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news.The UK's National Institute for Health and Care Excellence (NICE) has opened a consultation on preliminary draft guidance for Gilead Sciences' drug idelalisib (Zydelig) for adults with chronic lymphocytic leukemia.
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The company should now provide more information to NICE to make a final decision on the use of idelalisib in combination with rituximab for adults with chronic lymphocytic leukemia whose disease is refactory to other treatments when it is not considered appropriate to treat again with previous therapies.
NICE does not recommend idelalisib for adults with untreated chronic lymphocytic leukemia with a 17p deletion or TP53 mutation in their genes or chronic lymphocytic leukemia 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According to the draft guidance, idelalisib plus rituximab is not good value for money for these groups so should not be routinely funded by the National Health Service (NHS).
The draft guidance has now been issued for consultation and NICE has not yet published final guidance to the NHS.
NICE Health Technology Evaluation Centre Director Carole Longson 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 additional information should be submitted to NICE until 09 July following which the committee will review any extra evidence and develop further draft guidance.