Asked by: Lord Markham (Conservative - Life peer)
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.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
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.
Asked by: Lord Markham (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what steps they are taking in the upcoming national cancer plan to identify and address regional disparities in the diagnosis and treatment of ovarian cancer.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
It is a priority for the Government to support the National Health Service to diagnose cancer, including ovarian cancer, as quickly as possible, to treat it faster, and to improve outcomes. This is supported by NHS England’s key ambition on cancer to meet the Faster Diagnosis Standard, which sets a target of 28 days from urgent referral by a general practitioner or screening programme to patients being told that they have cancer, or that cancer is ruled out.
Reducing inequity and variation in cancer care is a priority for the Government, as is increasing early cancer diagnosis, as both are key contributors to reducing cancer health inequalities. Early cancer diagnosis is also a specific priority within the NHS’s wider Core20Plus5 approach to reducing healthcare inequalities.
In addition, we have committed to delivering an extra 40,000 operations, scans, and appointments each week, during our first year in Government as the first step to ensuring early diagnosis and faster treatment.
The recently announced National Cancer Plan will have patients at its heart and will cover the entirety of the cancer pathway, from referral and diagnosis to treatment and aftercare. It will seek to improve every aspect of cancer care to improve the experience and outcomes for people with cancer. This will include improving levels of early diagnosis across England. Our goal is to reduce the number of lives lost to cancer over the next ten years, including to ovarian cancer.