UnitedHealthcare Pharmacy Clinical Pharmacy Programs
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1 UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2018 P Program Prior Authorization - California and New York Regulatory Program - Weight Loss Medication Includes both brand and generic versions and all formulations of the listed products unless otherwise noted Xenical (orlistat), benzphetamine, diethylpropion, phendimetrazine, phentermine (all brand products including Adipex-P and Lomaira) Belviq, Belviq XR (lorcaserin), Contrave (naltrexone and bupropion), Qsymia (phentermine and topiramate extended-release), and Saxenda (liraglutide) P&T Approval Date 11/2015, 9/2016, 9/2018 Effective Date 12/1/2018; Oxford only: 12/1/ Background: Anti-obesity agents are indicated in the management of obesity as an adjunct to lifestyle modifications including diet, exercise and behavioral modification. Medication therapy may provide modest weight reduction in conjunction with lifestyle modifications and therapy selection may be based on a specific medications side effects and warnings. Body Mass Index (BMI) uses weight and height to create an index of underweight, overweight or obesity in adults. The international classification is as follows: Classification BMI(kg/m 2 ) Principal cut-off points 1 Additional cut-off points Underweight < < Severe thinness < < Moderate thinness Mild thinness Normal range Overweight Pre-obese Obese Obese class I Obese class II
2 Obese class III WHO Global Database on Body Mass Index This program uses Obese Class III and Obese Class I (with weight related comorbidities) as markers for coverage and is designed to meet regulatory requirements for coverage of weight loss medications in New York and morbid obesity in California. 2. Coverage Criteria: A. benzphetamine, diethylpropion, phendimetrazine, phentermine (Includes both brand and generic versions and all formulations of the listed products unless otherwise noted): 1. Initial Authorization: a. Coverage will be approved based on all of the following: (1) Treatment is being requested for weight loss (2) Patient is > 16 years of age (3) Failure to lose > 5% of body weight after at least 6 months of lifestyle modification alone (e.g., dietary or caloric restriction, exercise, behavioral support, community-based program). Document lifestyle modifications employed and total weight loss (4) One of the following: (a) Failure to lose > 5% of body weight after six months of treatment with OTC orlistat (Alli) (document date of trial of orlistat and total body weight lost) (b) Contraindication (including age) or intolerance to OTC orlistat (Alli) (5) Used as an adjunct to lifestyle modification. Document which lifestyle modification will be employed. (6) One of the following: (a) Body Mass Index (BMI) 40 kg/m 2 (Obesity Class III). Documentation of current height and weight required. -OR- (b) Both of the following: i. BMI 30 kg/m 2 (Obesity Class I). Documentation of current height and weight required. ii. Documentation of one of the following weight-related 2
3 comorbidities: Dyslipidemia defined as HDL < 40mg/dL, LDL cholesterol > 160 mg/dl or triglycerides > 500 mg/dl. Hypertension (systolic blood pressure higher than 140 mm Hg or diastolic blood pressure higher than 90 mm Hg) Type 2 diabetes Sleep apnea Authorization will be issued for 3 months. 2. Reauthorization: a. Coverage will be approved based on both of the following: (1) Documentation of current weight showing a weight loss of > 5% of baseline body weight (2) Documentation of continuation of lifestyle modification Authorization for will be issued for 6 months. B. Xenical, Contrave, Belviq, Belviq XR, or Qsymia (Includes both brand and generic versions and all formulations of the listed products unless otherwise noted): 1. Initial Authorization: a. Coverage will be approved based on all of the following: (1) Treatment is being requested for weight loss (2) One of the following: (a) Patient is 12 years of age for Xenical (b) Patient is 18 years of age for Belviq, Belviq XR, Contrave, Qsymia (3) Failure to lose > 5% of body weight through at least 6 months of lifestyle modification alone (e.g., dietary or caloric restriction, exercise, behavioral support, community-based program). Document lifestyle modifications employed and total weight loss (4) One of the following: (a) Failure to lose > 5% of body weight after six months of treatment with OTC orlistat (Alli) (document date of trial of orlistat and total body weight lost) (b) Contraindication (including age) or intolerance to OTC orlistat (Alli) 3
4 (5) Used as an adjunct to lifestyle modification. Document which lifestyle modification will be employed. (6) One of the following: (a) Body Mass Index (BMI) 40 kg/m 2 (Obesity Class III) Documentation of current height and weight required. (b) Both of the following: -OR- i. BMI 30 kg/m 2 (Obesity Class I) Documentation of current height and weight required. ii. Documentation of one of the following weight-related comorbidities: Dyslipidemia defined as HDL < 40mg/dL, LDL cholesterol > 160 mg/dl or triglycerides > 500 mg/dl. Hypertension (systolic blood pressure higher than 140 mm Hg or diastolic blood pressure higher than 90 mm Hg Type 2 diabetes Sleep apnea Belviq, Belviq XR: Authorization will be issued for 3 months. Contrave: Authorization will be issued for 4 months. Qsymia, Xenical: Authorization will be issued for 6 months. 2. Reauthorization C. Saxenda a. Coverage will be approved based on both of the following: (1) Documentation of current weight showing a weight loss of > 5% of baseline body weight (2) Documentation of continuation of lifestyle modification Authorization will be issued for 6 months. 1. Initial Authorization: a. Coverage will be approved based on all of the following: (1) Treatment is being requested for weight loss (2) Patient is 18 years of age 4
5 (3) Failure to lose > 5% of body weight through at least 6 months of lifestyle modification alone (e.g., dietary or caloric restriction, exercise, behavioral support, community-based program). Document lifestyle modifications employed and total weight loss (4) Both of the following: (a) One of the following: i. Failure to lose > 5% of body weight after six months of treatment with OTC orlistat (Alli) (document date of trial of orlistat and total body weight lost) ii. Contraindication (including age) or intolerance to OTC orlistat (Alli) (b) Contraindication, intolerance or failure to lose and maintain > 5% body weight following 3 month trial EACH, of two of the following medications (document date of trial of each medication and total body weight lost): i. Prescription Xenical ii. Qsymia iii. Belviq or Belviq XR iv. Contrave (5) Used as an adjunct to lifestyle modification. Document which lifestyle modification will be employed (6) One of the following: (a) Body Mass Index (BMI) 40 kg/m 2 (Obesity Class III). Documentation of current height and weight required. (b) Both of the following: -OR- i. BMI 30 kg/m 2 (Obesity Class I). Documentation of current height and weight required. ii. Documentation of one of the following weight-related comorbidities: Dyslipidemia defined as HDL < 40 mg/dl, LDL cholesterol > 160 mg/dl or triglycerides > 500 mg/dl. Hypertension (systolic blood pressure higher than 140 mm Hg or diastolic blood pressure higher than 90 mm Hg Type 2 diabetes Sleep apnea Authorization will be issued for 4 months. 5
6 2. Reauthorization a. Coverage will be approved based on both of the following: (1) Documentation of current weight showing a weight loss of > 5% of baseline body weight (2) Documentation of continuation of lifestyle modification Authorization will be issued for 6 months. 3. Additional Clinical Rules: Supply limits may be in place. 4. References: 1. AACE position statement on obesity and obesity medicine. September/October National Institutes of Health, National Heart, Lung, and Blood Institute, and North American Association for the Study of Obesity. The Practical Guide: Identification, Evaluation, and Treatment of Overweight and Obesity in Adults American Gastroenterological Association medical position statement on obesity. Gastroenterology 2002 Sep;123(3): Bray, GA, Ryan, DH. Medical Therapy for the Patient with Obesity. Circulation. 2012;125: Barlow, SE. Expert Committee Recommendations Regarding the Prevention, Assessment, and Treatment of Child and Adolescent Overweight and Obestiy: Summary Report. Pediatrics Product Information : Benzphentermine Tablets (Didrex Pharmacia Pharmaceuticals) August, Product Information : Diethylpropion Dospan (Tenuate - Merrell Pharmaceuticals). November, Product Information : Phendimetrazine Slow-Release Capsules (Bontril - Carnick Laboratories ) April, Adipex-P Product Information,Gate Pharmaceuticals. March Xenical Product Information. Roche Pharmaceuticals South San Francisco, CA. December Belviq Prescribing information. Eisai Inc, Woodcliff Lake, NJ. June Qsymia Prescribing Information. Vivus, Inc. Mountain View, CA March Contrave Prescribing Information. Takeda Pharmacuticals America, Inc. Deerfield, IL. September, Saxenda Prescribing Information. Novo Nordisk. Plainsboro, NJ. April Bray, GA. Obesity in Adults. In: UpToDate, Post TW (Ed), UpToDate, Waltham, MA. (Accessed on September 14, 2015.) 16. Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive summary of the third report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). JAMA. 2001;285:
7 17. Pharmacological Management of Obesity: An Endocrine Society Clinical Practice Guideline. The Journal of Clinical Endocrinology & Metabolism :2, AHA/ACC/TOS Prevention Guideline: 2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults: A Report to the American College of Cardiology/American Health Association Task Force on Practice Guidelines and The Obesity Society. Circulation. 2014; 129:S World Health Organization. (2006). Global Database on Body Mass Index. Retrieved from Belviq XR Prescribing Information. Eisai Inc, Woodcliff Lake, NJ. J. 21. Lomaira Prescribing Information. KVK-Tech, Inc. Newtown, PA. September Program Prior Authorization - California and New York Regulatory Program - Weight Loss Change Control Date Change 11/2015 New program. 9/2016 Annual review. Added Belviq XR. 9/2018 Added Lomaira as in scope. Updated references. Formatting changes. 7
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