CSL Vifor

As a result the treatment, Difelikefalin, is now providing much-needed relief for people across the UK who are living with the condition as well as informing health policy globally. 

The problem

Severe itching is a common side effect of kidney failure and one which, until recently, was without a clinically proven treatment. CSL Vifor developed the new treatment to provide relief for a condition which causes severe itching in thousands of people in the UK alone. However, while the treatment was proven to be effective in treating itching in clinical trials, its cost effectiveness and the wider health benefits resulting from reduced itching were unknown.

The company commissioned the University’s School of Medicine and Population Health, in partnership with Sheffield Teaching Hospitals, to drive the treatment forward and help reach those who need it.

Helping the company achieve its goal

James Fotheringham, Consultant Nephrologist and Honorary Professor of Nephrology at the University of Sheffield, said: "The University of Sheffield has a longstanding and collaborative relationship with CSL Vifor, and it was a privilege to work with them on this important project. 

"Our shared objective—ensuring timely access to effective treatments for individuals affected by this unpleasant condition—resulted in academically rigorous and impactful research for the University and contributed to a successful reimbursement outcome for this innovative therapy on behalf of CSL Vifor.

"In my role as a consultant at Sheffield Teaching Hospitals, I witnessed the significant impact this condition has on people with kidney failure. Serving as Principal Investigator for this research was therefore both professionally rewarding and personally meaningful".

The project team had three main objectives:

1. To systematically review existing literature on the link between worsening itching and decreased quality of life.
2. To collect and analyse new data to accurately quantify this relationship, supporting global use of Difelikefalin.
3. To collaborate with stakeholders - including clinicians, health economists, industry representatives and patients - to understand how to accurately assess the value of treating itching.

Sheffield Teaching Hospitals led data collection from 600 people with kidney failure across five hospitals. The data showed that people living with severe itching have a similar quality of life to people with severe heart failure.

By incorporating the new data with findings from existing clinical trials, the project team and CSL Vifor deepened their shared understanding of the disease, the impact of long-term itching on patients and the estimated costs to the NHS.

Global impact

The University team’s portfolio of research formed part of a submission to the National Institute of Health and Care Excellence (NICE), who approved Difelikefalin for use in people with kidney failure and associated itching. The decision-making body specifically referenced the University’s work as high quality evidence to support the decision.

While the collaboration directly led to the treatment being approved for use in the UK, its impact and reach is global. The project’s outputs have also supported evidence generation in other countries, and the treatment is now helping to improve people’s quality of life internationally. 

A CSL Vifor Global HEOR representative said: “Open dialogue, solid scientific attitude and easiness in finding reliable solutions, made our collaboration strong and successful”.

A mutually beneficial collaboration 

Through the collaboration, CSL Vifor was able to achieve its primary goal of successfully demonstrating the cost effectiveness of Difelikefalin and submitting a portfolio of high quality evidence to NICE. The partnership delivered impact in several other ways:

• New guidance on symptom assessment was produced, benefiting the wider kidney kidney community, who need support in designing clinical trials to help people with kidney failure.
• A kidney doctor was trained to continue research in the broader area of symptom identification and management in people with kidney failure.
• The University's clinical experts have spoken about their research to clinicians nationally, advocating identification of itching and its treatment.
• The research has both provided symptom relief interventions for chronic diseases and raised awareness, benefiting people with conditions beyond kidney failure.
• Early career researchers at the University were able to gain valuable research experience and publish first-author papers.

Overall the research has had a significant impact on patient care, health outcomes and the careers of researchers while serving as an excellent example of how academic institutions and industry can effectively collaborate to address health challenges.