Repatha — Medica
Primary hyperlipidemia
Initial criteria
- Approve if ALL of the following (i, ii, and iii) are met:
- i. age ≥ 18 years; AND
- ii. ONE of the following:
- a) coronary artery calcium or calcification score ≥ 300 Agatston units; OR
- b) diabetes; AND
- iii. ONE of the following:
- a) ALL of the following:
- (1) tried one high-intensity statin (atorvastatin ≥ 40 mg daily or rosuvastatin ≥ 20 mg daily); AND
- (2) tried that statin along with ezetimibe (single-entity or combination) for ≥ 8 continuous weeks; AND
- (3) LDL‑C after this regimen remains ≥ 70 mg/dL; OR
- b) statin‐intolerant, defined as EITHER:
- (1) statin‐related rhabdomyolysis; OR
- (2) ALL of the following:
- (a) skeletal‐related muscle symptoms (e.g., myopathy or myalgia); AND
- (b) symptoms occurred during separate trials of both atorvastatin and rosuvastatin (single‑entity or combination); AND
- (c) symptoms resolved upon discontinuation of each statin
Reauthorization criteria
- Approve if according to the prescriber, the patient has experienced a response to therapy (e.g., decreased LDL‑C, total cholesterol, non‑HDL‑C, or apolipoprotein B levels).
- If currently receiving Repatha without prior approval for this indication, review under Initial Therapy criteria.
- If restarting Repatha, Initial Therapy criteria must be met.
Approval duration
1 year