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 According to the draft guidance idelalisib  plus rituximab is not good value for money for these groups so should not be routinely funded by the NHS.

This draft guidance has now been issued for consultation: NICE has not yet published final guidance to the NHS.

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 The committee will then review any extra evidence and develop further draft guidance.

Until final guidance is issued, NHS bodies should make decisions locally on the funding of specific treatments.

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

Notes to Editors

About the draft guidance

1. The draft guidance, ‘Idelalisib for treating chronic lymphocytic      leukaemia’, will be available at from 18 June 2015, at:

 https://www.nice.org.uk/guidance/gid-tag488/resources/leukaemia-chronic-lymphocytic-previously-treated-idelalisib-id764-appraisal-consultation-document2

2. NICE requests further analyses from the company, which should be made available for the second appraisal committee meeting, and should include:

• a revised cost-effectiveness analysis for the comparison of idelalisib plus rituximab with rituximab alone, best supportive care and ofatumumab incorporating the changes made to the company model (see sections 3.48-3.50):

−     Reducing the length of treatment benefit for idelalisib plus rituximab to 5 years

−     Using utility values from Dretzke et al. (2010) for both the pre-progression and post-progression model states

• A sensitivity analysis exploring the length of treatment benefit of idelalisib plus rituximab from treatment discontinuation up to 5 years
• A sensitivity analysis exploring the effects of reducing the proportion of non-responders having intravenous immunoglobulin from 45% to 20% or less and increasing the number of responders having intravenous immunoglobulin from 0% to 20%
• A sensitivity analysis exploring the effect of using clinical effectiveness data from the subgroup of people in Study 116 whose disease is refractory.
• for untreated chronic lymphocytic leukaemia in adults with a 17p deletion or TP53 mutation or
• for chronic lymphocytic leukaemia in adults when the disease has been treated but has relapsed.

3. Idelalisib, in combination with rituximab, is not recommended:

4. In people with previously treated refractory      chronic lymphocytic leukaemia, the Committee agreed that it was not      possible to determine the most plausible ICER for the comparison of      idelalisib plus rituximab compared with rituximab. It concluded that further      analyses should be provided by the company.

1. For people with previously treated relapsed chronic lymphocytic leukaemia, the appraisal committee agreed that rituximab was not an appropriate comparator for this population and it therefore considered the results of the company’s exploratory analyses of idelalisib with rituximab compared with the other comparators listed in the NICE scope.

When the ERG’s amendments were applied the ICERs reported for all the comparisons were over £30,000 per QALY gained.

6. For people with untreated      chronic lymphocytic leukaemia with a 17p deletion or TP53 mutation, the Committee      noted that the clinical evidence provided by the company was limited and      that the company had not presented a cost-effectiveness analysis for this      population.