Maraviroc and Progressive Multifocal Leukoencephalopathy — House of Commons, 2019-09-30
Topic: Health
Johanna Peta Churchill (Conservative, Centre-right): 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.