescribing information]. Nutley, NJ: Roche Laboratories; August 2017.
16. Yanovski SZ, Yanovski JA. Obesity. N Engl J Med. 2002;346:591-601.
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