NICE wants more answers from Gilead on Zydelig
pharmafile | June 18, 2015 | News story | Sales and Marketing | Gilead, MabThera, NICE, Roche, UK, brett wells, zydelig
The National Institute for Health and Care Excellence has not recommended Gilead’s leukaemia drug Zydelig in draft guidance.
But the UK watchdog has opened a consultation towards gaining a final decision from the preliminary review for Zydelig (idelalisib) for adults with chronic lymphocytic leukaemia.
It has asked for further information from the US firm to make a final decision on its use in combination with Roche’s MabThera (rituximab) for adults with chronic lymphocytic leukaemia – whose disease is resistant to other treatments when it is not considered appropriate to treat again with previous therapies.
NICE also is not recommending Zydelig for adults with untreated chronic lymphocytic leukaemia 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According to the draft guidance Zydelig plus MabThera is not good value for money for these groups, so should not be routinely funded by the NHS.
Professor Carole Longson, NICE Health Technology Evaluation Centre director, says: “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.”
Gilead has until 15 July to submit the extra information to NICE. The committee will then review any extra evidence and develop further draft guidance.
Brett Wells
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