NICE says NO to ibrutinib again and asks company to put the drug forward for new Cancer Drugs Fund

We are extremely disappointed with the second preliminary decision by the National Institute for Health and Care Excellence (NICE) not to recommend ibrutinib to treat relapsed refractory CLL, this preliminary decision also confirms NICE are ‘minded’ not to recommend ibrutinib for treating patients with a 17p deletion or TP53 mutation.

This latest draft guidance is set out in a second appraisal consultation document    

Recommendations:

  • 1.1 ibrutinib is not recommended for treating chronic lymphocytic leukaemia in adults without a 17p deletion or TP53 mutation.
  • 1.2 The appraisal committee is minded not to recommend ibrutinib as an option for treating chronic lymphocytic leukaemia in adults with a 17p deletion or TP53 mutation. The committee invites the company to submit a proposal for inclusion in the Cancer Drugs Fund.  

Excerpt NICE press release :- If a proposal for ibrutinib entry into the new CDF is accepted by NICE and NHS, Ibrutinib will remain available to England 17p patients while more evidence is gathered to show how well it works. “In draft guidance the committee set out what the case for CDF consideration would need to look like. This includes details of data collection that would address uncertainties about the clinical benefits of ibrutinib and any necessary commercial access agreements to reduce the overall cost to the NHS.”

Excerpt NICE press release :-The committee also considered ibrutinib as an option for treating CLL without the 17p and TP53 genetic changes in people who have already received another treatment. Considerable uncertainty about the survival benefits and the fact it cost substantially more than treatments currently available on the NHS meant that the committee concluded that ibrutinib was not good value for money in this setting. NICE already recommends idelalisib and bendamustine for patients with CLL that has previously been treated.  

 Full NICE press release

The full preliminary guidance within the 2nd appraisal committee document can be downloaded along with the committee papers from the NICE website here, or a copy of the draft guidance can be viewed here 

These are preliminary recommendations only and may change ahead of the expected final appraisal decision following the third committee meeting in August. Should this preliminary guidance become final, those currently receiving Ibrutinib treatments under NHS would not be affected, treatment will continue until they and their clinician consider it appropriate to stop. 

Today’s NICE appraisal committee decision publication highlights that this NICE committee considers the high cost of ibrutinib compared to current therapies like idelalisib and bendamustine when combined with uncertainties about survival benefits is the main reason to prevent access via NHS for some patients?

This goes against the decisions made in countries across Europe where the treatment has been widely recommended and is available to patients.

Because patients are still alive and responding well (i.e. median progression-free survival (PFS) and overall survival has not yet been reached in the ibrutinib arm of the RESONATE clinical trial.) NICE are penalising this treatment. This leads us to believe that the NICE review procedure when considering the real benefits to patients and efficacy of this treatment is seriously flawed

We are also disappointed that NICE is continuing to insist that idelalisib is the only relevant comparator and are ignoring data from the comparison against ofatumumab  as well as the opinions and evidence provided by clinicians and patients..

CLL is an extremely heterogeneous condition and patients live with different comorbidities, treatment choices are a critical need. Treatment with ibrutinib does not just extend life but gives back to many, the opportunity to resume activities and maintain a near normal life again.  Ibrutinib is much needed as an option to treat relapsed refractory and 17p patients who do not respond to or are unable to tolerate conventional chemo therapeutics, this group have very few suitable options open to them. Not all patients are suitable for treatment with the idelalisib rituximab combination.

After the first ‘no’ from NICE we were deeply concerned that this may mean that patients will have access to even fewer effective new cancer medicines in the future

Our fears remain unchanged, we will continue to press our concerns and will participate in the next round of consultations. In the meantime we urge NICE to reconsider their latest preliminary recommendations.

 Nick York 

CLLSA trustee

 

Further information

Leukaemia Care - NICE ‘uncertain’ over ibrutinib benefit http://www.leukaemiacare.org.uk/news/nice-uncertain-over-ibrutinib-benefit

Janssen "extremely disappointed" with NICE refusal to recommend ibrutinib

http://www.pharmafield.co.uk/Pf-Fox-News/General/2016/06/Janssen-extremely-disappointed-with-NICE-refusal-to-recommend-ibrutinib

 CLLSA response following outcome of the first NICE appraisal committee meeting   http://www.cllsupport.org.uk/news/cllsa-response-nice-negative-draft-recommendation-ibrutinib-treat-chronic-lymphocytic-leukaemia#sthash.NDjJwvaO.dpuf