Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment he has made of the potential merits of vorasdenib for treatment of low-grade gliomas.
It is critical that medicines used in the United Kingdom are safe and effective and as such, medicines cannot be marketed in the UK without a marketing authorisation. These are granted by the Medicines and Healthcare products Regulatory Agency (MHRA) which assesses all medicines with regard to their quality, safety, and efficacy. Vorasidenib, sold under the brand name Voranigo, has not been licensed by the MHRA as a treatment for low-grade gliomas. It is the responsibility of the company to apply to the MHRA for the relevant marketing authorisation. Should an application for it be received, the MHRA will consider this accordingly.
In England, newly licensed medicines are also appraised by the National Institute for Health and Care Excellence (NICE) to determine whether they represent a clinically and cost-effective use of National Health Service resources. If the manufacturer of vorasidenib seeks a licence from the MHRA for the treatment of low-grade gliomas, then the NICE will consider it through the Technology Appraisal programme.