CurrentMississippi Division of MedicaidPolicy N/A

Praluent (alirocumab) — 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.

Defines prior authorization requirements for Praluent (alirocumab) for Mississippi Division of Medicaid members, including initial and re-authorization criteria, dosing, and formulation. Applies to providers requesting coverage for Praluent under Mississippi Medicaid.

Policy Summary

PayerMississippi Division of Medicaid

PolicyPraluent (alirocumab) — 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 supporting documentation (recent LDL-C within 30 days, statin/ezetimibe adherence evidence, prior Repatha trial or intolerance) to request prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 moInitial authorization duration

OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

CurrentMississippi Division of MedicaidPolicy N/A

Praluent (alirocumab) — 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.

Policy Summary

PayerMississippi Division of Medicaid

PolicyPraluent (alirocumab) — Prior Authorization Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateDec 9, 2025

Next Review DateN/A

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 moInitial authorization duration

Re-authorization duration

85%Adherence threshold

30 daysLDL‑C timing (initiation)

12 wksRe-auth lab window

Coverage Criteria for Praluent (alirocumab)

Initial Authorization Criteria

Covered when ALL of the following are met for initial authorization (12 months):

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

see dosing/pediatric age ≥8 yrs in label

Diagnosis (ONE required)

a. Severe primary hypercholesterolemia: Severe primary hypercholesterolemia with LDL-C ≥190 mg/dL.≥190 mg/dL
b. High 10-year ASCVD risk: At high risk for major adverse CV events defined as 10-year ASCVD risk ≥20%.≥20% 10-year ASCVD risk
c. HoFH: Homozygous familial hypercholesterolemia (HoFH) evidenced by either genetic confirmation of two mutant alleles at LDLR, ApoB, PCSK9, or LDLRAP1 (ARH) gene loci; OR an untreated LDL-C >500 mg/dL with either cutaneous or tendon xanthoma before age 10 years; OR untreated LDL-C levels consistent with HeFH in both parents (≥190 mg/dL).>500 mg/dL for specified HoFH criterion
d. HeFH: Heterozygous familial hypercholesterolemia (HeFH) evidenced by a functional mutation in LDLR, ApoB, PCSK9, or LDLRAP1; OR corneal arcus (<45 years), xanthelasma (<25 years), or tendon xanthomas; OR clinical diagnosis by Dutch Lipid Clinical Network score ≥6 or definite Simon Broome criteria.
e. Very high risk ASCVD criterion: LDL-C ≥55 mg/dL AND Very High Risk ASCVD (history of multiple major ASCVD events or 1 major ASCVD event plus multiple high-risk conditions).≥55 mg/dL

Recent LDL-C despite therapy

clinical ASCVD not very high risk: LDL-C ≥70 mg/dL for patients with clinical ASCVD and not at very high risk.≥70 mg/dL
severe primary hypercholesterolemia 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.≥100 mg/dL (or ≥70 mg/dL if 40–75 with diabetes)

Statin adherence or exception: 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 statin is contraindicated or documented intolerance (includes definitions for myopathy/myalgia and requirements for rechallenge).85%

Specific intolerance definitions and rechallenge requirements provided in policy.

Ezetimibe (Zetia) adherence or exception: 5. Adherence (defined as 85% by consistent pharmacy claims) to ezetimibe used concomitantly with a statin at maximally tolerated dose for the past 12 weeks, unless ezetimibe is contraindicated or there is documented intolerance; if ≥15% LDL-C reduction is required despite statin adherence, ezetimibe is not required.85%

Prior PCSK9 trial: 6. At least a 12-week trial with documented inadequate response, contraindication, or intolerance to Repatha (evolocumab) unless restricted by age.12 weeks

Combination therapy restriction: 7. Praluent will not be used in combination with Juxtapid (lomitapide) or another PCSK9 inhibitor.

Re-Authorization Criteria

Re-authorization (12 months) requires ALL of the following:

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

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

Restriction: Praluent (alirocumab) must not be used in combination with Juxtapid (lomitapide) or another PCSK9 inhibitor. Use of Praluent with these agents is prohibited and will result in denial of coverage if documented.

Coding, Thresholds, and Lab Timing

No codes listedmixed

No codes listed

LDL-C thresholds

Severe primary hypercholesterolemia thresholdLDL-C ≥190 mg/dL

Clinical ASCVD (not very high risk) thresholdLDL-C ≥70 mg/dL

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

Severe primary hypercholesterolemia without ASCVD but with multiple risk factorsLDL-C ≥100 mg/dL (or LDL ≥70 mg/dL for patients 40–75 years with diabetes)

Recent LDL-C timing

Timing required for initial authorizationRecent LDL‑C obtained within the last 30 days

Provider Actions, Documentation, and Denials

Prior Authorization

Prior authorization required; initial approvals for 12 months

Prior authorization is required for Praluent (alirocumab). Initial approvals are for 12 months when ALL criteria are met, including: patient age within the FDA label and one qualifying diagnosis (e.g., severe primary hypercholesterolemia with LDL‑C ≥190 mg/dL; high 10‑year ASCVD risk ≥20%; HeFH or HoFH with required evidence). Re‑authorization is also for 12 months and requires adherence and lab evidence of LDL‑C reduction within the last 12 weeks.

Initial Authorization: 12 months when all specified criteria are met (age per FDA label; one qualifying diagnosis).
Re‑authorization: 12 months with evidence of adherence and LDL‑C reduction within 12 weeks.

Step Therapy

Step therapy: trial of Repatha required; no combination with other PCSK9 inhibitors or lomitapide

Provider must document a trial of Repatha (evolocumab) of at least 12 weeks with inadequate response, contraindication, or intolerance before Praluent is authorized, unless restricted by age. Praluent must not be used in combination with another PCSK9 inhibitor or with lomitapide (Juxtapid); these combination restrictions are explicit and will affect authorization decisions.

Definitions and Diagnostic Evidence

Very High Risk ASCVD (policy definition)

DefinitionVery High Risk ASCVD: history of multiple major ASCVD events OR one major ASCVD event plus multiple high‑risk conditions

Clinical useUsed to determine LDL‑C threshold of ≥55 mg/dL for Praluent coverage in this risk group

Source contextApplied within initial authorization diagnosis criteria to identify patients meeting the lower LDL‑C threshold

HeFH / HoFH evidence

HeFH evidence - geneticFunctional mutation in LDLR, ApoB, PCSK9, or ARH (LDLRAP1) gene

HeFH evidence - clinical signsCorneal arcus <45 years, xanthelasma <25 years, or tendon xanthomas

Background

Praluent (alirocumab) is a PCSK9 inhibitor used to lower LDL-C and reduce risk of major adverse cardiovascular events as an adjunct to diet and other lipid‑lowering therapies. It is indicated for adults (and pediatric patients ≥8 years for certain familial hypercholesterolemia indications) when LDL‑C remains elevated despite maximally tolerated lipid‑lowering therapy and other criteria in this policy are met.

Revision History

Policy Summary

PayerMississippi Division of Medicaid

PolicyPraluent (alirocumab) — Prior Authorization Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateDec 9, 2025

Next Review DateN/A

SourceLink

On This Page

PurposeDemonstrates LDL‑C level despite maximally tolerated lipid‑lowering therapy for initial approval

DocumentationInclude lab result with Universal PA Form and supporting clinical documentation

Re-authorization lab timing

Re‑authorization lab timingLab results obtained within the last 12 weeks showing LDL‑C reduction since initiation of Praluent therapy

Duration of approvalRe‑authorization granted for 12 months when criteria met

Evidence requiredObjective LDL‑C decrease compared with baseline on initiation of therapy

At least a 12‑week trial and documented inadequate response, contraindication, or intolerance to Repatha unless age restricts use.
Do not prescribe Praluent concurrently with another PCSK9 inhibitor or lomitapide (Juxtapid).

Documentation Required

Submit Universal PA Form and supporting clinical documentation

Submit the Universal PA Form along with supporting clinical documentation to substantiate all authorization criteria. Expected attachments include chart notes, recent laboratory results showing LDL‑C (within 30 days for initiation), documentation of age per FDA label, records of statin and ezetimibe treatment history and adherence (85% pharmacy claims), evidence of Repatha trial/response or documented contraindication/intolerance, and any genetic or clinical testing supporting HeFH/HoFH diagnoses.

Universal PA Form (required).
Recent LDL‑C lab results (within 30 days for initiation).
Documentation of patient age per FDA label and qualifying diagnosis (e.g., genetic testing, clinical signs, Dutch Lipid Network/Simon Broome criteria).
Statin and ezetimibe treatment history and adherence evidence (85% pharmacy claims).
Documentation of Repatha trial and response, or documented contraindication/intolerance.

Denial Risk

Denial triggers: missing documentation, unmet step‑therapy or combination restrictions

Authorizations may be denied if required documentation or criteria are missing. Common denial triggers include absence of documentation for FDA‑recommended age, missing qualifying diagnosis or supporting genetic/clinical tests, lack of a recent LDL‑C despite maximally tolerated therapy, failure to document statin and ezetimibe adherence (85% pharmacy claims), no documented Repatha trial/contraindication/intolerance, or use in combination with another PCSK9 inhibitor or lomitapide.

Missing proof of patient age within FDA label.
No recent LDL‑C result showing levels despite maximally tolerated therapy (LDL‑C within 30 days for initiation).
No evidence of statin and/or ezetimibe adherence (85% pharmacy claims) or documented contraindication/intolerance.
No documentation of a ≥12‑week Repatha trial or documented intolerance/contraindication.
Request for Praluent in combination with another PCSK9 inhibitor or lomitapide.

HeFH evidence - scoringWorld Health Organization Dutch Lipid Clinical Network score ≥6 (probable) or definite by Simon Broome criteria

HoFH evidenceGenetic confirmation of two mutant alleles at LDLR, ApoB, PCSK9, or LDLRAP1 loci OR untreated LDL‑C >500 mg/dL with early xanthomas OR untreated parental LDL‑C consistent with HeFH (≥190 mg/dL)