Clinical Policy: Anti-obesity agents Reference Number: ERX.NSMN.06 Effective Date: 06/15 Revision Log Last Review Date: 09/16 Clinical policies are intended to be reflective of current scientific research and clinical thinking. This policy is current at the time of approval, may be updated and therefore is subject to change. This Clinical Policy is not intended to dictate to providers how to practice medicine, nor does it constitute a contract or guarantee regarding payment or results. Providers are expected to exercise professional medical judgment in providing the most appropriate care, and are solely responsible for the medical advice and treatment of members. This policy is the property of Envolve Pharmacy Solutions. Unauthorized copying, use, and distribution of this Policy or any information contained herein is strictly prohibited. By accessing this policy, you agree to be bound by the foregoing terms and conditions, in addition to the Site Use Agreement for Health Plans associated with Envolve Pharmacy Solutions. Description The intent of the criteria is to ensure that patients follow selection elements established by Envolve Pharmacy Solutions for the use of anti-obesity agents. Policy/Criteria It is the policy of health plans affiliated with Envolve Pharmacy Solutions® that the following anti-obesity agents: orlistat (Xenical®, Alli®), lorcaserin (Belviq®, Belviq XR®), phentermine/topiramate (Qsymia®), benzphetamine, phendimetrazine (Bontril PDM®), phentermine (Adipex-P®), diethylpropion, bupropion/naltrexone (Contrave®), and liraglutide (Saxenda®) are medically necessary for members meeting the following criteria: Initial Approval Criteria (must meet all): A. Age is in compliance with FDA recommendations for the requested therapy; B. BMI ≥ 30 OR BMI ≥ 27 with one of the following: diabetes, hypertension, dyslipidemia, or cardiovascular disease; C. If a non-PDL agent is requested, failure of 2 PDL agents, unless contraindicated; D. Request does not exceed FDA approved maximum recommended dose and health plan approved daily quantity limit. Approval duration: Saxenda: 16 weeks Belviq, Belviq XR, Contrave, orlistat, Qsymia: 12 weeks Benzphetamine, phendimetrazine, phentermine, diethylpropion: 6 weeks Continued Approval (must meet all): A. Previously received medication via health plan benefit or member has previously met all initial approval criteria; Page 1 of 4 CLINICAL POLICY Anti-obesity agents B. BMI ≥ 25; C. Member has lost weight and/or maintained weight loss on therapy; D. If request is for benzphetamine, phendimetrazine, phentermine, or diethylpropion, total treatment duration does not exceed 12 weeks; E. If this is the first renewal request for Belviq, Belviq XR, Contrave, or Saxenda, member has lost at least: a. 5% of initial body weight if Belviq, Belviq XR, or Contrave is requested; b. 4% of initial body weight if Saxenda is requested; F. If this is the second renewal request for Qsymia, member has lost at least 5% of initial body weight; G. If request is for a dose increase, request does not exceed FDA approved maximum recommended dose and health plan approved daily quantity limit. Approval duration: Belviq, Belviq XR, Contrave, orlistat, Saxenda, Qsymia: 12 weeks Benzphetamine, phendimetrazine, phentermine, diethylpropion: up to 12 weeks total Workflow Document USS.NSMN.06 Anti-obesity agents workflow.docx Background Description/Mechanism of Action The agents included in this policy all produce anti-obesity effects. They have varying mechanisms of action: Lorcaserin is a serotonin 2C receptor agonist. Benzphetamine is an indirect-acting sympathomimetic amine that is metabolized to various amphetamines. Contrave is a combination of naltrexone, an opioid antagonist, and bupropion, an aminoketone antidepressant. Diethylpropion and phentermine are sympathomimetic amine anorectics. Orlistat is a gastrointestinal lipase inhibitor. Phendimetrazine is an indirect-acting, nonamphetamine sympathomimetic amine anorectic. Qsymia is a combination of phentermine and topiramate extended-release, an antiepileptic drug. Liraglutide is a glucagon-like peptide-1 receptor agonist. FDA Approved Indications Page 2 of 4 CLINICAL POLICY Anti-obesity agents All pharmacological therapies for obesity are indicated as adjuncts to diet and exercise and should only be used in those who are unable to achieve sufficient weight loss with diet and exercise alone. Belviq, Belviq XR, Contrave, orlistat, Qsymia, and Saxenda are indicated for chronic weight management in those 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). Benzphetamine, diethylpropion, phendimetrazine, and phentermine are indicated for the short-term (<12 weeks) treatment of obesity in those with an initial BMI of 30 kg/m2 or greater. References 1. Belviq® prescribing information. Woodcliff Lake, NJ: Eisai Inc; December 2014. Available at: http://www.belviq.com. Accessed July 20, 2016. 2. Belviq XR® prescribing information. Woodcliff Lake, NJ: Eisai Inc; July 2016. Available at: http://www.belviqxr.com. Accessed July 20, 2016. 3. Contrave® prescribing information. Deerfield, IL: Takeda Pharmaceuticals America, Inc; September 2014. Available at: www.contrave.com. Accessed July 2016. 4. Qsymia® prescribing information. Mountain View, CA: Vivus, Inc; October 2014. Available at: www.qsymia.com. Accessed July 2016. 5. Saxenda® prescribing information. Plainsboro, NJ: Novo Nordisk Inc; January 2015. Available at: www.saxenda.com. Accessed July 2016. 6. Benzphetamine Monograph. Clinical Pharmacology. Accessed July 2016. http://www.clinicalpharmacology-ip.com. 7. Diethylpropion Monograph. Clinical Pharmacology. Accessed July 2016. http://www.clinicalpharmacology-ip.com. 8. Orlistat Monograph. Clinical Pharmacology. Accessed July 2016. http://www.clinicalpharmacology-ip.com. 9. Phendimetrazine Monograph. Clinical Pharmacology. Accessed July 2016. http://www.clinicalpharmacology-ip.com. 10. Phentermine Monograph. Clinical Pharmacology. Accessed July 2016. http://www.clinicalpharmacology-ip.com. 11. Bray GA. Obesity in adults: drug therapy. Pi-Sunyer FX (Ed.), UpToDate. Waltham MA. Accessed July 2016. Reviews, Revisions, and Approvals Date Approval Date Policy created. 06/15 06/15 Updated to new template (converted algorithm to bulleted criteria, 07/16 09/16 added background and references). Added Belviq XR to policy agents. Modified initial approval duration of Saxenda from 12 to 16 weeks and added continuation criteria requiring 4% body weight loss after initial course of Saxenda per FDA Page 3 of 4 CLINICAL POLICY Anti-obesity agents Reviews, Revisions, and Approvals Date Approval Date labeling. Modified continuation criteria requiring 5% body weight loss upon 1st renewal request to 2nd renewal request for Qysmia per FDA labeling. Page 4 of 4 .