Benzphetamine for weight management

Coverage Summary

Scope: Defines medical necessity criteria, initial and continued approval, dosing limits, contraindications, and documentation requirements for benzphetamine for weight management under Centene-affiliated health plans (commercial line). Coverage stance: covered_with_criteria. Subject: Benzphetamine for weight management. Status: CURRENT. Effective: 2018-06-01; Last review: 2025-05-25.

Brief summary of coverage: Benzphetamine (available as 25 mg and 50 mg tablets) is covered as a short-term adjunct for weight management when all criteria are met: the member meets adult BMI thresholds (≥ 30 kg/m2, or ≥ 27 kg/m2 with at least one cardiovascular risk or obesity-related condition), or if age <18 meets pediatric threshold (≥ 95th percentile standardized for age and sex); the member is aged ≥ 17 years; documentation shows the member has been actively enrolled in a weight loss program for at least 6 months and will continue to be enrolled in a program that includes reduced calorie diet, increased physical activity, and behavioral modification; and the dose does not exceed 150 mg per day. Total treatment duration is limited to up to 12 weeks.

Policy thresholds & limits

Maximum daily dose150 mg/day

Maximum treatment duration12 weeks (total)

Adult BMI eligibilityBMI ≥ 30 kg/m2 or ≥ 27 kg/m2 with ≥1 cardiovascular risk or obesity-related condition

Pediatric BMI (age 17) eligibilityBMI ≥ 95th percentile standardized for age and sex

Required weight loss program enrollment (initial)Actively enrolled for at least 6 months and will continue (reduced calorie diet, increased activity, behavioral modification)

Initial Therapy Criteria (Weight Management)

I. Initial Approval Criteria - Weight Management

Provider must submit documentation supporting that member has met all approval criteria. Benzphetamine is medically necessary when the following ALL criteria are met:

ALL of the following

Member meets one of the following
- Adult BMI - obese: BMI ≥ 30 kg/m2≥ 30 kg/m2
- Adult BMI - overweight with comorbidity: BMI ≥ 27 kg/m2 with at least one indicator of increased cardiovascular risk (e.g., coronary artery/heart disease, hypertension, dyslipidemia, diabetes, elevated waist circumference) or other obesity-related medical condition (e.g., sleep apnea)≥ 27 kg/m2

Initial Therapy — Other Diagnoses/Indications

I. Initial Approval Criteria - Other diagnoses/indications

If requested indication is not covered above:

ANY of the following

Recent label change guidance: If this drug has recently (within the last 6 months) undergone a label change that is not yet reflected in this policy, follow CP.CPA.190 (formulary/no coverage/non-formulary as applicable)Within last 6 months
Refer to CP.CPA.190 for commercial
Off-label use guidance: If the requested use is not specifically listed under section III and criterion 1 does not apply, refer to off-label use policy CP.CPA.09 for commercial

Continuation Therapy Criteria (Weight Management)

II. Continued Therapy - Weight Management

Must meet ALL of the following to continue therapy:

ALL of the following

Continuity/eligibility
- Receiving via benefit or prior initial approval: Currently receiving medication via Centene benefit or member has previously met initial approval criteria
- State continuity regulations: Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums CC.PHARM.03A and CC.PHARM.03B)
Clinical response: Member is responding positively to therapy as evidenced by weight loss from baseline

Continuation Therapy — Other Diagnoses/Indications

II. Continued Therapy - Other diagnoses/indications

If requested indication is not covered above:

ANY of the following

Recent label change guidance: If this drug has recently (within the last 6 months) undergone a label change that is not yet reflected in this policy, follow CP.CPA.190 (formulary/no coverage/non-formulary as applicable)Within last 6 months
Refer to CP.CPA.190 for commercial
Off-label use guidance: If the requested use is not specifically listed under section III and criterion 1 does not apply, refer to off-label use policy CP.CPA.09 for commercial

Diagnoses / Indications NOT Authorized

III. Diagnoses/Indications NOT authorized

Coverage is not authorized for:

Non-FDA approved indications which are not addressed in this policy are not authorized unless exceptions apply

Exceptions: sufficient documentation of efficacy and safety per off-label use policy CP.CPA.09 or evidence of coverage documents

Contraindications and denial risk: Coverage requests are at risk for denial when the member has any listed contraindication, including pregnancy, symptomatic cardiovascular disease, moderate to severe hypertension, history of drug abuse, hyperthyroidism, glaucoma, use of MAO inhibitors within 14 days, advanced arteriosclerosis, agitated states, concomitant use of CNS stimulants, or known hypersensitivity to sympathomimetic amines.

Providers must submit supporting documentation (office notes, labs, or other clinical information) and requests that conflict with these contraindications or lack required documentation are subject to denial.

Applicable Codes

Product Strengths (NDC not listed)mixed

25 mg tablet	Product availability
50 mg tablet	Product availability

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization required

Prior authorization is required per plan procedures before benzphetamine is initiated. Providers must document that dose and duration limits are met when requesting authorization.

Dose ≤ 150 mg/day
Total duration ≤ 12 weeks

Documentation Required

Submit supporting documentation

Submit supporting clinical documentation with the prior authorization request. Documentation should demonstrate the eligibility criteria and support both initiation and continuation requests.

Office chart notes documenting BMI and weight loss program participation
Relevant laboratory results (as applicable)

Clinical Evidence & References

Evidence cited includes the Benzphetamine Prescribing Information, Nivagen Pharmaceuticals; January 2016 and the 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults.

Policy aligns with the AHA/ACC/TOS guideline; the guideline emphasizes that behavioral programs (reduced calorie diet, increased physical activity, and behavioral modification) should be an integral part of pharmacotherapy for obesity.

Background

Background: Benzphetamine is a sympathomimetic amine indicated as a short-term adjunct to caloric restriction for the management of exogenous obesity in patients meeting BMI thresholds. The policy aligns with the ACC/AHA/TOS guideline and emphasizes that behavioral programs are integral to pharmacotherapy for obesity, requiring documentation of enrollment in such programs as part of coverage criteria.

BMI definition & pediatric examples

BMI calculation (definition)BMI = 703 × [weight (lbs) / height (inches)^2]

Pediatric BMI example (age 17 male, 95th percentile)28.2

Pediatric BMI example (age 17 female, 95th percentile)29.6

Pediatric BMI example (age 17.5 male, 95th percentile)28.6

Pediatric BMI example (age 17.5 female, 95th percentile)30.0

Revision History

2024-05-24material_changeLatest

2Q 2024 annual review: added requirement that members have been actively enrolled in a weight loss program for at least 6 months to initial criteria and added behavioral modification to the weight loss program documentation requirement; references reviewed and updated; P&T Approval Date = 05.24.

2023-05-23material_change

2Q 2023 annual review: for age 17 years, added obesity defined as BMI ≥ 95th percentile standardized for age and sex per AAP; removed continued therapy criterion of BMI ≥ 25 kg/m2; added 25 mg strength tablet; references reviewed and updated; P&T Approval Date = 05.23.

2021-05-21