Loading...

    Explore
    • Policy Monitoring
    • Live Policy Feed
    • Billing Codes
    • NPI Medicare & Medicaid
    • Healthcare Providers
    • Health Insurance Payers
    • States
    • Service Lines
    • Taxonomy Codes
    Lookup tools
    • Billing Code Lookup
    • CPT Modifier Lookup
    • Provider Taxonomy Code Lookup
    • Healthcare Provider & Facility Lookup
    • Health Insurance Payer Lookup
    • Payer Contact Directory

    Policy & Benchmark Tools

    • Prior Authorization Lookup
    • Coverage Criteria Lookup
    • Timely Filing Lookup
    • Billing Code Reimbursement Rates
    • Payer Comparison Dashboard
    • Facility Comparison Dashboard
    • All tools

    Company

    • About OpenPayer
    • Data Sources
    • Trek Health
    OpenPayerby Trek Health
    LinkedInYouTube

    © 2026 Trek Health. All rights reserved.

    OpenPayer is built and maintained by Trek Health.

    v1.0.28
    OpenPayerPolicy UpdatesCardiologycareoregon PCSK9 Prior Auth Coverage Update | Open…
    Ask Trek AI about this page
    CurrentcareoregonPolicy N/A

    PCSK9 Inhibitors (Repatha, Praluent) Prior Authorization Guideline

    Customize your policy alerts

    Sign up for all careoregon policy alerts

    Know when careoregon releases new policies or updates existing guidance.

    Monitor payer policy activity

    Receive email alerts as soon as relevant payer policies are published or updated.

    Prior authorization guideline for use of PCSK9 inhibitors (Repatha and Praluent) describing initial and reauthorization clinical criteria, prescriber requirements, and approval durations; applies to CareOregon members for formulary management.

    Policy Summary
    Payercareoregon
    PolicyPCSK9 Inhibitors (Repatha, Praluent) Prior Authorization Guideline
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateJul 1, 2026
    Next Review DateN/A
    Key ActionObtain prior authorization and document diagnosis, prior maximal tolerated high‑intensity statin + ezetimibe therapy (or intolerance), LDL values, and adherence; initial approvals are for 6 months.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    6 moinitial approval length
    Lifetimereauthorization approval
    ≥30%LDL reduction for continuation
    >55 mg/dLASCVD LDL threshold
    ≥190 mg/dLFamilial HF baseline threshold

    Coverage Criteria for PCSK9 Inhibitors

    Initial Therapy

    Covered when ALL of the following are met for initial authorization unless HoFH genetic confirmation pathway applies:

    Prescriber: Prescribed by or in consultation with a cardiologist, endocrinologist, or lipid specialist.

    Reauthorization / Continuation Therapy

    Reauthorization covered when ALL of the following are met:

    Ongoing adjunctive treatment: Patient is continuing maximum adjunctive treatment (e.g., statin, ezetimibe/BAS, low‑fat diet, exercise).
    Adherence: Patient has been adherent with the medication.

    Documentation of adherence should be available in medical records.

    Policy Summary
    Payercareoregon
    PolicyPCSK9 Inhibitors (Repatha, Praluent) Prior Authorization Guideline
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateJul 1, 2026
    Next Review DateN/A
    Key ActionObtain prior authorization and document diagnosis, prior maximal tolerated high‑intensity statin + ezetimibe therapy (or intolerance), LDL values, and adherence; initial approvals are for 6 months.
    SourceLink
    On This Page
    Coverage Criteria for PCSK9 InhibitorsProducts, Diagnoses, and LDL ThresholdsPrior Authorization, Step Therapy, and DocumentationBackgroundDefinitions

    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.

    Effectiveness: Patient has had a significant LDL reduction while on the medication (defined as greater than 30% decrease in LDL‑C).>30%

    Significant lowering of LDL‑C is defined in the guideline as >30% decrease.

    No explicit exclusions are listed in this guideline. The policy text does not state any drugs, diagnoses, or member populations that are categorically excluded from consideration for Repatha or Praluent; coverage is determined by whether the member meets the specified clinical criteria for initiation or continuation of therapy.

    The policy does not present a separate, explicit "not medically necessary" list. However, requests that fail to meet the required clinical criteria — for example lacking a qualifying diagnosis (HoFH, ASCVD, HeFH, or baseline LDL ≥190 mg/dL), absence of documented prior/maximally tolerated high‑intensity statin plus ezetimibe therapy (or documented statin intolerance), or missing required documentation — would be considered not medically necessary under this guideline.

    Products, Diagnoses, and LDL Thresholds

    Covered product namesNDC|product_namesCovered
    RepathaProduct name listed in guideline
    PraluentProduct name listed in guideline
    Relevant diagnoses referencedICD-10|abbreviations
    HoFHHomozygous Familial Hypercholesterolemia (diagnosis pathway mentioned)
    HeFHHeterozygous familial hypercholesterolemia (diagnosis pathway mentioned)
    ASCVDAtherosclerotic Cardiovascular Disease (diagnosis pathway mentioned)
    LDL thresholds
    ASCVD thresholdLDL >55 mg/dL despite maximum tolerated high‑intensity statin (atorvastatin 40–80 mg or rosuvastatin 20–40 mg) and ezetimibe.
    HeFH treatment thresholdLDL >100 mg/dL despite maximum tolerated high‑intensity statin (atorvastatin 40–80 mg or rosuvastatin 20–40 mg) and ezetimibe.
    Baseline LDL pathwayBaseline LDL ≥190 mg/dL with subsequent LDL >100 mg/dL despite maximum tolerated high‑intensity statin and ezetimibe.
    LDL reduction for continuation
    Required LDL reduction for continuationSignificant lowering of LDL‑C defined as greater than 30% decrease in LDL‑C for reauthorization/continuation.
    Context for measurementReduction must be documented while on the medication as part of reauthorization criteria.
    Related requirementPatient must be adherent and continue maximum adjunctive treatment during assessment of LDL response.

    Prior Authorization, Step Therapy, and Documentation

    Prior Authorization

    Prior authorization required; initial 6‑month approval, reauthorization requires adherence and LDL response

    Prior authorization is required for Repatha and Praluent. Initial authorizations are approved for 6 months; reauthorization is evaluated under the reauthorization criteria (lifetime approval through 12/31/2039 is listed for reauthorization). Reauthorization requires adherence and a significant LDL‑C reduction (>30%).

    • Initial approval length: 6 month(s).
    • Reauthorization approval listed as Lifetime (12/31/2039) and requires adherence plus >30% LDL‑C reduction.
    Step Therapy

    Step therapy: trial of high‑intensity statin + ezetimibe required (unless intolerant)

    Prior to initiating a PCSK9 inhibitor, document a prior trial of a high‑intensity statin (atorvastatin 40–80 mg or rosuvastatin 20–40 mg) PLUS ezetimibe unless the member has documented intolerance or a contraindication.

    • High‑intensity statin defined as atorvastatin 40–80 mg or rosuvastatin 20–40 mg.
    • Ezetimibe must have been used in combination with maximum tolerated statin unless intolerance/contraindication documented.
    Documentation Required

    Required documentation: diagnosis, genetic confirmation (HoFH), prior therapies, LDL values, and adherence/response

    Include supporting medical records/chart notes with the prior authorization: document the diagnosis pathway used (genetic confirmation for HoFH when claimed, ASCVD, HeFH, or baseline LDL ≥190 mg/dL), prior therapy trials or documented statin intolerance, and LDL values used to meet thresholds.

    • For HoFH claims, provide genetic test confirmation.
    • For ASCVD/HeFH/baseline LDL pathways, provide diagnosis documentation and LDL laboratory values showing the required thresholds.
    • Document prior use of maximum tolerated high‑intensity statin and ezetimibe or documentation of intolerance (chart notes describing severe statin side effects, failed re‑challenge, or non‑modifiable contraindication).
    • For reauthorization, document adherence and LDL‑C response (>30% reduction).
    Denial Risk

    Denial triggers: missing diagnosis, therapy trials, LDL thresholds, or response/adherence documentation

    Requests may be denied if required documentation or therapy trials are missing: absence of documentation of the qualifying diagnosis (HoFH, ASCVD, HeFH, or baseline LDL ≥190 mg/dL), lack of evidence of prior/maximally tolerated statin plus ezetimibe therapy (or documented intolerance), or missing LDL threshold or LDL‑response data.

    • No genetic confirmation provided when HoFH is claimed.
    • No documentation of ASCVD, HeFH, or baseline LDL ≥190 mg/dL.
    • No evidence of prior/maximally tolerated high‑intensity statin and ezetimibe trial, or no documentation of statin intolerance.
    • For reauthorization, no documentation of adherence or >30% LDL‑C reduction.

    Background

    PCSK9 inhibitors (Repatha, Praluent) are adjunctive lipid‑lowering therapies used for patients with familial hypercholesterolemia (heterozygous or homozygous) or established atherosclerotic cardiovascular disease who have inadequate LDL‑C control despite maximally tolerated high‑intensity statin and ezetimibe therapy, or who have documented statin intolerance. The guideline requires prescriber specialty (cardiologist, endocrinologist, or lipid specialist) and specifies LDL thresholds and genetic confirmation for HoFH when applicable.

    Definitions

    High‑intensity statin
    High‑intensity statin — atorvastatinAtorvastatin 40–80 mg.
    High‑intensity statin — rosuvastatinRosuvastatin 20–40 mg.
    Role in criteriaRequired as maximum tolerated dose (with ezetimibe) before PCSK9 initiation unless documented intolerance or contraindication.
    Significant LDL reduction
    Definition of significant LDL reductionGreater than 30% decrease in LDL‑C (used as the effectiveness threshold for reauthorization).
    Evidence requirementMust be demonstrated while on the medication and paired with adherence to therapy.
    Reauthorization implicationMeeting this >30% reduction is required for continued coverage under the reauthorization criteria.