This is the letter sent to Professor Peter Clarke on 2nd July 2018 for the review of Ibrutinib prescribing.
Professor Peter Clark
Chair NHS England Chemotherapy Clinical Reference Group and Clinical Lead for the Cancer Drugs Fund, Specialised Commissioning NHS England
CLLSA and Leukaemia Care welcome the decision by NHS England to review of the criteria and evidence for treating relapsed CLL patients with Ibrutinib and the opportunity to contribute.
The recent decision by NHSE to restrict access to relapsed CLL patients who have had a remission longer than three years or are younger than 65 is preventing treating clinicians and patients accessing a suitable NICE approved therapy. This has created a therapeutic void and health equity issue between patients in the relapsed setting as these restrictions are not in place in Scotland or Wales.
In contrast to the NICE STA, FAD and guidance determination process, the restrictions added by NHSE to the NICE guidance were not reached following a transparent consultation process involving clinical experts and patient groups. We therefore hope that this review will add transparency to a process where all evidence and expert clinical and patient perspectives are considered.
CLLSA and Leukaemia Care firmly support and endorse the review replies, positions and current combined evidence provided by the CLL Forum (the UK CLL clinical expert group) and Janssen (the manufacturer). We ask that all the clinical guidance, reasoning and evidence provided to the committee is accepted to remove all the restrictions that are causing CLL patients immense distress and harm and that NICE/NHSE consider removing others imposed at a time when data sets were not mature and real-world evidence was not available.
This review provides an opportunity for NHSE to ensure that the relapsed CLL treatment pathway is easily and transparently navigable by patients and their clinicians and remains relevant today.
• We appeal to NHSE to use this review to remove the restrictions for relapsed patients with remission durations greater than 3 years.
The most recent draft BSH CLL Therapy Guidelines based upon recent trial data and real-world data experience are now in press and are available to NHSE.
The BSH guidelines state that retreatment with chemoimmunotherapy may be considered an option for fit CLL patients who relapse after a prolonged remission. This should remain as an option for patients who may wish a treatment free period but this should be agreed between the patient and clinician as the best option in that patient’s particular circumstances. Many patients are unsuitable for retreatment with a chemoimmunotherapy or do not wish to endure the effects of accumulative toxicities and significant infection/bone marrow suppression risks associated with chemo-based regimens. The draft BSH CLL treatment guidelines state: ‘Idelalisib with rituximab or ibrutinib monotherapy are the treatments of choice for patients with CLL who are refractory to CIT, have relapsed after CIT, or for whom re-treatment with CIT is inappropriate.’
Data and patient experiences also show that 2nd remissions gained following second line use of chemo-based regimens are likely to be much shorter and the negative quality of life issues experienced by patients are more severe. It is unreasonable to expect treating clinicians to expose patients to these toxicities and risks when they do not feel that chemotherapy is the best option for their patient. Following a shorter second remission Ibrutinib is often then prescribed but after health capacities and quality of life have been impaired.
Patients are today very aware of what treatments should be available and understand the process of disease evolution in CLL. Repeated use of chemotherapeutic agents hastens this. Restricting access to patients is causing significant emotional and psychological damage because they know that Ibrutinib offers them the chance of a longer remission than further chemotherapy.
• We appeal to NHSE to use this review to remove the restriction for relapsed patients younger than 65
The arbitrary age cut off at 65 that restricts access for relapsed patients younger than 65 is harming patients, as patients of any age may not tolerate chemoimmunotherapy if they have co-morbidities.
In an era of patient engagement and involvement in healthcare decisions, choice is important for a patient when considering maintaining quality of life and maintaining commitments. Many in this group will be in work, education and contributing to the family and community and quality of life and ability to carry out daily activities is an important consideration.
Outside of the trial setting, retreatment with chemoimmunotherapy is currently likely to be the only available option for this group. Chemoimmunotherapy adds a financial burden to patients who will be unfit for normal activities or work while also burdening the NHS with infection related complications and day clinic time to administrate the antibody therapy.
• We appeal to NHSE to use this review to make Ibrutinib available to all relapsed patients as was intended in the NICE STA, FAD and guidance determination.
We request that guidance includes access for those relapsing from a chemo-based regimen without a CD20 antibody therapy or from a chemoimmunotherapy using a different antibody therapy and includes those who could not tolerate an antibody therapy. We also request that those relapsed patients who have disease related cytopenias are not excluded from NHSE treatment with ibrutinib
• We appeal to NHSE to use this review to consider appropriate access to Ibrutinib for patients who develop Idelalisib related toxicity after 6 months
Current NICE guidance for ibrutinib use prevents patients failing Idelalisib from treatment with ibrutinib unless the patient fails due to Idelalisib related toxicity within six months of commencement of treatment. It is not clear how this particular guidance was established as Idelalisib related toxicity can develop at any time during treatment. We therefore request that the new guidance includes access to Ibrutinib if a patient fails Idelalisib due to treatment toxicity related issues at any time since commencement of therapy.
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