Question to the Department of Health and Social Care:

To ask His Majesty's Government what steps they are taking to measure the effectiveness of and potential to rapidly adopt cancer therapies that require non-genomic biomarker testing.

The Medicines and Healthcare products Regulatory Agency (MHRA) has a key role in assessing the safety and efficacy of any medicine, and newly licensed medicines are appraised by the National Institute for Health and Care Excellence (NICE).

The NICE routinely appraises medicines with accompanying biomarkers/companion diagnostics and considers the relevant costs and implications in order to provide robust guidance and support rapid access to clinically and cost-effective medicines. Additionally, the MHRA and the NICE are already actively engaged in supporting industry through scientific advice ahead of, and as part of, the regulatory approval process for cancer therapies that require non-genomic biomarker testing. The MHRA is also working on guidance and further support for industry to better understand how biomarkers and similar products are considered in the regulatory process. This includes, but is not limited to, non-genomic testing.

The MHRA encourages potential applicants to engage early to establish the suitability of biomarkers in the Scientific Advice process, as these decisions are frequently specific to the indication and intended use. The MHRA also supports the development and availability of innovative medicines through a range of regulatory initiatives designed to enable earlier patient access while maintaining uncompromising standards of safety. Central to this is the Innovative Licensing and Access Pathway (ILAP), which offers a joined-up approach between the MHRA, the NICE, and National Health Service bodies, including within the devolved administrations. The ILAP provides early regulatory input through an Innovation Passport and a tailored roadmap to authorisation, helping promising new medicines reach patients more quickly.