The immunotherapy drug, made by Bristol-Myers Squibb, is recommended for use within the Cancer Drug Fund.
Hundreds of patients with head and neck cancer in the United Kingdom will soon have access to the immunotherapy drug nivolumab, according to the National Institute for Health and Care Excellence (NICE).
The drug, produced by Bristol-Myers Squibb, will be available for patients with head and neck cancer who have not responded to chemotherapy within 6 months and who have metastases.
Nivolumab, sold as Opdivo, works by attaching to certain proteins in cells, which then stimulates the immune system to attack and destroy cancer cells. Current clinical trial evidence shows that the drug extends life by more than 3 months, compared with other existing treatments.
When NICE first examined nivolumab, it was uncertain how effective it would be for treating head and neck cancer. Bristol-Myers Squibb then submitted a Cancer Drugs Fund (CDF) proposal to further the case for nivolumab.
“Nivolumab is an innovative drug that continues to draw attention, but its clinical evidence for some types of cancer can be uncertain,” said Professor Carole Longson, director of the Centre for Health Technology Evaluation at NICE said in a statement. “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 will be able to receive the drug through the NHS while it is in the CDF. Data on the drug’s effectiveness will be collected from patients receiving the drug and from a clinical trial. This will help address uncertainties in evidence.
Because evidence of the effectiveness of the drug after 2 years is uncertain, patients who are being treated with nivolumab will be required to stop after 2 years of uninterrupted treatment. They may be required to stop sooner if the cancer has spread further throughout the body.
In June this year, results from a US study that found nivolumab was more effective in reducing the rate of meaningful deterioration for patients with head and neck cancer compared with single-agent therapies. The CheckMate 141 trial compared nivolumab against single-agent cetuximab, methotrextate, and docetaxel among 129 platinum-refractory patients being treated for recurrent or metastatic head and neck cancer.
Results of the study showed that nivolumab delayed time of deterioration of patient-reported quality-of-life outcomes compared with single-agent therapy of investigator’s choice.