NHS England have not recommended funding obinutuzumab for people with lupus and secondary non-response to rituximab.

 

What is obinutuzumab?

Obinutuzumab is a biological medicine. It works by targeting a type of cell in the immune system called a B cell, signalling to the immune system to destroy them. Destroying these B cells can help to reduce the inflammation caused by the overactive immune system in people with lupus.

Obinutuzimab targets the same part of the immune system as rituximab, a biological medicine which has been used for around 20 years to treat moderate and severe lupus which doesn’t respond to other treatments.

Like rituximab, it is given as an intravenous infusion (drip) in hospital, typically with two infusions , two weeks apart. But obintuzumab is a more modern form of rituximab that is advantageous for some patients.

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How was obinutuzumab being used for people with lupus?

When new medicines are introduced in the NHS, they are given a license to be used for particular illnesses or particular groups of people. This is based on evidence from research which shows it is safe for that illness or group of people. Sometimes medicines are used for illnesses not listed in the license, which is called “off-label” use. This is usually when a doctor judges any benefit to be greater than any risk.

Obinutuzumab is licensed in the UK for some types of cancer. It was used off-label for a small number of people with lupus who had “secondary non-response” to rituximab. Having a “secondary non-response” means that they were given rituximab and at first it helped their symptoms, but it became ineffective later. They were then given obinutuzumab instead.

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Why wasn’t it recommended for lupus?

NHS England found there was evidence for the effectiveness of giving obinutuzumab to people with lupus who had a secondary non-response to rituximab. However, it was not rated as a high enough priority to be funded at the moment because of limits in their budget.

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What happens next?

The British Isles Lupus Assessment Group (BILAG) will be submitting an appeal against the decision. NHS England are prepared to consider funding obinutuzumab again in the future.

There are also ongoing trials to test obinutuzumab, which will provide further evidence about whether it works as a treatment for people with lupus specifically. This may lead to a review in the future.

We will provide an update on our website if obinutuzumab is re-considered in the future.

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What do LUPUS UK think about the decision?

 

Paul Howard, LUPUS UK’s Chief Executive, had this to say:

“We are incredibly disappointed by this decision. It is especially frustrating that NHS England agrees the evidence demonstrates this is a safe and effective treatment, but it is not considered a high priority for the current budget.

“Unfortunately, there are very few alternative treatment options for people with lupus who have a secondary non-response to rituximab. As a result, the small number of people who may have benefited from obinutuzimab may be left with insufficient treatment and higher doses of corticosteroids, having a potentially detrimental effect on their quality of life and longer-term health.

“LUPUS UK will continue to support the brilliant efforts by expert lupus specialists to have obinutuzumab made available through the NHS as a treatment option for some people with lupus.”

 

Ed Vital, the policy lead and chair of BILAG said:

“There are still good treatment options for most people with lupus but we think this policy is very important for some patients. The number of patients who need this drug rather than rituximab is currently quite small. But they have severe symptoms and, because we already know that they have responded to rituximab in the past, the chance of them responding to a new drug in the same class is very high. So we are confident we will be able to change this policy in future.”