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Prior Authorization Protocol
ADIPEX-PR, SUPRENZAR (phentermine), BELVIQR (lorcaserin hydrochloride), CONTRAVER (bupropion SR/naltrexone SR), DESOXYNR(methamphetamine), QSYMIAR (phentermine and topiramate extended release), XENICALR, ALLIR (orlistat), REGIMEXR, DIDREXR (benzphetamine hydrochloride), TENUATER, TENUATER DOSPANR (diethylpropion hydrochloride),SAXENDAR (liraglutide)


NATL

Coverage of drugs is first determined by the memberís pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    • Xenical is indicated for obesity management including weight loss and weight maintenance 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 (e.g., hypertension, diabetes, dyslipidemia).
    • Phentermine is indicated as a short term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index (BMI) > 30 kg/m2 or > 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, dyslipidemia).
    • Desoxyn is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children over 6 years of age with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity.
    • Desoxyn is indicated as a short-term (i.e., a few weeks) adjunct in a regimen of weight reduction based on caloric restriction, for patients in whom obesity is refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs.
    • Qsymia is indicated 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) of: 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbidity such as hypertension, type 2 diabetes mellitus, or dyslipidemia.
    • Belviq is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of:
      • ≥30 kg/m2 OR
      • ≥27 kg/m2 in the presence of at least one weight-related comorbid condition, (e.g. hypertension, dyslipidemia, type 2 diabetes)
    • Contrave is indicated 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) of: 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbidity (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia).
    • Alli is an over-the-counter product indicated for weight loss in overweight adults, when used along with a reduced-calorie and low-fat diet.
    • Tenuate is indicated as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for the management of exogenous obesity patients with an initial BMI of ≥30 kg/m2 and who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone.
    • Benzphetamine is indicated as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for the management of exogenous obesity patients with an initial BMI of ≥30 kg/m2 and who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone.
    • Saxenda is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight related comorbid condition (e.g. hypertension, type 2 diabetes mellitus, or dyslipidemia).
  2. Health Net Approved Indications and Usage Guidelines:
    Exogenous Obesity:
    • Patient has attempted to lose weight in a formalized weight management program (including hypocaloric diet, exercise and behavior modification) with continuing follow-up for at least 6 months prior to using drug therapy.

    AND

    • Body Mass Index (BMI) is > 30 kg/m2
    OR
    • Body Mass Index (BMI) is > 27 kg/m2 with one or more of the following severe co-morbid conditions such as:
      • Coronary artery/heart disease
      • Diabetes
      • Dyslipidemia
      • Hypertension
      • Obstructive sleep apnea
    AND
    • Documentation of the patient's baseline weight is required to determine response to therapy
    AND
    • For phentermine and Desoxyn requests only: Failure or clinically significant adverse events to XenicalR
    Attention Deficit Hyperactivity Disorder (ADHD) - for Desoxyn only:
    • Diagnosis of ADHD
  3. Coverage is Not Authorized For:
    • Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.
  4. General Information:
    • BMI = 703 x [Weight (lbs)/Height (inches)2]
    • Examples of coronary artery/heart disease include: Coronary Artery Bypass Graft, angina, history of myocardial infarction or stroke.
    • Phentermine is contraindicated in patients with a history of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hypertension), during or within 14 days following administration of monoamine oxidase inhibitors (MAOIs e.g., phenelzine), hyperthyroidism, glaucoma, agitated states, or history of drug abuse.
    • Xenical is contraindicated in patients with chronic malabsorption syndrome or cholestasis.
    • Desoxyn is contraindicated during or within 14 days following the administration of monoamine oxidase inhibitors. It is also contraindicated in patients with the following: glaucoma, advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, agitation or a history of drug abuse
    • Qsymia is contraindicated in pregnancy, glaucoma, hyperthyroidism, and use during or within 14 days of taking monoamine oxidase inhibitors (MAOI's).
    • Contrave is contraindicated in patients with uncontrolled hypertension, seizure disorders, anorexia nervosa or bulimia, those undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs, use of other bupropion-containing products, chronic opioid use, use during or within 14 days of taking monoamine oxidase inhibitors (MAOI's), and pregnancy.
    • Limitations of Use: The safety and efficacy of co-administering Belviq, or Contrave or Qsymia with other products intended for weight loss including prescription drugs (e.g. phentermine), over the counter drugs, herbal preparations have not been established. The effects of Belviq, or Contrave, Qsymia or Saxenda on cardiovascular morbidity and mortality have not been established.
    • Alli is contraindicated in patients with chronic malabsorption syndrome
    • Benzphetamine is contraindicated in patients with a history of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hypertension), during or within 14 days following administration of monoamine oxidase inhibitors (MAOI's e.g., phenelzine), hyperthyroidism, glaucoma, agitated states, or history of drug abuse.
    • Tenuate is contraindicated in patient pulmonary hypertension, advanced arteriosclerosis, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma, severe hypertension during or within 14 days following administration of monoamine oxidase inhibitors (MAOIs e.g., phenelzine), agitated states, or history of drug abuse.
    • Saxenda is not indicated for the treatment of type 2 diabetes and should not be used in combination with any other glucagon-like peptide-1 receptor agonist or insulin.
    • Saxenda is contraindicated in patients with personal or family history of medullary thyroid carcinoma (MTC) or patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
      • Belviq, Contrave or Saxenda - Safety and effectiveness in pediatric patients below the age of 18 have not been established and the use of Belviq, Contrave or Saxenda is not recommended in pediatric patients.
      • Tenuate - Safety and effectiveness in pediatric patients below the age of 16 have not been established.
      • Benzphetamine - Safety and effectiveness in pediatric patients below the age of 12 have not been established.
    • Qsymia is only available through certified pharmacies that are enrolled in the Qsymia certified pharmacy network. Additional information may be obtained via the website www.QsymiaREMS.com or by telephone at 1-888-998-4887.
    • The package labeling for Contrave includes black box warnings regarding the potential risk of increased suicidal thoughts and behavior and other neuropsychiatric reactions associated with bupropion use. Prescribers are urged to closely monitor for the emergence of such events when prescribing bupropion-containing agents such as Contrave.
    • The package labeling for Saxenda includes black box warnings regarding the potential risk of liraglutide causing thyroid C-cell tumors, including medullary thyroid carcinoma (MTC). Cases of MTC in patients treated with liraglutide have been reported in the postmarketing period. The data in these reports are insufficient to establish or exclude a causal relationship between MTC and liraglutide use in humans.
    • Pediatric Use
      • Phentermine - Safety and effectiveness in pediatric patients have not been established. The use of this product to treat pediatric obesity is not recommended.
      • Belviq or Contrave - Safety and effectiveness in pediatric patients below the age of 18 have not been established and the use of Belviq or Contrave is not recommended in pediatric patients.
      • Xenical - Safety and effectiveness in pediatric patients below the age of 12 have not been established.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

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    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Xenical

    120 mg PO TID with each main meal containing fat

    6 month initial trial.

    Reauthorization will require documentation of a 5% weight loss during the previous 6 month period for the first year of treatment, lack of side effects and continuation in a formalized weight management program.

    Therapy beyond the first year can be authorized every 6 months with documentation of weight maintenance, lack of side effects and continuation in a formalized weight management program, up to additional 3 years.
    Phentermine (Adipex-PR)
    15-37.5 mg PO QD before breakfast or
    1 to 2 hours after breakfast
    3 months.
    Phentermine is only indicated for
    short term use (8 to 12 weeks).

    SuprenzaR

    15 to 37.5 mg dissolved PO on tongue QD
    in the morning

    3 months
    Phentermine is only indicated for short term use (8 to 12 weeks)

    BelviqR

    10 mg PO BID

    3 months
    If > 5% weight loss is not achieved at week 12, then drug must be discontinued. If > 5% weight loss is achieved then an additional 12 weeks will be approved.
    Reauthorization:
    Documentation of a 5% weight loss during the previous 6 month period for the first year of treatment,

    Therapy beyond the first year can be authorized every 6 months with documentation of weight maintenance,
    lack of side effects and continuation in a formalized weight management program.

    Contrave

    8/90 mg PO QAM for one week, then 8/90 mg PO BID for one week; increase dose weekly by one tablet per day until the maintenance dose of two 8/90 mg tablets PO BID is reached (week4).

    16 weeks
    Reauthorization:
    If > 5% weight loss is not achieved after 12 weeks on the maintenance dose, then drug must be discontinued. If > 5% weight loss is achieved then an additional 12 weeks will be approved.
    Subsequent Reauthorizations:
    Documentation of a 5% weight loss during the previous 6 month period for the first year of treatment, lack of side effects and continuation in a formalized weight management program.

    Therapy beyond the first year can be authorized every 6 months with documentation of weight maintenance., lack of side effects and continuation in a formalized weight management program.

    Alli

    60 mg PO TID with each main meal containing fat

    6 month initial trial.
    Reauthorization:
    Documentation of a 5-10 pound weight loss during the previous 6 month period for the first year of treatment, lack of side effects and continuation in a formalized weight management program.

    Therapy beyond the first year can be authorized every 6 months with documentation of weight maintenance, lack of side effects and continuation in a formalized weight management program.

    TenuateR
    25 mg IR tablet PO TID, 1 hour before meals
    3 months
    Tenuate is only indicated for short term use (8 - 12 weeks).

    TenuateR DospanR

    75 mg ER tablet PO QD mid-morning

    3 months
    Tenuate Dospan is only indicated for short term use (8 - 12 weeks).

    DidrexR

    50 mg PO QD-TID

    3 months
    Didrex is only indicated for short term use (8 - 12 weeks).

    Saxenda

    3 mg SC daily
    Start with 0.6mg for 1 week and increase by 0.6mg increments per week until 3mg is reached.
    16 weeks
    Reauthorization:
    If patient has not lost at least 4% of baseline body weight by week 16, then drug must be discontinued. If > 4% weight loss is achieved then an additional 36 weeks will be approved.
    Therapy beyond the first year can be authorized every 6 months with documentation of weight maintenance.
  7. Product Availability:
    Adipex-P: 37.5 mg capsule and tablet
    Suprenza: 15 mg, 30 mg, 37.5 mg oral disintegrating tablet
    Desoxyn: 5 mg tablet
    Qsymia: 3.75 mg/23 mg, 7.5 mg/46 mg, 11.25 mg/69 mg, 15 mg/92 mg capsule
    Phentermine: 15 mg, 30 mg, 37.5 mg capsule; 37.5 mg tablet
    Belviq: 10 mg tablet
    Contrave: 8 mg naltrexone/90 mg bupropion extended-release tablet
    Xenical: 120 mg capsule
    Alli: 60 mg capsule
    Tenuate: 25 mg IR tablet
    Tenuate Dospan: 75 mg ER tablet
    Didrex: 50 mg tablet
    Regimex: 25 mg tablet
    Saxenda: 6mg/mL, 3mL pre-filled, multi-dose pens in boxes containing 3 or 5 pens
  8. References:
    1. Xenical [Prescribing Information] South San Francisco, CA: Genentech; December 2013.
    2. Adipex-P [Prescribing Information] Sellersville, PA: TevaPharmaceuticals; January 2013.
    3. Suprenza [Prescribing Information] Cranford, NJ; Akrimax Pharmaceuticals; June 2013.
    4. Belviq [Prescribing Information] Zofingen, Switzerland: Arena Pharmaceuticals GmbH; August 2012.
    5. Qsymia [package insert]. Mountain View, CA: Vivus Inc; April 2013.
    6. Desoxyn [Prescribing Information].Deerfield, IL: Lundbeck Inc. March 2007.
    7. Contrave [Prescribing Information]. Takeda Pharmaceuticals America, Inc. September 2014.
    8. Alli [Drug Facts] Moon Township, PA: GlaxoSmithKline
    9. Saxenda [Prescribing Information]. Plainsboro, NJ: Novo Nordisk A/S; December 2014.
    10. Tenuate [Prescribing Information] Bridgewater, NJ: Aventis Pharmaceuticals Inc. November 2003.
    11. Didrex [Prescribing Information]. New York, NY: Pfizer. August 2009.
    12. Regimex [Package Insert]. Atlanta, GA: Mikart, Inc. November 2012.
    13. Phentermine. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 12, 2014.
    14. Lorcaserin. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 12, 2014.
    15. Orlistat. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 12, 2014.
    16. MicromedexR Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed June 12, 2014.
    17. Clinical Pharmacology Web site. Available at: http://clinicalpharmacology-ip.com/default.aspx. Accessed June 12, 2014.
    18. National Heart, Lung, and Blood Institute (NHLBI). Clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults. The Evidence Report. NIH Publication No. 98-4083. 1998.
    19. Torgerson JS, Hauptman J, Boldrin MN, et al. 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 Care2004;27:155-161.
The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.