CurrentColorado Rocky Mountain Health PlansPolicy IEXD0115.06

Difelikefalin (Korsuva) for CKD-associated pruritus — Coverage Criteria

Medical benefit drug policy governing coverage criteria for difelikefalin (Korsuva) to treat moderate-to-severe pruritus associated with chronic kidney disease in adults receiving hemodialysis; applies to Individual Exchange plans except where excluded.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyDifelikefalin (Korsuva) for CKD-associated pruritus — Coverage Criteria

Policy CodePolicy IEXD0115.06

Change TypeBackground and references updated (administrative)

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization with documentation of hemodialysis status, baseline itch severity, prior treatment failure/contraindication, and nephrology prescribing or consultation.

SourceLink

POLICY UPDATE CHANGES

Updated Background and References sections to reflect the most current information and archived previous policy version IEXD00115.05.

0.5 mcg/kgDosing per admin

3x/week × 12wFrequency/duration

49.1% vs 27.9%WI-NRS ≥3 response

60%+CKD-aP prevalence (HD pts)

Coverage Criteria

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyDifelikefalin (Korsuva) for CKD-associated pruritus — Coverage Criteria

Policy CodePolicy IEXD0115.06

Change TypeBackground and references updated (administrative)

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization with documentation of hemodialysis status, baseline itch severity, prior treatment failure/contraindication, and nephrology prescribing or consultation.

SourceLink

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Coverage criteria

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

Initial therapy criteria: 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 approved labeling; initial authorization will be for no longer than 12 months.

Represents policy-specified initial authorization criteria.

Continuation (re-authorization) criteria: 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.

Represents policy-specified continuation criteria.

Korsuva (difelikefalin) has a Limitation of Use: it has not been studied in patients on peritoneal dialysis and is not recommended for use in that population.

Use of Korsuva is supported only when all policy criteria are met. The policy specifies that treatment is not supported when pruritus is attributable to causes other than end‑stage renal disease (for example, primary pruritic dermatologic disease or cholestatic liver disease), when pruritus occurs only during the dialysis session, when pruritus is localized only to the palms, when required prior therapies have not been tried or have not failed/are intolerable, or when the medication is not prescribed by or in consultation with a nephrologist. Denial is likely if these criteria are not satisfied.

Coding and Trial Measures

Applicable HCPCS CodesHCPCS

J0879

Injection, difelikefalin, 0.1 microgram

WI‑NRS improvement used in trials

Reported trial improvementProportion achieving ≥3-point WI‑NRS improvement at Week 12 reported (Korsuva vs placebo): 49.1% vs 27.9%

Primary efficacy endpoint in trialsProportion of subjects achieving ≥4‑point improvement from baseline in the weekly mean of daily 24‑hour WI‑NRS at Week 12

Dosing used in trials0.5 mcg/kg IV bolus at end of each hemodialysis session, 3 times per week for 12 weeks

Baseline WI‑NRS in trialsMean baseline WI‑NRS ~7.1–7.2 (SD ~1.4–1.5)

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization and Coding

Prior authorization is required for Korsuva (difelikefalin). Initial authorizations are limited to no longer than 12 months. Use HCPCS code J0879 for billing (Injection, difelikefalin, 0.1 microgram).

Prior authorization required
Initial authorization ≤ 12 months
Billing code: HCPCS J0879

Denial Risk

Denial Risk / Provider Actions

Denial is likely if the member is not undergoing hemodialysis or if pruritus is attributed to causes other than end-stage renal disease (ESRD) or its complications. Also watch for denials when pruritus occurs only during dialysis, is localized only to the palms, or when required prior treatments and documentation are not provided.

Member must be on hemodialysis — denial likely if not on hemodialysis
Pruritus must be due to chronic kidney disease/ESRD — denial likely for non-ESRD causes (e.g., dermatologic disease, cholestatic liver disease)
Denial likely if pruritus occurs only during dialysis or is localized only to the palms
History of failure, contraindication, or intolerance to other pruritus treatments must be documented

Documentation Required

Required Clinical Documentation

Required clinical documentation includes the diagnosis of moderate-to-severe pruritus associated with chronic kidney disease, confirmation that the patient is on hemodialysis, exclusion of other causes of pruritus, documentation that pruritus is not limited to dialysis sessions or localized only to the palms, evidence of prior treatment failure/contraindication/intolerance, prescribing by or in consultation with a nephrologist, dosing consistent with FDA labeling, and documentation of clinical response for continuation requests.

Diagnosis: moderate-to-severe pruritus associated with chronic kidney disease
Evidence the patient is on hemodialysis
Assessment excluding other causes of pruritus (e.g., dermatologic causes, cholestatic liver disease)
Documentation that pruritus is not limited to dialysis sessions and not localized only to the palms
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 per FDA-approved labeling
For continuation: documentation of positive clinical response (reduction in itch from baseline)

Definitions

CKD‑associated pruritus (CKD‑aP)

DefinitionIntense, generalized systemic itching in patients with chronic kidney disease undergoing hemodialysis (CKD‑associated pruritus, CKD‑aP)

Severity measurementPatient‑reported Worst Itching Intensity Numerical Rating Scale (WI‑NRS), 0 (no itch) to 10 (worst itch); moderate‑to‑severe defined by trial inclusion and baseline WI‑NRS mean ~7.1–7.2

Clinical impactAssociated with poor sleep, depression, reduced quality of life, increased infection risk, and increased risk of death

Limitation of Use

Limitation of useKorsuva has not been studied in patients on peritoneal dialysis and is not recommended for use in this population

Indication contextIndicated for moderate‑to‑severe pruritus associated with CKD in adults undergoing hemodialysis only

Regulatory sourceStatement consistent with FDA Limitation of Use language