MEGACE ES, Megestrol Acetate (Appetite) Form

Megestrol acetate oral suspension (Megace® ES) is a progestin. FDA Approved Indication(s) Megace ES is indicated for the treatment of anorexia, cachexia, or an unexplained significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS). Limitation(s) of use:
• Therapy with megestrol acetate for weight loss should only be instituted after treatable causes of weight loss are sought and addressed. These treatable causes include possible malignancies, systemic infections, and gastrointestinal disorders affecting absorption, endocrine disease, renal disease, or psychiatric diseases. • Megestrol acetate is not intended for prophylactic use to avoid weight loss. 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 Megace ES is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Request for Megace ES (must meet all):

1. Age ≥ 18 years;
   
   2. Member must use megestrol acetate 40 mg/mL oral suspension, unless contraindicated or clinically significant adverse effects are experienced;
2. Dose does not exceed 625 mg (5 mL) per day. Approval duration: 12 months B. Other diagnoses/indications: Not applicable
   II. Continued Therapy A. Request for Megace ES (must meet all):

3. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; Page 1 of 4

   CLINICAL POLICY Megesterol Acetate
   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);

4. If request is for a dose increase, new dose does not exceed 625 mg (5 mL) per day. Approval duration: 12 months B. Other diagnoses/indications: Not applicable III. Diagnoses/Indications for which coverage is NOT authorized: Not applicable IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key AIDS: acquired immunodeficiency syndrome FDA: Food and Drug Administration Dose Limit/ Maximum Dose 800 mg/day Appendix B: Therapeutic Alternatives
   This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
   Drug Name Dosing Regimen 400 to 800 mg PO QD megestrol acetate 40 mg/mL
   Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Appendix C: Contraindications/Boxed Warnings • Contraindication(s): hypersensitivity, known or suspected pregnancy • Boxed Warning(s): none reported Appendix D: General Information • Megace ES is not equivalent to other formulations on a mg-per-mg basis (e.g., megestrol acetate 40 mg/mL).
   V. Dosage and Administration
   Indication Anorexia, cachexia, or unexplained significant weight loss associated with AIDS Dosing Regimen 625 mg PO QD (5 mL or one teaspoon daily) Maximum Dose 625 mg (5 mL) per day VI. Product Availability
   Oral suspension: 625 mg/5 mL (125 mg/mL) Page 2 of 4

   CLINICAL POLICY Megesterol Acetate
   VII.