Bristol-Myers Squibb has announced that the Medicines Healthcare Products and Regulatory Agency (MHRA) has granted UK lung cancer patients access to treatment with the potentially life-extending investigational medicine nivolumab, through the Early Access to Medicines Scheme (EAMS), prior to the pending marketing authorisation decision. Through EAMS, nivolumab as monotherapy is indicated for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) after prior chemotherapy in adult patients whose tumours express programmed death ligand-1 (PD-L1). This is the first EAMS access to an immunotherapy medicine for non-squamous patients in the UK. In 2012 there were 35,000 deaths from lung cancer,1 which is more than those from breast and bowel cancer combined.2,3 Non-squamous NSCLC is thought to account for more than half of these cases.4,5
"Thanks to our Early Access to Medicines Scheme, NHS patients with this devastating form of lung cancer will be amongst the first in Europe to have access to this life‐enhancing medicine.", commented Life Sciences Minister, George Freeman MP. "This scheme, launched in 2014, is making a real difference in speeding up access to innovative medicines, but we want to go further, which is why the independent Accelerated Access Review will recommend how we can get new treatments to patients even faster."
NSCLC is the most common type of lung cancer in the UK and is further divided into squamous and non-squamous types based on the cells that it originates from.4
UK treatment access disparity
"Nivolumab is one of the biggest advances in this field in almost two decades and it is changing survival expectations in lung cancer. I am delighted that the MHRA has made nivolumab available to some non-squamous lung cancer patients expressing PD-L1 through EAMS. It is untenable however that the door remains closed for other patients, such as those with squamous NSCLC who must continue to wait for a NICE review. I hope that nivolumab can soon be made available to all patients who could potentially benefit from it.", said Professor Dean Fennell, Chair of Thoracic Medical Oncology, University of Leicester.
Nivolumab is a PD-1 (programmed death-1) immune checkpoint inhibitor that works by harnessing the ability of the immune system to fight cancer.6
Johanna Mercier, General Manager, Bristol-Myers Squibb UK & Ireland said, "It is great that we are now able to make nivolumab available to some non-squamous lung cancer patients through EAMS but it is also critical that we continue to work with the reimbursement authorities to open up access for patients with squamous lung cancer. NICE will make its final recommendation for squamous patients later this month and we acknowledge that longer-term change to the medicines review process is underway, although the timing of implementation and the measures of success for this are not clear. In the UK, many patients cannot afford to wait for these reforms." In the UK, around 30% of lung cancer patients will survive for one-year after diagnosis.7 However, five-year survival rates for stage IV (advanced or metastatic disease) lie between 2 and 13%.7
In 2015, nivolumab was licensed in the European Union in 2015 for the treatment of adult patients with locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after prior chemotherapy; NICE has since issued draft guidance not recommending it for reimbursement in NHS patients in this indication and a final decision from NICE is currently pending. In January 2016, NICE has recommended nivolumab as monotherapy for use within its licence, as an option for treating advanced (unresectable or metastatic) melanoma in adults.