Pharmacy Prior Authorization Criteria

Korsuva (difelikefalin)

Indications for Prior Authorization

Korsuva (difelikefalin) injection

• For diagnosis of Chronic kidney disease (CKD)
  Indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD). Limitations of use: Korsuva has not been studied in patients on peritoneal dialysis and is not recommended for use in this population.

Criteria

Korsuva

Prior Authorization (Initial Authorization)

Length of Approval: 3 Month(s)

• Diagnosis of chronic kidney disease (CKD)
AND
• Patient is currently undergoing hemodialysis (HD) at an optimal dialysis dose (e.g., Kt/V greater than or equal to 1.2) [A, B, 4]
AND
• Patient is experiencing moderate to severe pruritus associated with CKD (CKD-aP)
AND
• Exclusion of other causes of pruritus (e. g., eczema, infections, drug-induced skin dryness) [C, 3]
AND
• Trial and failure, contraindication, or intolerance to ONE topical anti-pruritic treatment: [2,3]
• emollient cream
• analgesics (e.g., pramoxine lotion, capsaicin)
• corticosteroids (e.g., hydrocortisone, triamcinolone)
AND
• Trial and failure, contraindication, or intolerance to ONE oral treatment: [2,3]
• antihistamine (e.g., diphenhydramine, hydroxyzine, loratadine)
• gabapentin
• pregabalin
AND
• Prescribed by or in consultation with one of the following:
• Nephrologist
• Dermatologist

Korsuva

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient is currently undergoing hemodialysis [A]
AND
• Patient demonstrates positive clinical response to therapy (e.g., improved quality of life, improved worst itching intensity numerical rating score from baseline)

P & T Revisions

2024-05-01, 2023-11-02, 2023-05-03, 2022-05-23

References

1. Korsuva Prescribing Information. Cara Therapeutics, Inc. Stamford, CT. August 2021.
2. Davison SN, Levin A, Moss AH, et al. Executive summary of the KDIGO Controversies Conference on Supportive Care in Chronic Kidney Disease: developing a roadmap to improving quality care. Kidney International. 2015;88(3):447-459.
3. Ragazzo J, Cesta A, Jassal SV, Chiang N, Battistella M. Development and Validation of a Uremic Pruritus Treatment Algorithm and Patient Information Toolkit in Patients With Chronic Kidney Disease and End Stage Kidney Disease. Journal of Pain and Symptom Management. 2020;59(2):279-292.e5.
4. Hemodialysis: Dose & Adequacy | NIDDK. National Institute of Diabetes and Digestive and Kidney Diseases. Accessed April 4, 2022.

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End Notes

1. Korsuva is administered by intravenous bolus injection into the venous line of the dialysis circuit at the end of each HD treatment. [1]
2. On average, a Kt/V of 1.2 is roughly equivalent to a URR of about 63 percent. Thus, another standard of adequate dialysis is a minimum Kt/V of 1.2. The Kidney Disease Outcomes Quality Initiative (KDOQI) group has adopted the Kt/V of 1.2 as the standard for dialysis adequacy. [4]
3. Pruritus associated with Chronic Kidney Disease (CKD-aP), previously known as uremic pruritus, may vary from a localized itch, commonly in the back, face, and arms, to a generalized itch involving the entire body. Primary skin lesions may present with similar symptoms, and any suspicion of an underlying primary lesion should be first evaluated by dermatology. [3]

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Revision History

• 2024-05-01: 2024 Annual Review - no changes
• 2023-11-02: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-05-03: 2023 Annual Review - no changes
• 2022-05-23: New Program

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