Cost regulators for the NHS in England and Wales have now published final guidelines endorsing Janssen's Imbruvica to treat some patients with chronic lymphocytic leukaemia (CLL).

The National Institute for Health and Care Excellence has approved funding the drug for use in patients who have had at least one prior therapy or who have a 17p deletion or TP53 mutation, and in whom chemo-immunotherapy is unsuitable.

Imbruvica (ibrutinib), a year's treatment with which costs more than £55,000 per patient (excluding the discount agreed in the patient access scheme), had only previously been available through the Cancer Drugs Fund (CDF).

"This is very welcome news for patients with CLL, who will now be entitled to routinely access ibrutinib on the NHS in England," said Jennifer Lee, director of Health Economics, Market Access and Reimbursement (HEMAR) and Advocacy at Janssen UK.

"We keenly await a similar positive decision by NICE for patients with mantle cell lymphoma and Waldenström's macroglobulinemia, who currently have limited treatment options available. It therefore continues to be our priority to work with NICE and NHS England to ensure that all patients who may benefit from ibrutinib can have access to it in the future."

NICE recently turned down Imbruvica for treating some people with Waldenstrom's macroglobulinaemia - a rare type of slow growing non-Hodgkin's lymphoma.

The Committee noted that there was no cost-effectiveness evidence submitted for part of the patient population - those whom chemo-immunotherapy is considered unsuitable, and that there were uncertainties in the evidence presented for other subsets. 

There were around 3,500 new cases of CLL in the UK in 2014, with around 59 percent diagnosed in people aged 70 and over.