It is looking likely that Janssen's Ibruvica will be available to treat some people with chronic lymphocytic leukaemia (CLL) routinely on the NHS, after cost regulators issued draft guidelines endorsing its use.
Imbruvica (ibrutinib) had only previously been available through the Cancer Drugs Fund (CDF), but following a price cut is now recommended as a routine option for people with CLL who have had treatment before, or who have genetic changes (known as 17p deletion or TP53 mutation).
Back in June NICE published draft guidelines rejecting the drug for treating pre-treated patients with CLL, but asked the company to put forward a case for including the drug on the new CDF for those with genetic changes.
The company made it clear that further data collected through the new CDF would not address the Committee's uncertainty about the drug's effectiveness for such patients, but did, however, offer a further discount in price which meant that the Institute could recommend Imbruvica for routine NHS use for both groups.
"Patients with this type of leukaemia are difficult to treat; they have very limited treatment options available and some treatments can cause severe side effects," said Professor Carole Longson, director of the centre for health technology evaluation at NICE.
"The committee found ibrutinib to be an innovative and effective drug for people who have had treatment before, or who have specific genetic changes. A further discount on price offered by the company meant that the committee could recommend ibrutinib as clinically effective and value for money for use in the NHS."
A year's treatment costs more than £55,000 per patient, but the NHS will pay less than this as per the confidential price cut.
Last month NICE turned down Imbruvica for treating some people with Waldenstrom's macroglobulinaemia (WM) - 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.