Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Cara Therapeutics made the announcement today (May 18) for the treatment called Kapruvia (difelikefalin).
The decision follows authorisation from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in April 2022.
Fabio Dorigotti, head global medical affairs of CSL Vifor, said: “The recommendation of Kapruvia® by NICE is a key step on our journey to bring this breakthrough treatment to in-centre haemodialysis patients living with moderate-to-severe CKD-associated pruritus in the UK.
“We look forward to continue working with the National Health Service to ensure access to this important medicine for patients as quickly as possible.”
The National Kidney Foundation describes CKD-associated pruritus as very itchy skin that is most common in patients with advanced CKD and end-stage kidney disease (ESKD), but which can also happen in the early stages of CKD. It says that CKD-aP is also known as uremic pruritus because the build-up of toxins and wastes in damaged kidneys, known as uremia, has been associated with itching. The foundation reports that recent scientific evidence suggests that uremia is not the exclusive cause of itching in CKD. As a result, the more appropriate name for this condition is CKD-associated pruritus.
It says CKD-associated pruritus is often ignored by both patients and their healthcare team; patients may not get the relief they need. This can lead to loss of sleep, shorter or missed dialysis sessions, fatigue, depression, and infections, among other problems.
“We are pleased that Kapruvia will be available to CKD patients in England, Wales and Northern Ireland who are undergoing haemodialysis and suffering from moderate-to-severe CKD-associated pruritus,” said Christopher Posner, president, and chief executive officer of Cara Therapeutics.
“Together with VFMCRP, we are committed to bringing our first-of-its kind therapy to providers and patients around the world to help change the way pruritus is managed.”
MHRA approval and the NICE recommendation were supported by positive data from two pivotal phase-III trials – KALM-1, conducted in the U.S. (New England Journal of Medicine 2020; 382:222-232), and the global KALM-2, as well as supportive data from an additional 32 clinical studies.
"Chronic kidney disease-related itch is common for people on haemodialysis and represents a significant unmet need; leading to poor sleep and reduced quality of life for patients,” said Kieran McCafferty, consultant nephrologist, Barts Health NHS Trust. “We now have an option to help reduce the burden of CKD-related itch.”