TkKurikawa
U.K.'s National Institute for Clinical Excellence (NICE) in its guidance recommended Cara Therapeutics (NASDAQ:CARA) and Vifor Fresenius Medical Care Renal Pharma's Kapruvia for use in the National Health Service (NHS).
The drug pricing watchdog recommended Kapruvia (difelikefalin) to treat moderate to severe pruritus (itch) in adults with chronic kidney disease (CKD) having in-center hemodialysis.
NICE said the cost-effectiveness estimates for difelikefalin were within the range which it usually considers an acceptable use of NHS resources, so, it was recommended.
NICE noted that the list price of 50-microgram 1-ml vials of difelikefalin is £420 for 12 vials (excluding VAT; BNF online accessed February). The company is making Kapruvia available to the NHS with a discount, the amount of which is confidential.
The agency added that usual treatment for pruritis (itching) in people with CKD having hemodialysis includes creams and emollients, antihistamines and gabapentin. Difelikefalin would be provided if usual therapies do not work well enough.
NICE, however, noted that data from trials showed that difelikefalin reduced itching compared with usual treatment, despite some uncertainty about how long it works for and if it improves people's quality of life.
Kapruvia was approved by U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) in April 2022.
The companies said the MHRA approval and the NICE recommendation were backed by data from phase 3 trials — KALM-1 conducted in the U.S., and the global study KALM-2 — and supportive data from an additional 32 clinical studies.
Vifor Fresenius is a joint company of CSL (OTCQX:CSLLY) (OTCQX:CMXHF) and Fresenius Medical Care (FMS). CSL had acquired Vifor Pharma in a ~$11.7B deal.
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