ADIPEX-P, Phentermine HCl Form

Phentermine (Adipex-P ®, LomairaTM) is a sympathomimetic amine with pharmacologic activity similar to the amphetamines. ____ *For Health Insurance Marketplace (HIM), Adipex-P/phentermine tablets and Lomaira are plan exclusions and are not covered.
FDA Approved Indication(s) Adipex-P and Lomaira are indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index (BMI) of: • 30 kg/m2 or greater (obese), or
• 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbidity such as hypertension, type 2 diabetes mellitus, or dyslipidemia. The limited usefulness of agents of this class, including Adipex-P and Lomaira, should be measured against possible risk factors inherent in their use. 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 Adipex-P and Lomaira are 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., coronary artery/heart disease, hypertension, dyslipidemia, diabetes, elevated waist circumference) or other obesity-related medical condition (e.g., sleep apnea); c. If age 17 years: BMI ≥ 95th percentile standardized for age and sex (see Appendix D);

   2. Age ≥ 17 years;
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   CLINICAL POLICY Phentermine

2. Member must use generic phentermine, unless contraindicated or clinically significant adverse effects are experienced;
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 one of the following (a or b): a. Adipex-P: 37.5 mg per day (1 capsule per day); b. Lomaira: 24 mg per day (3 tablets 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. Adipex-P: 37.5 mg per day (1 capsule per day); b. Lomaira: 24 mg per day (3 tablets per day). Approval duration: Up to 12 weeks total Page 2 of 6

    CLINICAL POLICY Phentermine
    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 or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key BMI: body mass index FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives
    Not applicable Appendix C: Contraindications/Boxed Warnings • Contraindication(s): pregnancy, nursing, glaucoma, hyperthyroidism, concomitant use or within 14 days use of monoamine oxidase inhibitors, known hypersensitivity to sympathomimetic amines, history of drug abuse, agitated states, and history of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hypertension) • Boxed warning(s): none reported Appendix D: General Information
    • BMI = 703 x [weight (lbs)/height (inches)2] • Examples of coronary artery/heart disease include: coronary artery bypass graft, angina, • history of myocardial infarction or stroke. If tolerance develops, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued. Page 3 of 6

    CLINICAL POLICY Phentermine
    • BMI cut-offs (95th percentile) for obesity by age and sex for adolescent patients aged ≥ 17 years:
    Age (in years) 17 17.5 Male 28.2 28.6 Female 29.6 30.0 95th Percentile BMI Value V. Dosage and Administration Drug Name Phentermine (Adipex-P) Phentermine (Lomaira) Dosing Regimen 15-37.5 mg PO QD 8 mg PO TID Maximum Dose 37.5 mg/day 24 mg/day VI. Product Availability Drug Name Phentermine Phentermine (Adipex-P) Phentermine (Lomaira) Availability Capsules: 15 mg, 30 mg, 37.5 mg Tablets: 37.5 mg Capsule: 37.5 mg Tablet: 37.5 mg Tablet: 8 mg VII.