Patients with classical Hodgkin lymphoma (cHL) living in England and Wales could now become the first to get routine access on the NHS to Bristol-Myers Squibb’s immunotherapy Opdivo after a u-turn saw cost regulators provisionally back the drug.
In a reversal of previous draft guidance on the back of new data, the National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination recommending the immunotherapy for the treatment of adult cHL patients whose cancer is progressing despite prior autologous stem cell transplantation (ASCT) and treatment with brentuximab vedotin.
Clinical data show that Opdivo (nivolumab) caused “considerable cancer reduction” in over two-thirds of patients (68 percent), measured as objective response rate (ORR), of which 8 percent saw a complete response (CR) where no recognisable sign of cancer remained.
The recommendation from NICE “will bring immense relief for many patients fighting this aggressive blood cancer,” said Dr Graham Collins, consultant haematologist, Oxford University Hospitals Foundation Trust.
“Nivolumab is the first licensed immunotherapy to provide durable response rates, with improved survival in this group of patients, many of whom previously would have faced palliative care. The availability of this much-needed immunotherapy on the NHS will bring a real opportunity for us to improve outcomes for these patients and is a turning point in the treatment of this disease.”
The drug was previously available to some patients in the UK after being accepted onto the Early Access to Medicines Scheme, prior to its European approval in November 2016.
cHL accounts for approximately 95 percent of all Hodgkin lymphoma cases. In the last 10 years, HL incidence rates have increased by 20 percent in the UK, with 2,106 people diagnosed with the cancer in 2014.
The guidance marks the third cancer type for which Opdivo has been recommended by NICE, after the drug was backed for skin cancer and advanced kidney cancer.