Nice rejects Janssen’s Imbruvica in draft guidance
The UK regulators have not recommended Janssen’s leukaemia drug Imbruvica (ibrutinib) to treat in draft guidance.
The National Institute for Health and Care Excellence (Nice) said although its advisory committee felt Imbruvica could benefit patients it recognised that with the current proposal, the drug was not cost effective.
Up to 1 in 10 adults with chronic lymphocytic leukaemia (CLL) have a form of cancer with genetic changes that make their disease progress quicker and more difficult to treat. The treatment options for CLL with these genetic changes (known as 17p deletion or TP53 mutation) are very limited.
Professor Carole Longson, Director of the Centre for Health Technology Evaluation at Nice said: “The incidence of chronic lymphocytic leukaemia (CLL) has been rising since the seventies, with thousands more people being diagnosed with the condition each year. 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 Imbruvica in the Cancer Drugs Fund (CDF).
“If the company puts forward a proposal that is accepted by Nice and NHS England, conditional funding will be made available for Imbruvica 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 Imbruvica and still ensure patients have access.”
Imbruvica works by blocking the signals which help cancerous cells multiply and survive. It is an oral tablet taken daily. A year’s treatment costs more than £55,000 per patient. The company have agreed to provide Imbruvica at a discounted price to the NHS.
Mark Hicken, managing director of Janssen UK, said: “There is very high clinical and patient demand for ibrutinib and we consider this latest draft decision from Nice to be very disappointing for patients with CLL, who currently have very limited 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.”