CurrentmhnPolicy HNCA.CP.CPA.336

Phentermine/Topiramate (Qsymia) coverage

This policy governs medical necessity criteria, dosing, administration, and product availability for phentermine/topiramate (Qsymia) for members, including updated pediatric indication information and documentation requirements for initial and continued therapy.

Policy Summary

Payermhn

PolicyPhentermine/Topiramate (Qsymia) coverage

Policy CodePolicy HNCA.CP.CPA.336

Change TypePediatric indication clarifieddocumentation and enrollment requirements added

Effective DateJun 1, 2018

Next Review DateN/A

Key ActionSubmit documentation of current height and weight within 30 days and evidence of enrollment in an approved weight-loss program when requesting prior authorization.

SourceLink

POLICY UPDATE CHANGES

Added redirection to generic for brand Qsymia requests.

Updated criteria to reflect FDA approved pediatric extension to age ≥ 12 years.

Added documentation of current height and weight within the last 30 days to initial criteria and for reauthorization added requirement for current weight within the last 30 days.

Added documentation that member will have follow-up visit to assess adherence and response to therapy.

4available capsule formulations

15 mg/92 mgdaily maximum dose

12 weeksinitial dosing & eval

≥12 yrs

Policy Summary

Payermhn

PolicyPhentermine/Topiramate (Qsymia) coverage

Policy CodePolicy HNCA.CP.CPA.336

Change TypePediatric indication clarifieddocumentation and enrollment requirements added

Effective DateJun 1, 2018

Next Review DateN/A

Key ActionSubmit documentation of current height and weight within 30 days and evidence of enrollment in an approved weight-loss program when requesting prior authorization.

SourceLink

On This Page

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Coverage criteria and clinical thresholds

Coverage criteria for initiation and continuation of Qsymia

Covered when ALL of the following dosing and monitoring criteria are met

Initial dosing and evaluation: Start Qsymia 3.75 mg/23 mg PO once daily for 14 days, then increase to 7.5 mg/46 mg PO once daily for up to 12 weeks; after 12 weeks on 7.5 mg/46 mg evaluate weight loss for adults or BMI reduction for pediatric patients (age ≥12 years). Adults must have ≥3% baseline body weight loss on 7.5/46 mg to continue; pediatric patients (≥12 years) must have ≥3% reduction in baseline BMI.≥3% weight or BMI reduction at 12 weeks

Do not exceed 7.5 mg/46 mg for patients with moderate/severe renal impairment or moderate hepatic impairment.

Dose escalation and discontinuation: If the 12-week evaluation criteria are met, increase to 11.25 mg/69 mg PO once daily for 14 days, then 15 mg/92 mg PO once daily. If a patient on 15 mg/92 mg has not lost at least 5% of baseline body weight, discontinue Qsymia because continued treatment is unlikely to provide clinically meaningful weight loss.<5% weight loss on 15/92 mg = discontinue

Maximum daily dose 15 mg/92 mg.

Pediatric monitoring: Monitor the rate of weight loss in pediatric patients; if weight loss exceeds 2 lbs (0.9 kg) per week, consider dose reduction.>0.9 kg/week

FDA pediatric indication applies to patients age ≥12 years as reflected in policy updates.

Behavioral and documentation requirements: Prior authorization and continuation require evidence of enrollment in an approved weight loss program (including behavioral modification per ACC/AHA-type programs) for at least 6 months, documentation of current height and weight within 30 days for initial requests and current weight within 30 days for reauthorization, and a documented plan for follow-up visits to assess adherence and response to therapy.6 months enrollment in approved program

Examples of approved programs and WHO weight classification provided in appendices; prescriber-recommended lifestyle modification plan expected.

The policy was updated during the 2Q 2023 annual review to remove the prior continued-therapy requirement that a patient maintain a BMI ≥25 kg/m2. This change is documented in the policy history and reflects a narrowing of that specific continuation threshold. The revision history also records a series of template and criteria updates across multiple review cycles, including clarification of cardiovascular risk indicators and the extension of the pediatric indication to age ≥12 years.

For patients who are escalated to the maximum regimen, therapy should be discontinued if they do not achieve the defined response: specifically, if a patient receiving Qsymia 15 mg/92 mg has not lost at least 5% of baseline body weight, discontinue Qsymia because ongoing treatment is unlikely to produce clinically meaningful weight loss.

Product formulations, dosing and evaluation thresholds

Available product formulationsNDC

NDC not listed

Product availability: Capsules 3.75 mg/23 mg, 7.5 mg/46 mg, 11.25 mg/69 mg, 15 mg/92 mg

inv-05: Weight loss evaluation thresholds for adults (3% at 12 weeks on 7.5/46 mg; 5% threshold at higher dose)

Adult evaluation at 12 weeksAdults treated with Qsymia should be evaluated after 12 weeks on 7.5 mg/46 mg; continue therapy only if the patient has lost at least 3% of baseline body weight.

Escalation after 12 weeksIf adult has lost ≥3% on 7.5/46 mg, may escalate to 11.25 mg/69 mg for 14 days then 15 mg/92 mg PO QD.

Discontinuation threshold at maximum doseIf patient on 15 mg/92 mg has not lost at least 5% of baseline body weight, discontinue Qsymia.

Dose limits for organ impairmentDo not exceed 7.5 mg/46 mg for patients with moderate or severe renal impairment or patients with moderate hepatic impairment.

inv-06: Pediatric weight monitoring — rate limits and dose-reduction guidance

Prior authorization, documentation and operational requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for initiation of phentermine/topiramate therapy. Requests must document enrollment in an approved weight loss program that includes behavioral modification (per ACC/AHA guidance) and evidence the member has been actively enrolled for at least 6 months when applicable. Prior authorization may redirect brand Qsymia requests to the generic formulation where applicable.

Applies to initial prior authorization requests and reauthorization where program enrollment evidence is requested.
See policy criteria for age and BMI thresholds and FDA-labeled indications.

Step Therapy

Step Therapy Note

Step therapy requirements and exceptions: if step therapy is not applicable for this member (for example, contraindication or intolerance to required prior agents), document the clinical rationale in the request. Operationally, absence of step therapy or modifications to step requirements should be referenced in the prior authorization notes to facilitate case review.

Include prior medication history and reasons for not meeting step therapy where relevant.

Key definitions and pediatric indication

inv-12: Pediatric indication — FDA extension to patients aged ≥12 years

FDA pediatric extensionThe policy was updated to reflect the FDA-approved extension of the pediatric indication to patients aged ≥12 years.

Evaluation after titrationPediatric patients should be evaluated after up to 12 weeks on 7.5 mg/46 mg for BMI reduction (≥3% target).

Monitoring requirementMonitor pediatric rate of weight loss and consider dose reduction if >0.9 kg (2 lbs)/week.

inv-13: Evaluation threshold at 12 weeks — adult ≥3% on 7.5/46 mg and related escalation/discontinuation thresholds

12-week adult thresholdAdults must lose at least 3% of baseline body weight after 12 weeks on 7.5 mg/46 mg to continue therapy.

Action if threshold met

Clinical background

Qsymia is a fixed-dose combination of phentermine and topiramate indicated for chronic weight management and is dosed using a titration schedule beginning with 3.75 mg/23 mg PO once daily for 14 days, then increasing to 7.5 mg/46 mg PO once daily for up to 12 weeks. After 12 weeks on 7.5/46 mg, adult patients should be evaluated for weight loss and pediatric patients (age ≥12 years) evaluated for BMI reduction; if response criteria are not met, dosing may be escalated to 11.25 mg/69 mg PO once daily for 14 days followed by a maintenance dose of 15 mg/92 mg PO once daily. The maximum recommended daily dose is 15 mg/92 mg. The policy history documents updates to the labeled pediatric indication (extension to age ≥12 years) and routine annual reviews of references and criteria.