Written questions by Milne.

Whether his Department (a) has made and (b) plans to make an assessment of the impact of exposure to chemicals on cancer incidence rates.

The UK REACH regulation aims to protect human health from the risks that can be posed by chemicals, including substances of very high concern such as carcinogens. This is led by the Health and Safety Executive, with the UK Health Security Agency contributing to the process. The Department is currently not planning to make an assessment of the impacts of chemicals on cancer incidence rates for this reason.

What discussions he has had with NICE on ensuring that the Single Technology Appraisal process takes into account the health-related quality-of-life impacts on carers for (a) all and (b) rare disease therapies.

The National Institute for Health and Care Excellence’s (NICE) technology appraisal process allows its independent committees to take all health-related costs and benefits, including health-related quality-of-life for carers, and impacts on personal social services, into account. The NICE’s methods are set out in its published health technology evaluations manual, which is available at the following link: https://www.nice.org.uk/process/pmg36 Evaluations should consider all health effects for patients, and, when relevant, carers. When presenting health effects for carers, evidence should show when a condition is associated with a substantial effect on a carer’s health-related quality of life, and how the technology affects carers. This applies for all therapies, including therapies for rare diseases. NICE appraisals specifically consider health-related quality of life, for both patients and carers, rather than quality of life as a whole.

What discussions he has had with steps NICE on ensuring greater (a) clarity and (b) transparency in relation to how carer quality of life is considered within its medicines appraisal framework.

The National Institute for Health and Care Excellence’s (NICE) technology appraisal process allows its independent committees to take all health-related costs and benefits, including health-related quality-of-life for carers, and impacts on personal social services, into account. The NICE’s methods are set out in its published health technology evaluations manual, which is available at the following link: https://www.nice.org.uk/process/pmg36 Evaluations should consider all health effects for patients, and, when relevant, carers. When presenting health effects for carers, evidence should show when a condition is associated with a substantial effect on a carer’s health-related quality of life, and how the technology affects carers. This applies for all therapies, including therapies for rare diseases. NICE appraisals specifically consider health-related quality of life, for both patients and carers, rather than quality of life as a whole.

What steps NHS England is taking to ensure that NHS Trusts are able to deliver emerging treatments for Duchenne muscular dystrophy when they are needed by patients.

The Department understands the impact that Duchenne muscular dystrophy has on those living with it and their families, and the urgent need for new treatment options. If new therapies for Duchenne muscular dystrophy are approved by the National Institute for Health and Care Excellence (NICE), then appropriate commissioning plans will be put in place to enable equitable access to treatment through Specialised Neurology Services.The delivery of timely and equitable access to new treatments for Duchenne muscular dystrophy under company-sponsored early access schemes is not the responsibility of NHS England. Individual pharmaceutical companies may put in place Early Access Programmes (EAPs) to allow early access to new medicines that do not yet have a marketing authorisation. Participation in EAPs is decided at an individual National Health Service trust level, and under these programmes, the cost of the drug is free to both patients taking part in it, and to the National Health Service, although NHS trusts must still cover administration costs and provide clinical resources to deliver the EAP.There are no common clinical, data, or regulatory standards for company-sponsored EAPs, meaning each one demands a new protocol to be devised and delivered by each participating trust, which can create significant pressures on clinical and financial resources. Companies providing a sponsored EAP also reserve the right to limit or to close registration of new patients at any time, meaning that any financial and clinical investment made by trusts to establish an EAP could be undermined by a commercial decision that would most likely happen in the event of the treatment not being recommended following an appraisal by NICE.NHS England has published guidance for integrated care systems (ICS) on free of charge (FoC) medicine schemes, including EAPs, providing advice on potential financial, resourcing, and clinical risks.ICSs should use the guidance to help determine whether to implement any FoC scheme, including assessing suitability and any risks in the short, medium, and long term. The guidance is available at the following link:https://www.england.nhs.uk/long-read/free-of-charge-foc-medicines-schemes-national-policy-recommendations-for-local-systems/

What steps his Department is taking to increase early diagnosis of invasive lobular carcinoma.

The Department is committed to getting the National Health Service diagnosing cancer earlier and treating it faster so that more patients, including those with lobular carcinoma, survive this horrible set of diseases. To achieve this, the NHS has delivered an extra 40,000 operations, scans, and appointments each week as the first step to ensuring early diagnosis and faster treatment.There are multiple NHS initiatives and funding streams across the NHS in England that support the early detection of breast cancer, and many organisations across the health service are involved.The Department spends £1.6 billion each year on research through its research delivery arm, the National Institute for Health and Care Research (NIHR), with cancer as the largest area of spend at more than £133 million in 2023/24. The NIHR spends more on cancer than any other disease group, reflecting its high priority. These investments in cancer, including lobular breast cancer, are pivotal to informing efforts to improve cancer prevention, treatment, and outcomes.The forthcoming National Cancer Plan will include further details on improving outcomes for cancer patients, including those with invasive lobular carcinoma, and will highlight how the Department will support the NHS to improve diagnosis rates for people in all parts of England.

Whether (a) he and (b) the Minister for Public Health and Prevention will attend the Lobular Moon Shot Project's drop in on Tuesday 6 May 2025 to discuss research into lobular breast cancer.

Due to diary pressures, neither myself nor my Rt Hon. Friend, the Secretary of State for Health and Social Care will be attending the Lobular Moon Shot Project’s drop in event on 6 May 2025. However, the Department will continue to fund research into lobular breast cancer through the National Institute for Health and Care Research (NIHR).The NIHR welcomes funding applications for research into any aspect of human health and care, including lobular breast cancer. These 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. Welcoming applications on lobular breast cancers to all NIHR programmes enables maximum flexibility both in terms of the amount of research funding a particular area can be awarded, and the type of research which can be funded.

What steps he is taking to ensure that glaucoma monitoring services are available to patients in (a) Horsham and (b) England.

Integrated care boards are responsible for commissioning primary and secondary eye care services in their areas to meet patient needs, and this includes services to meet the needs of patients with glaucoma.The Department worked with the eye care sector to develop a standard clinical specification for the commissioning of Community Minor and Urgent Eye Care Services, and this was published in February 2024. The specification is available at the following link:https://locsu.co.uk/wp-content/uploads/2024/02/1.-CUES-Service-specification-vs-1.43-Feb-2024.pdf

Whether his Department plans to issue new guidance on the provision of advanced community eye care services in (a) Horsham and (b) England.

Integrated care boards are responsible for commissioning primary and secondary eye care services in their areas to meet patient needs, and this includes services to meet the needs of patients with glaucoma.The Department worked with the eye care sector to develop a standard clinical specification for the commissioning of Community Minor and Urgent Eye Care Services, and this was published in February 2024. The specification is available at the following link:https://locsu.co.uk/wp-content/uploads/2024/02/1.-CUES-Service-specification-vs-1.43-Feb-2024.pdf

Whether his Department has made an assessment of the potential merits of offering the RSV vaccination to people over the age of 65.

The policy for the respiratory syncytial virus (RSV) programme is based on the advice of the Joint Committee on Vaccination and Immunisation (JCVI), an independent expert advisory committee. That advice is provided to the Government to inform, develop, and make policy.In 2023, RSV programmes for those aged over 65 years old and those aged over 75 years old were assessed by the JCVI for their potential impact and cost effectiveness. There was more certainty in the data available at the time to support a programme for those aged over 75 years old. Therefore, the JCVI advised a programme for older adults aged 75 years old and above. However, the JCVI did note that as more data accumulated, the impact and cost effectiveness for those aged over 65 years old could be kept under review.The committee keeps all vaccine programmes under review and will continue to update its advice as new evidence emerges.

If his Department will urge CEOs of relevant Trusts to provide (a) financial and (b) personnel support so that administration of givinostat can begin in weeks.

The National Institute for Health and Care Excellence (NICE) makes recommendations for the National Health Service on whether new licensed medicines should be routinely funded by the NHS independently, based on an assessment of their costs and benefits. The NHS in England is legally required to fund medicines recommended by the NICE, normally within three months of the publication of final guidance. The NICE is currently evaluating givinostat, and its Appraisal Committee will meet to consider its recommendations in May 2025.ITF Pharma UK, the United Kingdom marketing authorisation holder for givinostat, is providing access to givinostat through a type of compassionate use scheme called an Early Access Programme (EAP). NHS England does not have any initiatives to encourage participation in compassionate use schemes, which are the responsibility of individual pharmaceutical companies. Participation in the EAP for givinostat, which must be through one of the 23 NorthStar Centres in the UK, is decided at an individual NHS trust level, although there is general advice that trusts should engage with the relevant commissioner if they choose to participate. A NorthStar Centre will not be able to provide givinostat if its local trust has not approved participation. Under the EAP, givinostat is free to both patients taking part in it and to the NHS, but the trusts must still cover the cost of administering it to patients. Only Duchenne muscular dystrophy clinicians can make requests for givinostat for their patients. Decisions are made on a case-by-case basis for individual named patients aligned to eligibility criteria.

If he will meet the hon. Member for Horsham and Dr Susan Michaelis, founder of the Lobular Moon Shot Project, to discuss his Department's work on invasive lobular breast cancer.

The Health Mission sets the objective of building a National Health Service fit for the future. As part of that work, and in response to the Darzi report, we have launched an extensive programme of engagement to develop a 10-Year Health Plan to reform the NHS. The plan will set out a bold agenda to deliver on the three big shifts, from hospitals to the community, from analogue to digital, and from sickness to prevention. In addition, following publication of the 10-Year Health Plan, we will develop a new national cancer plan. The cancer plan will include more details about how to improve outcomes for all tumour types, including lobular breast cancer, and ensure that patients have access to the latest treatments and technology. We are now in discussions about what form that plan should take, and what its relationship to the 10-Year Health Plan and the Government’s wider Health Mission should be, and will provide updates on this, including on publication dates, at the earliest opportunity. We would encourage the Hon. Member for Horsham and Dr Michalis to input to the process, which would help to shape the national cancer plan.

If he will take steps to ensure that the early access programme for people with Duchennes is made available across all NHS trusts.

Access to the Early Access Programme (EAP) for givinostat must be through one of the 23 NorthStar Centres in the United Kingdom. However, participation in the EAP is decided at an individual National Health Service trust level, and a North Star Centre will not be able to provide givinostat if its local trust has not approved participation. Under the EAP, givinostat is free to both patients taking part in it and to the NHS, although the NHS trusts must still cover the cost of administering it to patients. Only Duchenne muscular dystrophy clinicians can make requests for givinostat for their patients. Decisions are made on a case-by-case basis for individual named patients aligned to eligibility criteria.

With reference to Prostate Cancer UK's research entitled Optimising the use of the prostate- specific antigen blood test in asymptomatic men for early prostate cancer detection in primary care: report from a UK clinical consensus, published on 25 July 2024, if he will take steps to implement the recommendation on reviewing guidelines on allowing primary care staff to proactively discuss (a) prostate cancer risk and (b) prostate specific antigen testing with men at highest-risk of developing that cancer.

The UK National Screening Committee is aware of the Prostate Cancer UK report, and this will be considered as part of its evidence review process, with further information available at the following link:https://www.gov.uk/government/publications/uk-nsc-evidence-review-process/uk-nsc-evidence-review-processThe Prostate Cancer Risk Management Programme (PCRMP) provides general practitioners (GPs) with information and guidance to counsel men who have no symptoms, but wish to have a Prostate Specific Antigen (PSA) test. It highlights the potential benefits and harms of PSA testing so that men, including those at higher risk, can make an informed decision about whether to have the test.Based on the current evidence, the PCRMP guidance is for GPs not to proactively offer a PSA to men without symptoms. This is because of the high level of inaccuracy of the PSA test which could lead to unnecessary tests and treatments that carry risks of life-changing harm, such as urinary and faecal incontinence, sexual dysfunction, as well as a smaller but serious risk of sepsis. Additionally, some prostate cancers may not produce elevated PSA levels, leading to false-negative results that provide deceptive reassurance.