Bristol-Myers Squibb’s Opdivo is being recommended by the National Institute for Health and Care Excellence to treat a certain form of lung cancer on the NHS in England, via the Cancer Drugs Fund.

The cost watchdog has issued a Final Appraisal Determination (FAD) recommending the drug’s use to treat both squamous and non-squamous forms of non-small cell lung cancer (NSCLC), after a new deal was put forward by the company.

Under the guidelines, Opdivo (nivolumab) will be made available immediately, via the CDF, for all patients with locally advanced or metastatic squamous NSCLC and in non-squamous NSCLC patients whose tumours are PD-L1 positive, but only after prior chemotherapy in both circumstances.

However, BMS is hoping that, as long-term data become available within the next two years, the drug’s scope will be expanded to include all advanced lung cancer patients.

Around 1,300 patients with lung cancer are expected to receive the drug as part of the CDF deal put forward by BMS, under which it treatment will be funded at a discounted price whilst more evidence is gathered on its value.

The firm recently presented "unprecedented long-term survival data" for Opdivo in patients with previously-treated NSCLC at the European Society for Medical Oncology congress, which showed that, at three years, the immunotherapy nearly tripled overall survival versus docetaxel in squamous NSCLC (16 percent versus 6 percent) and doubled overall survival in non-squamous NSCLC (18 percent versus 9 percent), respectively. 

NICE’s decision to back the drug via the CDF "is a real step forward for advanced lung cancer patients and their families in England," said Dr Alastair Greystoke, senior lecturer and honorary consultant in Medical Oncology, Freeman Hospital, Newcastle upon Tyne.

"With nivolumab we have a medicine that has been shown in clinical trials to be effective, and has shown promising long-term survival versus standard chemotherapy, in instances where prior chemotherapy has failed. Importantly this will now open the door to immunotherapy for more people than ever before."

He also noted that lung cancer "remains a major challenge", with a high number of people diagnosed with advanced disease in the UK dieing within one year. "With new treatments like nivolumab now available in England, the hope is that we may see this statistic significantly improve in coming years."

The Roy Castle Lung Cancer Foundation has also welcomed the guidelines. "This decision is a significant advance which can help some lung cancer patients to live longer and enjoy a better quality of life," said the charity’s chief executive, Paula Chadwick. "For those for whom nivolumab may be suitable, it represents a fresh option and a new hope."

Professor Paul Workman, chief executive of The Institute of Cancer Research, London, also welcomed the move as well as "NICE and the drug’s manufacturer showing flexibility in reaching agreement on the drug’s approval," but also argued that "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. Companies need to come to the table with their best, most realistic price offer right at the start, so we get new exciting drugs, such as immunotherapies, to patients as quickly as possible.