Korsuva™

Drug - Korsuva™ (difelikefalin) [Vifor Pharma Inc.]

October 2022

Therapeutic area - Pruritus associated with chronic kidney disease (CKD-aP)

Initial approval criteria

Patient is at least 18 years AND
Documented baseline score from an objective clinical evaluation tool, such as Worst Itching Intensity Numerical Rating Scale (WI-NRS), etc. AND

Universal Criteria

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

Pruritis Secondary to Chronic Kidney Disease (CKD-aP)

Patient has moderate to severe pruritis; AND
Patient is undergoing hemodialysis (Note: Coverage is excluded in patients on peritoneal dialysis)

Initial approval is for 6 months

Renewal criteria

Patient continues to meet the universal and other indication-specific relevant criteria identified in the initial approval criteria AND
Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: Severe dizziness, somnolence, mental status changes, and gait disturbances, etc. AND
Treatment has resulted in clinical improvement signs and symptoms of pruritis as documented by improvement from baseline using objective clinical evaluation tools such as Worst Itching Intensity Numerical Rating Scale (WI-NRS), etc.
Renewal approval is for 6 months

Quantity limits

0.5 mcg/kg at the end of each hemodialysis treatment
Patient’s dry body-weight (in kg) must be submitted at time of request

Billing for Korsuva

Korsuva must be billed as a medical claim.

Background

Korsuva is a kappa opioid receptor agonist indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD). Korsuva has not been studied in patients on peritoneal dialysis and is not recommended for use in this population.

Questions?

MHCP Provider Resource Center 651-431-2700 or 800-366-5411