Phendimetrazine Form

Phendimetrazine is a sympathomimetic amine with pharmacologic activity similar to the amphetamines. ____ *For Health Insurance Marketplace (HIM), if request is through pharmacy benefit, phendimetrazine ER is non- formulary for California and Florida HIM, a benefit exclusion for other HIMs, and should not be approved using these criteria. For California and Florida, refer to the formulary exception policy, HIM.PA.103. FDA Approved Indication(s) Phendimetrazine IR/ER 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.
Phendimetrazine ER is also indicated in patients with a BMI ≥ 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. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that phendimetrazine is medically necessary when the following criteria are met:
I. Initial Approval Criteria A. Weight Management (must meet all):

1. Member meets one of the following (a, b, or c):
   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 ≥ 17 years but < 18 years: BMI ≥ 95th percentile standardized for age and sex (see Appendix D);

2. Age is one of the following (a or b):
   a. If request is for phendimetrazine ER: ≥ 17 years;
   b. If request is for phendimetrazine IR: ≥ 18 years;
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   CLINICAL POLICY Phendimetrazine

3. Documentation that member is actively enrolled in a weight loss program that involves a reduced calorie diet and increased physical activity adjunct to therapy;
4. Dose does not exceed (a or b):
   a. Phendimetrazine IR: both of the following (i and ii): i. 210 mg per day; ii. 6 tablets per day; b. Phendimetrazine ER: both of the following (i and ii):
   i. 105 mg per day;
   ii. 1 capsule per day. Approval duration: 12 weeks B. Other diagnoses/indications (must meet 1 or 2):
5. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial and HIM.PA.33 for health insurance marketplace; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial and HIM.PA.103 for health insurance marketplace; or
6. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial and HIM.PA.154 for health insurance marketplace.
   II. Continued Therapy A. Weight Management (must meet all):
7. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
8. Member is responding positively to therapy as evidenced by weight loss from baseline;
9. Documentation that member is actively enrolled in a weight loss program that involves a reduced calorie diet and increased physical activity adjunct to therapy;

10. Total treatment duration does not exceed 12 weeks;

    5. If request is for a dose increase, new dose does not exceed (a or b): a. Phendimetrazine IR: both of the following (i and ii):
       i. 210 mg per day; ii. 6 tablets per day;
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    CLINICAL POLICY Phendimetrazine b. Phendimetrazine ER: both of the following (i and ii):
    i. 105 mg per day; ii. 1 capsule per day. Approval duration: Up to 12 weeks total B. Other diagnoses/indications (must meet 1 or 2):

11. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial and HIM.PA.33 for health insurance marketplace; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial and HIM.PA.103 for health insurance marketplace; or

12. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial and HIM.PA.154 for health insurance marketplace.
    III. Diagnoses/Indications for which coverage is NOT authorized:
    A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial and HIM.PA.154 for health insurance marketplace. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key BMI: body mass index ER: extended release
    Appendix B: Therapeutic Alternatives
    Not applicable FDA: Food and Drug Administration IR: immediate release Appendix C: Contraindications/Boxed Warnings
    • Contraindication(s):
    o Phendimetrazine IR: known hypersensitivity or idiosyncrasy to sympathomimetics, advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, glaucoma, highly nervous or agitated patients, patients with a history of drug abuse, patients taking other CNS stimulants including monoamine oxidase inhibitors o Phendimetrazine ER: history of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hypertension, pulmonary hypertension), during or within 14 days following administration of monoamine oxidase inhibitors, hyperthyroidism, glaucoma, agitated states, history of drug abuse, Page 3 of 6

    CLINICAL POLICY Phendimetrazine pregnancy, nursing, use in combination with other anorectic agents or CNS stimulants, known hypersensitivity or idiosyncratic reactions to sympathomimetics
    • Boxed warnings(s): none reported Appendix D: General Information
    • BMI = 703 x [weight (lbs)/height (inches)2] • BMI cut-offs (95th percentile) for obesity by age and sex for adolescent patients aged ≥
    17 years:
    95th Percentile BMI Value Age (in years) 17 17.5 Male 28.2 28.6 V. Dosage and Administration Indication Weight management Dosing Regimen IR: 35 mg PO BID-TID ER: 105 mg PO QD VI. Product Availability • Immediate-release tablet: 35 mg • Extended-release capsule: 105 mg Female 29.6 30.0 Maximum Dose IR: 210 mg/day ER: 105 mg/day VII.