ModifiedHealth NetPolicy CP.CPA.336

Phentermine/Topiramate (Qsymia)

Medical policy governing coverage and clinical criteria for phentermine/topiramate (Qsymia) for weight management for Health Net/Centene affiliated health plans, including initial and continued therapy requirements and limitations of use.

Policy Summary

PayerHealth Net

PolicyPhentermine/Topiramate (Qsymia)

Policy CodePolicy CP.CPA.336

Change TypeCriteria updatesgeneric redirectionpediatric extension

Effective Date06.01.18

Next Review Date

Key ActionSubmit prior authorization with documentation showing member meets BMI/age criteria, evidence of ≥6 months enrollment in a behavioral weight‑loss program, and dose ≤15 mg/92 mg.

SourceLink

POLICY UPDATE CHANGES

Added redirection to generic for brand Qsymia requests per SDC request.

For documentation of weight loss program, added requirement that member has been actively enrolled for at least 6 months and that program includes behavioral modification.

Updated criteria to reflect FDA approved pediatric extension to age ≥ 12 years and clarified hypertension should be 'controlled'; removed coronary artery/heart disease as an indicator.

Removed continued therapy criterion of BMI ≥ 25 kg/m2.

Updated FDA approved indication(s) section to reflect re-wording of labeled indication.

≥12minimum age for coverage

≥30 / ≥27+adult eligibility BMI thresholds

15/92maximum daily dose

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initial approval duration

6 mosubsequent reauth

Coverage Criteria for Phentermine/Topiramate (Qsymia)

inv-01: Initial Therapy — Covered when ALL of the following are met:

Covered when ALL of the following are met:

Initial Weight Management: 1) Member meets one of: a) BMI ≥ 30 kg/m2; b) BMI ≥ 27 kg/m2 with at least one indicator of increased cardiovascular risk (e.g., controlled hypertension, dyslipidemia, diabetes, elevated waist circumference) or other obesity‑related medical condition (e.g., sleep apnea); c) if age 12–17 years: BMI ≥ 95th percentile standardized for age and sex; 2) Age ≥ 12 years; 3) If request is for brand Qsymia, member must use generic phentermine/topiramate unless contraindicated or clinically significant adverse effects are experienced; 4) Documentation supports participation in a weight loss program that includes reduced‑calorie diet, increased physical activity, and behavioral modification AND: a) member has been actively enrolled for at least 6 months; and b) will continue to be actively enrolled as an adjunct to pharmacotherapy; 5) Dose does not exceed 15 mg/92 mg per day.see node text

Approval duration: 12 weeks

inv-02: Continuation Therapy — Covered for continued therapy when ALL of the following are met:

Covered for continued therapy when ALL of the following are met:

Continued Weight Management: 1) Member is currently receiving medication via the Centene benefit or previously met initial approval criteria (or continuity of care regulations apply); 2) Member is responding to therapy as evidenced by one of: a) first renewal—≥3% baseline weight loss (adults) or baseline BMI (pediatrics) after 12 weeks on Qsymia 7.5 mg/46 mg unless request is for dose escalation; b) second renewal—≥5% baseline weight loss (adults) or baseline BMI (pediatrics); c) third or subsequent renewal—has lost weight and/or maintained weight loss on therapy; 3) If request is for brand Qsymia, member must use generic phentermine/topiramate unless contraindicated or clinically significant adverse effects are experienced; 4) Documentation that member is actively enrolled in a weight loss program (reduced calorie diet, increased physical activity, behavioral modification) adjunct to therapy; 5) If request is for a dose increase, the new dose does not exceed 15 mg/92 mg per day.see node text

First reauthorization: 12 weeks; Subsequent reauthorizations: 6 months

inv-03: Updated initial therapy criteria (summary) — Policy updates and criteria referenced in this segment include:

Policy updates and criteria referenced in this segment include:

Initial therapy requirements (as updated): Member meets updated FDA‑labeled indication including pediatric use for age ≥ 12 years; member has been actively enrolled in a weight loss program that includes behavioral modification for at least 6 months; hypertension, if present, should be controlled; coronary artery/heart disease was removed as an indicator of increased cardiovascular risk in the criteria; per SDC request, brand Qsymia requests are redirected to generic when applicable.age ≥ 12 years; 6 months enrollment

Derived from policy revisions and RT notes; see references for dates of changes.

Requests for uses that are not included in the FDA‑approved labeling and are not specifically addressed in this policy will not be authorized unless the provider submits sufficient documentation of safety and efficacy consistent with Health Net’s off‑label use policy CP.CPA.09.

The criteria were updated to remove coronary artery/heart disease as an indicator of increased cardiovascular risk; this condition is no longer used as a qualifying comorbidity when applying the BMI-with-comorbidity pathway of the initial approval criteria.

Continued therapy is not supported if the member has not achieved at least 5% reduction in baseline body weight while on Qsymia 15 mg/92 mg; per the dosing guidance, if a patient has not lost ≥5% of baseline body weight on the 15/92 mg dose, Qsymia should be discontinued.

The prior requirement that members meet a continued‑therapy BMI threshold of ≥25 kg/m2 has been removed and is no longer required for reauthorization decisions.

Eligibility Thresholds and Key Metrics

Pediatric age threshold

Pediatric age threshold>= 12 years (pediatric FDA extension and criteria require age >= 12 years)

Supporting detailPediatric BMI cutoff: >=95th percentile for ages 12-17 as standardized for age and sex

Documentation noteClinical documentation should support age >=12 years for pediatric use

Removed continued therapy BMI threshold

Removed continued therapy BMI thresholdBMI >= 25 kg/m2 requirement for continued therapy has been removed from the criteria

Review referenceChange recorded in 2Q 2023 annual review (removed continued therapy criterion of BMI >= 25 kg/m2)

Provider Requirements, Prior Authorization, and Operational Rules

Prior Authorization

Prior Authorization Required for Initial Therapy

Prior authorization is required for initiation of phentermine/topiramate (including Qsymia). Provider must submit clinical documentation (office chart notes, lab results, weight/BMI documentation, and program enrollment verification) supporting that the member meets all approval criteria before therapy is authorized.

Applies to initial therapy and brand or generic product requests
Documentation must show BMI/age criteria, weight‑loss program enrollment, and relevant clinical status

Prior Authorization

Prior Authorization Requirements

Requests must include documentation that the member meets the policy's prior authorization requirements: BMI and age thresholds, evidence of enrollment in a qualified weight‑loss program for ≥ 6 months (initial requests), participation plans to continue program adjunct to therapy, and that doses do not exceed the policy maximum. For pediatric patients, documentation must support age ≥ 12 years and BMI percentile per Appendix D.

BMI ≥ 30 kg/m2 OR BMI ≥ 27 kg/m2 with ≥1 obesity‑related comorbidity (e.g., controlled hypertension, dyslipidemia, diabetes, elevated waist circumference) OR age 12–17 with BMI ≥ 95th percentile

Background on Phentermine/Topiramate (Qsymia)

Phentermine/topiramate (Qsymia) is a combination product containing phentermine (a sympathomimetic anorectic) and topiramate (an anticonvulsant). It is indicated as an adjunct to a reduced‑calorie diet and increased physical activity to promote weight loss and weight‑loss maintenance in adults and in pediatric patients aged 12 years and older. The effect of Qsymia on cardiovascular morbidity and mortality has not been established.

Definitions and Calculation Notes

Phentermine/topiramate (Qsymia) — drug composition

CompositionCombination of phentermine (sympathomimetic amine anorectic) and topiramate (anticonvulsant)

Brand nameQsymia is the branded phentermine/topiramate product referenced in this policy

Indication contextUsed as adjunct to reduced-calorie diet and increased physical activity for weight management (see policy criteria)

BMI — calculation

BMI formula (US customary)BMI = 703 x [weight (lbs) / height (inches)^2]

Source contextFormula provided in policy Appendix C for BMI calculation

Policy Summary

PayerHealth Net

PolicyPhentermine/Topiramate (Qsymia)

Policy CodePolicy CP.CPA.336

Change TypeCriteria updatesgeneric redirectionpediatric extension

Effective Date06.01.18

Next Review Date

Key ActionSubmit prior authorization with documentation showing member meets BMI/age criteria, evidence of ≥6 months enrollment in a behavioral weight‑loss program, and dose ≤15 mg/92 mg.

SourceLink

On This Page

ImplicationContinued coverage decisions should not rely on a BMI >= 25 kg/m2 cutoff

Age ≥ 12 years for Qsymia per FDA labeling extension

Dose requests must not exceed 15 mg/92 mg per day

Denial Risk

Non‑Covered Indications / Off‑Label Use

Requests for indications that are not FDA‑approved and not addressed by this policy are not authorized unless there is sufficient documentation to meet the off‑label use policy (CP.CPA.09) or other applicable evidence of coverage guidance.

Non‑FDA approved indications require separate off‑label policy approval

Denial Risk

Excess Dose / Dose Limits

Dose requests that would result in total daily dosing above the policy maximum (15 mg/92 mg per day) are subject to denial. If a dose escalation is requested, documentation must justify the increase and must not exceed the stated maximum.

Maximum allowable dose: 15 mg/92 mg per day
Dose increases require supporting justification and adherence to maximum

Documentation Required

REMS / Teratogenicity Considerations

Qsymia (phentermine/topiramate) is only available through the Qsymia REMS program due to teratogenic risk. For females of reproductive potential, providers must document REMS program participation, negative pregnancy test prior to initiation, counseling on teratogenic risk, and appropriate pregnancy prevention measures during therapy.

REMS enrollment and documentation required for females of reproductive potential
Pregnancy test negative prior to initiation and ongoing pregnancy prevention counseling

Documentation Required

Weight‑Loss Program Documentation

Documentation must demonstrate that the member has been actively enrolled in a comprehensive weight‑loss program that includes a reduced‑calorie diet, increased physical activity, and behavioral modification. For initial approval, active enrollment for at least 6 months is required and the member must continue adjunctive program participation while on therapy.

Active enrollment ≥ 6 months required for initial requests
Program must include behavioral modification per ACC/AHA guidance
Provider should submit program records or clinician notes verifying participation

Documentation Required

Clinical Condition Documentation

Clinical documentation should reflect the member's baseline and ongoing clinical condition: controlled hypertension if listed as a comorbidity, baseline weight/BMI (or pediatric BMI percentile), and response to therapy for renewals (e.g., ≥3% weight loss at first renewal on 7.5 mg/46 mg at 12 weeks, ≥5% at second renewal, or maintenance thereafter).

Show baseline and follow‑up weight/BMI measurements
Document controlled hypertension when used as cardiovascular risk indicator
Pediatric support: age ≥ 12 years and BMI ≥ 95th percentile

Billing Rule

Generic Redirection for Brand Requests

Generic first: requests for brand Qsymia will be redirected to generic phentermine/topiramate when a generic is available. Providers must show contraindication to or intolerance of the generic to receive brand product.

Brand Qsymia requests require trial of generic phentermine/topiramate unless contraindicated or adverse effects occur
Provider must document intolerance or clinical contraindication to generic

Billing Rule

Brand‑to‑Generic Redirection (Operational Rule)

Operationally, pharmacy or utilization management may redirect brand Qsymia requests to the generic formulation per SDC request. If redirection is applied, providers may submit documentation of medical necessity for brand product to request escalation or exception.

Per SDC request (05.28.25), brand-to-generic redirection may be applied
Providers may appeal redirection with documentation of generic contraindication

Documentation Required

Required Documentation for Prior Authorization

Provider must submit supporting documentation (office notes, lab results, weight/BMI records, REMS enrollment verification, and weight‑loss program records) with prior authorization requests to demonstrate that the member meets all listed approval criteria.

Typical documents: chart notes, program enrollment verification, pregnancy test results, prior therapy history
Incomplete documentation may result in denial or request for additional information

Apply this formula when height/weight are recorded in pounds and inches per policy guidance

Weight loss program (as used in policy)

DefinitionA program that includes behavioral modification and in which the member has been actively enrolled for at least 6 months, per ACC/AHA guidance incorporated into the policy

Documentation requirementProvider must submit evidence of active enrollment for >=6 months as part of prior authorization

Role in therapyMember must continue active enrollment in the program adjunct to pharmacotherapy for approval and reauthorization