NICE asks for further information to make a final decision on use of idelalisib with rituximab to treat adults with chronic lymphocytic leukaemia

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18 June 2015

NICE has asked for further information from the company 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 refactory 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 According to the draft guidance idelalisib  plus rituximab is not good value for money for these groups so should not be routinely funded by the NHS.

 

NICE PRESS RELEASE

https://www.nice.org.uk/news/press-and-media/nice-seeks-more-information...

Draft Guidance

https://www.nice.org.uk/guidance/gid-tag488/resources/leukaemia-chronic-...

 

Note that Scottish medicines Consortium recently approved Idelalisib (Zydelig) for NHS scotland  use... https://www.scottishmedicines.org.uk/SMC_Advice/Advice/1026_15_idelalisi...

While this preliminary announcement by NICE is disappointing this is not final guidance, there are many areas requiring clarification not least verification of best appropriate data modelling so when applied to ICERs  there will be a true reflection in the QALY calculation. There is a serious unmet clinical need for this population of patients who have few or no effective treatments available to them.   

CLLSA has been participating during the appraisal process along with UK leukaemia charities and the clinical community to provide the patient group perspective and clinical need (see  draft guidance) We will  continue to participate in this consultation to voice strongly the need for access to this treatment technology for a group who otherwise have few options.

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.

The company has until Thursday 9 July 2015 to submit the extra information to NICE. The committee will then review any extra evidence and develop further draft guidance.