UK NICE to deny NHS access to BMS’s blood cancer drug Opdivo

The UK’s National Institute for Health and Care Excellence (NICE) has issued a draft guidance that could deny access to Bristol-Myers Squibb’s immunotherapy Opdivo (nivolumab) for National Health Service (NHS) patients suffering from an aggressive blood cancer.

In the guidance, NICE is instructed not to recommend Opdivo for patients suffering from classical Hodgkin lymphoma (cHL) that is progressing (relapsed or refractory) in spite of prior autologous stem-cell transplantation (ASCT), as well as treatment with brentuximab vedotin (BV).

cHL is a relatively aggressive cancer that affects cells called B-lymphocytes and grows in the lymphatic system, which is a network of vessels and glands spread throughout the body and forms a major part of the body’s immune system.

Clinical trials conducted on nivolumab have revealed that 95% of cHL patients continue to live even one year after commencing the treatment.

"We remain committed to finding a solution for patients and their families, and will be working with NICE to assess how we can reverse this decision and provide patients with access."

Bristol-Myers Squibb UK and Ireland general manager Benjamin Hickey said: "We are disappointed that NICE has not recommended nivolumab for the treatment of patients with this rare and aggressive form of blood cancer in its preliminary guidance.

"This comes despite nivolumab being the first immunotherapy licensed and shown to improve survival in cHL patients who’ve tried all alternative options.

"We remain committed to finding a solution for patients and their families, and will be working with NICE to assess how we can reverse this decision and provide patients with access."

Nivolumab has a unique mode of action that works by using the ability of the immune system to combat cancer.

Last year, the UK Medicines and Healthcare products Regulatory Agency (MHRA) declared nivolumab as a promising innovative medicine (PIM) and approved it for the Early Access to Medicines Scheme (EAMS).