Maraviroc and Progressive Multifocal Leukoencephalopathy
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The Parliamentary Under-Secretary of State for Health and Social Care (Jo Churchill)
I thank the hon. Member for Feltham and Heston (Seema Malhotra) for raising this matter in the House, and for the comprehensive and sensitive way in which she has set out problems that will certainly be well recognised by many patients—not only her constituent, but people throughout the rare disease community. A number of the issues that she has raised affect what are often very small cohorts trying to put their case for particular drugs.
As we have heard from the hon. Lady, progressive multifocal leukoencephalopathy is a terrible disease which can have devastating effects on patients whose immune systems are already impaired, often as a result of taking medicines. Maraviroc is an antiretroviral drug approved by the Medicines and Healthcare Products Regulatory Agency for the treatment of HIV. In this case, the hon. Lady’s constituent, who unfortunately has multiple sclerosis, has been paying privately for the drug, which I understand she feels has a positive effect on her condition.
The use of Maraviroc for people with MS is “off-label”. Medicines sold and supplied in the UK must, rightly, have a licence, which specifies the medical conditions that they are approved to treat, and also specifies the recommended doses, contra-indications, and special warnings as specified by the MHRA. All that is intended to ensure the safety of the patient. Off-label use, as I am sure the hon. Lady is aware, describes that situation where the licensed medicine is used for an indication other than that for which it is licensed originally. However, as she said, a decision to use a medicine off-label is one for the individual clinician. In each case, it is for that professional to make that decision if they think the treatment is appropriate for a patient and they are satisfied that there is robust evidence to support their prescribing decision.
As the drug in question is a licensed medicine for the treatment of HIV, not PML, it has not been fully tested with PML patients in clinical trials. Therefore, it has not been approved as safe and effective. Crucially, it is important to note that the use of this drug to treat Natalizumab-induced PML currently has an evidence base limited to small observational studies where no conclusive evidence of patient benefit was found. However, I fully appreciate that it is a real challenge to establish a clinical evidence base when the patient population is so small.
In fact, as the hon. Lady mentioned, NHS England and NHS Improvement were asked in 2018 to develop a commissioning policy on the use of Maraviroc for the treatment of Natalizumab-induced PML. They concluded, however, that there was insufficient evidence of benefit and advised against routine commissioning. Maraviroc is not currently appraised or recommended by national bodies for the treatment of PML, because there is a lack of evidence of effectiveness and a lack of any evidence-based clinical support in the treatment of PML. NHS England has therefore concluded that there is not sufficient evidence to support the routine commissioning of the drug—a conclusion that clinical commissioning groups are minded to follow. Of course, that position would be reviewed should further evidence become available.
Despite Maraviroc not being routinely commissioned by the NHS, it remains possible for patients to access the drug through the individual funding request, which, as the hon. Lady has said, her constituent did. An independent panel would have considered the circumstances of the request before making a decision. In this case I understand that the IFR was rejected, which I know would have been upsetting for the hon. Lady’s constituent. Following the outcome of the IFR, the reasons for the decision would, I am sure, have been explained to her constituent. If not, I urge the hon. Lady to ensure that they are explained in full.
Seema Malhotra
I understand that this is a technical matter in some respects, but I am a little surprised that I have not heard the Minister say anything new compared with the responses I have received to parliamentary questions. I have laid out the evidence and shown that there are nuances. In the case of my constituent, the medical benefits have been clear. I am surprised that the IFR was denied, including subsequently on appeal, and, given that I have laid out the evidence, that the Minister is not in a position to give advice on how we can move forward so that we do not keep going around in circles.
Jo Churchill
I think that part of the confusion has come from the fact that the NHSE advice not to commission is different from the independent funding route process. Clinicians can always apply for IFR funding in exceptional circumstances. The MHRA parliamentary question was about availability. One offer I can make is that we will try to unpick those four answers and to understand a little more in the round how we can be of assistance and give the hon. Lady’s constituent clarity, if nothing else.
Seema Malhotra
The Minister is very generous in giving way. Rather than restating the policy, will she support the request for the medical advice that was the reason for the treatment and funding being refused? There must have been some medical input into the decision made by the panel at NHS England. Will she also be able to meet me to review the process and what my constituent has been through? Clearly my constituent is in a very rare circumstance—she is possibly one of fewer than 10 people in the country—but surely we are able to work a bit faster and with more agility in a situation where, in a sense, the patient and the experts in the field should be leading.
Jo Churchill
I am, of course, happy to meet the hon. Lady, but we must be led by clinicians. As she says, her constituent has been supported by her clinicians, and it is up to them to make clinical judgments and to put the case for the best course of treatment in each particular case. The first thing to do is to seek clarification on where we know we are going, and hopefully we can move forward from there.
As the hon. Lady says, the PML group is around 10 in number, so getting robust evidence is obviously a challenge—that is all part and parcel of the issue. As she knows, another challenge is that the Department of Health and Social Care does not have direct responsibility for what is routinely commissioned. Instead, it is the responsibility of NHS England, NHS Improvement and the CCGs. Faced with an unprecedented level of demand for services, all those involved have to make difficult decisions about commissioning cost-effective care on a daily basis. They make those decisions based on patient need and clinical evidence, which I acknowledge can feel very cyclical for the rare disease community.
Seema Malhotra
Does the Minister agree it is slightly more problematic in this case, because the cost of Maraviroc is arguably a bit less than the MRI scans and the steroids every month that the NHS would otherwise prescribe or suggest to my constituent? The negative health impact of that treatment should also be taken into account.
Jo Churchill
I thank the hon. Lady, but I return to the fact that it is a judgment for clinicians to make; it is not one for me to make at the Dispatch Box.
My colleague Baroness Blackwood rightly said this summer that we need a national conversation on rare diseases to identify the big areas on which we need to focus so that we can offer the best possible care for rare disease patients and their families, who are often affected by what their loved ones are going through. I could not agree more so, starting this autumn, we will be engaging with patients, researchers and clinicians to gather evidence and identify the major challenges faced in this field.
Jim Shannon
I am pleased to see the Minister in her place. I offer her congratulations; it is well deserved.
Will money be set aside at the end of the consultation to address the medicines that are needed for those rare diseases? If money is not set aside, it will not go anywhere.
Jo Churchill
I am not in a position to say. Although each cohort is small, the overall rare disease community is large. That is why such debates make an important contribution to the broader conversation. I am grateful for how they raise awareness of the rare disease community, which comprises some 3.5 million people in this country.
Seema Malhotra
I will make this my last intervention. I just want to welcome the work that will be done in respect of the rare disease community. May I add to the comments in this House in welcoming the Minister to her place? I know that her experience will be extremely valuable in the work that she does in the Department.
Jo Churchill
I thank the hon. Lady sincerely for that and for speaking so passionately here today about the situation on behalf of her constituent. I know that her constituent may not feel that this is the answer that she wanted, but I cannot emphasise enough the positive effect of bringing this issue to the Chamber. Not only will it raise awareness, to help inform Government strategy, but it will support others in the rare disease community. As the hon. Lady said, allowing their voice to be heard is what is important here.
Question put and agreed to.