CurrentUnitedHealthcarePolicy CSIND0115.04

Korsuva (Difelikefalin) (for Indiana Only)

State-specific UnitedHealthcare Medical Benefit Drug Policy governing coverage and prior authorization criteria for difelikefalin (Korsuva) for adults with moderate-to-severe pruritus associated with chronic kidney disease who are undergoing hemodialysis in Indiana.

Policy Summary

PayerUnitedHealthcare

PolicyKorsuva (Difelikefalin) (for Indiana Only)

Policy CodePolicy CSIND0115.04

Change TypeSupporting information updated

Effective DateJul 1, 2025

Next Review Date

Key ActionDocument that the patient meets all coverage criteria (diagnosis of moderate-to-severe CKD-associated pruritus, on hemodialysis, exclusion of other causes, prior treatment failure/contraindication/intolerance, nephrology involvement, and FDA-consistent dosing) and limit initial and reauthorization approvals to no longer than 12 months.

SourceLink

POLICY UPDATE CHANGES

Background and References sections updated to reflect the most current information; previous policy version CSIND00115.03 archived.

Adults on hemodialysisPopulation indicated

Initial up to 12 moAuthorization length

Reauth up to 12 moContinuation authorization length

Not for peritoneal dialysisLimitation of use

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Medical Necessity Criteria for Korsuva (difelikefalin)

Medically Necessary — Initial therapy

Korsuva is proven and medically necessary when ALL of the following are met for initial therapy:

ALL of the following

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
Examples include 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

Medically Necessary — Continuation (Reauthorization)

For continuation of therapy, ALL of the following must be documented:

ALL of the following

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

Not recommended population / Limitation of use

Use is not recommended/has not been studied for:

ANY of the following

Patients on peritoneal dialysis (Korsuva has not been studied in this population and is not recommended)

Applicable Codes (Reference Only)

Applicable codes (reference only)mixed

No codes listed

Prior Authorization, Documentation, and Denial Risks

Prior Authorization

Prior authorization requirement and duration

Initial and reauthorization approvals are each limited to no longer than 12 months. Coverage requires documentation that all listed criteria are met, including diagnosis of moderate-to-severe CKD-associated pruritus, patient is on hemodialysis, exclusion of non-ESRD causes, prior treatment failure/contraindication/intolerance, nephrology prescribing or consultation, and dosing consistent with FDA labeling.

Initial authorization: up to 12 months
Reauthorization: up to 12 months
Coverage contingent on documentation of all policy criteria (diagnosis, dialysis modality, exclusion of other causes, prior treatment history, nephrology involvement, FDA-consistent dosing)

Documentation Required

Documentation of treatment history and response

For initial approval, document history of failure, contraindication, or intolerance to other pruritus treatments (examples: antihistamines, corticosteroids, gabapentin, pregabalin, capsaicin). For continuation (reauthorization), document a positive clinical response, i.e., reduction in itch from baseline.

Clinical Background

Chronic kidney disease-associated (uremic) pruritus commonly affects patients receiving hemodialysis and can be moderate-to-severe; estimates suggest more than 60% of hemodialysis patients experience pruritus and 20–40% report moderate-to-severe symptoms. This intense, often generalized itching is associated with poor sleep quality, depression, reduced quality of life, increased risk of infection, and increased mortality risk. The pathogenesis is not fully understood, with proposed mechanisms including metabolic disturbances, immune dysregulation, and imbalances in the endogenous opioid system where peripheral kappa opioid receptors (KOR) may play a role.

Korsuva (difelikefalin) is a peripherally acting kappa opioid receptor agonist approved for adults undergoing hemodialysis with moderate-to-severe CKD-associated pruritus. Its efficacy was evaluated in two randomized, double-blind, placebo-controlled Phase 3 trials that enrolled a total of 851 adults on hemodialysis with baseline mean WI-NRS scores around 7/10. In both trials, intravenous Korsuva 0.5 mcg/kg administered at the end of each hemodialysis session three times weekly for 12 weeks produced significant reductions in itch intensity versus placebo.

At Week 12, a substantially greater proportion of Korsuva-treated patients achieved clinically meaningful itch improvement compared with placebo (e.g., ≥3-point and ≥4-point reductions on the WI-NRS), with the treatment effect evident as early as Week 1. Secondary measures of itch-related quality of life (including the 5-D itch scale and Skindex-10) also showed significant improvements with Korsuva versus placebo. The policy notes that Korsuva has not been studied in patients on peritoneal dialysis and is not recommended for that population.

Defined Terms

Key definitions

Moderate-to-severe pruritusAs used in trials and labeling, pruritus with elevated patient-reported WI-NRS scores (baseline trial means ~7/10); policy requires a diagnosis of moderate-to-severe pruritus associated with chronic kidney disease.

FDA-consistent dosingIntravenous 0.5 mcg/kg into the venous line of the hemodialysis circuit at the end of each hemodialysis session three times per week in adults (per U.S. FDA approved labeling).

Policy Update Changes

2025-07-01clarifiedLatest