CurrentColorado Rocky Mountain Health PlansPolicy N/A

PCSK9 inhibitor prior authorization (antihyperlipidemics)

Prior authorization requirements and form elements for PCSK9 inhibitor therapies for members (including HeFH, HoFH, ASCVD, and secondary prevention) — what clinicians must document and submit to obtain coverage.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyPCSK9 inhibitor prior authorization (antihyperlipidemics)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization form (fax 866-940-7328) including diagnosis, statin trial details (≥6 weeks or intolerance), LDL values, and prescriber specialty.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

24+form size

>=6 wksrequired statin duration

>=50%LDL % threshold

>=100/130/190LDL absolute thresholds

Coverage Criteria and Medical Necessity

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inv-01: Coverage criteria by indication

Covered when ALL of the following are met (criteria vary by indication):

General requirements: Completed prior authorization form including diagnosis, prescriber specialty or consultation, medication details, and physician signature; documentation of trial of highest-tolerated statin regimen for at least 6 consecutive weeks or documented statin intolerance; documentation of LDL values and percent reduction from baseline as applicable.statin trial >=6 weeks; LDL percent and absolute thresholds as specified

Indication-specific diagnostic definitions: HeFH: clinical diagnosis by validated tools (e.g., US MedPed, Simon Broome, Dutch Lipid Panel), OR age ≥20 with LDL ≥190 mg/dL on maximally tolerated statin, OR age <20 with LDL ≥160 mg/dL, OR genetic confirmation. HoFH: history of untreated LDL ≥500 mg/dL with xanthoma before age 10, OR evidence of HeFH in both parents, OR genetic confirmation. ASCVD/CVD prevention: history of MI, ACS, severe angina, stroke/TIA, coronary revascularization, or peripheral arterial disease.LDL thresholds vary by indication (see HeFH/HoFH/ASCVD criteria)

LDL thresholds and percent-reduction requirements: When applicable, documentation must include whether LDL has achieved at least 50% reduction from baseline after ≥6 weeks on highest-tolerated statin and whether LDL has remained ≥100 mg/dL or ≥130 mg/dL (depending on form section); list actual LDL values.≥50% LDL reduction (when queried); LDL remaining ≥100 mg/dL or ≥130 mg/dL as applicable

Combination therapy exclusions: Requested medication must not be used in combination with another PCSK9 inhibitor, lomitapide (Juxtapid), or mipomersen (Kynamro) unless documented; the form asks whether combination therapy will be used and requires disclosure.

Step therapy / formulary alternatives: Provider must document failure or intolerance to one preferred PCSK9 inhibitor or attest that no preferred formulary alternative is available; include reason for failure/intolerance and prior medication details.

Prescriber and specialty requirement: Requested medication should be prescribed by, or in consultation with, a provider specializing in lipid management (e.g., cardiologist, lipid specialist, or endocrinologist).

Continuation of therapy: For continuation requests, documentation must show continued use of maximum tolerated statin (unless contraindicated/intolerant) and evidence of clinical benefit, for example ≥30% LDL reduction from initiation of the PCSK9 inhibitor or achievement of a patient-specific goal; list statin and dose and describe benefit.>=30% LDL reduction or patient-specific goal for continuation

Diagnosis, LDL Thresholds, and Statin Trial Coding

Form fields for diagnosis codesmixed

ICD10 field (unspecified)

Form includes an ICD10 Code field to specify diagnosis

Required statin trial duration (inv-05)

Required durationAt least 6 consecutive weeks on the highest-tolerated statin regimen (document dose and dates) or documented statin intolerance

Documentation neededSection D must list medication name, dose, dates of trial, and reason for discontinuation if statin intolerance

Prior authorization impactRequests may be denied if documentation does not show the required >=6-week trial or documented intolerance

LDL percent reduction (inv-06)

Minimum percent reductionAt least 50% reduction in LDL from baseline (assessed after ≥6 consecutive weeks on highest-tolerated statin when applicable)

Form fieldForm asks: 'Has the patient's LDL achieved at least 50% reduction from baseline?' and requests the LDL reduction value if yes

Continuation contextContinuation requests require documentation of clinical benefit; initial coverage queries the ≥50% reduction for some indications

LDL absolute thresholds (inv-07)

LDL threshold ≥100 mg/dLForm queries whether LDL has remained ≥100 mg/dL after ≥6 weeks on highest-tolerated statin (applicable to some indications)

LDL threshold ≥130 mg/dLForm asks if the patient's LDL has remained ≥130 mg/dL after ≥6 weeks on highest-tolerated statin (used in certain request sections)

Baseline LDL ≥190 mg/dLFor HeFH (age ≥20): provider may indicate age ≥20 and LDL ≥190 mg/dL on maximally tolerated statin therapy as diagnostic criterion

Submission Requirements and Provider Responsibilities

Prior Authorization

Prior authorization form and submission

Prior authorization is required. Complete the Antihyperlipidemics, PCSK9 Inhibitors prior authorization request form and fax to 866-940-7328. Allow at least 24 hours for review. If you have questions, call 800-310-6826.

Fax: 866-940-7328
Phone: 800-310-6826
Complete entire multi-page form to avoid delay
Allow ≥24 hours for review

Step Therapy

Step therapy / preferred alternatives

Document failure or intolerance to a preferred formulary PCSK9 inhibitor or state that no preferred formulary alternative is available (select N/A). If a preferred agent was tried, include medication name, dose, dates of trial, and reason for discontinuation.

Indicate trial outcome: Failure, Intolerance, or N/A (no preferred formulary alternative)
Provide medication name, dose, trial dates, and reason for discontinuation

Documentation Required

Required clinical and administrative documentation

Include complete clinical and administrative documentation with the prior authorization submission: patient and provider details, diagnosis (select appropriate ICD-10/clinical indication), full medication details (name, dose, route, quantity, directions, refills), prescriber signature, and specialty consultation if applicable. Attach all pertinent clinical information that supports the stated diagnosis and therapy.

Patient demographics: name, DOB
Provider information and physician signature (signature authorizes specialty pharmacy to dispense/coordinate)
Diagnosis and ICD-10 code or description
Medication details: name, quantity, directions, refills, dose, route
Attach pertinent clinical records and supporting documentation

Denial Risk

Documentation and trial requirements

For initial and continuation requests, document statin therapy status and clinical response. For initial requests, confirm whether the patient has had concomitant therapy with the highest-tolerated statin regimen for ≥6 consecutive weeks or is statin intolerant; if yes, provide statin name, dose, dates, and reason for discontinuation. For continuation requests, document ongoing maximum tolerated statin (unless contraindicated), and evidence of continued clinical benefit (for example ≥30% LDL reduction since PCSK9 initiation or achievement of patient-specific LDL goal). Failure to provide documentation of a ≥6-week highest-tolerated statin trial (or evidence of statin intolerance) and other required information may result in denial.

Initial requests: document 6-week highest-tolerated statin trial OR documented statin intolerance (include medication, dose, dates, reason)
Report LDL response: percent reduction from baseline and current LDL value if applicable
Continuation requests: list current statin and dose and document clinical benefit (e.g., ≥30% LDL reduction or patient-specific goal)
Missing required documentation or trial evidence may lead to denial

Background and Context

PCSK9 inhibitors are indicated in the clinical contexts captured on the form: familial hypercholesterolemia (both heterozygous familial hypercholesterolemia — HeFH and homozygous familial hypercholesterolemia — HoFH), primary hypercholesterolemia with established atherosclerotic cardiovascular disease (ASCVD), and to reduce recurrent events in adults with established cardiovascular disease (myocardial infarction, stroke, or need for coronary revascularization). The form emphasizes prior use of the maximum tolerated statin (or documented statin intolerance) and requires LDL measurement and percent reduction documentation to support initiation or continuation of therapy.

OpenPayer

PCSK9 inhibitor prior authorization (antihyperlipidemics)

Coverage Criteria and Medical Necessity

Diagnosis, LDL Thresholds, and Statin Trial Coding

Submission Requirements and Provider Responsibilities

Background and Context

Key Definitions