NICE has rejected a new blood cancer drug from Gilead but has opened a consultation on its decision.
Specifically, England’s drug pricing watchdog has opened a consultation on its preliminary draft guidance for the drug Zydelig (idelalisib) for patients with chronic lymphocytic leukaemia (CLL).
NICE is asking for further information from Gilead to make a final decision on the use of Zydelig, in combination with Roche’s MabThera (rituximab), for CLL patients whose disease is resistant to other treatments when it is not considered appropriate to treat again with previous therapies.
Meanwhile, NICE also does not recommend the treatment in its second lincence, for patients with untreated CLL with a 17p deletion or TP53 mutation in their genes, or chronic lymphocytic leukaemia when the disease has been treated but has relapsed.
According to NICE, Zydelig and MabThera are “not good value for money for these groups”, and therefore should not be funded by the NHS.
This draft guidance has now been issued for consultation, meaning NICE has not yet published final guidance to the NHS. The drug remains available under England’s £280m a year Cancer Drugs Fund.
Professor Carole Longson, NICE’s health technology evaluation centre director, said: “The independent appraisal committee, which is developing the guidance on behalf of NICE, considered evidence from the company, clinical experts and patient representatives.
“It concluded there were still questions to be answered about the cost effectiveness of the treatment. We have requested further analysis from the company; we want to ensure we have as much information as possible to make an informed recommendation.”
The company has until Thursday 15 July 2015 to submit the extra information to NICE. The committee will then review any extra evidence and develop further draft guidance.