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Weight Loss Agents Prior Authorization with Quantity Limit Program Summary
Policy Number: PH-1105
This is an optional prior authorization that applies to Blue Partner, Commercial, GenPlus, NetResults A series, and SourceRx formularies.
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
10-01-2024 |
04-01-2019 |
FDA LABELED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Adipex-P®, Lomaira™, Phentermine*~ Tablet |
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 in patients with an initial BMI greater than or equal to 30 kg/m^2 or greater than or equal to 27 kg/m^2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). |
* Generic available ~ The safety and efficacy of coadministration with other weight loss drug products, including prescribed drugs, over-the-counter preparations, and herbal products have not been established. Therefore, coadministration is not recommended. |
5,6,11 |
Benzphetamine*~ Tablet |
Short-term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater than or equal to 30 kg/m^2 who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. |
* Generic available ~ The safety and efficacy of coadministration with other weight loss drug products, including prescribed drugs, over-the-counter preparations, and herbal products have not been established. Therefore, coadministration is not recommended. |
2 |
Contrave® (naltrexone/bupropion)~ Tablet ER |
Adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:
Limitations of Use:
|
~ The safety and efficacy of coadministration with other weight loss drug products, including prescribed drugs, over-the-counter preparations, and herbal products have not been established. Therefore, coadministration is not recommended. |
3 |
Diethylpropion* Tablet Tablet ER |
Short-term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction in the management of exogenous obesity for patients with an initial body mass index (BMI) greater than or equal to 30 kg/m^2 and who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Indicated for use as monotherapy only. |
* Generic available
|
9 |
Phendimetrazine* Capsule ER |
Short-term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction in the management of exogenous obesity for patients with an initial BMI greater than or equal to 30 kg/m^2 or greater than or equal to 27 kg/m^2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia) who have not responded to appropriate weight reducing regimen alone (diet and/or exercise) Indicated for use as monotherapy only. |
* Generic available
|
7 |
Phendimetrazine* Tablet |
Short-term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction in the management of exogenous obesity for patients with an initial BMI greater than or equal to 30 kg/m^2 who have not responded to appropriate weight reducing regimen alone (diet and/or exercise). Indicated for use as monotherapy only. |
* Generic available
|
10 |
Qsymia® (phentermine/topiramate)~ Capsule |
Adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in:
Limitations of Use:
|
~ The safety and efficacy of coadministration with other weight loss drug products, including prescribed drugs, over-the-counter preparations, and herbal products have not been established. Therefore, coadministration is not recommended. |
1 |
Xenical®, Orlistat Capsule |
Obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet and to reduce the risk for weight regain after prior weight loss. It is indicated for obese patients with an initial body mass index (BMI) greater than or equal to 30 kg/m^2 or greater than or equal to 27 kg/m^2 in the presence of other risk factors (e.g., hypertension, diabetes, dyslipidemia) |
|
4,20 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
Obesity |
Obesity rates have increased sharply over the last 30 years, creating a global public health crisis. The National Health and Nutrition Examination Surveys show that nearly 2 of 3 US adults are overweight or obese, and 1 of 3 adults are obese. Adults with body mass index (BMI) 25-29.9 kg/m^2 are considered overweight; those with BMI greater than or equal to 30 kg/m^2 are considered obese.(14) Weight loss is difficult for most people and weight loss medications help reinforce behavioral strategies to lose weight. Medications for weight loss do not work on their own. Numerous guidelines recommend the addition of weight loss medications only in conjunction with lifestyle and behavioral modifications.(13,14,15,21) The American Association of Clinical Endocrinologists and American College of Endocrinology comprehensive clinical practice guidelines for medical care of patients with obesity recommends the following:(14)
*Certain ethnicities (A BMI cutoff point value of greater than or equal to 23 kg/m^2 should be used in the screening and confirmation of excess adiposity in South Asian, Southeast Asian, and East Asian adults) The Endocrine Society clinical practice guidelines suggests medications approved for chronic weight management can be useful adjuncts to lifestyle change for patients who have been unsuccessful with diet and exercise alone. They recommend adherence to American Heart Association Guidelines (2013) [see below] which include advice for assessment and treatment with diet and exercise, as well as bariatric surgery for appropriate candidates.(13)
The American Heart Association/American College of Cardiology/Obesity Society Guideline (2013) suggests if weight and lifestyle history indicates the patient has never participated in a comprehensive lifestyle intervention program as defined in the guidelines (i.e., trained interventionist or nutritional professional supervision of diet, exercise, and behavior therapy), it is recommended that the patient undertake such a program before addition of adjunctive therapies (e.g., pharmacotherapy), since a substantial proportion of patients will lose sufficient weight to improve health with comprehensive lifestyle management alone. If a patient has been unable to lose weight or sustain weight loss with comprehensive lifestyle intervention and has BMI greater than or equal to 30 kg/m^2 or greater than or equal to 27 kg/m^2 with greater than or equal to 1 obesity-associated comorbid condition(s), adjunctive therapy may be considered. The expert panel did not review comprehensive evidence on pharmacotherapy for weight loss. Medications should be FDA approved and clinicians should be knowledgeable about the product label. The provider should weigh potential risks of the medication vs. potential benefits of successful weight loss for the individual patient. If the patient is currently taking an obesity medication but has not lost at least 5% of initial body weight after 12 weeks on a maximal dose of the medication, the provider should reassess the risk-to-benefit ratio of that medication for the patient and consider discontinuation of that drug.(15) The Veterans Affairs and Department of Defense (VA/DoD) Clinical Practice Guideline (2020), suggests offering prescribed pharmacotherapy in patients with a BMI greater than or equal to 30 kg/m^2 or greater than or equal to 27 kg/m^2 with greater than or equal to 1 obesity-associated comorbid condition(s), in conjunction with a comprehensive lifestyle intervention.(18) Four centrally-acting noradrenergic agents (phentermine, diethylpropion, phendimetrazine, benzphetamine) are FDA-approved for the “short-term” (usually considered less than or equal to 12 weeks) management of obesity. However, the short-term designation was given since all were approved before the necessity of long-term treatment for obesity was established.(12) Since then some of these agents, such as phentermine and diethylpropion, have had literature published in support of long-term use.(13,19) Given the wide clinical prescribing of phentermine for greater than 20 years and lack of evidence of serious side effects, even in the absence of long-term controlled safety and efficacy data, it seems reasonable for clinicians to prescribe phentermine long term. (13) A clinical study found that diethylpropion plus a standard dietary intervention produced sustained and clinically significant weight loss over 1 year, and demonstrated safety under the cardiovascular and psychiatric point of view.(19) |
Pediatric Obesity |
Pediatric obesity has become an epidemic and international problem. In the United States, the prevalence of obesity in children has risen from 5% in 1970 to 17% in 2004. Genetics and environment are the underlying causes of the increase in pediatric obesity. Obese children and adolescents are at risk of developing the same comorbid conditions as obese and overweight adults. Obesity and overweight in children are defined on percentages specific for age and gender defined BMI values. The American Academy of Pediatrics (AAP) define obesity as a BMI greater than or equal to 95th percentile or a BMI greater than or equal to 30 kg/m^2, whichever is lower, and overweight as a BMI within 85th to 94th percentile for children and adolescents 2 years of age and older.(17,22) The AAP recommends that clinicians should assess medical and behavioral risks in any child with a BMI above the 85th percentile before initiating any intervention.(17,22) The Endocrine Society Pediatric Obesity Treatment Guidelines also recommend that clinicians should evaluate for potential comorbidities in children and adolescents with a BMI greater than or equal to 85th percentile.(16) The 2023 AAP guidelines recommend the use of weight loss agents in conjunction with lifestyle and behavioral changes. Pediatricians and other primary healthcare providers should treat children and adolescents for overweight with comorbidities (BMI greater than or equal to 85th percentile; comorbidities such as dyslipidemia, prediabetes, Type 2 diabetes, fatty liver disease, hypertension) and obesity (BMI greater than or equal to 95th percentile).(22) The 2017 Endocrine Society guidelines only recommend the use of FDA approved pharmacotherapy in pediatric patients as adjunctive therapy to lifestyle modifications of the highest intensity available and only by clinicians that are experienced in the use of anti-obesity agents.(16)
|
Safety |
Phentermine has the following contraindications:(5,6,11)
Benzphetamine has the following contraindications:(2)
Phendimetrazine has the following contraindications:(7,10)
Diethylpropion has the following contraindications:(9)
Phentermine/topiramate has the following contraindications:(1)
Naltrexone/bupropion (NB) has the following:(3)
Orlistat has the following contraindications:(4)
Co-Administration None of the FDA approved weight loss agents have approval for co-administration with another weight loss agent. New guidelines do not support the use of co-administration of weight loss pharmacological agents.(13,14,18) Use of non-approved drug combinations for obesity treatment should be limited to clinical trials, and patients should be informed when drugs are being used off label alone or in combination.(12) |
REFERENCES
Number |
Reference |
1 |
Qsymia prescribing information. Vivus, Inc. June 2023. |
2 |
Benzphetamine prescribing information. Nivagen Pharmaceuticals. January 2016. |
3 |
Contrave prescribing information. Nalpropion Pharmaceuticals LLC. November 2021. |
4 |
Xenical prescribing information. H2-Pharma, LLC. November 2022. |
5 |
Adipex-P prescribing information. Teva Pharmaceuticals. September 2020. |
6 |
Phentermine prescribing information. Aurolife Pharma LLC. January 2019. |
7 |
Phendimetrazine ER prescribing information. Virtus Pharmaceuticals, LLC. May 2020. |
8 |
Reference No Longer Used |
9 |
Diethylpropion prescribing information. Lannett Company, Inc. December 2019. |
10 |
Phendimetrazine prescribing information. KVK-Tech, Inc. December 2019. |
11 |
Lomaira prescribing information. KVK-Tech Inc. December 2023. |
12 |
Yanovski SZ, Yanovski JA. Long-Term Drug Treatment for Obesity: A Systematic and Clinical Review. JAMA. 2014 Jan;311(1):74-86. |
13 |
Apovian CM, Aronne LJ, Bessesen DH, et al. Pharmacological Management of Obesity: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2015 Feb;100(2):342–362. |
14 |
American Association of Clinical Endocrinologists and American College of Endocrinology Comprehensive Clinical Practice Guidelines for Medical Care of Patients with Obesity. Endocr Pract. 2016 Jul:22(Suppl 3):1-203. |
15 |
Jensen MD, Ryan DH, Apovian CM, 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. Circulation. 2014;129(25 Suppl 2):S102–S138. |
16 |
Styne DM, Arslanian SA, Connor EL, et al. Pediatric Obesity – Assessment, Treatment, and Prevention: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2017 Jan;102(3):709–757. |
17 |
Barlow SE, et al. Expert Committee Recommendations Regarding the Prevention, Assessment, and Treatment of Child and Adolescent Overweight and Obesity: Summary Report. Pediatrics. 2007 Dec;120(Suppl 4):S164-S192. |
18 |
Department of Veterans Affairs and the Department of Defense Clinical Practice Guideline for the Management of Adult Overweight and Obesity – Version 3.0. 2020. Available at: https://www.healthquality.va.gov/guidelines/CD/obesity/. |
19 |
Cercato C, Roizenblatt VA, Leanca CC, et al. A Randomized Double-Blind Placebo-Controlled Study of the Long-Term Efficacy and Safety of Diethylpropion in the Treatment of Obese Subjects. Int J Obes (Lond). 2009 Aug;33(8):857-865. |
20 |
Orlistat prescribing information. H2-Pharma, LLC. June 2022. |
21 |
American Gastroenterological Association (AGA) Clinical Practice Guideline on Pharmacological Interventions for Adults with Obesity. Gastroenterology. 2022 Nov;163(5):1198-1225. |
22 |
American Academy of Pediatrics (AAP) Clinical Practice Guideline for the Evaluation and Treatment of Children and Adolescents with Obesity. Pediatrics. 2023 Jan;151(2):1-100. |
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
Target Brand Agent(s) |
Target Generic Agent(s) |
Strength |
Targeted MSC |
Available MSC |
Final Age Limit |
Preferred Status |
|
||||||
|
benzphetamine hcl tab |
50 MG |
M ; N ; O ; Y |
Y |
|
|
|
diethylpropion hcl tab ; diethylpropion hcl tab er |
25 MG ; 75 MG |
M ; N ; O ; Y |
M ; Y |
|
|
Contrave |
naltrexone hcl-bupropion hcl tab er |
8-90 MG |
M ; N ; O ; Y |
N |
|
|
Xenical |
Orlistat Cap 120 MG |
120 MG |
M ; N ; O ; Y |
N |
|
|
|
phendimetrazine tartrate cap er ; phendimetrazine tartrate tab |
105 MG ; 35 MG |
M ; N ; O ; Y |
N ; Y |
|
|
Adipex-p ; Lomaira |
phentermine hcl cap ; phentermine hcl tab |
15 MG ; 30 MG ; 37.5 MG ; 8 MG |
M ; N ; O ; Y |
N ; O ; Y |
|
|
Qsymia |
phentermine hcl-topiramate cap er |
11.25-69 MG ; 15-92 MG ; 3.75-23 MG ; 7.5-46 MG |
M ; N ; O ; Y |
N |
|
|
POLICY AGENT SUMMARY QUANTITY LIMIT
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
QL Amount |
Dose Form |
Day Supply |
Duration |
Addtl QL Info |
Allowed Exceptions |
Targeted NDCs When Exclusions Exist |
|
|||||||||
|
Benzphetamine HCl Tab 25 MG |
|
90 |
Tablets |
30 |
DAYS |
|
|
|
|
Benzphetamine HCl Tab 50 MG |
50 MG |
90 |
Tablets |
30 |
DAYS |
|
|
|
|
Diethylpropion HCl Tab 25 MG |
25 MG |
90 |
Tablet |
30 |
DAYS |
|
|
|
|
Diethylpropion HCl Tab ER 24HR 75 MG |
75 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
|
Phendimetrazine Tartrate Cap ER 24HR 105 MG |
105 MG |
30 |
Capsules |
30 |
DAYS |
|
|
|
|
Phendimetrazine Tartrate Tab 35 MG |
35 MG |
180 |
Tablets |
30 |
DAYS |
|
|
|
Adipex-p |
phentermine hcl cap |
15 MG ; 30 MG ; 37.5 MG |
30 |
Capsules |
30 |
DAYS |
|
|
|
Adipex-p |
Phentermine HCl Tab 37.5 MG |
37.5 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Contrave |
Naltrexone HCl-Bupropion HCl Tab ER 12HR 8-90 MG |
8-90 MG |
120 |
Tablets |
30 |
DAYS |
|
|
|
Lomaira |
Phentermine HCl Tab 8 MG |
8 MG |
90 |
Tablets |
30 |
DAYS |
|
|
|
Qsymia |
phentermine hcl-topiramate cap er |
11.25-69 MG ; 15-92 MG ; 3.75-23 MG ; 7.5-46 MG |
30 |
Capsules |
30 |
DAYS |
|
|
|
Xenical |
Orlistat Cap 120 MG |
120 MG |
90 |
Capsules |
30 |
DAYS |
|
|
|
CLIENT SUMMARY – PRIOR AUTHORIZATION
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
|
benzphetamine hcl tab |
50 MG |
Blue Partner ; Commercial ; GenPlus ; NetResults A Series ; SourceRx |
|
diethylpropion hcl tab ; diethylpropion hcl tab er |
25 MG ; 75 MG |
Blue Partner ; Commercial ; GenPlus ; NetResults A Series ; SourceRx |
|
phendimetrazine tartrate cap er ; phendimetrazine tartrate tab |
105 MG ; 35 MG |
Blue Partner ; Commercial ; GenPlus ; NetResults A Series ; SourceRx |
Adipex-p ; Lomaira |
phentermine hcl cap ; phentermine hcl tab |
15 MG ; 30 MG ; 37.5 MG ; 8 MG |
Blue Partner ; Commercial ; GenPlus ; NetResults A Series ; SourceRx |
Contrave |
naltrexone hcl-bupropion hcl tab er |
8-90 MG |
Blue Partner ; Commercial ; GenPlus ; NetResults A Series ; SourceRx |
Qsymia |
phentermine hcl-topiramate cap er |
11.25-69 MG ; 15-92 MG ; 3.75-23 MG ; 7.5-46 MG |
Blue Partner ; Commercial ; GenPlus ; NetResults A Series ; SourceRx |
Xenical |
Orlistat Cap 120 MG |
120 MG |
Blue Partner ; Commercial ; GenPlus ; NetResults A Series ; SourceRx |
CLIENT SUMMARY – QUANTITY LIMITS
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
|
Benzphetamine HCl Tab 25 MG |
|
Blue Partner ; Commercial ; GenPlus ; NetResults A Series ; SourceRx |
|
Benzphetamine HCl Tab 50 MG |
50 MG |
Blue Partner ; Commercial ; GenPlus ; NetResults A Series ; SourceRx |
|
Diethylpropion HCl Tab 25 MG |
25 MG |
Blue Partner ; Commercial ; GenPlus ; NetResults A Series ; SourceRx |
|
Diethylpropion HCl Tab ER 24HR 75 MG |
75 MG |
Blue Partner ; Commercial ; GenPlus ; NetResults A Series ; SourceRx |
|
Phendimetrazine Tartrate Cap ER 24HR 105 MG |
105 MG |
Blue Partner ; Commercial ; GenPlus ; NetResults A Series ; SourceRx |
|
Phendimetrazine Tartrate Tab 35 MG |
35 MG |
Blue Partner ; Commercial ; GenPlus ; NetResults A Series ; SourceRx |
Adipex-p |
phentermine hcl cap |
15 MG ; 30 MG ; 37.5 MG |
Blue Partner ; Commercial ; GenPlus ; NetResults A Series ; SourceRx |
Adipex-p |
Phentermine HCl Tab 37.5 MG |
37.5 MG |
Blue Partner ; Commercial ; GenPlus ; NetResults A Series ; SourceRx |
Contrave |
Naltrexone HCl-Bupropion HCl Tab ER 12HR 8-90 MG |
8-90 MG |
Blue Partner ; Commercial ; GenPlus ; NetResults A Series ; SourceRx |
Lomaira |
Phentermine HCl Tab 8 MG |
8 MG |
Blue Partner ; Commercial ; GenPlus ; NetResults A Series ; SourceRx |
Qsymia |
phentermine hcl-topiramate cap er |
11.25-69 MG ; 15-92 MG ; 3.75-23 MG ; 7.5-46 MG |
Blue Partner ; Commercial ; GenPlus ; NetResults A Series ; SourceRx |
Xenical |
Orlistat Cap 120 MG |
120 MG |
Blue Partner ; Commercial ; GenPlus ; NetResults A Series ; SourceRx |
PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
|
Initial Evaluation (Patient new to therapy, new to Prime, or attempting a repeat weight loss course of therapy) Target Agent(s) will be approved when ALL the following are met:
Length of Approval: 3 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.
Renewal Evaluation (Patient continuing a current weight loss course of therapy) Target Agent(s) will be approved when ALL of the following are met:
Length of Approval:
NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. |
QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
|
Quantity limit for the Target Agent(s) will be approved when ONE of the following is met:
Length of Approval: up to 12 months
|
This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.
Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.
Commercial _ PS _ Weight_Loss_Agents_PAQL _ProgSum_ 10-01-2024