NICE seeks more information on idelalisib from Gilead

The National Institute for Health and Care Excellence (NICE) has opened a consultation on preliminary draft guidance for the drug idelalisib (Zydelig) for adults with chronic lymphocytic leukaemia.

NICE has asked for further information from Gilead Sciences to make a final decision on the use of idelalisib in combination with the drug 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.

Meanwhile, NICE does not recommend idelalisib 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 According to the draft guidance, idelalisib plus rituximab is not good value for money for these groups so should not be routinely funded by the NHS.

This draft guidance has now been issued for consultation: NICE has not yet published final guidance to the NHS.

Still questions to be answered regarding the cost effectiveness of idelalisib

Professor Carole Longson, NICE 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.”

Gilead 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 The committee will then review any extra evidence and develop further draft guidance.

Once NICE issues its final guidance on a technology, it replaces local recommendations across the country.