Weight loss medications

Weight loss medications are used as part of a comprehensive treatment plan for chronic weight management, in addition to diet and exercise. These medications primarily work by reducing appetite and daily caloric intake. Weight loss and management have numerous health benefits, including a decreased risk of diabetes, high blood pressure, and heart conditions, as well as increased energy levels.

A multifaceted approach to weight loss is generally recommended, which includes dietary therapy and exercise. Drug therapy can be added for individuals who are obese or have other comorbid conditions. Weight loss medications are available in various formulations, including oral tablets (such as Contrave and Qsymia) and subcutaneous injections (such as Saxenda and Wegovy).

NOTE: Coverage of prescription drugs prescribed for the treatment of obesity or for use in any weight reduction, weight loss, or dietary control varies depending on a member’s benefit policy.

• Please refer to the applicable benefit plan document to determine benefit availability and the terms and conditions of coverage.
• This Clinical Guideline only applies to members whose Plan covers prescription drugs prescribed for the treatment of obesity or for use in any weight reduction, weight loss, or dietary control.

Definitions

• "Body Mass Index (BMI)" is a value that is calculated based on an individual’s weight and height and helps determine whether a person is underweight, overweight, or normal weight.
• "Caloric intake" is the amount of calories (energy that comes from foods such as fats, proteins, and sugars) an individual intakes per day.
• "Compendia" are summaries of drug information and medical evidence to support decision-making about the appropriate use of drugs and medical procedures. Examples include, but are not limited to:
1. American Hospital Formulary Service Drug Information
2. Clinical pharmacology
3. National Comprehensive Cancer Network Drugs and Biologics Compendium
4. Thomson Micromedex DrugDex
5. United States Pharmacopeia-National Formulary (USP-NF)

Medical Necessity Criteria for Initial Authorization

The Plan considers Weight Loss Agents medically necessary when ALL of the following criteria are met:

1. The requested medication is age-appropriate based on FDA approval or evidence-based guidelines for the specific medication; AND
2. Recent documentation [within one (1) month] showing:
   • For adults:
     1. Body mass index (BMI) greater than or equal to 30 kg/m²; or
     2. BMI greater than or equal to 27 kg/m² AND has at least one (≥1) weight-related comorbid condition (e.g., cardiovascular disease, dyslipidemia, hypertension, obstructive sleep apnea, type 2 diabetes mellitus).
   • For pediatrics, usage aligned to the specific medication's FDA approval or evidence- based guidelines based on BMI percentile standardized for age and sex.
   • The member’s baseline (i.e., pre-treatment) body weight.
   • At least 6 months participation in a comprehensive weight management program prior to drug therapy, with documentation of body weight before and after.
3. Medication will be used as an adjunct to a reduced-calorie diet and increased physical activity.

Requested medication will NOT be used in combination with other weight loss products (including prescription drugs, over-the-counter drugs, and herbal preparations) or co-administered with similar products (i.e., with a similar mechanism of action, in the same drug class) unless specifically recommended per the drug's official label/prescribing information.

If the above prior authorization criteria are met, the requested weight loss medication will be approved as follow:

• For 12 weeks:
  • Adipex-P (phentermine)
  • Alli (orlistat)
  • Bontril PDM® (phendimetrazine)
  • Bontril Slow Release (phendimetrazine)
  • Contrave (naltrexone HCI/bupropion HCl)
  • Didrex (benzphetamine)
  • Lomaira (phentermine HCL)
  • Qsymia (phentermine /topiramate)
  • Regimex (benzphetamine)
  • Suprenza (phentermine)
  • Tenuate (diethylpropion)
  • Xenical (orlistat)
• For 16 weeks:
  • Saxenda (liraglutide)
  • Wegovy (semaglutide)
• For 6-months:
  • Zepbound (tirzepatide)

Medical Necessity Criteria for Reauthorization

Alli (orlistat), Contrave (naltrexone HCI/bupropion HCl), Qsymia (phentermine/topiramate), Saxenda (liraglutide), Wegovy (semaglutide), Xenical (orlistat), or Zepbound (tirzepatide) will be reauthorized for six (6) months if the member has recent chart documentation within one (1) month showing:

1. Continued lifestyle modifications (e.g., reduced calorie diet in conjunction with physical activity and behavioral therapy); AND
2. The member has achieved or sustained clinically meaningful weight loss, defined as:
   • For adults, at least 5% of baseline body weight;
   • For pediatrics, a reduction of at least 5% of baseline BMI.

Adipex-P (phentermine), Bontril PDM ® (phendimetrazine), Bontril Slow Release (phendimetrazine), Didrex (benzphetamine), Lomaira (phentermine HCL), Regimex (benzphetamine), Suprenza (phentermine), and Tenuate (diethylpropion), are NOT eligible for reauthorization.

Experimental or Investigational / Not Medically Necessary

Weight loss medications for any other indication is considered not medically necessary by the Plan, as it is deemed to be experimental, investigational, or unproven. The use of Adipex-P (phentermine), Bontril PDM (phendimetrazine), Bontril Slow Release (phendimetrazine), Didrex (benzphetamine), Lomaira (phentermine HCL), Regimex (benzphetamine), Suprenza (phentermine), and Tenuate (diethylpropion) for long-term weight management is considered not medically necessary.

References

1. Adipex-P (phentermine) [prescribing information]. Parsippany, NJ: Teva Pharmaceuticals USA, Inc; September 2020.
2. Alli (orlistat) [prescribing information]. Moon Township, PA: GlaxoSmithKline; September 2014.
3. American College of Obstetricians and Gynecologists (ACOG) Committee on Practice Bulletins– Obstetrics. ACOG Practice Bulletin No. 230: Obesity in pregnancy. Obstet Gynecol. 2021;137(6):e128-e144. doi:10.1097/AOG.0000000000004395
4. Apovian CM, Aronne LJ, Bessesen DH, et al; Endocrine Society. Pharmacological management of obesity: an endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2015;100(2):342-362. doi:10.1210/jc.2014-3415
5. Bontril PDM (phendimetrazine) [prescribing information]. Aliso Viejo, CA: Valeant; October 2007.
6. Contrave (naltrexone and bupropion) [prescribing information]. Bentwood, TN: CurraxPharmaceuticals LLC; November 2021.
7. Didrex CIII (benzphetamine) [prescribing information]. New York, NY: Pfizer; March 2020.
8. 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. Endocr Pract. 2016;22(suppl 3):1-203. doi:10.4158/EP161365.GL
9. Grunvald E, Shah R, Hernaez R, et al. AGA clinical practice guideline on pharmacological interventions for adults with obesity. Gastroenterology. 2022;163(5):1198-1225. doi:10.1053/j.gastro.2022.08.045[PubMed 36273831]

References

1. Leigh Perreault, MD and Caroline Apovian, MD. Obesity in adults: Overview of management. UpToDate. Waltham, MA: UpToDate Inc. Updated: Apr 28, 2020. Accessed August 24, 2020.
2. Lomaira (phentermine) [prescribing information]. Newtown, PA: KVK-Tech; September 2016.
3. Perreault L. Obesity in adults: drug therapy. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed July 29, 2022.
4. Phendimetrazine ER capsules [prescribing information]. Langhorne, PA: Virtus Pharmaceuticals LLC; March 2021.
5. Phentermine hydrochloride capsules [prescribing information]. Sellersville, PA: Teva Pharmaceuticals; January 2013.
6. Qsymia (phentermine/topiramate) [prescribing information]. Campbell, CA: VIVUS LLC; June 2023.
7. Sarah E. Hampl, Sandra G. Hassink, Asheley C. Skinner, Sarah C. Armstrong, Sarah E. Barlow, Christopher F. Bolling, Kimberly C. Avila Edwards, Ihuoma Eneli, Robin Hamre, Madeline M. Joseph, Doug Lunsford, Eneida Mendonca, Marc P. Michalsky, Nazrat Mirza, Eduardo R. Ochoa, Mona Sharifi, Amanda E. Staiano, Ashley E. Weedn, Susan K. Flinn, Jeanne Lindros, Kymika Okechukwu; Clinical Practice Guideline for the Evaluation and Treatment of Children and Adolescents With Obesity. Pediatrics February 2023; 151 (2): e2022060640. doi:10.1542/peds.2022-060640
8. Saxenda (liraglutide) [prescribing information]. Plainsboro, NJ: Novo Nordisk Inc; April 2023.
9. Suprenza (phentermine) [prescribing information]. Cranford, NJ: Akrimax Pharmaceuticals; June 2013.
10. Wegovy (semaglutide) [prescribing information]. Plainsboro, NJ: Novo Nordisk Inc; July 2023.
11. Wharton S, Lau DCW, Vallis M, et al. Obesity in adults: a clinical practice guideline. CMAJ. 2020;192(31):E875-E891. doi:10.1503/cmaj.191707
12. Wharton S, Lau DCW, Vallis M, et al. Obesity in adults: a clinical practice guideline. CMAJ. 2020;192(31):E875-E891. doi:10.1503/cmaj.191707[PubMed 32753461]
13. Xenical (orlistat) [prescribing information]. Montgomery, AL: H2-Pharma LLC; January 2018.
14. Yanovski SZ, Yanovski JA. Long-term drug treatment for obesity: a systematic and clinical review. JAMA. 2014;311(1):74-86. doi:10.1001/jama.2013.2813615
15. Zepbound (tirzepatide) [prescribing information]. Indianapolis, IN: Lilly USA LLC; November 2023.

Clinical Guideline Revision / History Information

• Original Date: 11/05/2020
• Reviewed/Revised: 10/14/2021, 12/01/2021, 9/15/2022, 12/14/2023