CurrentUnitedHealthcarePolicy CS2025D00115F

Korsuva (Difelikefalin) — Medical Benefit Drug Policy (CKD-associated pruritus in hemodialysis patients)

Defines medical benefit drug coverage criteria for use of Korsuva (difelikefalin) to treat moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis for UnitedHealthcare Community Plan members in North Carolina.

Policy Summary

PayerUnitedHealthcare

PolicyKorsuva (Difelikefalin) — Medical Benefit Drug Policy

Policy CodePolicy CS2025D00115F

Change TypeNon-material editorial updates (Background/References)

Effective DateJul 1, 2025

Next Review Date

Key ActionObtain prior authorization with documentation of hemodialysis status, diagnosis of moderate-to-severe CKD-associated pruritus, prior therapies tried or contraindications, nephrology involvement, and dosing per FDA labeling.

SourceLink

POLICY UPDATE CHANGES

Updated Background and References sections to reflect the most current information.

0.5 mcg/kgFDA-approved dose per hemodialysis session

12 monthsMax approval duration

J0879HCPCS code

Adults on hemodialysisCovered population

Moderate-to-severe

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Coverage Criteria for Korsuva (difelikefalin)

Initial Therapy

Covered when ALL of the following are met:

Initial Therapy: Diagnosis of moderate-to-severe pruritus associated with chronic kidney disease; patient is on hemodialysis; pruritus is not attributed to a cause other than end stage renal disease or its complications (e.g., pruritic dermatological disease, cholestatic liver disease); pruritus is not limited to occurring only during the dialysis session; pruritus is not localized to just 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 (FDA)-approved labeling; initial authorization will be for no longer than 12 months

Follow limitation of use: not studied in peritoneal dialysis; indicated only for adults on hemodialysis.

Continuation Therapy

Covered when ALL of the following are met:

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

Positive clinical response should be documented in the medical record.

Korsuva (difelikefalin) is not recommended/studied for patients on peritoneal dialysis; the FDA-labeled limitation of use specifies that it has not been studied in this population and therefore should not be used for peritoneal dialysis patients. In addition, coverage requires that the patient’s pruritus be attributed to chronic kidney disease (CKD) related causes — pruritus clearly due to other diagnoses (for example, pruritic dermatologic disease or cholestatic liver disease) is excluded from coverage under these criteria. Lastly, pruritus that is limited to occurring only during the dialysis session or that is localized solely to the palms of the hands is not consistent with the covered indication.

Use of Korsuva is limited to adults undergoing hemodialysis for CKD-associated moderate-to-severe pruritus; therefore, requests for use in patients who are not on hemodialysis do not meet the policy’s medical necessity criteria. Therapy is also not covered when pruritus is attributable solely to an identified non-CKD cause, when pruritus is localized only to the palms, or when the clinical record lacks a history of failure, contraindication, or intolerance to prior pruritus treatments (for example, antihistamines, corticosteroids, gabapentin, pregabalin, or topical capsaicin). Additionally, the product’s FDA limitation that it has not been studied in peritoneal dialysis patients informs coverage exclusions for that population.

Billing and Coding

Applicable HCPCS CodesHCPCS

J0879

Injection, difelikefalin, 0.1 microgram

WI‑NRS improvement thresholds used in Korsuva trials

Trial primary outcome thresholdsTrials assessed both >=4-point improvement (weekly mean WI-NRS at Week 12 as primary efficacy) and reported results for >=3-point improvement (percent achieving >=3-point decrease at Week 12)

Specific trial endpoint (>=4)Each randomized trial used the proportion of subjects achieving a 4-point or greater improvement from baseline in weekly mean daily WI‑NRS at Week 12 as the prespecified primary efficacy outcome

Specific trial endpoint (>=3)Analyses also reported the percentage of patients achieving at least a 3-point improvement on the WI‑NRS at Week 12 (49.1% Korsuva vs. 27.9% placebo)

Provider Requirements and Authorization Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial authorization is limited to no longer than 12 months; reauthorization (continuation therapy) is also limited to no longer than 12 months.

Initial and reauthorization limits: <= 12 months
Prescriber requirement: prescribed by or in consultation with a nephrologist

Step Therapy

Step Therapy / Failure Requirement

Policy requires a documented history of failure, contraindication, or intolerance to other pruritus treatments prior to approval.

Examples include antihistamines, corticosteroids, gabapentin, pregabalin, capsaicin
Step can also be satisfied by documented contraindication or intolerance to those therapies

Key Definitions

Moderate‑to‑severe CKD‑associated pruritus — definition and trial context

DefinitionModerate‑to‑severe CKD‑associated pruritus is itch related to chronic kidney disease in adults receiving hemodialysis, not attributable to other causes (eg, dermatologic or cholestatic liver disease) and not limited to dialysis sessions or palms only

Baseline severity in trialsMean baseline WI‑NRS approximately 7.1 to 7.2 (SD ~1.4–1.5) in the two pivotal trials enrolling adults on hemodialysis

Trial population/contextTwo randomized, multicenter, double‑blind, placebo‑controlled trials enrolled 851 adults (≥18 years) undergoing hemodialysis with moderate‑to‑severe pruritus; dosing was 0.5 mcg/kg IV at end of each hemodialysis session three times weekly for 12 weeks

Regulatory indication/limitationFDA‑approved indication: treatment of moderate‑to‑severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis; not studied in peritoneal dialysis

Background

Chronic kidney disease–associated pruritus (uremic pruritus) is a common and clinically important problem among adults receiving hemodialysis. The policy recognizes Korsuva as indicated for moderate-to-severe pruritus associated with CKD in adults undergoing hemodialysis. The pathogenesis of CKD-associated pruritus is incompletely understood but is thought to involve metabolic disturbances, immune dysregulation, and imbalances of the endogenous opioid system; Korsuva is a peripherally acting kappa opioid receptor (KOR) agonist. Clinical trial evidence supporting use in the hemodialysis population underlies the policy’s requirement that patients be on hemodialysis and that other causes of pruritus be excluded prior to treatment.

Revision History

2025-07-01RevisionLatest

Updated Background and References sections; archived previous policy version CS2024D00115E.