The National Institute for Health and Care Excellence (NICE) is the independent body that makes evidence-based recommendations on whether new medicines should be routinely funded by the National Health Service based on an assessment of clinical and cost effectiveness. NICE is currently evaluating vorasidenib for treating astrocytoma or oligodendroglioma with IDH1 or IDH2 mutations after surgery in people 12 years old and over.

NICE published its draft guidance for consultation on 15 October and was unable to recommend it as a clinically and cost-effective use of NHS resources. The appraisal is still ongoing, and NICE will take the comments received fully into account in developing its final recommendations. The committee reviewed the consultation comments at the committee meeting on 20 November 2025. NICE currently expect to publish final guidance in January 2026.

The National Institute for Health and Care Excellence (NICE) is the independent body that makes evidence-based recommendations for the National Health Service on whether new medicines should be routinely funded by the NHS on the basis of an assessment of clinical and cost effectiveness. NICE develops its guidance through extensive engagement with interested parties, including patient groups.

NICE is currently evaluating vorasidenib for treating astrocytoma or oligodendroglioma with IDH1 or IDH2 mutations after surgery in people 12 years old and over. As part of the appraisal process, NICE’s independent committee was provided with evidence submissions from three patient groups. The committee also heard expert personal perspectives from two patient experts.

The draft guidance was shared with all stakeholders as well as being published on the NICE website for public comment as part of the consultation which took place between 15 October and 4 November 2025. The committee reviewed the consultation comments at the committee meeting on 20 November 2025. NICE currently expects to publish final guidance in January 2026.

While the Department has made no assessment, the National Institute for Health and Care Excellence (NICE) is the independent body that makes evidence-based recommendations for the National Health Service on whether new medicines should be routinely funded by the NHS on the basis of an assessment of clinical and cost effectiveness. NICE is currently evaluating vorasidenib for treating astrocytoma or oligodendroglioma with IDH1 or IDH2 mutations after surgery in people 12 years old and over.

The draft guidance was shared with all stakeholders as well as being published on the NICE website for public comment as part of the consultation which took place between 15 October and 4 November 2025. The committee reviewed the consultation comments at the committee meeting on 20 November 2025. NICE currently expect to publish final guidance in January 2026.

This topic has not yet been referred to NHS England for a commercial negotiation by the National Institute for Health and Care Excellence (NICE). This is because the NICE appraisal process has not yet concluded and the preferred assumptions of the independent NICE committee on the comparative benefits and health and care related costs of vorasidenib following consultation have not yet been confirmed.

NHS England has signalled a willingness to engage in discussions with Servier pending further information following the second NICE appraisal committee meeting scheduled for 20 November, which will help to determine what, if any, approach to commercial arrangements, or managed access arrangements may be appropriate for this topic.

Department officials regularly speak with colleagues in the National Institute for Health and Care Excellence (NICE) to discuss a range of issues, including the status of individual appraisals. As NICE is an independent body, it would not be appropriate for the Department to interfere in the development of NICE’s recommendations on specific medicines. The Department has had no discussions about the appraisal of vorasidenib with Servier.

NICE recently published draft guidance for consultation on the use of vorasidenib for treating astrocytoma or oligodendroglioma with IDH1 or IDH2 mutations after surgery in people aged 12 years and over. The consultation closed on 4 November 2025 and NICE’s independent appraisal committee is scheduled to meet on 20 November 2025 to consider its recommendations in light of the consultation responses.

It is important that we have a system in place for making evidence-based decisions on whether new medicines should be routinely funded by the National Health Service, based on an objective assessment of their costs and benefits.

Research is crucial in tackling brain cancer, which is why the Department spends £1.5 billion each year on research through its research delivery arm, the National Institute for Health and Care Research (NIHR), with cancer as one of the largest areas of investment, at over £121.8 million in 2022/23, reflecting its high priority.

The NIHR welcomes funding applications for research into any aspect of human health, including clinical trials for brain cancer treatments. Applications are subject to peer review and judged in open competition, with awards being made on the basis of the importance of the topic to patients and health and care services, value for money, and scientific quality.

The Department aims to ensure that all patients, including those with brain tumours, have access to cutting-edge clinical research and innovative, lifesaving treatments. In order to maximise our potential to be a world leader and develop a more competitive, efficient, and accessible clinical research system, the Department is committed to rapidly implementing recommendations from the Lord O'Shaughnessy independent review of commercial clinical trials, and going further in our support for the forthcoming 10-Year Health Plan.

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.

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.

If the manufacturer applies for a marketing authorisation in the United Kingdom, the Medicines and Healthcare products Regulatory Agency will consider clinical trial evidence in making a licensing decision. Subject to licensing, the National Institute for Health and Care Excellence will consider the clinical trial evidence, when making decisions on whether vorasidenib should be recommended for routine National Health Service funding.

The Department has had no specific discussions with Servier regarding vorasidenib, and neither has the Medicines and Healthcare Products Regulatory Agency (MHRA). The MHRA has not issued a scientific opinion for Vorasidenib under the early access to medicines scheme but should an application for this be received, the MHRA will consider this accordingly.

The Medicines and Healthcare products Regulatory Agency (MHRA) has not granted a marketing authorisation for Vorasidenib, however should an application be received from Servier Laboratories, the MHRA has licensing pathways available, with the aim of ensuring the products can be made available for patients in the United Kingdom in the shortest time possible and to support and protect public health. While the MHRA will assess any submitted applications and is willing to facilitate the appropriate regulatory processes, the agency cannot actively seek these applications and as such there are currently no plans to discuss Vorasidenib with Servier Laboratories.

In the United Kingdom, medicines need to have a licence before they can be marketed, and these are granted by the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA has not issued a scientific opinion for Vorasidenib. Should an application for Vorasidenib be received, the MHRA will consider this accordingly.

The Secretary of State and the Department have had no specific discussions with Servier about making Vorasidenib available to clinically suitable brain tumour patients in the United Kingdom under the Early Access to Medicines Scheme (EAMS).

The Medicines and Healthcare Products Regulatory Agency (MHRA) has also not had any specific discussions with the Secretary of State regarding Vorasidenib. The MHRA has not issued a scientific opinion for Vorasidenib under EAMS but should an application for this be received, the MHRA will consider this accordingly.