It is looking likely that patients with the most common form of lung cancer will not be able to access treatment with Bristol-Myers Squibb's immunotherapy Opdivo on the National Health Service in England and Wales.
The National Institute for Health and Care Excellence has now published draft guidelines turning down the drug's use in adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose disease has progressed after prior chemotherapy.
BMS says the rejection comes despite the offer of several schemes to make Opdivo (nivolumab) more cost effective in the lung cancer setting, including funding treatment after the first year.
This decision is set to be a major set-back for patients who will be denied access to the first immunotherapy that has shown superior overall survival in the disease and better quality of life compared to chemotherapy, with an 18 month survival rate of 39 percent vs 23 percent, the firm argues.
In 2012, almost 44,500 people in the UK were diagnosed with lung cancer, of which around 12,000 people have the non-squamous NSCLC form. Outlook for these lung cancer patients is poor, with around 80 percent of those diagnosed with advanced disease dying within one year.
"Lung cancer is the UK's biggest cause of cancer deaths and making new medicines available to NHS patients is a vital part of raising standards of cancer care and survival rates in Britain to the levels seen in other European countries," said Professor Dean Fennell, Chair of Thoracic Medical Oncology at the University of Leicester.
"Nivolumab has the potential to provide increased long-term survival, compared with chemotherapy and with far less side effects. I hope that NICE will reconsider the value of this treatment and reverse its decision so that patients can benefit from nivolumab as soon as possible."
The drug was available to patients with advanced lung cancer in the UK through the Early Access to Medicines Scheme prior to it's European approval. NICE has since rejected Opdivo for patients with squamous NSCLC and for those with non-squamous NSCLC, leaving NHS patients with advanced lung cancer no route for accessing it outside of clinical trials.
"While today's decision is disappointing for lung cancer patients, it is also a setback for British cancer care because it shows that the system which is intended to provide UK patients with new medicines has denied them yet again," said Johanna Mercier, General Manager, Bristol-Myers Squibb UK & Ireland.