Chronic Lymphocytic Leukaemia: Ibrutinib

Lord O'Shaughnessy Excerpts

Thursday 7th June 2018 Lords Chamber

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord O'Shaughnessy) (Con)]

My Lords, the National Institute for Health and Care Excellence recommends Ibrutinib for the treatment of patients with chronic lymphocytic leukaemia who meet specified clinical criteria. NHS England is required to make funding available so that clinicians can prescribe treatments in line with NICE’s recommendations. NHS England has processes in place to transfer NICE’s recommendations into its commissioning systems, and I will be meeting both NHS England and NICE on Tuesday to seek assurance that their processes were appropriate in this case.

[Lord Forsyth of Drumlean (Con)]

My Lords, I am very grateful to my noble friend for that Answer and for his courtesy in meeting the patient support group at very short notice before the recess. What is the point of NICE if NHS England can get away with denying funding to some patients with relapsed chronic lymphocytic leukaemia, contrary to NICE guidance that Ibrutinib was an option for all patients relapsing after chemo-immunotherapy? Is my noble friend comfortable that clinicians in England, but not in Scotland or Wales, are being forced to reuse chemotherapy against their clinical judgment and at considerable risk and suffering to their patients? Is it not now time to listen to the advice set out in a letter to the Times of 18 May by our leading clinicians and bring the bean counters in NHS England to heel?

[Lord O'Shaughnessy]

First, I thank my noble friend for the question and for the opportunity to meet sufferers of this illness two weeks ago. As he and the House know, the point of NICE is to provide that expert, objective evaluation of the benefits of drugs both clinically and in terms of value for money. It has clearly made a recommendation in this case. I also know that there is concern about the discrepancy between NICE’s guidance—or, I should say, the summary in section 1 of that guidance—and NHS England’s commissioning guidance, which is narrower. It is precisely that concern about a discrepancy that we are investigating at the moment, and which will be the subject of the meeting that we are having. Once I have more information on that, I shall of course write to him and place a copy of that letter in the Library.

[Lord Patel (CB)]

My Lords, I agree with all the things that the noble Lord, Lord Forsyth of Drumlean, has said. Ibrutinib as a drug was developed after an extensive study to understand the biology of the disease, chronic lymphocytic leukaemia, which increasingly affects older people. Because it was developed following an extensive biological study, it is a targeted drug. In technological terms, it is a tyrosine kinase inhibitor. Therefore, it is more effective in the treatment of this disease and has a better outcome, and some countries have adopted this drug as the first line of treatment. We have used the guidelines that say that the first line of treatment—apart from patients who meet certain criteria, such as those with 17p deletion, who will be given the drug—will be chemotherapy. That then subjects people who have relapsed to a second toxic treatment with chemotherapy, which is wrong. For NHS England to use criteria that are completely arbitrary, except for cost, is also wrong. It should be required to produce the scientific evidence for that, and I hope that the Minister will agree.

[Lord O'Shaughnessy]

I thank the noble Lord for his question. There are two important issues here. First, on this treatment as a first-line treatment, the evidence that was put into NICE by the company itself did not propose its use as a first-line treatment, which is why it has been proposed as a second-line treatment. It is important to distinguish there. However, clearly there is this apparent discrepancy between the NICE guidelines and NHS England. I have, obviously, investigated this, subsequent to the meeting with my noble friend and sufferers. NHS England’s view is that its commissioning guidelines are consistent with the commissioning when the drug was in the cancer drugs fund, and the full NICE guidance, but I also know that that is not satisfactory to some of the patients suffering from this illness who have been in remission for three years. That is precisely what I want to get to the bottom of next week.

[The Lord Bishop of Carlisle]

My Lords, I am most grateful to the Minister for meeting some of the patients suffering from this terrible disease. Can he tell us whether anyone directly affected by blood cancer was consulted before the initial decision was made by NHS England to restrict access to Ibrutinib? Can he assure the House that NICE guidelines will not often be varied—and then only after consultation with patients?

[Lord O'Shaughnessy]

I thank the right reverend Prelate for that question. As he will know, NICE consults widely with patient groups and others in making its decisions. I am not clear at this stage whether NHS England met patient groups and others in designing its clinical commissioning guidelines, which is of course what I shall investigate next week.

[Lord Blunkett (Lab)]

First, I commend the Minister for being prepared to come to the noble Baroness Jowell’s funeral last week, which was greatly appreciated. Secondly, I commend him for his obvious commitment and detailed understanding on this particular issue that has been raised this morning. Is it not exactly the same issue as Baroness Jowell was raising, although on a very different treatment and challenge, which is that the best and most appropriate treatment should be available as quickly and easily as possible everywhere and to everyone, wherever they live?

[Lord O'Shaughnessy]

I am grateful to the noble Lord for that. I was privileged to be invited to the funeral, which was a very moving occasion for a very special lady. On his overall point, NICE approves 71% of cancer drugs that are applied for, so there is an absolute focus on making sure that the most effective cancer drugs can be brought to patients in England as soon as possible. Under the reformed cancer drugs fund, that can now happen from the point at which there is a draft guideline, which is often many months before it would otherwise be the case. That means that tens of thousands of people have been able to access cancer drugs earlier than they would ever have done before and, as a consequence, many lives have been saved.

[Baroness Jolly (LD)]

My Lords, the NHS constitution states that patients have a legal right to,

“drugs and treatments that have been recommended by NICE for use in the NHS”.

At the moment, in England, there are many men and women who have cataracts that are deemed by NICE as being ready for operation and for replacement, but the CCGs are refusing to commission and they are having to wait longer and longer. Can the Minister shed any light on this?

[Lord O'Shaughnessy]

I am afraid I do not know—it is a slight handbrake turn on the topic. I would of course be happy to meet the noble Baroness to discuss this issue; I was not aware of it, but I will happy to investigate it for her.

[Baroness Seccombe (Con)]

My Lords, can my noble friend the Minister explain why this NICE recommendation was rejected for the treatment for chronic lymphocytic leukaemia? NHSE operates a closed system whereas NICE is in direct contrast. There is no input in NHSE from patients or experts on this dreadful condition. If it is not reversed, will we not see poorer results for patients and, ultimately, higher costs for the NHS?

[Lord O'Shaughnessy]

I thank my noble friend for that question. This debate has highlighted just how passionately people care about this issue and making sure that we have good and quick access to the most effective cancer drugs. It is important to point out that, for this particular disease, Ibrutinib is available for many groups. There is clearly a concern about a potential discrepancy between the NICE guideline and the NHS commissioning guidelines. That is what I will try to get to the bottom of next week. I have to restate, however, that NHS England’s view is that its guidelines are based on the full guidance that came from NICE, not just the summary; it is that that I need to explore.