CurrentCentenePolicy CP PCH.13

Clinical Policy: Phentermine (Adipex-P, Lomaira)

Defines medical necessity, prior authorization, dosing limits, contraindications, and coverage criteria for phentermine products (Adipex-P and Lomaira) for Centene-affiliated health plans; affects providers requesting coverage for these medications across specified lines of business.

Policy Summary

PayerCentene

PolicyClinical Policy: Phentermine (Adipex-P, Lomaira)

Policy CodePolicy CP PCH.13

Change TypeNo material change

Effective DateMay 1, 2017

Next Review Date

Key ActionProvider must submit chart notes, lab results, or clinical information demonstrating BMI, enrollment in a weight loss program (≥6 months), and dosing limits to support prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 weeksmaximum approved treatment duration

37.5 mgmax Adipex-P daily dose

24 mgmax Lomaira daily dose

BMI ≥30 / ≥27+FDA-indicated BMI criteria

6 monthsmin program enrollment

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Coverage Criteria for Phentermine (Adipex-P, Lomaira)

Initial Approval Criteria

Covered when ALL of the following are met:

Initial Approval

Age/BMI: Either: Age ≥ 18 years with BMI ≥ 30 kg/m2 OR BMI ≥ 27 kg/m2 with at least one indicator of increased cardiovascular risk or other obesity‑related medical condition OR Age 17 years with BMI ≥ 95th percentile for age and sexadult and adolescent BMI criteria
Indicators of increased cardiovascular risk include controlled hypertension, dyslipidemia, diabetes, elevated waist circumference, or other obesity‑related conditions (e.g., sleep apnea)
Weight Management Program: Documentation supports member's participation in a weight loss program that involves a reduced calorie diet, increased physical activity, and behavioral modification>= 6 months
Member has been actively enrolled for at least 6 months and will continue to be actively enrolled; documentation must be provided
Product and Dose: Member must use generic phentermine unless contraindicated or clinically significant adverse effects occur; daily dose must not exceed the listed maximumsAdipex‑P ≤ 37.5 mg/day; Lomaira ≤ 24 mg/day
Dose limits per product labeling; approval duration is up to 12 weeks

Provider Documentation: Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria, including evidence of weight loss program enrollment and any comorbidity documentation such as controlled hypertension when applicable

Continuation Therapy

Covered when ALL of the following are met:

Continuation: Member is currently receiving the medication via the Centene benefit or previously met initial approval criteria; documentation of active enrollment in a weight loss program is provided; member is responding positively to therapy as evidenced by weight loss from baseline; total treatment duration does not exceed 12 weeksTotal treatment duration ≤ 12 weeks

If request is for a dose increase, the new dose must not exceed Adipex‑P 37.5 mg/day or Lomaira 24 mg/day

Initial Therapy

Covered when ALL of the following are met

Initial authorization criteria: Member has been actively enrolled in a weight loss program that includes behavioral modification for at least 6 months and will continue enrollment; hypertension is controlled per product labeling where applicable>= 6 months

Behavioral modification requirement and controlled hypertension clarification added in recent edits; provider must supply supporting documentation

Coverage does not extend to non‑FDA approved indications that are not specifically addressed in this policy. Requests for off‑label use must be supported by appropriate documentation of efficacy and safety in accordance with applicable off‑label use policies (see CP.CPA.09 for commercial lines of business and HIM.PA.154 for marketplace plans) or evidence of coverage documentation.

Contraindications and other exclusionary considerations noted in the product labeling remain applicable; where the product labeling requires a condition to be controlled (for example, hypertension), the condition must be documented as controlled prior to approval. Documentation that previously uncontrolled conditions are now controlled should be provided with the authorization request.

Per product labeling, therapy is contraindicated in individuals who are pregnant or nursing, those with glaucoma or hyperthyroidism, patients with concomitant use of monoamine oxidase inhibitors within the preceding 14 days, and those with known hypersensitivity to sympathomimetic amines. Other contraindications listed include a history of drug abuse, agitated states, history of heart failure, and uncontrolled hypertension.

Therapy is considered not medically necessary when required documentation is not provided. Examples include lack of evidence that the member has been actively enrolled in a qualifying weight loss program for the required duration (see policy criteria) or missing documentation that a condition required to be controlled per product labeling (such as hypertension) is in fact controlled. Requests that do not include the supporting chart notes, lab results, or other clinical information necessary to verify program enrollment and clinical eligibility will be denied.

Product Codes, BMI Criteria, and Related Coding

Product availability / NDCNDC

NDC (various)

Phentermine formulations: capsules 15 mg, 30 mg, 37.5 mg; Adipex-P capsule 37.5 mg; Lomaira tablet (24 mg daily regimen)

Prior authorization affected codesmixed

affected codes

placeholder for codes affected by prior authorization as referenced in the policy

BMI eligibility thresholds

Adult BMI (age ≥ 18 years)BMI ≥ 30 kg/m2

Adult BMI with comorbidityBMI ≥ 27 kg/m2 with at least one obesity‑related risk factor (e.g., controlled hypertension, diabetes, hyperlipidemia)

Adolescent (age 17 years)BMI ≥ 95th percentile for age and sex

Weight loss program enrollment duration

Required enrollment duration>= 6 months of active participation in a weight loss program

Program documentationProvider must submit chart notes or other clinical information showing continuous enrollment for the required duration

Provider Requirements and Prior Authorization Instructions

Prior Authorization

Prior Authorization Required

Prior authorization is required for phentermine products. Submit a prior authorization request that demonstrates the member meets all approval criteria before therapy is started.

Approval duration: up to 12 weeks (initial approvals typically 12 weeks)
Member must use generic phentermine unless contraindicated or intolerant

Documentation Required

Required Documentation and Documentation Risks

Provider must submit supporting clinical documentation with the prior authorization. Lack of adequate documentation may result in denial of the request.

Acceptable documentation: office chart notes, recent weight/BMI measurements, laboratory results, and documentation of adverse effects or contraindications if relevant
If documentation does not show criteria are met (e.g., enrollment in a weight loss program, controlled comorbidities), the request may be denied

Clinical Background

Phentermine is indicated as a short‑term adjunct to reduced calorie diet, increased physical activity, and behavioral modification for the management of exogenous obesity. Its clinical usefulness is limited by class risks and contraindications; if tolerance to the drug develops, dosing should not be escalated in an attempt to regain effect and therapy should be discontinued rather than increased. Treatment decisions should balance potential benefit against known safety considerations and the need for documented participation in a comprehensive weight management program.

Definitions and Program Elements

Obesity BMI criteria (FDA indication and pediatric definition)

FDA indication — primary BMI thresholdBMI ≥ 30 kg/m2

FDA indication — BMI with risk factorsBMI ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia)

Pediatric definition (age 17)For age 17 years, obesity is defined as BMI ≥ 95th percentile for age and sex

Active weight loss program characteristics

Behavioral modification requirementProgram must include behavioral modification consistent with ACC/AHA guidance

Core program componentsReduced‑calorie diet and increased physical activity plus behavioral modification