CurrentAvMedPolicy N/A

Korsuva (Medical)

Prior authorization and step-edit request form and medical coverage criteria for Korsuva (difelikefalin) solution for IV infusion (J0879) when used for pruritus in hemodialysis patients; includes initial and reauthorization clinical criteria, dosing quantity limits, and required documentation.

Policy Summary

PayerAvMed

PolicyKorsuva (Medical)

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrescriber must complete and sign the prior authorization/step-edit request form and fax to 1-844-668-1550 with all supporting documentation (WI-NRS baseline, weight, trial history, lab/results, chart notes).

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes in this update.

1HCPCS code specified

6Authorization duration (months)

3Max HD sessions/week

baseline ≥4; ≥4-point improvementWI-NRS thresholds

0.5 mcg/kgDose per HD session

Coverage Summary

Scope: This policy covers medical benefit use of difelikefalin (Korsuva) Solution for IV infusion (HCPCS J0879) for treatment of moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP) in adult patients receiving hemodialysis when the stated clinical criteria are met. Required documentation includes baseline WI-NRS, current dry weight and date weight obtained, and verification of prior therapy trials. Medicare Part B outpatient drug coverage references and applicable NCDs/LCDs are noted in the form and must be followed. Additional indications may be considered at the health plan's discretion.

Policy-level thresholds and authorization duration

WI-NRS baseline severity>= 4 (moderate-to-severe)

WI-NRS improvement for reauthorization>= 4-point decrease from baseline

Dose per HD session0.5 mcg/kg per HD session

Weekly HD sessionsMaximum 3 sessions/week

Authorization durationInitial: 6 months; Reauthorization: 6 months

Initial Therapy Criteria (Initial Authorization — 6 months)

Initial Authorization (6 months)

Covered when ALL of the following are met:

ALL of the following

Member is 18 years of age or older with diagnosis of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) and is undergoing hemodialysis (HD)
Member's current dry weight is documented
Weight field required on form; date weight obtained must be provided
Baseline Worst Itching Intensity Numerical Rating Scale (WI-NRS) score documenting moderate- to-severe pruritus (score of at least 4) is submitted>= 4
At least TWO of the following therapies tried with insufficient response (verified by chart notes and/or pharmacy claims)

Continuation Therapy Criteria (Reauthorization — 6 months)

Reauthorization (6 months)

Covered when ALL of the following are met:

ALL of the following

Member continues to meet all initial authorization criteria
Member's current dry weight is documented
Member's WI-NRS score has decreased by at least 4 points from baseline (submit current scale with score)>= 4-point decrease
Member is NOT experiencing any significant adverse effects while using requested medication

Quantity Limits / Dosing

Operational dosing limit provided on form:

ALL of the following

Maximum of 0.5 mcg/kg per hemodialysis (HD) session0.5 mcg/kg per HD session
Maximum of 3 HD sessions per week<= 3 sessions/week

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Exclusions, Safety Monitoring, and Operational Notes

Exclusion Criteria

Exclusion criteria (member must NOT have any):

Severe hepatic impairment
Noncompliance with dialysis treatment
Scheduled to receive a kidney transplant
Requesting for use with peritoneal dialysis

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Safety monitoring: members must be assessed for central nervous system effects including dizziness, somnolence, mental status changes, and gait disturbances (including falls) while using difelikefalin. Members must be counseled and documented as advised to avoid potentially hazardous activities, such as driving and operating machinery, immediately after receiving the infusion.

Applicable Codes

Primary HCPCS codeHCPCSCovered

J0879

Injection, difelikefalin, 0.01 mg

Diagnosis coding (examples)ICD-10

No codes listed

Provider Actions & Requirements

Prior Authorization

Submit prior authorization request

Submit the prior authorization/step-edit request form signed by the prescriber and fax with all supporting documentation to 1-844-668-1550. Include baseline WI-NRS score, current weight and date weight obtained, verification of prior therapy trials, relevant labs/results, and chart notes.

Baseline WI-NRS score
Current dry weight and date weight obtained
Verification of trials and insufficient response to at least two prior therapies (claims/chart notes)
Relevant labs and results
Chart notes

Documentation Required

Document therapy trials

Definitions & Background

Background and intended use: This form and clinical criteria establish prior authorization for the medical benefit administration of IV difelikefalin (Korsuva, J0879) for moderate-to-severe CKD-associated pruritus in adult hemodialysis patients. The form notes Medicare Part B coverage guidance (Medicare Benefit Policy Manual, Pub. 100-2, Chapter 15, §50) and that National and Local Coverage Determinations may apply; additional indications may be covered at the plan’s discretion. Definition: WI-NRS = Worst Itching Intensity Numerical Rating Scale, used to document baseline severity and response for authorization and reauthorization.

Defined terms

WI-NRSWorst Itching Intensity Numerical Rating Scale

Revision History

Policy Summary

PayerAvMed

PolicyKorsuva (Medical)

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

SourceLink

On This Page

antihistamines
glucocorticoids
skin emollients
topical anesthetic agents
opioids
ultraviolet B phototherapy
gabapentin
pregabalin
topical calcineurin inhibitors

Other underlying causes of pruritus have been considered and addressed (e.g., sub-optimal dialysis Kt/V targets, hyperparathyroidism, hyperphosphatemia, and hypermagnesemia)

Exclusion criteria (member must NOT have any):

Severe hepatic impairment
Noncompliance with dialysis treatment
Scheduled to receive a kidney transplant
Requesting for use with peritoneal dialysis

Member will be assessed for CNS effects of dizziness, somnolence, mental status changes, and gait disturbances, including falls, while using requested medication

Member will NOT perform potentially hazardous activities, such as driving and operating machinery, immediately after receiving requested medication

Billing Rule

Quantity limits affect billing (J0879)

Dosing and session limits must be reflected on claims. Do not bill for doses exceeding 0.5 mcg/kg per hemodialysis (HD) session or for more than 3 HD sessions per week. Billing should reflect weight-based dosing and the per-session/session-per-week limits for J0879.

Documentation Required

Monitor and document adverse effects and functional restrictions

Document assessment and monitoring for CNS-related adverse effects (dizziness, somnolence, mental status changes, gait disturbances/falls) and document counseling given to the patient to avoid hazardous activities (e.g., driving, operating machinery) immediately after infusion.

Provide verification of trials and insufficient response to at least two of the listed therapies. Verification must be via pharmacy paid claims and/or submitted chart notes and included with the request.

At least two therapies tried with insufficient response (e.g., antihistamines, gabapentin, pregabalin, topical agents, UVB, etc.)
Verification via pharmacy paid claims and/or chart notes

Prior Authorization

Authorization duration

Initial and reauthorization approvals are for 6 months. For reauthorization, submit documentation showing a decrease in WI-NRS of at least 4 points from baseline and that the member is not experiencing significant adverse effects.

Initial authorization: 6 months
Reauthorization: 6 months
Reauthorization requires ≥4-point WI-NRS improvement from baseline and absence of significant adverse effects

Billing Rule

Quantity limits enforcement

Dosing must not exceed 0.5 mcg/kg per HD session and a maximum of 3 HD sessions per week. Claims/billing should reflect weight-based dosing and the session limits for J0879.