CurrentUnitedHealthcarePolicy CSOH2025D00115.C

Korsuva (difelikefalin) — Medical Benefit Drug Policy (Ohio)

This UnitedHealthcare Medical Benefit Drug Policy governs coverage criteria for Korsuva (difelikefalin) for treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis in Ohio; it directs prior authorization and clinical requirements for providers and reviewers.

Policy Summary

PayerUnitedHealthcare

PolicyKorsuva (difelikefalin) — Medical Benefit Drug Policy (Ohio)

Policy CodePolicy CSOH2025D00115.C

Change TypeNon-material revision

Effective DateAug 1, 2025

Next Review Date

Key ActionObtain prior authorization and document hemodialysis status, diagnosis of moderate-to-severe CKD-associated pruritus, prior treatment history, and nephrologist involvement.

SourceLink

POLICY UPDATE CHANGES

Updated Background and References sections to reflect the most current information; archived previous policy version CSOH2024D00115.B.

>=60%Hemodialysis patients affected

20-40%Moderate-to-severe cases

851Trial subjects

49.1% vs 27.9%≥3-point WI-NRS response

0.5 mcg/kgTrial dosing

Policy Summary

PayerUnitedHealthcare

PolicyKorsuva (difelikefalin) — Medical Benefit Drug Policy (Ohio)

Policy CodePolicy CSOH2025D00115.C

Change TypeNon-material revision

Effective DateAug 1, 2025

Next Review Date

Key ActionObtain prior authorization and document hemodialysis status, diagnosis of moderate-to-severe CKD-associated pruritus, prior treatment history, and nephrologist involvement.

SourceLink

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Coverage Criteria for Korsuva (difelikefalin)

Initial Therapy

Covered when ALL of the following are met for initial therapy:

Initial therapy: Diagnosis of moderate-to-severe pruritus associated with chronic kidney disease

Hemodialysis status: Patient is on hemodialysis

Attribution: Pruritus is not attributed to a cause other than end stage renal disease or its complications (e.g., pruritic dermatologic disease, cholestatic liver disease)

Timing: Pruritus is not limited to occurring only during the dialysis session

Localization: Pruritus is not localized to just the palms of the hands

Prior treatments: History of failure, contraindication, or intolerance to other pruritus treatments (examples: antihistamines, corticosteroids, gabapentin, pregabalin, capsaicin)

Prescriber: Prescribed by or in consultation with a nephrologist

Dosing is in accordance with the United States Food and Drug Administration (FDA)-approved labeling

Authorization duration: Initial authorization will be for no longer than 12 months

Continuation Therapy

Covered when ALL of the following are met for continuation of therapy:

Clinical response: Documentation of a positive clinical response (i.e., reduction in itch from baseline)

Prescriber: Prescribed by or in consultation with a nephrologist

Dosing is in accordance with the United States Food and Drug Administration approved labeling

Reauthorization duration: Reauthorization will be for no longer than 12 months

Not recommended for peritoneal dialysis: Korsuva® (difelikefalin) has not been studied in patients receiving peritoneal dialysis and is not recommended for use in this population.

Coverage exclusion — not medically necessary: Use of Korsuva in patients who do not meet all specified initial or continuation criteria is considered not supported by this policy. This includes, but is not limited to, patients who are not on hemodialysis, patients whose pruritus is attributed to causes other than end-stage renal disease (for example pruritic dermatologic disease or cholestatic liver disease), patients whose pruritus is limited to occurring only during the dialysis session or localized only to the palms, patients without documented failure/contraindication/intolerance to other pruritus treatments, or prescriptions not by or in consultation with a nephrologist. Additionally, Korsuva is not recommended for patients on peritoneal dialysis.

Coding and Outcome Thresholds

Referenced codes (not listed)mixed

No codes listed

WI-NRS improvement threshold

Primary trial endpoint (prespecified)4-point or greater improvement in weekly mean WI-NRS at Week 12

Reported clinically meaningful comparison presented in trials>= 3-point improvement in WI-NRS (used for reported responder analyses)

Observed responder rates (Korsuva vs placebo)49.1% vs. 27.9% achieving >=3-point WI-NRS improvement at Week 12

Trial population and dosing contextTwo randomized trials (n=851) evaluating 0.5 mcg/kg IV thrice-weekly at end of hemodialysis for 12 weeks; WI-NRS measured daily and summarized as weekly mean

Prescriber and Reviewer Actions

Prior Authorization

Prior Authorization and Duration Limits

Prior authorization is required for Korsuva (difelikefalin). Initial authorization is limited to a maximum duration of 12 months. Reauthorization (continuation) approvals are also issued for no longer than 12 months at a time.

Prior authorization required before dispensing
Initial authorization: up to 12 months
Reauthorization/continuation: up to 12 months

Step Therapy

Step Therapy Requirement

Step therapy must be met prior to approval: documentation that the member has a history of failure, contraindication, or intolerance to other reasonable antipruritic therapies is required.

Required history of failure, contraindication, or intolerance to other pruritus treatments (e.g., antihistamines, corticosteroids, gabapentin, pregabalin, capsaicin)

Background

Chronic kidney disease–associated pruritus (CKD-aP) is a common and clinically important complication among patients with advanced kidney disease. This policy addresses treatment of moderate-to-severe pruritus in adults undergoing hemodialysis and specifies that Korsuva is indicated for CKD-aP in that population as a kappa opioid receptor agonist. The policy requires documentation that pruritus is not attributable to other causes, that symptoms are not limited to dialysis sessions or localized only to the palms, and that prior therapies have failed or are contraindicated before initiating Korsuva. The FDA has not studied Korsuva in peritoneal dialysis patients and the drug is not recommended for that group.

Definitions

CKD-associated pruritus (CKD-aP) in hemodialysis patients

DefinitionModerate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis — clinically significant systemic itching not attributable to other causes and not limited to dialysis session or only the palms.

Prevalence among hemodialysis patients>= 60% of patients experience CKD-associated pruritus; 20–40% report moderate-to-severe symptoms.

Clinical significanceIntense generalized itching is associated with poor sleep, depression, reduced quality of life, increased infection risk, and higher mortality.

Therapeutic contextKorsuva (difelikefalin), a kappa opioid receptor agonist, is indicated for CKD-aP in adults on hemodialysis; not studied or recommended for peritoneal dialysis.