Myalept prior authorization form / submission template
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Template and instructions for clinicians to request prior authorization from CVS Caremark (for HMSA members) for Myalept (metreleptin). It governs submission requirements and clinical questions needed to determine coverage for patients with lipodystrophy.
No material clinical or coverage changes in this revision.
Myalept Coverage Criteria
Myalept prior authorization criteria
Covered when the following clinical questions and documentation are provided to support prior authorization for Myalept (metreleptin).
ALL of the following
- Dispense location (e.g., Office, Outpatient Hospital, Ambulatory Surgical, Inpatient Hospital, Pharmacy, Home, Other).
- Administration location (e.g., Ambulatory surgical, Home, Inpatient hospital, Office, Outpatient Hospital, Pharmacy).
- Provide ICD-10 code.
ALL of the following
- Was Myalept previously authorized for this member? (Yes / No / Unknown). If No or Unknown, continue to diagnosis-specific questions.
ALL of the following
- Has the patient experienced improvement from baseline in metabolic control (e.g., improved glycemic control, decreased triglycerides, decreased hepatic enzyme levels)?
If Generalized Lipodystrophy
- Type of generalized lipodystrophy: Congenital generalized lipodystrophy (Berardinelli-Seip syndrome), Acquired generalized lipodystrophy (Lawrence syndrome), or Other.
- Leptin deficiency confirmed by laboratory testing (pre-treatment leptin < 12 ng/mL)? ACTION REQUIRED: If Yes, attach pretreatment leptin lab report.
- At least one complication of lipodystrophy present (e.g., diabetes mellitus, hypertriglyceridemia, increased fasting insulin level)?
If Partial Lipodystrophy
- Leptin deficiency confirmed by laboratory testing (pre-treatment leptin < 12 ng/mL)? ACTION REQUIRED: If Yes, attach pretreatment leptin lab report.
- At least one complication of lipodystrophy present (e.g., diabetes mellitus, hypertriglyceridemia, increased fasting insulin level)?
ALL of the following
- Prescriber signature attesting that the information is accurate and that supporting documentation is available for review if requested by CVS Caremark or the benefit plan sponsor.
Diagnosis and Test Thresholds
| Field requests the ICD-10 diagnosis code for the indication |
Submission, Documentation, and Approval Notes
Submission and contact information
Submit the completed prior authorization form by fax to CVS Caremark Specialty Programs at 1-866-237-5512. For prior authorization questions, contact CVS Caremark at 1-808-254-4414. For eligibility, copay, or delivery inquiries contact CaremarkConnect (Specialty Customer Care) at 1-800-237-2767.
Approval limits may apply
Approvals may be subject to dosing limits in accordance with FDA‑approved labeling, accepted compendia, and/or evidence‑based practice guidelines.
Attach pretreatment leptin lab report and lipodystrophy documentation
If leptin deficiency is confirmed (pre‑treatment leptin < 12 ng/mL), attach the pretreatment leptin laboratory report. Also include documentation showing at least one complication of lipodystrophy (for example, diabetes mellitus, hypertriglyceridemia, or increased fasting insulin).
Key Definitions
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