CurrentHealth NetPolicy CP PMN.179

Clinical Policy: Megestrol Acetate

Medical necessity and prior authorization criteria for megestrol acetate 125 mg/mL oral solution for treatment of anorexia/cachexia or unexplained significant weight loss in patients with AIDS; applies to Health Net / Centene-affiliated health plans (HIM, Medicaid).

Policy Summary

PayerHealth Net

PolicyClinical Policy: Megestrol Acetate

Policy CodePolicy CP PMN.179

Change TypeRemoved brandclarified generic applicability

Effective DateDec 1, 2018

Next Review Date

Key ActionObtain prior authorization and document that patient meets initial approval criteria, including trial of 40 mg/mL suspension unless contraindicated and dose ≤625 mg/day.

SourceLink

POLICY UPDATE CHANGES

Removed brand Megace ES from policy due to product discontinuation.

Clarified that this policy is applicable to generic megestrol acetate 125 mg/mL oral solution.

625 mg/dayMax daily dose

12 monthsApproval duration

125 mg/mLConcentration

Try 40 mg/mL firstStep requirement

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Initial Therapy

Covered when ALL of the following are met

Initial Approval: 1) Patient age >= 18 years; 2) Request is for megestrol acetate 125 mg/mL oral solution; 3) Member has used megestrol acetate 40 mg/mL oral suspension unless contraindicated or clinically significant adverse effects are experienced; 4) Requested dose does not exceed 625 mg (5 mL) per day; Approval duration: 12 months.<= 625 mg/day

Prior authorization required; provider must document that the patient meets these criteria.

Continuation Therapy

Covered when ONE of the following is met and continued dose limits are respected

Continued Therapy: a) Member is currently receiving medication via Centene benefit OR b) Member previously met initial approval criteria OR c) Member is currently receiving medication and is enrolled in a state/product with continuity of care regulations.If request is for a dose increase, new dose must not exceed 625 mg (5 mL) per day.

Approval duration: 12 months.

Megestrol acetate therapy is not intended for prophylactic use to avoid weight loss. Requests for treatment should reflect a clinical indication such as anorexia, cachexia, or unexplained significant weight loss after evaluation for treatable causes.

Use of megestrol acetate solely for prophylactic prevention of weight loss is not an intended or supported indication. Therapy should only be initiated after treatable causes of weight loss have been sought and addressed.

Initial Therapy

Initial authorization requires meeting all criteria below

Initial: Age >= 18 years; Request is for megestrol acetate 125 mg/mL oral solution; Trial of megestrol acetate 40 mg/mL oral suspension unless contraindicated or clinically significant adverse effects are experienced; Requested dose must be <= 625 mg (5 mL) per day.<= 625 mg/day

Approval duration 12 months. Prior authorization required; provider must submit documentation supporting that member meets all approval criteria.

Continuation / Renewal Criteria

Continued Therapy

Continued therapy is approved when member meets continuation criteria or has continuity protections; dose increases limited.

Continued Therapy: Member currently receiving medication via Centene benefit OR member previously met initial approval criteria OR member currently receiving medication and enrolled in a state/product with continuity of care regulations.If request is for a dose increase, new dose must not exceed 625 mg (5 mL) per day.

Approval duration: 12 months.

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Provider must document that the patient meets the written initial approval criteria, including age, prior use of the preferred formulation, and that the requested dose does not exceed the maximum allowed.

Prior authorization required for megestrol acetate 125 mg/mL oral solution
Approval duration: 12 months
Maximum dose: 625 mg/day (5 mL/day)

Step Therapy

Step Requirement to Preferred Formulation

Member must use megestrol acetate 40 mg/mL oral suspension (preferred alternative) unless contraindicated or clinically significant adverse effects are experienced. This step requirement must be documented in the medical record.

Preferred alternative: megestrol acetate 40 mg/mL oral suspension
Therapeutic alternative maximum listed: 800 mg/day

Documentation Required

Required Documentation

Provider must submit documentation (such as chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria. Requests without adequate documentation will be denied.

Include documentation of prior intolerance or contraindication to the 40 mg/mL suspension if requesting 125 mg/mL solution as alternative
Document age (must be ≥ 18 years) and indication for therapy

Denial Risk

Documentation and Dosing Limits

Requests lacking documentation that the member meets all approval criteria, or requests exceeding the maximum dose of 625 mg/day, may be denied. Ensure dosing does not exceed 625 mg (5 mL) per day and that supporting clinical information is provided.

Dose limit: do not exceed 625 mg/day (5 mL/day)
Denial risk if documentation of step therapy (use of 40 mg/mL) or clinical justification for higher dose is not provided

Step	Requirement	Notes
1	Member must use megestrol acetate 40 mg/mL oral suspension prior to approval of megestrol acetate 125 mg/mL oral solution unless contraindicated or clinically significant adverse effects are experienced	Preferred alternative and step requirement referenced in Initial Approval Criteria and Appendix B; policy language clarified to apply to generic 125 mg/mL solution

Definitions

inv-11: Megestrol acetate (oral suspension)

Drug class and formulationMegestrol acetate oral suspension — a progestin

IndicationTreatment of anorexia, cachexia, or unexplained significant weight loss associated with AIDS

Common use caseUsed to promote weight gain in patients with AIDS-related weight loss

inv-12: Limitations of use

Not for prophylactic useMegestrol acetate is not intended for prophylactic prevention of weight loss

Evaluate treatable causes firstTherapy should only be instituted after treatable causes of weight loss are sought and addressed (e.g., malignancy, infection, GI malabsorption, endocrine, renal, psychiatric disorders)

Scope of limitationUse solely to prevent weight loss without evaluation is not a supported indication

Background

Megestrol acetate is a progestin used for treatment of anorexia, cachexia, or unexplained significant weight loss in appropriate patients. Limitations of use specify that it is not for prophylactic prevention of weight loss, and therapy should be considered only after evaluation and management of treatable causes (for example malignancy, systemic infection, gastrointestinal malabsorption, endocrine or renal disease, or psychiatric conditions).

Policy Summary

PayerHealth Net

PolicyClinical Policy: Megestrol Acetate

Policy CodePolicy CP PMN.179

Change TypeRemoved brandclarified generic applicability

Effective DateDec 1, 2018

Next Review Date

Key ActionObtain prior authorization and document that patient meets initial approval criteria, including trial of 40 mg/mL suspension unless contraindicated and dose ≤625 mg/day.

SourceLink

On This Page

OpenPayer

Clinical Policy: Megestrol Acetate

Coverage Criteria

Initial Therapy

Continuation / Renewal Criteria

Provider Actions & Requirements

Step Therapy Requirements

Coding & Dose Limits

Quantity Limits

Definitions

Background