Subject: Antiobesity Agents PA Policy 18-A 07-2020

Drug

benzphetamine products

diethylpropion products

phendimetrazine products

phentermine products

Policy:

FDA-approved Indications           

Benzphetamine

Benzphetamine is indicated in the management of exogenous obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m² or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. The limited usefulness of agents of this class should be weighed against possible risks inherent in their use. Benzphetamine is indicated for use as monotherapy only.

Limitations of Use:

• The effect on cardiovascular morbidity and mortality has not been established.
• The safety and effectiveness of these agents in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.

Diethylpropion

Diethylpropion is indicated in the management of exogenous obesity as a short-term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index of 30 kg/m² or higher and who have not responded to an appropriate weight reducing regimen (diet and/or exercise) alone. The usefulness of agents of this class should be measured against possible risk factors inherent in their use. Diethylpropion is indicated for use as monotherapy only.

Limitations of Use:

• The effect on cardiovascular morbidity and mortality has not been established.
• The safety and effectiveness of these agents in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.

Phendimetrazine

Phendimetrazine tartrate extended-release capsules are indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of greater than or equal to 30 kg/m² or greater than or equal to 27 kg/m² in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia) who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. The limited usefulness of agents of this class should be weighed against possible risks inherent in their use. Phendimetrazine tartrate is indicated for use as monotherapy only.

Phendimetrazine tartrate is indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m² or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. The limited usefulness of agents of this class should be weighed against possible risks inherent in their use. Phendimetrazine tartrate is indicated for use as monotherapy only.

Limitations of Use:

• The effect on cardiovascular morbidity and mortality has not been established.
• The safety and effectiveness of these agents in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.

Phentermine

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 greater than or equal to 30 kg/m², or greater than or equal to 27 kg/m² in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). The limited usefulness of agents of this class should be measured against possible risk factors inherent in their use.

Limitations of Use:

• The effect on cardiovascular morbidity and mortality has not been established.
• The safety and effectiveness of these agents in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.

1. Precertification Criteria

The requested drug will be covered with prior authorization when the following criteria are met:

• The patient has not received 3 months of therapy with the requested drug within the past 365 days

      AND

• The requested drug will be used with a reduced calorie diet and increased physical activity AND
  • The patient has a body mass index (BMI) greater than or equal to 30 kg per square meter
    OR
    
  • The patient has a body mass index (BMI) greater than or equal to 27 kg per square meter AND has additional risk factors

     AND

• If the request is for phentermine it will not be used in a patient who is also using Fintepla (fenfluramine)

Place of Service:

Outpatient

The above policy is based on the following references:

1. Adipex-P [package insert]. Parsippany, NJ: Teva Pharmaceuticals USA, Inc.; March 2020.
2. Benzphetamine [package insert]. East Brunswick, NJ: Avet Pharmaceuticals Inc; December 2019.
3. Diethylpropion [package insert]. Philadelphia, PA: Lannett Company, Inc.; December 2019.
4. Phendimetrazine [package insert]. Northvale, NJ: Elite Laboratories , Inc.; January 2019.
5. Phendimetrazine extended-release [package insert]. Langhorne, PA: Virtus Pharmaceuticals, LLC.; February 2020.
6. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Hudson, OH: Wolters Kluwer Clinical Drug Information, Inc. http://online.lexi.com/. Accessed July 2020.
7. Micromedex (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. http://www.micromedexsolutions.com/. Accessed July 2020.
8. Pharmacological Management of Obesity: An Endocrine Society Clinical Practice Guideline. The Journal of Clinical Endocrinology & Metabolism, Volume 100, Issue 2, 1 February 2015, Pages 342–362. https://academic.oup.com/jcem/article/100/2/342/2813109. Accessed July 2020.
9. Jensen MD, et al. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. 2013; 129:S102–S138
10. FDA Announces Withdrawal Fenfluramine and Dexfenfluramine (Fen-Phen). July 2005. Available at: https://wayback.archive-it.org/7993/20170723090512/https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm179871.htm. Accessed July 2020.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

January 01, 2021