US-based Bristol-Myers Squibb has confirmed that the National Institute for Health and Care Excellence (NICE) has issued draft guidance that ignores recommendation of investigational cancer immunotherapy Opdivo (nivolumab).
Opdivo will be used for patients with difficult-to-treat, platinum, refractory, advanced head and neck cancer.
A pivotal Phase III trial of nivolumab carried out last year showed that more than double the number of patients on treatment were alive after one year compared to chemotherapy.
Bristol-Myers Squibb UK and Ireland general manager Benjamin Hickey said: “Advanced head and neck cancer has a very poor prognosis and new therapies are urgently needed to help prolong survival.
“Today’s decision is deeply concerning and we have grave concerns that if NICE does not recognise the value of this breakthrough medicine for head and neck cancer and lung cancer patients, it could set a precedent for access to other innovative medicines in the future.”
Nivolumab’s innovative mode of action works by harnessing the ability of the immune system to fight cancer.
The NICE committee is all set to meet to make nivolumab available on the NHS for advanced lung cancer patients following a lengthy process of negotiations for 18 months. In case the negative decision is not overturned, no access will be available to nivolumab for lung cancer patients in England and Wales.
More than 30 different types of head and neck cancer are categorised by the area in which the cancer originates.
About 31 people are diagnosed with a form of the disease every day in the UK, and more than 3,300 people will die each year.
NICE has assessed the benefits of using nivolumab to treat different types of cancer and the drug has been recommended for kidney cancer.
NICE health technology evaluation centre director Professor Carole Longson said: “We understand that treatment options in this area are limited, and it’s important to patients that treatments both extend and improve their quality of life.
"Evidence for nivolumab extending the long-term survival and quality of life for people with head and neck cancer is uncertain. Therefore, the additional costs for these potential benefits was considered too high for NHS use at present."