Updated 09/10/2023

NICE & the SMC have made a recommendation to the NHS that a new treatment, voclosporin, can be used in combination with mycophenolate mofetil (MMF) to treat some patients with lupus nephritis.

 

“I am absolutely delighted to hear approval has been granted for Voclosporin. Having suffered from lupus nephritis since I was 12 years old, and having experienced several occasions where available treatments did not work, it is great news to know there is now another option, designed specifically for Lupus Nephritis that should help so many patients with their suffering.”

Sian (a person living with lupus)

 

“Fewer then one half of patients with lupus affecting their kidneys (lupus nephritis) achieve satisfactory control of their disease within one year and most suffer side-effects from the treatments they receive, especially steroids. Voclosporin is the first oral drug approved by regulatory authorities for the treatment of lupus nephritis and has been shown in clinical trials to both improve the chances of achieving remission and allow much less steroid to be used. The agreement by NICE to approve use of voclosporin in England is welcome and will allow lupus nephritis patients to benefit from this new treatment.”

Prof David Jayne (Director of the Vasculitis and Lupus Service, Addenbrooke’s Hospital, responding to the NICE approval in May 2023)

 

What is lupus nephritis?

Lupus is an auto-immune disease, which means that the immune system is dysfunctional and attacks the body’s own tissues. Sometimes the immune system attacks the kidneys and causes inflammation or damage, and this is called ‘lupus nephritis’. About one in three people with lupus have kidney involvement, with younger patients and people from Black or Asian ethnic backgrounds more likely to develop kidney disease.

In most cases, treatments are effective and kidney function is preserved. However, for some patients, the kidneys are damaged and less able to work properly. Some patients also have a successful treatment of their lupus nephritis, but then experience a ‘flare’ or ‘relapse’ and need further treatment.

You can find more information about lupus nephritis in our booklet HERE.

What is voclosporin?

Vocolosporin is an immunosuppressant used to stop lupus nephritis from worsening. It is used together with another immunosuppressant called mycophenolate mofetil (MMF).

Voclosporin is a calcineurin inhibitor. Calcineurin is an enzyme that activates a type of immune cell called ‘T-cells’ to start working, so voclosporin works by reducing the amount of calcineurin in the body, which results in less T-cell activity. This then reduces the amount of inflammation in the kidneys that causes the symptoms of lupus nephritis.

Voclosporin is administered as an oral tablet, typically three capsules twice a day. It is given together with MMF.

The main reason NICE and the SMC recommended it was that evidence suggested that using voclosporin with MMF was more effective than using MMF alone, and that this is cost-effective.

Who can have voclosporin?

NICE and the SMC both recommended that voclosporin can be used (in combination with MMF) to treat class 3 to 5 lupus nephritis. Doctors use a classification system to divide lupus nephritis into 6 stages, from least severe (class 1) to most severe (class 6). A description of the different classes is given below:

At this stage, it is unclear which lupus nephritis patients will be offered voclosporin. There may be some variation between healthcare professionals and how they use the new treatment. We will provide more information as NHS guidance is developed.

When will voclosporin become available?

NICE (England and Wales) published their recommendation for this treatment on 3rd May 2023. The SMC (Scotland) published their recommendations on 9th October 2023. The process used by the NHS and length of time to adopt recommendations varies slightly between the different nations of the UK.

England
NHS England has a legal obligation to make the treatment available through clinical pathways within 90 days (3 months).

Wales
NHS Wales must usually provide the funding and resources for the treatment within 60 days (2 months).

Scotland
NHS Scotland does not have a set timeline for making a treatment available. After the SMC makes a decision, each local Health Board decides how to implement the new medicine.

Northern Ireland
Northern Ireland does not have an appraisal system like NICE or the SMC. In practice, most NICE decisions are implemented, which should mean that voclosporin becomes available in Northern Ireland, though the timescale is not clear.

We will provide updates when we have information about how to access the treatment through NHS pathways.

 

What is LUPUS UK’s reaction to the recommendation?

“We are delighted that NICE and the Scottish Medicines Consortium (SMC) have recommended the NHS use voclosporin in the treatment of some people with lupus nephritis. This is very exciting news because voclosporin is only the second treatment developed specifically for lupus to be approved in within the UK; the previous treatment was belimumab (Benlysta) which finally received a recommendation in 2021.

“In recent decades there have been significant improvements in treatment strategies, prognosis and decreased mortality for lupus nephritis. Despite this, the percentage of patients progressing to end-stage renal disease (ESRD) has remained steady. This indicates limitations in the effectiveness of current treatments. We hope that the introduction of treatments like voclosporin can result in meaningful progress and better outcomes for people living with lupus nephritis.

“The treatment of lupus nephritis is also overly dependent on corticosteroids which, whilst potentially life-saving, can cause significant adverse side-effects and comorbidities over a lifetime. It is hoped that advances in treatment, such as the introduction of voclosporin, could help reduce the amount of steroids a person needs to effectively manage the disease.

“We also hope that this decision will be an incentive to increase investment in lupus research and clinical trials so that further breakthroughs are made.”

Paul Howard (Chief Executive of LUPUS UK)

 

“It is wonderful that Voclosporin has been recommended for use in the NHS. It gives much needed options to Lupus patients in a disease which affects each patient so differently. It was my first time as a patient expert on a HTA appraisal and I found the process extremely interesting and empowering, the NICE team supported me throughout and the committee were very open to our involvement. I am thankful to Lupus UK for the opportunity and their continued support and involvement to increase access to medications for patients.”

Amy (a person living with lupus who took part in the NICE appraisal)

 

Further reading

NICE published final recommendations on 03/05/2023 – you can see them in full HERE. 

The SMC published final recommendations on 09/10/2023 – you can read them in full HERE.

You can find out more about lupus nephritis in our booklet HERE.

The patient information leaflet about voclosporin, including a list of ingredients, can be found HERE.