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Korsuva (difelikefalin) — Medical Benefit Drug Coverage Criteria (Ohio)
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Medical benefit drug coverage criteria for Korsuva (difelikefalin) for adults with moderate-to-severe CKD-associated pruritus receiving hemodialysis in Ohio.
Applicable ICD-10 diagnosis codes L29.89 and L29.9 were added to the policy.
Supporting information: previous policy version CSOH2025D00115.C was archived.
Coverage Criteria for Korsuva (difelikefalin)
Initial Therapy — Covered when ALL of the following are met:
Covered when ALL of the following are met:
Continuation of Therapy — Covered when ALL of the following are met:
Covered when ALL of the following are met:
Korsuva (difelikefalin) has not been studied in patients receiving peritoneal dialysis and is not recommended for use in this population. Requests for treatment of individuals on peritoneal dialysis may be denied because the safety and effectiveness of Korsuva in that setting have not been established.
Coverage is limited to pruritus that is attributable to end-stage renal disease (CKD-associated pruritus). Use of Korsuva for itching caused by other dermatologic or systemic conditions, or when pruritus occurs only during dialysis sessions or is limited to the palms, is not supported by the coverage criteria and would not meet medical necessity. Approval also requires documented failure, intolerance, or contraindication to other pruritus treatments and that the request be consistent with the policy’s prescribing and documentation requirements.
Coding and Clinical Thresholds
| J0879 | Injection, difelikefalin, 0.1 microgram |
| L29.89 | Other pruritus |
| L29.9 | Pruritus, unspecified |
Provider Actions, Prior Authorization, and Documentation
Prior authorization required (HCPCS J0879)
Prior authorization is required for Korsuva (difelikefalin). The request must include documentation that meets either the Initial Therapy or Continuation of Therapy criteria; bill using HCPCS code J0879 (Injection, difelikefalin, 0.1 microgram).
- Initial authorization up to 12 months; reauthorization up to 12 months.
Step therapy — prior failure/intolerance required
Policy requires a documented history of failure, contraindication, or intolerance to other pruritus treatments (examples provided in policy) before approval of Korsuva.
- Examples listed: antihistamines, corticosteroids, gabapentin, pregabalin, capsaicin.
Required clinical documentation to support PA
Include clinical documentation to support the request: diagnosis of moderate-to-severe CKD-associated pruritus, confirmation the patient is on hemodialysis, evidence pruritus is not due to another cause, and documentation of prior treatment failure/contraindication/intolerance.
- Evidence of nephrology involvement (prescribed by or in consultation with a nephrologist).
- Dosing must be consistent with FDA-approved labeling.
Reauthorization — document positive clinical response
For continuation/reauthorization, provide documentation of a positive clinical response, defined as reduction in itch from baseline; reauthorization requests must also show nephrology involvement and FDA-consistent dosing.
- Reauthorization will be for no longer than 12 months.
- Documentation of improvement must be included with the request.
Denial risk for criteria nonconformance
Requests that do not meet the coverage criteria risk denial. Examples include patients not on hemodialysis, pruritus attributed to non‑ESRD causes, pruritus limited only to dialysis sessions or only to the palms, lack of prior failure/intolerance/contraindication to other therapies, or therapy not prescribed by/with nephrology involvement or dosed per FDA labeling.
- Nonconformance with any Initial or Continuation criterion may result in denial.
Peritoneal dialysis — not recommended; possible denial
Korsuva has not been studied in patients on peritoneal dialysis and is not recommended for use in this population; requests for patients on peritoneal dialysis may be denied.
- Peritoneal dialysis use is a stated limitation of use in the policy.
Background and Clinical Context
Chronic kidney disease–associated pruritus (CKD-aP), often called uremic pruritus, is common among people receiving hemodialysis; approximately 20–40% of patients report moderate-to-severe symptoms. CKD-aP negatively affects sleep and mood, reduces quality of life, and has been linked with higher infection risk and increased mortality. The pathogenesis is not fully understood but likely involves metabolic and immune disturbances and imbalance of the opioid system, with peripheral kappa opioid receptors implicated—providing the rationale for using a kappa opioid receptor agonist such as difelikefalin (Korsuva) in hemodialysis patients. Korsuva is indicated for adults with moderate-to-severe CKD-associated pruritus who are undergoing hemodialysis; however, it has not been studied in patients on peritoneal dialysis and is not recommended for that population.
Definitions and Limitations of Use
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