Thursday, 6 May 2021.

As Bladder Cancer Awareness Month kicks off, the National Institute of Health and Care Excellence (NICE) has announced that it is not recommending avelumab (Bavencio) for use as a maintenance treatment for people with locally advanced or metastatic urothelial (bladder) cancer after chemotherapy. This is deeply disappointing, and we urge NICE and the manufacturer to continue discussions. There are currently no maintenance treatments – treatments that can slow the rate of cancer and stop it progressing – routinely available for these types of patients on the NHS.

Professor Alison Birtle, oncologist and trustee at Fight Bladder Cancer said “This is a plea to NICE and the manufacturer. Please continue your discussions and resolve your current uncertainties around cost-effectiveness. Patients are not numbers – this drug can give them good quality time and is the biggest change in bladder cancer management we have had in decades. This decision, if it stands, will be hugely disappointing to so many patients with bladder cancer, who could see their lives greatly extended if they had access to this drug. Whilst other cancers have seen life extending drugs funded time and again, bladder cancer survival has not improved over the last 20 years in the UK.”

Although NICE agreed that “clinical trial evidence shows that if people take avelumab it takes longer for their cancer to get worse, and they live longer than if they have best supportive care”, NICE stated that “the most likely cost-effectiveness estimates are much higher than what NICE normally considers an acceptable use of NHS resources”.

Danielle Marr, bladder cancer patient and Fight Bladder Cancer trustee said “NICE has the opportunity to extend these patients’ lives by many months. I am extremely saddened to learn that this opportunity may never be given to those with end stage bladder cancer. Quality time with children, parents or loved ones is something you can never get back.”

The main sticking point between the manufacturer and NICE seems to be whether or not people with advanced/metastatic bladder cancer that have responded to chemotherapy are at their end of their lives. NICE defines end of life as less than 24 months, and sometimes pays more for these therapies.

In a recent clinical trial, the median length of survival of people with advanced/metastatic bladder cancer that responded to chemotherapy was 14.3 months. avelumab extended the median overall survival to 21.4 months (N Engl J Med 2020; 383:1218-1230).

In this case, NICE used the mean length of survival, rather than the median, to define end of life. The mean is the average, calculated by adding up all the numbers and dividing by how many numbers there are. The median is the middle value in the list of numbers – an equal number of values are less than and more than the median. Mean survival tends to be longer than median survival, because some people, who respond especially well to treatment, survive for a very long time, taking the mathematical average up.

In a statement published on their website, NICE said “avelumab does not meet NICE’s criteria to be considered a life-extending treatment at the end of life. This is because it is uncertain how long people in the NHS who would be eligible for avelumab live for.”

Professor Alison Birtle commented “These people are currently at the end of their lives, and have no other routine treatment options. In my clinic, the length of survival for people with this diagnosis is 12 to 14 months, and is well under 24 months.”

Furthermore, NICE has stated that “avelumab is not suitable for use within the Cancer Drugs Fund because it is unlikely to be cost effective and further data collection is not an option.”

Around 20,500 people are diagnosed with bladder cancer in the UK every year. NICE decisions are usually adopted in Wales and Northern Ireland as well as England, so the decision is likely to affect patients in all 3 nations. Scotland has a separate process for reviewing drug decisions, and will be examining avelumab later this year.

This initial decision will be reviewed by NICE on Thursday 17 June. People who wish to comment can do so on the NICE website before 5pm on Thursday 27 May.

The full press release can be found here.