Download Appetite Suppressants

Drug Therapy Guidelines
Applicable
Medical Benefit
Appetite Suppressants (Anorexients) & Weight Loss
Agents: Adipex®, phentermine, Bontril®,
phendimetrazine, Didrex®, benzphetamine,
Suprenza®, Tenuate®, diethylpropion, Xenical®,
Qsymia®, Belviq®, Contrave®, Saxenda®
Effective: 7/19/16
Pharmacy- Formulary 1
x
Next Review: 6/17
Pharmacy- Formulary 2
x
Date of Origin: 10/06
Pharmacy- Formulary 3/Exclusive
x
Pharmacy- Formulary 4/AON
x
Review Dates: 10/15/06, 11/5/07, 12/15/08,12/09, 12/10, 12/11,
12/12, 12/13, 6/14, 6/15, 6/16
Pharmacy- Medicaid
I.
Medication Description
Either appetite suppressants or weight loss agents are used for the treatment of obesity in conjunction with
behavior modification and a weight reduction program based on calorie restriction. Appetite suppressants work
to decrease food intake by acting on the body’s satiety center and to increase energy expenditure. Xenical, a
weight loss agent, is a reversible intestinal lipase inhibitor (an enzyme which breaks down fat). Xenical
decreases in the amount of fat absorbed and increases in the amount of fat excreted. As much as 30% of
ingested fat may be excreted in this manner. Belviq is believed to decrease food consumption and promote
satiety by selectively activating serotonin 2C receptors in the brain.
II.
Position Statement
Coverage is determined through a prior authorization process with supporting clinical documentation for every
request.
III.
Policy
Coverage for appetite suppressants/weight loss agents is provided in accord with the following:
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Patient must be 12 years of age or older for Xenical or benzphetamine, 16 years of age or older for
phendimetrazine, 17 years of age or older for phentermine and diethylpropion, and 18 years of age or
older for Belviq, Qsymia, or Saxenda AND
Patient must be at least 30% over ideal weight or have a Body Mass Index (BMI) ≥ 30kg/m2; or be 20%
over ideal weight or have a BMI ≥ 27 kg/m2 in the presence of a significant co-morbid condition (e.g.,
hypertension, hyperlipidemia, or diabetes) AND
Therapy must be used in conjunction with a behavior modification or dietary restriction program AND
Saxenda is not used in combination with any other GLP-1 receptor agonist or with insulin.
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IV.
Quantity Limitations
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Quantities covered for dosing within FDA approved dosage guidelines.
For consideration of coverage, there will be a total lifetime limit of 24 months of treatment with any of
these medications or combinations of medications (lifetime limit of 12 months of benzphetamine,
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Drug Therapy Guidelines
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V.
Appetite Suppressants & Weight Loss
Last Review Date: 6/2016
diethylpropion, phendimetrazine, phentermine treatment applies). Treatment obtained through other
means such as studies will be included in the calculation of total treatment duration.
Treatment beyond the above coverage duration will be evaluated on a case by case basis by the Medical
Director based on clinical case and data from prescriber supporting safety and continued efficacy of
requested use and duration of therapy.
Requests for change in therapy after a treatment failure of a full or partial course of one agent will be
dependent on evidence presented of compliance with therapy and nonpharmacologic weight loss measures
(including dietary counseling, enrollment in organized weight loss programs, exercise programs and any
applicable lifestyle changes). The above noted total lifetime limits apply.
Qsymia 3.75mg/23mg and 11.25mg/69mg are only approved for titration purposes. Member must utilize a
treatment dose of 7.5mg/46mg or 15mg/92mg when approved for Qsymia.
Qsymia 3.75mg/23mg and 11.25mg/69mg limited to 14 capsules per 30 days.
Coverage Duration
Initial coverage durations:
• Xenical and Saxenda – 4 months, may be renewed
• All others – 3 months, may be renewed
VI.
Coverage Renewal Criteria
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Xenical
o First renewal: 8 months in situations where patients have lost ≥ 5% of baseline weight and are free
of adverse effects. May be renewed.
o Second renewal: 12 months in situations where patients have lost additional ≥ 5% of body weight
after initial coverage and are free of adverse effects. No further coverage is available.
Belviq
o First renewal: 9 months in situations where patients have lost ≥ 5% of baseline weight and are free
of adverse effects. May be renewed.
o Second renewal: 12 months in situations where patients have lost ≥ 10% of baseline weight and are
free of adverse effects. No further coverage is available.
Qsymia
o First renewal:
3 months in situations where patients have lost ≥ 3% of baseline weight and are free of
adverse effects. May be renewed.
3 months in situations where member has been on 7.5mg/46mg dose and has not lost ≥ 3%
of baseline weight and dose is being increased to 15mg/92mg. May be renewed.
o Second renewal: 6 months in situations where patients have lost ≥ 5% of baseline weight and are
free of adverse effects. No further coverage is available.
Saxenda
o First renewal: 9 months in situations where patients have lost ≥ 4% of baseline weight and are free
of adverse effects. No further coverage is available.
All others
o First renewal: 3 months in situations where patients have lost ≥ 5% of baseline weight or at least 10
pounds from their baseline and are free of adverse effects. May be renewed.
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Drug Therapy Guidelines
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VII.
Appetite Suppressants & Weight Loss
Last Review Date: 6/2016
Second renewal: 6 months in situations where patients have lost ≥ 10% of baseline weight or at least
20 pounds from their baseline weight and are free of adverse effects. No further coverage is
available.
Billing/Coding/ Product Information
n/a
VIII.
Summary of Policy Changes
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IX.
3/1/11: Meridia removed from guidelines, addition of Warnings/Precautions section
3/2012: Suprenza added to policy
6/15/12: Minimum age requirements changed
9/2012: Qsymia and Belviq added to policy, exclusion section modified
3/15/13: Contraindication section updated
3/15/14: Age restriction added for Qsymia; policy updated to reflect combination therapy is not covered
9/15/14: quantity limit added for titration doses of Qsymia and renewal criteria for Qsymia updated to allow
dose escalation per prescribing information.
11/30/14: Contrave added to policy
1/2015: Saxenda added to policy upon FDA approval
7/1/15: formulary distinctions made
9/15/15: no policy changes
7/19/16: updated age requirements for diethylpropion; clarification of drug interactions included for
Saxenda
References
1. AACE/ACE position statement on the prevention, diagnosis, and treatment of obesity. AACE/ACE Obesity
Task Force. 1998 revision. (accessed 11/09: http://www.aace.com/pub/pdf/guidelines/obesityguide.pdf)
2. Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults.
Bethesda, MD: National Institutes of Health, National Heart, Lung, and Blood Institute, June 1998.
3. American Gastroenterological Association medical position statement on obesity. Gastroenterology 2002
Sep;123(3):879-81.
4. Davidson MH, Hauptman J, DiGirolamo M, et al. Weight control and risk factor reduction in obese subjects
treated for 2 years with orlistat: a randomized controlled trial. JAMA 1999; 281:235-42.
5. Heck AM, Yanovski JA, Calis KA. Orlistat, a new lipase inhibitor for the management of obesity.
Pharmacotherapy 2000 Mar; 20 (3): 270-9.
6. James WPT, Astrup A, Finer N, et al. Effect of sibutramine on weight maintenance after weight loss: a
randomized trial.
7. The STORM Study Group. Lancet 2000;356:2119-25.
8. Rossner S, Sjostrom L, Noack R, et al. Weight loss, weight maintenance, and improved cardiovascular risk
factors after 2 years treatment with orlistat for obesity. European Orlistat Obesity Study Group. Obesity
Research 2000;8:49-61.
9. Sjostrom L, Rissanen A, Andersen T, et al. Randomized placebo-controlled trial of orlistat for weight loss and
prevention of weight regain in obese patients. Lancet 1998;352:167-73.
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Drug Therapy Guidelines
Appetite Suppressants & Weight Loss
Last Review Date: 6/2016
10. Torgerson JS, Hauptman J, Boldrin MN, Sjostrom L. Xenical® in the prevention of diabetes in obese subjects
(XENDOS) study: a randomized study of orlistat as an adjunct to lifestyle changes for the prevention of type
2 diabetes in obese patients. Diabetes Care 2004 Jan;27(1):155-61.
11. Clinical Pharmacology (www.clinicalpharmacology.com). Gold Standard- Elsevier. 2016. Accessed 5/2016.
12. Micromedex. (www.thomsonhc.com). Thomson-Reuters 1974-2010. Accessed 5/2016.
13. Product Information: Orlistat Capsules (Xenical®). Roche/ Genentech, Genentech Inc., South San Francisco,
CA, 94080-4990, Revised 12/2013.
14. Product information: Qsymia. Vivus/Catalent Pharma Solutions. Mountain View, CA 94040. 10/2014.
15. Product information: Belviq® (lorcaserin). Arena Pharmaceuticals, Switzerland/Elsai Inc. Woodcliff Lake, NJ
07677. 12/2014.
16. Product information: Contrave®. Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015. Issued 9/2014.
17. Product Information: Saxenda®. Novo Nordisk. Plainsboro, NJ 08536. Issued 1/2015.
The Plan fully expects that only appropriate and medically necessary services will be rendered. The Plan reserves the right to conduct pre-payment and post-payment
reviews to assess the medical appropriateness of the above-referenced therapies.
Drug therapy initiated with samples will not be considered as meeting medical necessity for coverage for non-preferred or prior authorized medications.
The preceding policy applies only to members for whom the above named pharmacy benefit medications are included on their covered formulary. Members with
closed formulary benefits are subject to trying all appropriate formulary alternatives before a coverage exception for a non-formulary agent will be considered.
The preceding policy is a guideline to allow for coverage of the pertinent medication/product, and is not meant to serve as a clinical practice guideline.
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