CurrentColorado Rocky Mountain Health PlansPolicy N/A

Step therapy for Praluent (alirocumab)

Defines step therapy requirements for coverage of Praluent (alirocumab) for members with primary hyperlipidemia, HeFH, HoFH, or ASCVD who require additional LDL-C lowering; applies to UnitedHealthcare Pharmacy Clinical Pharmacy Programs for Colorado Rocky Mountain Health Plans.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyStep therapy for Praluent (alirocumab)

Policy CodePolicy N/A

Change TypeMaterial clinical updates (pediatric criterion addedRepatha documentation required)

Effective DateAug 1, 2025

Next Review DateAug 1, 2025

Key ActionObtain and submit prior authorization with documented trials of statin therapy and, when required, trial date and reason for failure/intolerance/contraindication to Repatha.

SourceLink

POLICY UPDATE CHANGES

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

Clarified criterion for contraindication to statins without change to clinical intent.

Added requirement that Repatha (evolocumab) be tried and documented prior to Praluent for certain indications including HoFH.

12 monthsAuthorization duration

Step therapyProgram type

Repatha required priorPrior biologic required

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Coverage Criteria for Praluent (alirocumab)

inv-01: Initial Therapy - Hyperlipidemia

Praluent will be approved when ALL of the following are met:

Diagnosis: Patient has a diagnosis of primary hyperlipidemia OR heterozygous familial hypercholesterolemia (HeFH) OR atherosclerotic cardiovascular disease (ASCVD).

See ASCVD examples in policy (e.g., acute coronary syndromes, myocardial infarction, angina, revascularization, stroke, TIA, or peripheral arterial disease of atherosclerotic origin).

Statin requirement: Either: (1) Patient has received at least 12 consecutive weeks of high-intensity statin therapy and will continue high-intensity statin at maximally tolerated dose (e.g., atorvastatin 40-80 mg or rosuvastatin 20-40 mg); OR (2) Patient is unable to tolerate high-intensity statin with documented intolerable/persistent (>2 weeks) symptoms (myalgia or myositis with CK <10x ULN) and has received at least 12 consecutive weeks of low- or moderate-intensity statin therapy and will continue at maximally tolerated dose; OR (3) Patient is unable to tolerate low/moderate- and high-intensity statins as shown by (a) intolerable/persistent symptoms (myalgia or myositis with CK <10x ULN), OR (b) a contraindication to all statins, OR (c) rhabdomyolysis or muscle symptoms with CK >10x ULN.12 weeks

Intolerance definitions per policy: myalgia, myositis (CK <10x ULN), rhabdomyolysis (CK >10x ULN); contraindication pathway allowed.

Age or Repatha trial: Either: (1) Patient is less than 10 years of age; OR (2) History of failure, contraindication, or intolerance to Repatha (evolocumab) with documentation of trial date and reason for therapeutic failure, contraindication, or intolerance.

Authorization will be issued for 12 months. Pediatric label alignment noted in policy (pediatric HeFH approved at ages 8+).

inv-02: Initial Therapy - HoFH

Praluent will be approved when ALL of the following are met:

Diagnosis: Patient has a diagnosis of homozygous familial hypercholesterolemia (HoFH).

Repatha requirement: History of failure, contraindication, or intolerance to Repatha (evolocumab) with documentation of trial date and reason for therapeutic failure, contraindication, or intolerance.

Authorization will be issued for 12 months.

inv-03: Other Diagnoses

For other diagnoses the policy allows approval as specified by plan mandates and benefit coverage:

Other: Praluent may be approved for other diagnoses per state mandates and the member-specific benefit plan; federal requirements and other utilization management programs may also apply.

Praluent is typically excluded from coverage for some plans; check plan specifics for tried/failed criteria and exclusions.

Coverage for Praluent (alirocumab) varies by member benefit plan. Praluent is typically excluded from coverage for some plans, and tried/failed criteria or other plan-specific exclusions may apply. State mandates, federal requirements, and the member’s specific benefit plan can affect whether the drug is covered; refer to the member’s plan documents and benefit summary to determine applicability and any exclusion status.

Medical necessity determinations, notification requirements, and supply limits established by the plan or utilization management program can affect approval. UnitedHealthcare programs may approve requests based solely on previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic using automated approval or re‑approval processes as available. Providers should confirm any applicable medical necessity rules, prior notification procedures, and quantity/supply limits in the member’s plan prior to submitting an authorization request.

Coding and Statin Trial Details

Covered CPT Codesmixed

No codes listed

Statin trial duration

Required durationAt least 12 consecutive weeks of statin therapy is required for statin trial pathways (high-intensity or low/moderate-intensity as specified).

High‑intensity pathwayPatient must have received at least 12 consecutive weeks of high‑intensity statin therapy and will continue high‑intensity statin at maximally tolerated dose (e.g., atorvastatin 40–80 mg, rosuvastatin 20–40 mg).

Low/moderate‑intensity pathwayIf unable to tolerate high‑intensity statin, patient must have received at least 12 consecutive weeks of low‑ or moderate‑intensity statin therapy and continue at maximally tolerated dose.

Intolerance/contraindication pathwayIf unable to tolerate low/moderate and high‑intensity statins, documented intolerable/persistent symptoms, contraindication to all statins, or rhabdomyolysis (CK >10× ULN) may satisfy requirement (statin duration still referenced where applicable).

Provider Actions, Prior Authorization and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must include documentation that the member meets diagnosis and step‑therapy criteria and any applicable statin therapy or prior PCSK9 inhibitor trial requirements. Authorization, when approved, will be issued for 12 months.

Applicability: primary hyperlipidemia, HeFH, HoFH, or ASCVD where additional LDL‑C lowering with a PCSK9 inhibitor is sought
Include: diagnosis, dates and details of prior medication trials, and reason for failure/intolerance or contraindication when applicable

Step Therapy

Step Therapy Requirements

Members must trial maximally tolerated high‑intensity statin therapy and Repatha (evolocumab) prior to Praluent (alirocumab) for primary hyperlipidemia, HeFH, and ASCVD indications. For HoFH, a trial of Repatha is required prior to Praluent. Document the duration and outcome of each trial.

High‑intensity statin defined examples: atorvastatin 40–80 mg, rosuvastatin 20–40 mg

Definitions and Statin Intensity Examples

ASCVD — examples and definition

DefinitionAtherosclerotic cardiovascular disease (ASCVD) includes 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.

Clinical examplesAcute coronary syndrome, prior myocardial infarction, prior coronary revascularization (e.g., CABG, PCI).

Cerebrovascular examplesIschemic stroke or transient ischemic attack presumed to be atherosclerotic in origin.

Peripheral vascular examplePeripheral arterial disease believed to be due to atherosclerosis.

Statin intensity examples

High‑intensity statins (examples)

Initial Therapy Criteria

inv-15: Initial Therapy — Initial approval criteria for Praluent

Initial approval criteria for Praluent:

Diagnosis: See covered indications list: primary hyperlipidemia, heterozygous familial hypercholesterolemia (HeFH), atherosclerotic cardiovascular disease (ASCVD), or homozygous familial hypercholesterolemia (HoFH).

Statin trial or intolerance: Require at least a 12-week trial of high-intensity statin therapy unless there is documented intolerance. If intolerant to high-intensity statin, require a 12-week trial of low- or moderate-intensity statin and continuation at maximally tolerated dose; alternatively, documented inability to tolerate any statin (per policy definitions) is acceptable.12 weeks

Intolerance defined in policy (myalgia, myositis with CK <10x ULN, rhabdomyolysis with CK >10x ULN, or contraindication to all statins).

Repatha requirement or pediatric exception:

Continuation / Reauthorization Criteria

inv-16: Continuation Therapy / Reauthorization

Reauthorization/continuation rules:

Duration: Authorizations will be issued for 12 months for approved indications; continuation may follow the same documentation and prior trial logic as initial approval or rely on previous claim/medication history per program automation.12 months

Automated re-approval may occur based on claims and diagnosis codes; documentation of prior Repatha trial (date and reason) should be available when required.

Step Therapy Requirements

Step	Requirement	Notes
1
Member must have diagnosis of primary hyperlipidemia, HeFH, ASCVD, or HoFH (HoFH specific requirement described separately).
See policy for ASCVD examples (acute coronary syndromes, MI, stroke, revascularization, TIA, PAD).
2
Trial of maximally tolerated high-intensity statin for at least 12 consecutive weeks OR documented statin intolerance/contraindication with required documentation (see policy).
High-intensity statin examples: atorvastatin 40-80 mg, rosuvastatin 20-40 mg. Intolerance definitions include myalgia, myositis (CK <10x ULN), rhabdomyolysis (CK >10x ULN).
3
Trial of Repatha (evolocumab) is required prior to Praluent for most indications; for HoFH a documented trial/failure/contraindication/intolerance to Repatha is required.
Document date of Repatha trial and reason for therapeutic failure, contraindication, or intolerance. Authorizations issued for 12 months when approved.

Background

Praluent (alirocumab) is a PCSK9 inhibitor used as an adjunct to diet and maximally tolerated statin therapy to reduce low‑density lipoprotein cholesterol (LDL‑C) and reduce cardiovascular risk in adults with established cardiovascular disease and to treat primary hyperlipidemia including familial forms. The program is intended to encourage use of lower‑cost alternatives and incorporates step therapy requirements — including documented statin trials and, for many indications, a trial of Repatha (evolocumab) — prior to approval of Praluent. Authorization for approved indications is typically issued for 12 months.