KORSUVA (difelikefalin)

KORSUVA (difelikefalin)

Medical Administration – Intravenous

Diagnosis considered for coverage: 

•    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.

Coverage Criteria:

For diagnosis of pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD):

• Dose does not exceed 0.5 mcg/kg IV bolus into the venous line of the dialysis circuit at the end of each HD treatment, AND
• Patient is 18 years of age or older, AND
• Prescribed by or in consultation with a nephrologist or dermatologist, AND
• 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), 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), AND
• Trial and failure, contraindication, or intolerance to ONE topical anti-pruritic treatment:
  • emollient cream
  • analgesics (e.g., pramoxine lotion, capsaicin),
  • corticosteroids (e.g., hydrocortisone, triamcinolone), AND
• Trial and failure, contraindication, or intolerance to ONE oral treatment:
  • antihistamine (e.g., diphenhydramine, hydroxyzine, loratadine)
  • gabapentin
  • pregabalin

Reauthorization Criteria:

For diagnosis of pruitus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD):

• Dose does not exceed 0.5 mcg/kg IV bolus into the venous line of the dialysis circuit at the end of each HD treatment, AND
• Patient is currently undergoing hemodialysis, AND
• Documentation of positive clinical response to therapy (e.g., improved quality of life, improved worst itching intensity numerical rating score from baseline)

Coverage Duration: 

• Initial: 3 months
• Reauthorization: 12 months

Authorization is not covered for the following:
The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• Korsuva is removed by the dialyzer membrane and must be administered after blood is no longer circulating through the dialyzer.

Policy Updates:

• 08/16/2022 – New policy approved by P&T.

References:

• Korsuva Prescribing Information. Cara Therapeutics, Inc. Stamford, CT. August 2021. 
• 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. 
• 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. 
• Hemodialysis: Dose & Adequacy | NIDDK. National Institute of Diabetes and Digestive and Kidney Diseases. Accessed April 4, 2022