People with a certain type of advanced kidney cancer will not be able to have a combination of two immunotherapy drugs on the NHS in England.
The National Institute for Health and Care Excellence (NICE) concluded that giving the immunotherapy drugs, called ipilimumab (Yervoy) and nivolumab (Opdivo), to people with advanced and aggressive kidney cancer as a first treatment option is not cost effective.
This draft decision comes after results of a phase 3 clinical trial showed that the drug combination was more effective than current treatment and caused less side effects.
NICE said it rejected the drug combination because it was too expensive and the drug company who ran the trial had not collected enough long-term data on how patients were doing.
Rose Gray, Cancer Research UK’s policy manager, said this decision is disappointing for patients with this specific type of kidney cancer.
“Clinical trial evidence suggests this combination of drugs could help patients live longer or delay their cancer growing,” she said.
“It would also have been the first immunotherapy treatment available for patients with untreated and advanced disease.”
Uncertain trial results
Standard treatment for NHS patients with advanced kidney cancer is a targeted cancer drug called sunitinib (Sutent).
Doctors can classify kidney cancers that have spread into three groups based on how well patients might do on treatment (prognosis). These groups range from those who have the best prognosis, called the favourable risk group, to those who have the poorest prognosis, the poor risk group.
A clinical trial set out to see if the immunotherapy combination was more effective. It included 847 patients whose condition placed them in the poor and middle risk groups. Around half received ipilimumab and nivolumab and the other half sunitinib.
Kidney cancer remained stable for around 3 months longer for people who took the drug combination compared with those on standard treatment.
The immunotherapy drugs also boosted survival. Around 75 in 100 people taking the combination were alive 18 months after treatment compared to 60 in 100 taking sunitinib.
The most common side effects experienced by both groups of patients were tiredness, diarrhoea and itchy skin, but this was less common in those who took immunotherapy.
The researchers stopped monitoring the patients on the trial at around 25 months after treatment. This was because they’d already shown that the drug combination was more effective than sunitinib.
However, NICE said it couldn’t be confident that the drug combination offered value for money compared to existing treatments because there wasn’t enough data to tell if this benefit would last long term.
Gray said she hopes an agreement can be reached to make the drug available in the near future.
“We urge NICE, NHS England and the drugs’ manufacturers to work together to agree a deal which will allow the treatment to be approved when NICE reviews this decision in the New Year.”
Ipilimumab and nivolumab both work by interacting with immune cells called T cells. They stick to molecules on the surface of T cells and stop the immune cells being put to sleep by cancer cells. This allows the T cells to attack and kill the cancer cells.