Bladder cancer treatment rejected for routine use on NHS in England
An immunotherapy treatment for some people with bladder cancer, currently available through the Cancer Drugs Fund, has been given an initial "no" for routine use in England.
Pembrolizumab (Ketruda) will continue to be available as a treatment option on the NHS until at least January 2020, when the National Institute for Health and Care Excellence (NICE) reviews this initial decision.
In giving its initial rejection, NICE said they couldn't be confident pembrolizumab provided value for money for the NHS at its current price.
Anyone already receiving pembrolizumab to treat their bladder cancer will continue to be able to receive the drug, and new patients will be able to start treatment up to the point a rejection is confirmed in January.
Rose Gray, Cancer Research UK's policy manager called the decision "disappointing".
Boosting the immune system
Pembrolizumab is an immunotherapy that seeks to enhance the immune system's ability to recognize and kill cancer cells, by blocking a molecule called PD-L1 from interacting with immune cells.
Adults with a type of bladder called urothelial cancer that's begun to spread to other parts of the body are eligible for the treatment. It would only be an option for people who've already undergone platinum-containing chemotherapy.
Pembrolizumab was approved for use in the Cancer Drugs Fund in March 2018. This meant eligible patients were able to quickly begin receiving the drug on the NHS, while data on the longer-term outcomes of patients receiving the drug was being gathered from an ongoing clinical trial.
Medicines available through the Cancer Drugs Fund have to be considered again by NICE at a later date, once more data on their long-term benefits is available. It's at this point that a final decision is made about whether the NHS should routinely pay for the treatment.
Better sense of survival benefits
In this case, NICE pointed out that updated clinical trial data had given a better sense the survival benefits for the majority of patients, when compared to the current standard of care, docetaxel or paclitaxel.
People taking pembrolizumab lived for 10.1 months, compared with 6.2 months for those taking chemotherapy, according to data published in the latest NICE guidance.
But there's still uncertainty around how long this benefit is sustained for the minority of patients who survive for more than 2 years after taking pembrolizumab, which is when the treatment is stopped.
Without knowing this, Gray explained, NICE can't be sure that the medicine offers enough benefit to the whole group of patients to justify its cost to the NHS.
"We now know that it's more effective than some other treatments, but we still don't know how well it works long term, or whether it's better than some of the newer treatments which have become available recently," said Gray.
NICE approved another immunotherapy drug, atezolizumab (Tecentriq), for people with this type of bladder cancer last year.
"This decision will be reviewed in the new year, so we urge NICE, NHS England and the manufacturer to work together and agree a deal which will mean patients can still access this drug."