CurrentMississippi Division of MedicaidPolicy N/A

REPATHA (evolocumab) — Prior Authorization / Coverage Criteria

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Prior authorization requirements, dosing, and reauthorization criteria for REPATHA (evolocumab) under Mississippi Division of Medicaid; applies to providers requesting coverage for this medication.

Policy Summary

PayerMississippi Division of Medicaid

PolicyREPATHA (evolocumab) — Prior Authorization / Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateDec 9, 2025

Next Review DateN/A

Key ActionSubmit a Universal PA Form with recent LDL-C labs, documentation of diagnosis, and pharmacy claims showing 85% adherence to required lipid therapies.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 moauthorization duration

≥190/≥100/≥70/≥55LDL-C thresholds

85%adherence requirement

140 mg q2w / 420 mg qMrecommended dosing

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CurrentMississippi Division of MedicaidPolicy N/A

REPATHA (evolocumab) — Prior Authorization / Coverage Criteria

Customize your policy alerts

Sign up for all Mississippi Division of Medicaid policy alerts

Know when Mississippi Division of Medicaid releases new policies or updates existing guidance.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Prior authorization requirements, dosing, and reauthorization criteria for REPATHA (evolocumab) under Mississippi Division of Medicaid; applies to providers requesting coverage for this medication.

Policy Summary

PayerMississippi Division of Medicaid

PolicyREPATHA (evolocumab) — Prior Authorization / Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateDec 9, 2025

Next Review DateN/A

Key ActionSubmit a Universal PA Form with recent LDL-C labs, documentation of diagnosis, and pharmacy claims showing 85% adherence to required lipid therapies.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 moauthorization duration

≥190/≥100/≥70/≥55LDL-C thresholds

85%adherence requirement

140 mg q2w / 420 mg qMrecommended dosing

Coverage Criteria for REPATHA (evolocumab)

Initial Authorization

Covered when ALL of the following are met:

Initial Authorization: 1) Age of the patient is within the age range as recommended by the FDA label.

Documented diagnosis (ONE of)

a. Severe primary hypercholesterolemia: Severe primary hypercholesterolemia with LDL-C ≥190 mg/dL
b. High 10-year ASCVD risk: At high risk for major adverse CV events defined as 10-year ASCVD risk percent ≥ 20%
c. Homozygous familial hypercholesterolemia (HoFH): HoFH evidenced by one of: genetic confirmation of two mutant alleles at LDLR, ApoB, PCSK9, or LDLRAP1 (or ARH adaptor protein) locus; cutaneous or tendon xanthoma before age 10 years; OR untreated LDL-C > 500 mg/dL; OR untreated LDL-C levels consistent with HeFH in both parents (≥190 mg/dL)

Recent LDL-C (within 30 days)

Very high risk ASCVD: LDL-C ≥55 mg/dL in patients with Very High Risk ASCVD (history of multiple major ASCVD events or 1 major ASCVD event plus multiple high-risk conditions)
Clinical ASCVD not very high risk: LDL-C ≥70 mg/dL for patients with clinical ASCVD and not at very high risk
Severe primary hypercholesterolemia or HeFH without ASCVD: LDL-C ≥100 mg/dL (or LDL-C ≥70 mg/dL for patients 40–75 years with diabetes) for severe primary hypercholesterolemia (including HeFH) without ASCVD but with multiple risk factors
HeFH diagnostic criteria: HeFH evidenced by functional mutation in LDLR/ApoB/PCSK9/LDLRAP1; corneal arcus (<45 years), xanthelasma (<25 years), or tendon xanthomas; OR clinical diagnosis by WHO Dutch Lipid Network criteria (probable score ≥6) or definite by Simon Broome criteria

Adherence to statin: 4) Adherence (defined as 85% by consistent pharmacy claims) to a high-intensity statin regimen for at least 12 weeks, or to a moderate-intensity statin for at least 12 weeks if unable to tolerate high-intensity, unless one of: statin contraindication; documented statin risk factors; rhabdomyolysis or muscle symptoms with CK elevations; myopathy; or statin intolerance (including myalgia with re-challenge criteria)

Adherence to ezetimibe (Zetia): 5) Adherence (85% pharmacy claims) to ezetimibe concomitant with statin at maximally tolerated dose for the past 12 weeks unless: ezetimibe contraindicated; history of ezetimibe intolerance; OR if a ≥15% LDL-C reduction requirement applies, ezetimibe is not required

Exclusions: 6) Repatha will not be used in combination with Juxtapid (lomitapide) or another PCSK9 inhibitor.

Re-Authorization

Re-authorization covered when ALL of the following are met:

Adherence: 1) Evidence of adherence (defined as 85% consistent pharmacy claims) to ongoing lipid-lowering therapy as applicable.

LDL-C response: 2) Laboratory results obtained within the last 12 weeks showing an LDL-C reduction since initiation of Repatha therapy.

Repatha (evolocumab) will not be used in combination with Juxtapid (lomitapide) or with another PCSK9 inhibitor.

Drug Formulations, Codes, and LDL-C Thresholds

Drug formulations and billing codesmixed

No billing codes listed

The document does not list CPT, HCPCS, NDC, or ICD-10 codes; only drug name, formulations, and dosing are provided.

Available REPATHA formulationsmixed

140 mg/mL SureClick autoinjector	140 mg/mL solution prefilled single-dose SureClick® autoinjector
140 mg/mL prefilled syringe	140 mg/mL solution prefilled single-dose syringe
420 mg/3.5 mL Pushtronex system	420 mg/3.5 mL solution single-dose Pushtronex® system (on-body infusor with prefilled cartridge)

LDL-C thresholds — policy-specified

LDL-C ≥190 mg/dLSevere primary hypercholesterolemia threshold used for initial authorization

LDL-C ≥100 mg/dLThreshold for severe primary hypercholesterolemia without ASCVD but with multiple risk factors

LDL-C ≥70 mg/dLThreshold for clinical ASCVD (not very high risk) and for patients 40–75 with diabetes as an alternative for severe primary hypercholesterolemia

LDL-C ≥55 mg/dLThreshold when patient has Very High Risk ASCVD (history of multiple major ASCVD events or 1 major event plus multiple high‑risk conditions)

Prior Authorization, Documentation, and Background Therapy Requirements

Prior Authorization

Prior authorization required for REPATHA

Prior authorization is required for REPATHA (evolocumab). Approval will be considered when the patient’s age is within the FDA-labeled range, a qualifying diagnosis is documented, recent LDL-C despite maximally tolerated therapy is provided, adherence to required background therapies is demonstrated, and the request does not involve combination use with lomitapide or another PCSK9 inhibitor. Submit the Universal PA Form with supporting clinical documentation when requesting authorization.

Step Therapy

Background lipid therapy and adherence requirements

Document an adequate trial and adherence to lipid-lowering background therapy: a high-intensity statin for at least 12 weeks (or a moderate-intensity statin for 12 weeks if high-intensity is not tolerated), and concomitant ezetimibe (Zetia) with statin for 12 weeks when required unless contraindicated or intolerant.

High‑intensity statin ≥12 weeks (or moderate‑intensity ≥12 weeks if high‑intensity not tolerated)
Adherence defined as 85% by consistent pharmacy claims

Key Definitions

Very High Risk ASCVD — policy definition

DefinitionHistory of multiple major ASCVD events OR one major ASCVD event plus multiple high‑risk conditions (policy-defined) — used to determine LDL-C threshold of ≥55 mg/dL

Use in criteriaApplied to identify patients meeting the 'very high risk' category for whom the LDL‑C threshold for therapy is ≥55 mg/dL

Source contextReferenced within documentation requirements for recent LDL‑C despite maximally tolerated therapy

Adherence — policy definition

Adherence definition85% adherence as measured by consistent pharmacy claims for required background lipid‑lowering therapies

Applied to statin therapyRequires 85% adherence to a high‑intensity statin for ≥12 weeks (or to a moderate‑intensity statin for ≥12 weeks if high intensity not tolerated) unless exceptions apply

Background on Evolocumab (REPATHA)

Evolocumab (REPATHA) is a PCSK9 inhibitor indicated to lower LDL‑C and reduce cardiovascular risk as an adjunct to diet and other lipid‑lowering therapies; the policy requires documentation of diagnosis, recent LDL‑C values, and adherence to background statin and ezetimibe therapy where applicable.