NICE nod for Amgen’s rare leukaemia drug

Patients with a rare form of leukaemia look set to win routine access to a novel treatment option on the NHS in England and Wales after Amgen’s Blincyto was backed by cost watchdog NICE.

The Institute has published final draft guidance recommending Blincyto (blinatumomab) as an option for treating adults with Philadelphia-chromosome-negative (Ph-) relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL), on the basis of the discount agreed in the patient access scheme.

ALL is a rare and rapidly progressing cancer of the blood and bone marrow, with around 760 new cases in the UK a year, but as yet there is no widely accepted standard treatment regimen given to patients with relapsed or refractory ALL beyond chemotherapy.

Blincyto is an example of a BiTE antibody construct, a type of immunotherapy designed to help the body’s immune system to detect and target malignant cells, and the first of its kind to be approved by regulators. The modified antibodies engage two different targets simultaneously, thereby juxtaposing killer T cells to cancer cells to trigger apoptosis.

"Living with ALL, particularly when first line treatment has failed, can have a profound impact on the person’s physical and psychological wellbeing. It can also place a big emotional strain on their families and friends," said Zack Pemberton-Whiteley from Leukaemia CARE.

"For patients, the knowledge that there are alternative treatments available can provide some relief. We are pleased that NICE has recommended blinatumomab to be made routinely available to patients in England and Wales. This is consistent with a previous decision from the Scottish Medicines Consortium, ending the variations in access between England and Scotland."

After considering clinical evidence from the Phase III TOWER and Phase II MT 103-211 studies, which showed that median overall survival was 7.7 months for Blincyto versus 4.0 months for standard of care chemotherapy, and taking end-of-life considerations and the PAS into account, NICE concluded that the drug does offer the NHS value for money

"Amgen is committed to ensuring patients in the UK get access to effective therapies for hard-to-treat cancers like ALL. Patients with relapsed or refractory ALL have an extremely poor prognosis and we are pleased that NICE has recommended blinatumomab for routine use on the NHS, giving patients and their physicians a novel option to help manage their disease," said Tony Patrikios, Executive Medical Director, Amgen UK and Ireland.

The drug picked up a conditional marketing nod Europe in 2015, following accelerated approval in the US back in December 2014.