The immunotherapy drug, nivolumab, also known as Opdivo made by Bristol-Myers Squibb, will be available for patients with head and neck cancer who have not responded to chemotherapy within 6 months, and the cancer has spread to other parts of the body.
Nivolumab works by binding to certain proteins in cells. This then stimulates the body’s immune system to attack cancerous cells and destroy them.
When NICE first reviewed nivolumab, it was found that the evidence for its effectiveness in treating head and neck cancer was uncertain. NICE invited Bristol-Myers Squibb to submit a CDF proposal to show how they would strengthen the evidence for nivolumab.
Patients can now have access to the drug via the NHS whilst it is within the CDF. During this time, further data will be collected from how well patients do who access the drug through the CDF and from a clinical trial to help address uncertainties in the evidence.
Professor Carole Longson, director of the Centre for Health Technology Evaluation at NICE said: “Nivolumab is an innovative drug that continues to draw attention, but its clinical evidence for some types of cancer can be uncertain. I am pleased the company has worked with us and NHS England to develop a managed access agreement and that we have found a way to provide for patients despite these uncertainties.”
Patients who are being treated with nivolumab must stop at two years of uninterrupted treatment, or earlier if the cancer has spread further around the body. This is because evidence for the effectiveness of nivolumab after two years is uncertain.
There are almost 10,000 cases of newly diagnosed head and neck cancer per year in the UK. An estimated 900 patients are expected to receive nivolumab during the managed access period whilst it is on the CDF for the next two years.
The current clinical trial evidence showed that the drug extends life by more than 3 months compared to current treatments.
The list price for nivolumab is £1,097 per 100mg vial which is to be administered intravenously in 3mg/kg doses every two weeks per patient. The company has agreed a commercial access agreement with NHS England that provides the drug at a confidential discounted price.