Prior Authorization Criteria — PCSK9 Inhibitors (REPATHA, PRALUENT)
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Prior authorization criteria and approval requirements for the PCSK9 inhibitor drugs REPATHA (evolocumab) and PRALUENT (alirocumab) for West Virginia Bureau for Medical Services members.
No material clinical or coverage changes in this revision.
Coverage Criteria Overview
inv-01: Initial Therapy
Covered when ALL of the following are met:
Initial approval duration: 90 days.
inv-02: Continuation Therapy
Covered when ALL of the following are met:
No additional explicit exclusions are listed in this policy beyond the scope and FDA-labeled indications for REPATHA (evolocumab) and PRALUENT (alirocumab).
Initial Therapy
inv-13: Initial Therapy
Initial authorization requirements:
Initial approval for 90 days.
Continuation of Therapy
inv-14: Continuation of Therapy
Criteria required for continued coverage after initial approval:
Key Clinical Thresholds and Coding
Provider Actions & Documentation Requirements
Initial prior authorization — 90-day initial approval
Prior authorization is required. When all initial criteria are met (including FDA-label age/indication and required statin trial documentation), initial approval will be granted for 90 days.
Required statin trial — 8‑week atorvastatin or rosuvastatin
An 8-week trial of either atorvastatin 40–80 mg OR rosuvastatin 20–40 mg is required before approval. If the patient failed to tolerate the first statin, they must be trialed on the second statin for 8 weeks or until intolerance occurs.
- Trial duration: 8 weeks on atorvastatin 40–80 mg OR rosuvastatin 20–40 mg
- If intolerant to first statin, trial the alternate statin for 8 weeks or until intolerance
Required documentation — FDA age/indication, LDL <70 mg/dL, prescriber goal
Submit documentation showing the patient meets FDA age and indication restrictions, and that the patient failed to reach LDL <70 mg/dL and the prescriber’s LDL-C goal after the required statin trial. For continuation, provide evidence of continued compliance and LDL-C response.
- Evidence patient meets FDA age/indication per current label
- Lab results demonstrating failure to reach LDL <70 mg/dL and prescriber LDL-C goal after the 8‑week statin trial
- For continuation: documentation of continued compliance and ≥40% LDL‑C reduction from pre‑treatment
Denial risk — missing age/indication or LDL‑goal documentation
Failure to document age and indication consistent with the current FDA label, or failure to provide documentation showing the patient failed to reach LDL <70 mg/dL and the prescriber’s LDL‑C goal after the required statin trial, will result in denial.
Step Therapy Requirements
| Step | Required trial | Duration / notes |
|---|---|---|
| 1 | Trial of atorvastatin 40-80 mg OR rosuvastatin 20-40 mg; if intolerant to the first statin, trial the second statin | 8-week trial (trial the second for 8 weeks or until intolerance occurs); initial approval granted for 90 days when criteria met |
Definitions
Background
PCSK9 inhibitors are monoclonal antibodies that target proprotein convertase subtilisin kexin type 9 and lower low-density lipoprotein cholesterol (LDL-C). Agents covered by this policy (REPATHA/evolocumab and PRALUENT/alirocumab) are indicated to reduce cardiovascular events in adults with established atherosclerotic cardiovascular disease and to treat primary hyperlipidemia, including heterozygous familial hypercholesterolemia; some indications include homozygous familial hypercholesterolemia and pediatric patients ≥10 years as stated in the FDA-labeled uses.
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