CurrentUnitedHealthcarePolicy 2025 P 2062-21

UnitedHealthcare Pharmacy Clinical Pharmacy Programs

UnitedHealthcare prior authorization/medical necessity program for Praluent (alirocumab) specifying approval criteria for primary hyperlipidemia (including HeFH), ASCVD, and homozygous familial hypercholesterolemia (HoFH), exclusions (combination with other PCSK9 inhibitors and inclisiran), required prior therapies, LDL-C thresholds, and authorization duration.

Policy Summary

PayerUnitedHealthcare

PolicyUnitedHealthcare Pharmacy Clinical Pharmacy Programs

Policy CodePolicy 2025 P 2062-21

Change TypeCriteria revised; exclusions and pediatric criterion added

Effective DateMay 1, 2025

Next Review Date

Key ActionAuthorization must meet the detailed clinical criteria (diagnosis, prior statin/ezetimibe trials or documented intolerance/contraindication, LDL-C threshold, and not used in combination with disallowed agents); authorization will be issued for 12 months.

POLICY UPDATE CHANGES

Simplified diagnosis requirements for HeFH, ASCVD, and primary hyperlipidemia; diet requirement removed; HoFH criteria revised with more precise genetic terminology; LDL-C threshold lowered from 100 to 55 mg/dL.

Added criterion for patients less than 10 years of age to align with new pediatric label (ages 8 and older with HeFH).

Added exclusion: Praluent not to be used in combination with Leqvio (inclisiran).

Added requirement for history of failure, contraindication, or intolerance to Repatha (evolocumab) in criteria.

12 monthsAuthorization Duration

>= 55 mg/dLLDL-C initiation threshold

>= 12 weeksPrior statin/ezetimibe trial duration

>400 mg/dLHoFH diagnostic threshold

Coverage Summary

UnitedHealthcare prior authorization/medical necessity program for Praluent (alirocumab) specifies approval criteria for primary hyperlipidemia (including HeFH), ASCVD, and HoFH. Exclusions include use in combination with another PCSK9 inhibitor (e.g., Repatha/evolocumab) and with Leqvio (inclisiran); for HoFH, combination with Juxtapid (lomitapide) is also excluded. Required prior therapies and documentation include a guideline-directed stepped statin pathway (e.g., ≥ 12 consecutive weeks of high-intensity statin therapy or documented intolerance/contraindication with the alternative statin pathways) and, for LDL-C lowering adjunctive use, evidence of ≥ 12 consecutive weeks of ezetimibe therapy or documented ezetimibe intolerance. The LDL-C initiation threshold for primary hyperlipidemia/ASCVD is ≥ 55 mg/dL; for HoFH diagnostic pathway an untreated LDL-C threshold of > 400 mg/dL is used. Authorizations are issued for 12 months.

Key thresholds and authorization

LDL-C initiation threshold>= 55 mg/dL

Untreated LDL-C for HoFH diagnostic pathway> 400 mg/dL

Duration of prior statin therapy>= 12 consecutive weeks

Duration of prior ezetimibe therapy>= 12 consecutive weeks (or documented contraindication/intolerance)

Authorization Duration12 months

Initial Therapy Criteria — Primary Hyperlipidemia (including HeFH) and ASCVD

Primary Hyperlipidemia (including HeFH) and ASCVD - Initial Approval

Praluent will be approved based on all of the following criteria:

ALL of the following

One of the following diagnoses
- Heterozygous familial hypercholesterolemia (HeFH)
- Atherosclerotic cardiovascular disease (ASCVD) (e.g., acute coronary syndromes, history of myocardial infarction, stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack, or peripheral arterial disease presumed to be of atherosclerotic origin)
- Primary hyperlipidemia
One of the following statin therapy pathways

Initial Therapy Criteria — Homozygous Familial Hypercholesterolemia (HoFH)

Homozygous Familial Hypercholesterolemia (HoFH) - Initial Approval

Praluent will be approved based on all of the following criteria:

ALL of the following

Diagnosis confirmation
- Submission of medical records confirming genetic confirmation of bi-allelic pathogenic/likely pathogenic variants on different chromosomes at the LDLR, APOB, PCSK9, or LDLRAP1 genes or ≥ 2 such variants at different loci
- ALL of the following
  - Xanthoma before 10 years of age
  - Evidence of familial hypercholesterolemia in at least one parent

Continuation Therapy Criteria

Approvals (initial and re-authorization) are issued for 12 months. Continued authorization requires ongoing receipt of maximally tolerated statin therapy where applicable and documentation of response and adherence per the policy (including dates and reasons for therapeutic failure, contraindication, or intolerance to prior agents such as statins, ezetimibe, or evolocumab/Repatha).

Unapproved Combinations / Exclusions

Exclusion: Combination therapies

Exclusions

Not used in combination with another PCSK9 inhibitor (e.g., Repatha (evolocumab))
Not used in combination with Leqvio (inclisiran)
Not used in combination with Juxtapid (lomitapide)

Applicable Codes & Notes

ICD-10 Diagnoses referenced for coverage decision (examples provided in policy text)ICD-10

No codes listed

Notes on excluded combination therapiesmixedNot Covered

Repatha (evolocumab)	PCSK9 inhibitor — not to be used in combination
Leqvio (inclisiran)	siRNA LDL-C lowering therapy — not to be used in combination
Juxtapid (lomitapide)	Not to be used in combination for HoFH

Provider Actions

Prior Authorization

Prior authorization required

Authorization must meet the detailed clinical criteria (diagnosis, prior statin/ezetimibe trials or documented intolerance/contraindication, LDL-C threshold, and not used in combination with disallowed agents); authorization will be issued for 12 months.

Authorization issued for 12 months

Documentation Required

Document prior therapy and intolerance

Providers must document dates and reasons for therapeutic failure, contraindication, or intolerance to Repatha (evolocumab) and to ezetimibe or statins where applicable; for HoFH, submit genetic confirmation or specified clinical criteria.

Document dates and reason for Repatha (evolocumab) trial failure, contraindication, or intolerance

Clinical Evidence & Sources

Source: Praluent package insert (March 2024) and multiple guideline and trial references (ACC/AHA, ESC, WHO, clinical trials).

Background

Praluent (alirocumab) is a PCSK9 inhibitor indicated to reduce cardiovascular events and reduce LDL-C in adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia), as adjunct therapy in adult patients with homozygous familial hypercholesterolemia (HoFH), and in pediatric patients aged 8 years and older with HeFH. Coverage criteria reflect guideline-directed stepped therapy and require prior statin and ezetimibe trials or documented intolerance/contraindication, as specified in the policy.

Definitions

High-intensity statin therapyExamples: atorvastatin 40-80 mg, rosuvastatin 20-40 mg

Low/moderate-intensity statin therapyExamples: atorvastatin 10-20 mg, rosuvastatin 5-10 mg, simvastatin >= 10 mg, pravastatin >= 10 mg, lovastatin 20-40 mg, fluvastatin (XL 80 mg or 20-40 mg up to 40 mg twice daily), pitavastatin >= 1 mg

Intolerance (statin/ezetimibe)Intolerable and persistent (> 2 weeks) symptoms such as myalgia (muscle symptoms without CK elevations) or myositis (muscle symptoms with CK elevations < 10x ULN); rhabdomyolysis defined as CK elevations > 10x ULN

Revision History

6/2021added

Added requirement for history of failure, contraindication, or intolerance to Repatha (evolocumab) in criteria; removed prescriber specialist requirement and standardized initial authorization duration to 12 months.

6/2023added

Added exclusion: Praluent not to be used in combination with Leqvio (inclisiran); updated diet requirement.

5/2024added

Added criterion for patients less than 10 years of age to align with new pediatric label (pediatric indication for ages 8 years and older with HeFH).

Policy Summary

PayerUnitedHealthcare

PolicyUnitedHealthcare Pharmacy Clinical Pharmacy Programs

Policy CodePolicy 2025 P 2062-21

Change TypeCriteria revised; exclusions and pediatric criterion added

Effective DateMay 1, 2025

Next Review Date

On This Page

Patient has been receiving at least 12 consecutive weeks of high-intensity statin therapy (i.e., atorvastatin 40-80 mg, rosuvastatin 20-40 mg) and will continue to receive a high-intensity statin at maximally tolerated dose

Unable to tolerate high-intensity statin pathway

Patient is unable to tolerate high-intensity statin as evidenced by one of the following intolerable and persistent (> 2 weeks) symptoms: Myalgia (muscle symptoms without CK elevations) OR Myositis (muscle symptoms with CK elevations < 10 times upper limit of normal [ULN])
Patient has been receiving at least 12 consecutive weeks of low-intensity or moderate-intensity statin therapy (i.e., atorvastatin 10-20 mg, rosuvastatin 5-10 mg, simvastatin ≥ 10 mg, pravastatin ≥ 10 mg, lovastatin 20-40 mg, fluvastatin XL 80 mg, fluvastatin 20-40 mg up to 40 mg twice daily or Livalo (pitavastatin) ≥ 1 mg) and will continue to receive a low- or moderate-intensity statin at maximally tolerated dose

Unable to tolerate low/moderate and high-intensity statins pathway

Patient is unable to tolerate low or moderate-, and high-intensity statins as evidenced by intolerable and persistent (> 2 weeks) symptoms: Myalgia (muscle symptoms without CK elevations) OR Myositis (muscle symptoms with CK elevations < 10 times ULN)
Patient has a contraindication to all statins
Patient has experienced rhabdomyolysis or muscle symptoms with statin treatment with CK elevations > 10 times ULN

LDL-C and ezetimibe requirements

Patient has LDL-C greater than or equal to 55 mg/dL>= 55 mg/dL
ANY of the following
- Patient has been receiving at least 12 consecutive weeks of ezetimibe therapy as adjunct to maximally tolerated statin therapy
- Patient has a history of contraindication, or intolerance to ezetimibe

Age or prior PCSK9 failure

Patient is less than 10 years of age
History of failure, contraindication, or intolerance to Repatha (evolocumab) (document date of trial and list reason for therapeutic failure, contraindication, or intolerance)

Exclusions

Not used in combination with another proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor (e.g., Repatha (evolocumab))
Not used in combination with Leqvio (inclisiran)

Concomitant therapy

Patient is receiving other lipid-lowering therapy (e.g., statin, ezetimibe, LDL apheresis)

Exclusions and combination restrictions

Not used in combination with another proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor (e.g., Repatha (evolocumab))
Not used in combination with Juxtapid (lomitapide)

Repatha failure requirement

History of failure, contraindication, or intolerance to Repatha (evolocumab) (document date of trial and list reason for therapeutic failure, contraindication, or intolerance)

Document dates and reason for ezetimibe and statin trial failures or intolerance where applicable (e.g., duration of trials, symptoms and CK values)

For HoFH, submit genetic confirmation of bi-allelic pathogenic/likely pathogenic variants on different chromosomes at LDLR, APOB, PCSK9, or LDLRAP1 or specified clinical criteria (untreated LDL-C > 400 mg/dL with supporting findings)

Billing Rule

Authorization duration

Initial and re-authorization approvals are issued for 12 months.

Step Therapy

Step therapy / supply limits may apply

Supply limits and plan-specific exclusions or step therapy may apply. UnitedHealthcare may approve initial and re-authorization based solely on prior claim/medication history, diagnosis codes, and claim logic; automated approvals vary by program.

Supply limits and step therapy may be in place
Automated approvals may be based on medication/claim history and diagnosis codes

2/2025revisedLatest

Material update: Simplified diagnosis requirements for HeFH, ASCVD, and primary hyperlipidemia; removed diet requirement; revised HoFH criteria with more precise genetic terminology; lowered LDL-C initiation threshold from 100 mg/dL to 55 mg/dL.