NHS England removes restrictions that were preventing relapsed CLL patients from gaining access to ibrutinib

Today (9th August 2018) NHS England removes restrictions that had been preventing relapsed chronic lymphocytic leukaemia patients from getting treatment with ibrutinib a NICE approved therapy.

Leukaemia Care welcome today’s decision by NHS England (NHSE) to remove several restrictions that were preventing groups of relapsed chronic lymphocytic leukaemia (CLL) patients from gaining access to ibrutinib, a NICE approved therapy. https://www.england.nhs.uk/cancer/cdf/cancer-drugs-fund-list

Patients are advised that in two weeks ibrutinib will become available those who have relapsed from a treatment after 3 years, without age restrictions.

We also welcome the decision by the company Janssen to fund some of the additional costs this involves.

In June we were dismayed that ibrutinib was not available to patients if they had relapsed more than three years after treatment or if younger than 65.  It was unclear how NHSE could implement such arbitrary restrictions, without a transparent process and evidence to overrule guidance from NICE. Read more here.

Today’s decision follows a July evidence review by NHSE, that gave patients, patient groups, the company and the clinical CLL community the opportunity to provide current evidence to support NHSE reinstating access to ibrutinib for several groups of patients. Read more here.

We are pleased with the broad scope of this review, the proper engagement with patient groups and the thoroughness of the review process. This has gone a long way to making ibrutinib available to the majority of relapsed CLL patients as per the licensed indication in this setting.

The review also looked at previous removal of bendamustine from the Cancer Drugs Fund (CDF) when Ibrutinib was included.  NHSE see this is an issue in CLL and are currently having this reviewed by the NHS England Specialised Commissioning policy prioritisation process. It is important that there are a range of options for patients and their clinicians when determining the most appropriate treatment.

Although we welcome today’s decisions by NHSE, we object to a policy that could enable NHSE to restrict NICE guidance and our concern is this may be happening to other drugs within other indications following issue of NICE guidance.

NHSE involvement within the NICE appraisal process needs to be more transparent and engagement earlier within the new drug scoping process; this may ensure appropriate positioning of a treatment, agreement of relevant data and understanding of the wider value of a treatment to patients when NICE determines a treatment guidance.

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