CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Repatha (evolocumab) coverage

Defines medical necessity, authorization, dosing, quantity limits, and continuation criteria for Repatha (evolocumab) for Medicaid members when approval criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRepatha (evolocumab) coverage

Policy CodePolicy N/A

Change TypeNo material change

Effective DateSep 1, 2017

Next Review DateJul 1, 2025

Key ActionSubmit prior authorization with diagnosis, baseline and current LDL-C, and documentation of ≥3 months high‑intensity statin plus ezetimibe trial or statin intolerance.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial authorization length

12 monthscontinuation authorization length

140 / 420 mgavailable dosing

2/28 daysqty limit 140 mg

1/28 daysqty limit 420 mg

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inv-01: Initial 6‑month authorization criteria by indication

Authorization of 6 months may be granted when ALL of the following for the selected indication are met:

A. Clinical ASCVD: 1) Documentation that the member has a history of clinical ASCVD (See Appendix A). 2) Documentation that the member meets at least one of the following: a) Member has a current LDL-C level ≥ 70 mg/dL after at least three months of treatment with a high-intensity statin dose in combination with ezetimibe (if unable to tolerate high-intensity, a moderate-intensity statin may be used); OR b) Member has a current LDL-C level ≥ 70 mg/dL with a contraindication or intolerance to statins (See Appendix B and C).LDL-C >= 70 mg/dL

B. Primary hyperlipidemia: 1) Documentation that the member had an untreated (before any lipid-lowering therapy) LDL-C level ≥ 190 mg/dL in the absence of a secondary cause. 2) Documentation that the member meets at least one of the following: a) Member has a current LDL-C level ≥ 100 mg/dL after at least three months of treatment with a high-intensity statin dose in combination with ezetimibe (if unable to tolerate high-intensity, a moderate-intensity statin may be used); OR b) Member has a current LDL-C level ≥ 100 mg/dL with a contraindication or intolerance to statins (See Appendix B and C).untreated LDL-C >= 190 mg/dL; current LDL-C >= 100 mg/dL

C. Heterozygous familial hypercholesterolemia (HeFH): 1) Documentation that the member meets either: a) Age ≥ 18 with an untreated (before any lipid-lowering therapy) LDL-C level ≥ 190 mg/dL in the absence of a secondary cause; OR b) Age < 18 with an untreated LDL-C level ≥ 160 mg/dL in the absence of a secondary cause. 2) Documentation that the member meets at least one of the following: a) Member has a current LDL-C level ≥ 100 mg/dL after at least three months of treatment with a high-intensity statin dose in combination with ezetimibe (if unable to tolerate high-intensity, a moderate-intensity statin may be used); OR b) Member has a current LDL-C level ≥ 100 mg/dL with a contraindication or intolerance to statins (See Appendix B and C).age-dependent untreated LDL thresholds; current LDL-C >= 100 mg/dL

D. Homozygous familial hypercholesterolemia (HoFH): 1) Documentation that the member meets either: a) Age ≥ 18 with an untreated (before any lipid-lowering therapy) LDL-C level ≥ 190 mg/dL in the absence of a secondary cause; OR b) Age < 18 with an untreated LDL-C level ≥ 160 mg/dL in the absence of a secondary cause. 2) Documentation that the member meets at least one of the following: a) Member has a current LDL-C level ≥ 100 mg/dL after at least three months of treatment with a high-intensity statin dose in combination with ezetimibe (if unable to tolerate high-intensity, a moderate-intensity statin may be used); OR b) Member has a current LDL-C level ≥ 100 mg/dL with a contraindication or intolerance to statins (See Appendix B and C). 3) Documentation that the member's dose does not exceed FDA-approved labeling.untreated and current LDL-C thresholds; dose within FDA labeling

inv-02: Continuation/reauthorization

Authorization of 12 months may be granted for continued treatment when ALL of the following are met:

Continuation of therapy: Member achieves or maintains a documented LDL-C reduction (e.g., LDL-C at goal or robust lowering) and the member's dose does not exceed FDA-approved labeling.documented LDL-C reduction

All indications not listed as FDA‑approved or compendial uses are considered experimental/investigational and are excluded from coverage.

Use for indications other than the FDA‑approved or compendial uses listed is considered not medically necessary.

Clinical Thresholds and Coding-related Criteria

inv-05: LDL‑C thresholds

ASCVD (clinical atherosclerotic cardiovascular disease)Current LDL-C ≥ 70 mg/dL after ≥3 months high‑intensity statin + ezetimibe (moderate‑intensity allowed if high‑intensity not tolerated), or current LDL‑C ≥ 70 mg/dL with statin contraindication/intolerance.

Primary hyperlipidemiaUntreated LDL-C ≥ 190 mg/dL (no secondary cause) AND current LDL-C ≥ 100 mg/dL after ≥3 months high‑intensity statin + ezetimibe (or with documented statin contraindication/intolerance).

Heterozygous familial hypercholesterolemia (HeFH)If ≥18 years: untreated LDL-C ≥ 190 mg/dL; if <18 years: untreated LDL-C ≥ 160 mg/dL — AND current LDL-C ≥ 100 mg/dL after ≥3 months high‑intensity statin + ezetimibe (or with documented statin contraindication/intolerance).

Homozygous familial hypercholesterolemia (HoFH)If ≥18 years: untreated LDL-C ≥ 190 mg/dL; if <18 years: untreated LDL-C ≥ 160 mg/dL — AND current LDL-C ≥ 100 mg/dL after ≥3 months high‑intensity statin + ezetimibe (or with documented statin contraindication/intolerance). Dose must not exceed FDA‑approved labeling.

Provider Requirements and Operational Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required for Repatha (evolocumab). Requests should include clinical documentation supporting the applicable coverage criteria (see clinical criteria sections).

Authorization length: 6 months
Include diagnosis and recent LDL‑C values
Include prior lipid‑lowering therapy documentation when applicable

Step Therapy

Statin ± Ezetimibe Trial Requirement

For most indications (ASCVD, primary hyperlipidemia, HeFH, HoFH) a trial of maximally tolerated statin therapy in combination with ezetimibe for at least 3 months is required prior to approval, unless there is documented contraindication or intolerance to statins. If the member is unable to tolerate a high‑intensity statin dose, a moderate‑intensity statin dose may be used; documented contraindication or intolerance allows bypassing the statin trial requirement.

ASCVD: LDL‑C ≥ 70 mg/dL after ≥3 months high‑intensity statin + ezetimibe (or moderate if high‑intensity not tolerated)
Primary hyperlipidemia: untreated LDL‑C ≥ 190 mg/dL and current LDL‑C ≥ 100 mg/dL after ≥3 months high‑intensity statin + ezetimibe (or moderate if high‑intensity not tolerated)
HeFH: age-based untreated LDL‑C thresholds (≥190 mg/dL if ≥18 y; ≥160 mg/dL if <18 y) and current LDL‑C ≥100 mg/dL after ≥3 months high‑intensity statin + ezetimibe (or moderate if high‑intensity not tolerated)
HoFH: same age-based untreated LDL‑C thresholds and current LDL‑C ≥100 mg/dL after ≥3 months high‑intensity statin + ezetimibe (or moderate if high‑intensity not tolerated)

Documentation Required

Required Clinical Documentation

Provide documentation of prior therapies, LDL‑C values (including untreated baseline when required), reason for statin intolerance or contraindication (if applicable), diagnosis supporting the indication, and prescribed dose. For HoFH, ensure submitted dose does not exceed FDA‑approved labeling.

Baseline (untreated) LDL‑C when required (e.g., primary hyperlipidemia, HeFH, HoFH)
Recent on‑therapy LDL‑C after ≥3 months of statin ± ezetimibe
Documentation of statin intolerance or contraindication (if used to meet criteria)
Medication history and current Repatha dose (HoFH: dose must not exceed FDA labeling)

Denial Risk

Non‑approved Indications — Experimental/Investigational Exclusion

Use of Repatha for indications not listed in the FDA‑Approved Indications (e.g., any indication other than ASCVD, primary hyperlipidemia/HeFH, pediatric HeFH ≥10 years, and HoFH) is considered experimental/investigational and will be denied.

All other indications are not medically necessary and subject to denial

Denial Risk

Excess Dosing — Dose Exceeding FDA‑Approved Labeling for HoFH Not Permitted

Dosing submitted for members with homozygous familial hypercholesterolemia (HoFH) must not exceed FDA‑approved labeling; requests with doses above labeled recommendations will not be approved.

Ensure prescribed dose for HoFH is within FDA‑approved dosing limits

Definitions and Diagnostic Criteria

inv-12: Clinical ASCVD definition

Clinical ASCVD – included conditionsAcute coronary syndromes; myocardial infarction; stable or unstable angina; coronary or other arterial revascularization (e.g., PCI, CABG); stroke of presumed atherosclerotic origin; transient ischemic attack (TIA); non‑cardiac peripheral arterial disease of atherosclerotic origin (e.g., carotid stenosis, lower extremity PAD); obstructive coronary artery disease (≥50% stenosis); Coronary Artery Calcium (CAC) Score ≥ 1000.

inv-13: Statin intolerance examples/criteria

SAMS‑CI scoreScore of 7 or higher on the Statin‑Associated Muscle Symptom Clinical Index (SAMS‑CI).

Marked CK elevationStatin‑associated creatine kinase (CK) elevation ≥ 10 times the upper limit of normal (ULN).

Statin re‑challenge guidanceStatin re‑challenge is NOT required for members who have experienced CK elevation ≥ 10× ULN while on statin therapy.

inv-14: Statin contraindications

Active liver diseaseActive liver disease, including unexplained persistent elevations in hepatic transaminases (e.g., ALT ≥ 3 times ULN).

Pregnancy or planned pregnancyPregnancy or planned pregnancy precludes statin use.

BreastfeedingBreastfeeding is a contraindication to statin therapy.

OpenPayer

Repatha (evolocumab) coverage

Coverage and Authorization Criteria

Clinical Thresholds and Coding-related Criteria

Provider Requirements and Operational Rules

Background on Repatha (evolocumab)

Definitions and Diagnostic Criteria