Community update: Managed Access Programme from ILTOO Pharma

Since this article was published, we have learnt that ILTOO Pharma have changed the eligibility criteria for their Managed Access Programme (MAP) so it is now only accessible to people who were on the MIROCALS trial. This is because NHS Trusts were unable to approve access to the MAP without the trial data being available. You can find more information from MND Association's statement from 12th August 2024.

As part of our ongoing commitment to give options and hope to people living with MND, we’ve been continuing our discussions with ILTOO Pharma, clinicians, researchers and the community about rapid and efficient access to IL-2 (aldesleukin).

We understand from ILTOO that their Managed Access Program (MAP) for ILT-101 (the company’s manufactured form of IL-2) is now fully open and functioning for those living with MND who did not take part in the MIROCALS trial. Applications for any interested patients must be made to ILTOO Pharma by the neurologist of that individual, with approval sought via the Medicines and Healthcare products Regulatory Agency (MHRA). The guidance on the ILTOO Pharma website for submitting such a request is as follows:

“Requests for participation in a ILTOO Pharma MAP must be unsolicited and submitted by the treating physician on behalf of the patient. The request process includes the following steps:

• The treating physician submits a request through the following email address: aac.ilt-101@iltoopharma.fr
• ILTOO Pharma medical teams review the request fairly and promptly, providing a response once all required medical information has been received and, if applicable, national and local requirements or government Health Authority approval.
• If the request for MAP is approved, the treating physician must submit, collect, and complete all necessary documents and data to comply with appropriate rules, local regulations, and ILTOO Pharma policy throughout the treatment period.”

We would like to highlight that data on the effectiveness of IL-2 in the MIROCALS study has still not been released or rigorously assessed. Therefore we are simply passing on information that is likely to be of interest to the MND community, rather than giving medical advice. The outcome will depend on each individual NHS Trust and their willingness to apply for an unlicensed medicine, as well as any Trust-specific rules and procedures. Some neurologists and their Trusts may not sanction a request until the full MIROCALS trial data are released.

Sean McGrath, Medical Affairs Lead at My Name’5 Doddie Foundation, says: “We will continue to monitor the situation regarding access to IL-2, converse with all interested parties, and do all we can to expedite the process, so that in the event that a positive clinical consensus is formed upon release of the data, people living with MND can access the treatment as soon as possible.”