Janssen has slammed a draft decision by the National Institute for Health and Care Excellence rejecting NHS funding for its cancer drug Imbruvica to treat patients with Chronic Lymphocytic Leukaemia (CLL).
The Institute does not recommend Imbruvica (ibrutinib) for the treatment of adults with relapsed or refractory CLL without a 17p deletion or TP53 mutation who are not suitable for chemo-immunotherapy, and is also minded to reject the drug as an option for patients that do carry either of these mutations (around 10 percent).
However, the Institute has asked Janssen to set out a case for including the drug on the Cancer Drugs Fund, to determine whether it could be funded on the NHS for certain patients while additional data on its use is collected.
NICE's independent advisory committee felt that the drug could benefit patients whose CLL has these genetic changes, particularly those who have not yet received treatment. As such, further evidence could be collected on the 17p deletion group, and on the use of ibrutinib as the first treatment (an indication which has just been approved in Europe), before a final decision is reached, it said.
"Treating CLL is complex for some, options are limited and current treatments can have serious side effects. As part of our commitment to give patients faster access to promising new cancer drugs, we have invited Janssen to submit a proposal to include ibrutinib in the Cancer Drugs Fund (CDF)," noted Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE.
"If the company puts forward a proposal that is accepted by NICE and NHS England, conditional funding will be made available for ibrutinib in the CDF while more evidence is gathered to show how well it works. This will allow us to carefully monitor and evaluate the full benefits of ibrutinib and still ensure patients have access."
But in a statement Janssen said the decision "means that once again, the UK lags well behind other European countries that have already opted to fund or reimburse the medicine for a patient population who have very few treatment options".
"What is even more concerning is that, without changes to the way NICE appraises cancer medicines, such decisions are likely to become commonplace, under the new Cancer Drugs Fund or 'Managed Access Fund' process; resulting in patients receiving access to even fewer innovative cancer medicines in the future," added Mark Hicken, Managing Director of Janssen UK.