CurrentUnitedHealthcarePolicy N/A

Prior authorization criteria for PCSK9 inhibitors (Praluent/alirocumab and Repatha/evolocumab)

Requirements and clinical questions for prior authorization of PCSK9 inhibitors (alirocumab/Praluent and evolocumab/Repatha) for UnitedHealthcare members; governs prescribers and pharmacists submitting PA requests.

Policy Summary

PayerUnitedHealthcare

PolicyPrior authorization criteria for PCSK9 inhibitors (Praluent/alirocumab and Repatha/evolocumab)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionComplete the prior authorization questionnaire and attach LDL results before and after statin therapy plus documentation of statin intolerance when claimed.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

20PA form fields

90 daysStatin duration

>70 mg/dLPost-statin LDL threshold

>=18 / >=10Age eligibility

Coverage Criteria for PCSK9 Inhibitors

Initial coverage criteria common to PCSK9 inhibitors

Covered when ALL of the following are met as documented on the PA form:

Statin treatment: Beneficiary is currently taking the maximum dose, for his/her age, of atorvastatin or rosuvastatin AND has completed 90 days of treatment90 days

Lab documentation required

Post-statin LDL: Beneficiary's LDL level is > 70 mg/dL after statin therapy>70 mg/dL

Attach LDL laboratory results before and after statin therapy

Statin intolerance: Beneficiary has clinically significant intolerance or allergic reaction to atorvastatin or rosuvastatin (examples: severe muscle pain, significant liver abnormalities, rhabdomyolysis); intolerance excludes fatigue, cognitive impairment, or mild aches

Policy Summary

PayerUnitedHealthcare

PolicyPrior authorization criteria for PCSK9 inhibitors (Praluent/alirocumab and Repatha/evolocumab)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionComplete the prior authorization questionnaire and attach LDL results before and after statin therapy plus documentation of statin intolerance when claimed.

SourceLink

On This Page

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Documentation of clinically significant intolerance or allergic reaction must be attached

Praluent specific criteria

Drug-specific eligibility for Praluent (alirocumab):

Age: Beneficiary is 18 years of age or older>=18 yrs

Indications: Diagnosis of Heterozygous Familial Hypercholesterolemia OR clinical atherosclerotic cardiovascular disease OR Severe Primary Hyperlipidemia (LDL-C >190 mg/dL)

Repatha specific criteria

Drug-specific eligibility for Repatha (evolocumab):

Age: Beneficiary is 10 years of age or older>=10 yrs

Indications: Diagnosis of Heterozygous Familial Hypercholesterolemia OR Homozygous Familial Hypercholesterolemia OR clinical atherosclerotic cardiovascular disease OR Severe Primary Hyperlipidemia (LDL-C >190 mg/dL)

Continuation criteria

Continuation/renewal criteria:

Response documentation: Provider has submitted documentation that indicates a positive clinical response to therapy

Continuation requires evidence of benefit

Concomitant therapy: Beneficiary is continuing to receive other lipid-lowering therapy

Question asked on form

Single PCSK9 agent: Beneficiary is not receiving more than one PCSK9 inhibitor concurrently

For the purposes of the prior authorization questionnaire, clinically significant statin intolerance is limited to substantial adverse events such as severe muscle pain, significant liver abnormalities, or rhabdomyolysis. The policy explicitly excludes non‑specific or mild complaints from qualifying as statin intolerance — for example, fatigue, cognitive impairment, and mild aches do not meet the definition and therefore are not acceptable reasons to bypass the statin trial requirement.

The policy requires that a member's LDL be documented as > 70 mg/dL after completing an adequate statin trial (maximum dose for age of atorvastatin or rosuvastatin for 90 days). If the post‑statin LDL is not >70 mg/dL and there is no documented clinically significant statin intolerance, the request does not meet the stated coverage criteria and would not qualify for approval under these guidelines.

Key Clinical Thresholds & Coding-Related Values

Statin therapy duration required prior to PA — 90 days

Required duration of statin therapy90 days of treatment with maximum-dose atorvastatin or rosuvastatin for age

Form question referenceClinical question 1 asks if beneficiary has completed 90 days of treatment

Documentation noteLab documentation before and after statin required when claiming inadequate response

Post-statin LDL threshold — > 70 mg/dL

Post-statin LDL threshold> 70 mg/dL (LDL after 90 days of atorvastatin or rosuvastatin)

Form question referenceClinical question 2 asks if LDL level > 70 mg/dL after 90 days of statin therapy

ConsequenceIf LDL is not >70 mg/dL and no documented intolerance, therapy does not meet criteria

Severe Primary Hyperlipidemia LDL threshold — > 190 mg/dL

Severe Primary Hyperlipidemia LDL threshold> 190 mg/dL (LDL-C)

Form question reference (Praluent)Clinical question 12 defines Severe Primary Hyperlipidemia as LDL-C > 190 mg/dL

Form question reference (Repatha)Clinical question 17 asks whether beneficiary has Severe Primary Hyperlipidemia (LDL-C > 190 mg/dL)

Required Provider Actions and Documentation

Prior Authorization

Prior Authorization Questionnaire Completion

Prior authorization requires completion of the PSCK9 inhibitors clinical questionnaire and all applicable clinical items, including confirmation of prior high‑intensity statin use and attached lab documentation.

Complete the full PA clinical questionnaire (all applicable questions in sections for Praluent/Repatha/other PCSK9 inhibitors).
Confirm responses to statin trial and LDL questions are completed.

Denial Risk

Missing LDL Documentation — Denial Risk

The PA request must include LDL laboratory results both before starting statin therapy and after statin therapy (post‑trial). Failure to attach these LDL values may result in denial of the request.

Attach baseline LDL prior to statin treatment.
Attach LDL after completing the 90‑day statin trial.
Missing either pre‑ or post‑statin LDL lab results may trigger denial.

Documentation Required

Statin Trial Requirement

Patient must have been taking the maximum tolerated (age‑appropriate) dose of atorvastatin or rosuvastatin for at least 90 days prior to approval, or have documented clinically significant intolerance or allergy to these statins.

Document maximum dose of atorvastatin or rosuvastatin and that the patient completed 90 days of therapy.
If the patient cannot tolerate statins, attach documentation of clinically significant statin intolerance or allergy (e.g., severe muscle pain, significant liver abnormalities, rhabdomyolysis).
Intolerance does not include fatigue, cognitive complaints, or mild aches.

Background

PCSK9 inhibitors (the monoclonal antibodies referenced in this policy) are injectable lipid‑lowering therapies intended for patients whose LDL cholesterol remains elevated despite appropriate statin therapy or who have documented, clinically significant statin intolerance. The prior authorization form requests baseline and post‑statin LDL values and documentation of prior high‑intensity statin use (atorvastatin or rosuvastatin) to confirm inadequate response or intolerance before a PCSK9 agent will be considered.

Definitions

Severe Primary Hyperlipidemia defined as LDL-C > 190 mg/dL

DefinitionSevere Primary Hyperlipidemia defined as LDL-C > 190 mg/dL

Where usedListed as an indication on both Praluent and Repatha clinical questions

ActionSelects eligibility pathway for PCSK9 inhibitor when present

Clinically significant statin intolerance examples

Examples of clinically significant statin intoleranceSevere muscle pain, significant liver abnormalities, rhabdomyolysis

Exclusions from statin intoleranceFatigue, cognitive impairment, or mild aches are not considered clinically significant intolerance

Documentation requirementDocumentation of clinically significant intolerance must be attached to the prior authorization request