CurrentCommunity-CarePolicy N/A

Difelikefalin (for CKD-associated pruritus) — Coverage Criteria

Customize your policy alerts

Sign up for all Community-Care policy alerts

Know when Community-Care releases new policies or updates existing guidance.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Medical benefit policy governing coverage criteria for difelikefalin to treat moderate-to-severe pruritus in patients with end-stage kidney disease on hemodialysis; affects prescribers, dialysis providers, and payers.

Policy Summary

PayerCommunity-Care

PolicyDifelikefalin (for CKD-associated pruritus) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Last ReviewSep 1, 2022

Next Review DateN/A

Key ActionObtain prior authorization with documentation showing hemodialysis, diagnosis of ESKD with moderate-to-severe pruritus, required step-therapy trials, and patient weight.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3 moinitial authorization

1 yrcontinuation authorization

6 mcg/kg/28dquantity limit

OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

CurrentCommunity-CarePolicy N/A

Difelikefalin (for CKD-associated pruritus) — Coverage Criteria

Customize your policy alerts

Sign up for all Community-Care policy alerts

Know when Community-Care releases new policies or updates existing guidance.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Policy Summary

PayerCommunity-Care

PolicyDifelikefalin (for CKD-associated pruritus) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Last ReviewSep 1, 2022

Next Review DateN/A

Key ActionObtain prior authorization with documentation showing hemodialysis, diagnosis of ESKD with moderate-to-severe pruritus, required step-therapy trials, and patient weight.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3 moinitial authorization

1 yrcontinuation authorization

6 mcg/kg/28dquantity limit

Coverage Criteria for Difelikefalin

Initial Therapy

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

Initial Approval - CKD-associated pruritus on HD: 1) Prescribed by, or in consultation with, a nephrologist; 2) Diagnosis of end-stage kidney disease (ESKD); 3) Currently receiving hemodialysis; 4) Documentation that moderate-to-severe pruritus is affecting quality of life (e.g., sleep disruption, fatigue, mood); 5) A trial of all of the following was ineffective, contraindicated, or not tolerated: (a) GABA analog (gabapentin or pregabalin) AND (b) oral antihistamine.

Continuation Therapy

Continued coverage allowed when ALL of the following are met:

Continuation Therapy: 1) Diagnosis of severe pruritus associated with end-stage kidney disease (ESKD); 2) Currently receiving hemodialysis; 3) Documentation (written explanation accepted) of improvement in pruritus intensity or quality of life (e.g., sleep, mood).

Patients with end-stage kidney disease who are receiving peritoneal dialysis are excluded from coverage. The clinical trial population and prescribing information support use of difelikefalin in patients receiving hemodialysis only, and requests for patients on peritoneal dialysis are not allowed under this policy.

Coding and Quantity Limits

Applicable HCPCS CodesHCPCSCovered

J0879

Injection, difelikefalin, 0.1 microgram, (for ESRD on Dialysis)

Quantity limit

Quantity limitUp to 6 mcg/kg per 28 days (patient weight required for dosing)

Authorization noteApplies when difelikefalin is approved for moderate-to-severe CKD-associated pruritus

Measurement basisDose calculated by patient weight (mcg/kg)

Provider Requirements and Prior Authorization

Prior Authorization

Prior authorization required; prescriber must be or consult with a nephrologist

Prior authorization is required for both initial and continuation requests; the prescriber must be the treating nephrologist or the request must document consultation with a nephrologist. Include all required supporting documentation with the authorization request.

Step Therapy

Required step therapy trials before initial approval

For initial approval, documentation must demonstrate a trial and lack of efficacy, contraindication, or intolerance to both a GABA analog (gabapentin or pregabalin) AND an oral antihistamine before difelikefalin will be authorized.

Trial of a GABA analog (gabapentin or pregabalin) — ineffective, contraindicated, or not tolerated
Trial of an oral antihistamine — ineffective, contraindicated, or not tolerated

Key Definitions

Moderate-to-severe pruritus associated with chronic kidney disease

DefinitionPruritus in patients with end-stage kidney disease causing significant impact on quality of life.

Examples of impactSleep disruption

Examples of impactFatigue

Examples of impactMood disturbance or reduced quality of life

Eligible dialysis modality

Required modalityPatient must be currently receiving in-center hemodialysis (HD)

Excluded modalityPeritoneal dialysis patients are excluded from coverage

Background

Chronic kidney disease–associated pruritus can substantially impair quality of life for patients with end-stage kidney disease on hemodialysis, causing problems such as sleep disruption, fatigue, and mood disturbances. Difelikefalin is indicated for moderate-to-severe pruritus associated with ESKD in patients receiving hemodialysis and was studied in that population; the policy therefore limits eligibility to patients currently receiving hemodialysis and requires documentation that pruritus is affecting quality of life.

Documentation Required

Documentation required with prior authorization

Required documentation with the request must include diagnosis of end-stage kidney disease, confirmation that the patient is currently receiving hemodialysis, documentation that moderate-to-severe pruritus is affecting quality of life, prior trial history of the required therapies, and the patient’s weight for dosing.

Diagnosis of end-stage kidney disease (ESKD)
Current receipt of hemodialysis
Documentation that moderate-to-severe pruritus affects quality of life (e.g., sleep disruption, fatigue, mood) — written explanation accepted for continuation
Prior trial history showing trials of the required agents
Patient weight (required for dosing/quantity limit)