Oncology nurses have welcomed a draft ruling by the National Institute for Health and Care Excellence that a lung cancer drug should be made available to some patients in England.
NICE has today recommended that nivolumab (Opdivo) be made available for lung cancer after its manufacturer, Bristol-Myers Squibb, agreed a fast-track deal through the Cancer Drugs Fund (CDF).
“This new deal means that we can give patients access to what we know is a promising treatment”
The deal put forward by the company will see the immunotherapy drug become available for patients with squamous and non-squamous advanced non-small cell lung cancer.
Around 1,300 patients are expected to receive nivolumab as part of the deal, which will see the drug that can extend life by months funded at a discount while more evidence is gathered on its value.
Nivolumab will now be immediately available to some people with advanced non-small cell lung cancer if they have already been treated with chemotherapy. It is given intravenously in hospital every two weeks.
Specifically, around 950 patients with squamous and 350 patients with non-squamous non-small cell lung cancer are expected to receive treatment for the duration of the CDF arrangement.
“We welcome improved access to any new, innovative medicines”
At its full price, nivolumab costs £439 per 40-mg vial. However, exact treatment costs depend on a person’s weight and their type of lung cancer. For example, for someone weighing 73 kg, a month’s treatment would cost £5,268 at the drug’s full price.
The move to approve nivolumab represents a change from an earlier draft version of guidance on the drug, published by NICE last year.
It had said that nivolumab was not cost effective for all patients with squamous and non-squamous advanced non-small cell lung cancer – but it did appear to benefit some more than others.
Although not the first immunotherapy drug available for advanced lung cancer – pembrolizumab was approved by NICE in December 2016 – nivolumab hit the headlines due to high profile campaigners.
In particular, the late Sunday Times restaurant critic AA Gill wrote a widely-publicised article during his final weeks of life, which name-checked the drug and the previous lack of NHS access to it.
In addition, in November 2016, two patients submitted petitions with a total of 270,000 signatures urging NICE to approve the drug.
“This is another instance where patients in the UK have had to wait far longer than necessary”
Professor Carole Longson, director of the NICE centre for health technology evaluation, said: “We know that nivolumab is clinically effective for some people with lung cancer but the full extent of its benefit is not clear.
“This new deal means that we can give patients access to what we know is a promising treatment whilst more evidence is gathered on its value,” she said.
The National Lung Cancer Forum for Nurses, which is part of UK Lung Cancer Coalition (UKLCC), welcomed the decision by NICE.
“We welcome improved access to any new, innovative medicines which may help to improve outcomes for patients with lung cancer, said forum member Carol Davies.
“Lung cancer is the UK’s biggest cancer killer yet survival rates across the UK still lag severely behind our European counterparts and compare poorly with other major common cancer types,” she said.
“The UKLCC wants governments, commissioners and the health care community to work together to raise five-year lung cancer survival rates to 25% by 2025,” she added.
Professor Paul Workman, chief executive of the Institute of Cancer Research, London, said: “It’s great news that people in the UK with non-small cell lung cancer will now gain more time with their loved ones.
Professor Paul Workman
“I’m pleased to see NICE and the drug’s manufacturer showing flexibility in reaching agreement on the drug’s approval,” he said. “But this is another instance where patients in the UK have had to wait far longer than necessary to access an innovative new treatment.
“Initially the drug was priced far too high to ever have been judged cost-effective by NICE,” he said. “Companies need to come to the table with their best, most realistic price offer right at the start.”
He added: “Immunotherapies are currently very expensive, but one of the ways to make them more cost-effective is to direct them to patients most likely to respond. Today’s decision is a welcome step in the right direction in its requirement for use of the PD-L1 biomarker for some patients.”
Nivolumab works by targeting a protein on the surface of cells known as programmed cell death protein – 1 (PD-1) receptor.
PD-1 reduces the activity of the body’s immune cells when it binds to another protein called programmed death-ligand 1 (PD-L1), which is found on both normal and cancerous cells.
Cancerous lung cells have more PD-L1 than normal cells which stops the body from attacking the tumour.
In trials, the effectiveness of nivolumab appeared to differ according to the level of PD-L1 in people with non-squamous non-small cell lung cancer.
People taking nivolumab who had more PD-L1 on their cancer cells lived longer than those with less. But in people with squamous non-small cell lung cancer, the results did not suggest a clinically significant difference according to PD-L1 expression.
Professor Carole Longson
Bristol-Myers Squibb put forward a further submission that included new evidence, as well as a CDF proposal to explore the benefit of nivolumab beyond three years according to PD-L1 levels.
The NICE committee concluded that the case was not strong enough for routine NHS use. However, as trials were ongoing, the committee felt it would be appropriate to include nivolumab in the CDF.
The latest draft guidance on the drug from the institute is now with consultees, who have the opportunity to appeal against it until 4 October.
NICE is also looking at nivolumab in a number of different cancer indications.
Meanwhile, nivolumab will also be available to patients in Wales under separate arrangements that will see the drug funded within two months.
The Scottish Medicines Consortium has already issued advice backing nivolumab to treat locally advanced or metastatic squamous non-small cell lung cancer after prior chemotherapy in adults.