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    v1.0.31
    OpenPayerPolicy UpdatesNephrologyAetna Korsuva prior auth Coverage Criteria | OpenP…
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    CurrentAetnaPolicy N/A

    Korsuva (difelikefalin injection) Medication Precertification Request — Coverage Criteria

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    Aetna precertification request form and required clinical information for coverage consideration of Korsuva for treatment of pruritus, primarily in patients with CKD on dialysis; applies to providers requesting prior authorization for initiation or continuation of therapy.

    Policy Summary
    PayerAetna
    PolicyKorsuva (difelikefalin) precertification / coverage criteria
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit precertification using Aetna's form with completed checklist, documentation of CKD-associated pruritus (WI-NRS baseline), dialysis status, prior therapies tried/failed, and requested dosing within 0.5 mcg/kg per HD treatment (≤3 doses/week).
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    2 pagesform length
    1 phone + 1 faxcontact
    WI-NRSscoring tool
    0.5 mcg/kgdose limit

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    Coverage Criteria for Korsuva (difelikefalin injection)

    Initial and continuation coverage criteria

    Coverage consideration requires completed clinical checklist items documenting ALL of the following for initiation and continuation as applicable.

    Initial therapy: Patient has diagnosis of pruritus; requested drug will be used for moderate-to-severe pruritus; prescribed by or in consultation with a nephrologist; patient is on peritoneal dialysis or hemodialysis as applicable; pruritus is associated with chronic kidney disease (uremic pruritus) supported by baseline scoring (e.g., WI-NRS, VAS/NRS); non-uremic dermatologic and systemic causes have been considered and are not the primary cause; patient has tried and failed other pruritus treatments (e.g., antihistamines, gabapentin, pregabalin, topical emollients/analgesics) or has contraindications to those therapies; proposed dosing does not exceed 0.5 mcg/kg per hemodialysis treatment and will not exceed three doses per weekall items on form checked/documented

    Modeled from the form's required clinical checklist

    Continuation therapy: For continuation, patient has demonstrated a positive clinical response in pruritus symptoms (e.g., improvement of at least 4 points from baseline on the WI-NRS) and ongoing dosing remains within stated limits (≤0.5 mcg/kg per hemodialysis treatment and ≤3 doses per week)≥4-point WI-NRS improvement for continuation

    Continuation response criterion appears on the form

    If the member’s pruritus is primarily attributable to non-uremic dermatologic conditions (for example, drug-induced hypersensitivity, allergies, dermatitis, psoriasis) or to systemic causes (for example, liver disease, malignancy/lymphoma, post‑herpetic neuralgia, HIV), the form requires the provider to indicate this. Such non-uremic dermatologic or systemic etiologies should be considered and documented because they may exclude CKD‑associated (uremic) pruritus as the primary diagnosis for which Korsuva is being requested.

    Requests that do not include the required clinical information risk denial or delay. The form specifically requires documentation that the patient has pruritus and that the indication is for moderate‑to‑severe symptoms, whether the prescriber is a nephrologist (or in consultation with one), dialysis modality (hemodialysis or peritoneal dialysis), and confirmation that the pruritus is associated with CKD using a baseline scoring tool (for example, the WI‑NRS, VAS or NRS). The checklist also asks whether prior pruritus therapies (such as antihistamines, gabapentin, pregabalin, topical emollients/analgesics) were tried and failed or are contraindicated; absence of these prior‑therapy fields may lead to a request being judged not medically necessary or require additional information.

    Coding and Dose Limits

    Administration CPT codes (placeholder)CPT
    Administration code(s) (CPT)Placeholder on form for relevant CPT administration codes
    Dose limits — Korsuva (difelikefalin injection)
    Per‑treatment weight‑based maximumDo not exceed 0.5 mcg/kg per hemodialysis treatment
    Maximum frequencyDo not exceed three doses per week
    Form checkbox confirmationPrecertification form includes explicit checkboxes confirming proposed dosing does not exceed 0.5 mcg/kg per HD treatment and does not exceed three doses/week

    Precertification and Provider Requirements

    Prior Authorization

    Precertification submission required via Aetna form

    Submit precertification using Aetna's Korsuva (difelikefalin) Medication Precertification Request form. Send submissions to Aetna Precertification Notification via phone or fax; use the Medicare request form for Medicare Advantage Part B submissions.

    • Aetna Precertification Notification phone: 1-866-752-7021 (TTY: 711)
    • Aetna Precertification Notification fax: 1-888-267-3277
    • For Medicare Advantage Part B, use the Medicare request form
    Step Therapy

    Document prior therapy trials/failures

    Document prior trials and failures of other pruritus therapies on the clinical checklist—responses are required about whether the patient has tried and failed listed treatments or has contraindications to them.

    • Checkbox documents trials/failures of antihistamines

    Background

    Korsuva (difelikefalin injection) is indicated on the precertification form for treatment of pruritus, including pruritus associated with chronic kidney disease in patients undergoing dialysis. The form anchors clinical review to baseline and follow‑up severity scoring (for example, the Worst Itching Intensity Numerical Rating Scale) and documents dialysis status and prior treatment history to support both initiation and continuation decisions.

    Definitions and Scoring Tools

    WI‑NRS — Baseline and follow‑up severity/response scoring
    Tool nameWorst Itching Intensity Numerical Rating Scale (WI‑NRS)
    Use on formReferenced for baseline severity documentation to support CKD‑associated pruritus (e.g., initial assessment)
    Use for continuationReferenced for response assessment; continuation example is ≥4‑point improvement from baseline on WI‑NRS
    Alternate scales notedForm also lists visual analog scale (VAS)/numeric rating scale (NRS) as examples for baseline scoring
    Policy Summary
    PayerAetna
    PolicyKorsuva (difelikefalin) precertification / coverage criteria
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit precertification using Aetna's form with completed checklist, documentation of CKD-associated pruritus (WI-NRS baseline), dialysis status, prior therapies tried/failed, and requested dosing within 0.5 mcg/kg per HD treatment (≤3 doses/week).
    SourceLink
    On This Page
    Coverage Criteria for Korsuva (difelikefalin injection)Coding and Dose LimitsPrecertification and Provider RequirementsBackgroundDefinitions and Scoring Tools
  1. Checkbox documents trials/failures of gabapentin or pregabalin
  2. Checkbox documents trials/failures of topical emollients/analgesics
  3. Checkbox for contraindications to these therapies
  4. Documentation Required

    Provide required patient, prescriber, dispensing, dosing, and diagnosis details

    Include complete patient demographics, weight and height, prescriber and dispensing provider details, requested Korsuva dose and frequency, and diagnosis coding along with the completed clinical checklist fields.

    • Patient name, DOB, contact information, current weight and height
    • Prescriber name, credentials, specialty, phone, fax, NPI and state license
    • Dispensing provider/place of administration selection
    • Requested Korsuva dose and frequency (as entered on product information section)
    • Primary and any secondary ICD codes
    • Completed clinical checklist including diagnosis, dialysis status, baseline WI-NRS and prior therapies
    Denial Risk

    Incomplete clinical documentation may cause denial or delay

    Incomplete or missing required clinical checklist items may result in denial or the need for additional information and delay of the precertification decision.

    • Absence of documented diagnosis of pruritus or CKD-associated pruritus with baseline scoring
    • Missing dialysis status or prescriber specialty checkbox
    • Unanswered items about prior therapies, contraindications, or dosing limits