Currentsierra health and lifePolicy 2025D0115E

Korsuva (difelikefalin) for CKD‑associated pruritus in hemodialysis patients

Defines medical necessity and authorization criteria for use of difelikefalin (Korsuva) to treat moderate-to-severe pruritus associated with chronic kidney disease in adults receiving hemodialysis; intended for providers and utilization reviewers making coverage decisions under Sierra Health and Life/UHC standard plans.

Policy Summary

Payersierra health and life

PolicyKorsuva (difelikefalin) for CKD‑associated pruritus in hemodialysis patients

Policy CodePolicy 2025D0115E

Change TypeRevised coverage criteriaadded continuation requirements

Effective DateJul 1, 2025

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, hemodialysis status, prior therapy history, dosing per FDA labeling, and for reauthorization include documentation of a positive clinical response.

SourceLink

POLICY UPDATE CHANGES

Revised proven coverage criteria and added continuation of therapy criteria requiring documentation of a positive clinical response, dosing per FDA labeling, and reauthorization limits of no longer than 12 months.

Added Benefit Considerations section and updated Background and References.

0.5 mcg/kg IV TWWFDA dosing

12 monthsMax approval period

49.1% vs 27.9%WI-NRS ≥3 response (Wk12)

J0879

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Coverage Criteria for Korsuva (difelikefalin)

inv-01: Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial therapy criteria: Diagnosis of moderate-to-severe pruritus associated with chronic kidney disease; patient is on hemodialysis; dosing is in accordance with the United States Food and Drug Administration approved labeling; initial authorization will be for no longer than 12 months.

inv-02: Initial Therapy — additional clinical requirements

Additional covered conditions for initial approval

Additional initial criteria: Pruritus is not attributed to a cause other than end-stage renal disease or its complications (e.g., pruritic dermatologic disease, cholestatic liver disease); pruritus is not limited to occurring only during the dialysis session; pruritus is not localized only to the palms of the hands; history of failure, contraindication, or intolerance to other pruritus treatments (e.g., antihistamines, corticosteroids, gabapentin, pregabalin, capsaicin); prescribed by or in consultation with a nephrologist; dosing is in accordance with the United States Food and Drug Administration approved labeling; initial authorization will be for no longer than 12 months.

inv-03: Continuation of Therapy (Reauthorization) — Covered when ALL of the following are met

Covered when ALL of the following are met

Continuation criteria: Documentation of a positive clinical response (i.e., reduction in itch from baseline); dosing is in accordance with the United States Food and Drug Administration approved labeling; prescribed by or in consultation with a nephrologist; reauthorization will be for no longer than 12 months.

Documentation of response is required for reauthorization as of the policy revision (07/01/2025).

Korsuva (difelikefalin) is not recommended for patients on peritoneal dialysis. The agent was studied and is indicated for adults undergoing hemodialysis; per the FDA labeling, Korsuva has not been studied in patients on peritoneal dialysis and its use in that population is not recommended.

Difelikefalin (Korsuva) is intended for moderate-to-severe pruritus associated with chronic kidney disease in patients on hemodialysis. Use of Korsuva for pruritus that is attributable to non-CKD causes — for example, primary pruritic dermatologic conditions or cholestatic liver disease — does not meet the policy’s medical necessity criteria and should be excluded. The policy also excludes cases where pruritus is limited to occurring only during dialysis sessions or is localized only to the palms.

Billing and Coding

HCPCS CodesHCPCS

J0879

Injection, difelikefalin, 0.1 microgram

WI-NRS improvement threshold used in trials

Trial primary endpointPrimary endpoint assessed proportion with ≥4-point improvement in weekly mean of daily WI-NRS at Week 12 (trial primary outcome definition).

Reported responder threshold (trial publications)Proportion achieving ≥3‑point WI‑NRS improvement at Week 12 was reported and used for responder analyses (49.1% Korsuva vs 27.9% placebo).

Sensitivity analysesSensitivity analyses using on-treatment data showed similar responder rates (51.0% vs 27.6%).

Authorization, Documentation, and Clinician Responsibilities

Prior Authorization

Prior Authorization Required

Prior authorization required for both initial and continuation therapy. Initial and reauthorization periods may be approved for up to 12 months.

Initial and continuation therapy require prior authorization
Authorization periods up to 12 months

Step Therapy

Step Therapy / Prior Therapies

History of failure, contraindication, or intolerance to other pruritus treatments is required before approving initial therapy.

Examples: antihistamines, corticosteroids, gabapentin, pregabalin, capsaicin
Prescribed by or in consultation with a nephrologist

Background

Chronic kidney disease–associated pruritus (CKD-aP, or uremic pruritus) is a common and clinically important symptom in patients with advanced kidney disease receiving dialysis. Clinical guidance notes that many hemodialysis patients experience pruritus, with a substantial proportion reporting moderate-to-severe symptoms that impair sleep, mood, and quality of life and are associated with worse clinical outcomes. Difelikefalin is a peripherally acting kappa opioid receptor agonist evaluated in randomized controlled trials showing clinically significant reductions in itch intensity in adults on hemodialysis. The U.S. FDA approves Korsuva specifically for moderate-to-severe pruritus associated with CKD in adults undergoing hemodialysis, and the label includes a limitation of use that it has not been studied in peritoneal dialysis patients.

Definitions

Moderate-to-severe pruritus — WI-NRS measurement and trial baseline definitions

Measurement instrumentWorst Itching Intensity Numerical Rating Scale (WI‑NRS): daily 24‑hour patient‑reported score from 0 (no itch) to 10 (worst itch imaginable).

Baseline definition and run‑inA 7‑day run‑in period prior to randomization was used to confirm moderate‑to‑severe pruritus and to establish baseline daily WI‑NRS scores (mean baselines ~7.1 and 7.2 in trials).

Assessment timingPrimary efficacy assessed as change in the weekly mean of daily WI‑NRS scores at Week 12.

Population — adults on hemodialysis; not studied for peritoneal dialysis

Indicated populationAdults undergoing hemodialysis (HD).

Not studied / not recommended populationKorsuva has not been studied in patients on peritoneal dialysis and is not recommended for that population (Limitation of Use).