New immunotherapy is approved for some people after bladder cancer surgery on the NHS in England, Wales, and Northern Ireland

Published on 7 July 2022

The Department of Health and Social Care recommends nivolumab for high-risk people who have had surgery to remove their bladder cancer to reduce the risk of cancer returning and where chemotherapy is unsuitable. Nivolumab works by attaching to a protein called PD-L1, allowing the immune system to increase its activity against the cancer cells. Around 400 people each year will be able to access this treatment on the NHS. Clinical trials indicate that treatment reduces the risk of cancer coming back. 

The Department of Health and Social Care has published final draft guidance recommending nivolumab to be offered by the NHS for treating some people with bladder cancer at high risk of recurrence after their bladders are removed by surgery.

Nivolumab (also known as Opdivo and made by Bristol Myers Squibb) has been recommended for high-risk people who have had surgery to remove their bladder cancer to reduce the risk of cancer returning and where chemotherapy is unsuitable.

John Hester, aged 75, bladder cancer patient and Chair of Fight Bladder Cancer, commented: “When I had my bladder cancer surgery, there was no immunotherapy treatment available to me afterwards. We just had to watch and wait. I am delighted that the approval of this treatment means we can reduce the risk of cancer coming back in some people with high-risk bladder cancer after their surgery, without reducing their quality of life.”

Dr Lydia Makaroff, Chief Executive of Fight Bladder Cancer, commented: “We are delighted with this decision. Until now, there was no immunotherapy treatment available on the NHS in England, Wales, and Northern Ireland immediately after bladder cancer surgery. This positive decision may have the potential to give hundreds of people with bladder cancer more good quality time with their loved ones.”

Fight Bladder Cancer has been involved in the nivolumab appraisal process since 2020, when the charity was invited to participate as a patient and carer group. Fight Bladder Cancer contributed to the draft scope, technical engagement, joined the committee meeting, and shared insights from people who had experienced the treatment first-hand.

Nivolumab is a monoclonal antibody, a type of protein designed to recognise and attach to a specific target substance in the body.

It is recommended in people whose tumours express PD-L1 at a level of 1% or more. PD-L1 is a protein which can weaken the body’s immune system. Nivolumab works by attaching to the protein, allowing the immune system to increase its activity against the cancer cells.

There are around 400 people who would be eligible for nivolumab treatment every year.

Bladder cancer is not a rare cancer. It is a neglected cancer. 21,181 people are diagnosed with bladder cancer each year in the UK.  18,959 in England, 1,691 in Scotland, 669 in Wales, and 226 in Northern Ireland. Despite this, bladder cancer currently receives just 1% of cancer research funding in the UK despite the high number of people diagnosed.

Most people diagnosed with bladder cancer are over 60 years old. However, people of all ages can be affected by the disease. The main risk factor for bladder cancer is increasing age but smoking and exposure to some industrial chemicals also increase the risk.

Bladder cancer is more common in men. Bladder cancer can affect people of all ages and genders. Out of every 100,000 people, 56 men and 18 women are diagnosed with bladder cancer each year.

Bladder cancer can often have a worse outcome in women. Women in England and Wales have between 15% and 45% higher odds of being diagnosed with advanced disease compared to men.

Bladder cancer is usually identified based on visible blood in the pee or blood found on urine testing, but emergency admission is a common way for bladder cancer to present and is often associated with a poor prognosis.

Clinical trial evidence shows that treatment with nivolumab for up to one year after surgical bladder removal reduces the risk of cancer coming back, compared with placebo. However, it is uncertain whether nivolumab increases how long people live because this data is not available yet.

Bristol Myers Squibb has a commercial arrangement with the NHS, which makes nivolumab available to the NHS at a discounted price.