Written questions by Mierlo.

What discussions he has had with the National Institute for Health and Care Excellence on securing long term access to cerliponase alfa.

Officials in the Department have had a number of discussions with colleagues in the National Institute for Health and Care Excellence (NICE) about the ongoing appraisal of cerliponase alfa (Brineura) for the treatment of neuronal ceroid lipofuscinosis type 2 (CLN2). The Government understands the devastating impact of this condition on those affected, and how important the availability of effective new treatments is to patients and their families.An agreement has now been reached between NHS England and the manufacturer of Brineura, BioMarin, that secures continued access for patients who have already started treatment with Brineura or who begin treatment before the end of this year.NICE is, at present, unable to recommend Brineura for routine National Health Service funding for new patients in its draft guidance published in August. This decision comes after commercial negotiations between NHS England and BioMarin failed to secure a price for the treatment that properly reflects the limited evidence of its long-term effectiveness.I recognise how disappointing this will be to all those affected, but I would like to underline that NICE has not yet concluded its appraisal. Stakeholders, including patient groups and the company, have had an opportunity to appeal the final draft guidance. If no appeal goes ahead, NICE expects to publish its final recommendations on cerliponase alfa in October.

Pursuant to the Answer of 7 March 2025 to Question 35541 and and the Answer of 12 May to Question 50770 on Hormone Replacement Therapy, (a) what progress has been made and (b) what further steps are being taken to ensure a continued supply of HRT implants for patients.

The Department is continuing to work closely with the Medicines and Healthcare products Regulatory Agency (MHRA) to ensure safe access to oestrogen and testosterone hormone replacement therapy (HRT) implants, which are not licensed in the United Kingdom.The MHRA has been working closely with the current importers of the product and is also looking to encourage other applications for a licensed medicinal product. The MHRA is currently assured that there are over 13 months of product in the UK based on currently available stocks and usage rates.As oestrogen and testosterone HRT implants are not licensed in the UK, we are encouraging applications to supply products through the licensed medicines route.The Department is working closely with the MHRA to ensure safe access to these products. The Department have also reached out to specialist importers, who can source unlicensed medicines, to find alternative sources of both HRT implants for UK patients. The Department will continue to work closely with the MHRA and the National Health Service to ensure that suitable alternatives are available for patients.

Pursuant to the Answer of 15 July to Question 66814 on Health Services: Oxfordshire, what steps he is taking to ensure that Oxford University Hospitals NHS Foundation Trust is able to recruit and retain midwives in the context of efficiency savings.

The Government is committed to ensuring the National Health Service can both recruit and retain staff. We recently announced the Graduate Guarantee for nurses and midwives, which will ensure that there are enough positions available for every newly qualified midwife in England, and includes £8 million to support the temporary conversion of vacant maternity support worker posts to band 5 registered midwifery roles.Additionally, NHS England is undertaking targeted retention programme for midwives, led by the Chief Nursing Officer. This includes: a midwifery and nursing retention self-assessment tool; mentoring schemes; strengthened advice and support on pensions and flexible retirement options; and the publication of menopause policies and guidance. NHS England has also invested in unit-based leads in every trust who focus on retention and provide pastoral support to midwives. This initiative, alongside investment in workforce capacity, has seen a reduction in vacancy, leaver and turnover rates.

When he plans to respond to the letter of 10 July 2025 from the hon. Member for Henley and Thame on maternity services.

The letter has been passed to Baroness Amos as chair of the independent investigation into National Health Service maternity and neonatal care, and she will respond directly in due course.

Pursuant to the Answer of 14 July 2025 to Question 64336 on Vamorolone, what the consequences are for (a) Integrated Care Boards and (b) NHS Trusts for not making NICE recommended medicines available within 90 days of publication of relevant guidance.

Commissioners have a statutory responsibility to make funding available for a medicine or treatment recommended by a National Institute of Health and Care Excellence (NICE) technology appraisal (TA) or highly specialised technology evaluation (HST) within the timeframe recommended in that guidance, usually within three months of the TA or HST being published.Under the National Health Service Constitution, patients have a right to receive all medicines and treatments recommended by NICE if they and their healthcare professional think that the medicine is right for them. In practical terms, the effect of this legal obligation and the NHS constitution is that all NICE-approved treatments must be included in local formularies for use in line with the TA or HST recommendations and with no additional funding or formulary restrictions.The only exception is if the technology is not relevant to the care provided by the organisation; for example, cancer treatments would not need to be included in the formulary of a mental health trust, and treatments for dementia would not need to be included in the formulary of a specialist children’s hospital. There is no provision to take affordability into account when adding NICE-approved medicines to local formularies.NHS enforcement guidance relating to its statutory accountability and oversight role, under the NHS Act 2006, the 2012 Act and the 2022 Act is available at the following link:https://www.england.nhs.uk/long-read/nhs-enforcement-guidance/The evolving NHS operating model will strengthen capabilities and clarify roles in overseeing performance. As set out in the 10-Year Health Plan for England, we will move to a Single National Formulary (SNF) for medicines within the next two years. The SNF will play a role in driving rapid and equitable adoption of clinically and cost-effective innovations.

Pursuant to the Answer of 27 January to Question 25553 on Methylphenidate Shortages, if he will make an assessment of the adequacy of the current supply of methylphenidate for ADHD.

The Department has worked closely with industry stakeholders, and, following extensive collaborative efforts, previous issues have been resolved and all strengths of lisdexamfetamine, atomoxetine capsules, atomoxetine oral solution, guanfacine prolonged-release tablets and methylphenidate prolonged-release tablets and prolonged-release capsules are now available.We continue to support the NHS England Attention Deficit Hyperactivity Disorder (ADHD) taskforce, which brings together expertise from the National Health Service, education, and justice sectors to coordinate a system-wide response to rising demand. In collaboration with NHS England’s national ADHD data improvement plan, we are developing future growth forecasts to support improved demand planning. These forecasts will be shared with industry to help ensure a more responsive and sustainable supply of ADHD medicines.In parallel, we are also engaging with new suppliers for ADHD medicines to increase supply capacity and resilience.The Department also maintains and regularly updates a list of currently available and unavailable ADHD products on the Specialist Pharmacy Service website. This resource supports prescribers and dispensers in making informed decisions with patients. The list is available at the following link:www.sps.nhs.uk/articles/prescribing-available-medicines-to-treat-adhd

What steps his Department is taking to ensure that the impact on carers is included in NICE technology appraisals for rare and progressive diseases.

NICE’s technology appraisal process allows its independent committees to take societal benefits, such as health-related quality-of-life for carers and impact on personal social services, into account. 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 the condition is associated with a substantial effect on 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 his Department is taking to ensure that NICE appraisals for (a) Duchenne muscular dystrophy and (b) other rare, progressive conditions take into account urgency of access.

The National Institute for Health and Care Excellence (NICE) aims wherever possible to issue guidance on new medicines close to the time of licensing to ensure that patients can benefit from rapid access to clinically and cost-effective new medicines. NICE’s ability to do so is contingent on the company notifying NICE of its launch plans at an early stage and providing a timely evidence submission.The Life Sciences Sector Plan sets out the measures we are taking that will mean that patients are able to access medicines three to six months faster, including improved alignment between decisions from the Medicines and Healthcare products Regulatory Agency and NICE guidance publication.The Life Sciences Sector Plan is available at the following link:https://assets.publishing.service.gov.uk/media/688c90a8e8ba9507fc1b090c/Life_Sciences_Sector_Plan.pdf

Which NHS Trusts will be involved in the Rapid National Investigation into maternity and neonatal services.

On 14 August 2025, my Rt Hon. Friend, the Secretary of State for Health and Social Care, announced the appointment of Baroness Amos as Chair of the Independent Maternity and Neonatal Investigation, with further information available at the following link:https://www.gov.uk/government/news/baroness-amos-to-spearhead-maternity-and-neonatal-investigation#The investigation will carry out rapid reviews of up to ten trusts with specific issues. The Chair is working closely with families to finalise the terms of reference, including the selection criteria to select the trusts, which will be announced as soon as possible.

How many (a) births and (b) elective c-sections occurred in each NHS trust in England in 2024.

The National Health Service routinely publishes data on maternity activity for NHS hospitals, including data relating to the number of births, the method of onset of labour, delivery methods, and places of delivery. An annual publication for this data, covering the financial year ending March 2024, is available at the following link:https://digital.nhs.uk/data-and-information/publications/statistical/nhs-maternity-statistics/2023-24A monthly breakdown of statistics is also available, at the following link:https://digital.nhs.uk/data-and-information/publications/statistical/maternity-services-monthly-statistics/final-may-2025-provisional-june-2025-official-statistics

What assessment he has made of the potential merits of ensuring that the national review of Maternity Services (a) includes representations from (i) patients and (ii) campaign groups and (b) encourages their active involvement.

On 23 June, my Rt Hon. Friend, the Secretary of State for Health and Social Care announced an independent investigation into National Health Service maternity and neonatal services to understand the systemic issues behind why so many women, babies, and families experience unacceptable care. He has held a series of meetings with harmed and bereaved families from across the country and has committed to ensuring that the voices of women and families are at the heart of improving standards.In addition, on 14 August, the appointment was announced of the Rt Hon. the Baroness Amos as chair of the independent maternity and neonatal investigation. Further information is available at the following link:https://www.gov.uk/government/news/baroness-amos-to-spearhead-maternity-and-neonatal-investigationThe Rt. Hon. the Baroness Amos was selected after feedback from bereaved families who expressed a preference for someone with distance from the NHS. Support will be given by a team of esteemed expert advisors, who will be selected following further engagement with families. The chair is working with families to finalise the terms of reference for the investigation, and these will be published shortly.The Government is also establishing a National Maternity and Neonatal Taskforce, chaired by my Rt Hon. Friend, the Secretary of State for Health and Social Care, and this is to be made up of a panel of experts and family, charity, and staff representatives.The taskforce will use the recommendations from the independent investigation to develop a national plan to drive improvements across maternity and neonatal care. The taskforce will work closely with families in developing the action plan, ensuring their voices are central to this work.

What steps he has taken to (a) improve access to antenatal care education for women and families and (b) ensure that high-quality (a) information and (b) information on birthing is delivered during antenatal classes.

Maternity services are commissioned by integrated care boards (ICBs), and it is the responsibility of local commissioners to ensure services, including antenatal education, are designed to be accessible and high-quality. As was set out in the 2025/26 National Health Service operational planning and contracting guidance, when taking decisions, ICBs and providers are asked to pay particular attention to challenged and fragile services, including maternity and neonatal services, thereby delivering the key actions of the Three Year Delivery Plan and continuing to address variation in access, experiences, and outcomes. Antenatal care is a key focus of the plan. In addition, NHS England expects ICBs to have due regard to relevant National Institute for Health and Care Excellence (NICE) guidelines. For antenatal care education, NICE guidelines recommend offering antenatal classes to all first-time mothers and their partners, covering a range of topics, including preparing for labour and birth. It also advises that classes should be considered for women in subsequent pregnancies where there may be a benefit.

If he will make an assessment of the potential merits of introducing a regulatory body for antenatal education organisations.

As outlined in the 10-Year Health Plan, we are cutting the number of regulatory bodies as they are overwhelming the National Health Service system and taking focus away from the basics of patient care. The changes we are making will improve quality and safety by making it clear where responsibility and accountability sits at all levels of the system, and making it easier for staff, patients, and users to directly feed into the system to improve quality of care. We therefore have no plans currently to introduce a further regulatory body specific to antenatal education organisations.

If he will make an assessment of the potential merits of the inclusion of Oxford University Hospitals Trust in the rapid review of NHS maternity services.

The investigation will carry out rapid reviews of up to ten trusts with specific issues. The process of determining which trusts to review is ongoing, and once decided, they will be announced as soon as possible.

What steps he is taking to support NHS Trusts with (a) additional pharmacist staff salaries, (b) the cost of additional monitoring blood tests and (c) additional service delivery costs when new drug treatments are funded for NHS patients.

The 2025/26 NHS Payment Scheme, published on 4 April 2025, governs transactions between providers and commissioners of secondary healthcare by setting the rules for determining the amount payable for the provision of healthcare services. In short, it defines the basis for fairly reimbursing National Health Service trusts for the work they do. More information on the scheme is available at the following link:https://www.england.nhs.uk/long-read/25-26-nhs-payment-scheme/Prices in the scheme have been updated to reflect the latest NHS pay awards. The 2025/26 prices have been calculated in part by updating 2024/25 pay award prices, published in September 2024. for inflation and efficiency;The scheme includes a published list of 2025/26 prices reflecting the latest pay awards, which are available at the following link:https://www.england.nhs.uk/publication/2025-26-nhs-payment-scheme/This list includes the price paid to NHS trusts for persons who solely require a blood test. High-cost drugs, which can include those that have just received approval, are excluded from prices and are subject to separate agreement on appropriate funding between providers and commissioners.

What assessment he has made of the potential impact of the requirement upon Oxford University Hospitals NHS Foundation Trust to make savings of £99 million this year on the delivery of health services in Oxfordshire.

Like many other trusts, the Oxford University Hospitals NHS Foundation Trust overspent against their own plan in 2024/25, despite receiving significant additional support to deliver that plan. We can no longer accept overspends as standard. It is critical that all National Health Service organisations maximise every penny available to them and deliver the plans that they agree to. All efficiency savings will be used by organisations such as the Oxford University Hospitals NHS Foundation Trust to reinvest in services and deliver on their plans. All systems have agreed breakeven financial plans for 2025/26, requiring £11 billion of efficiencies and other savings, or 7.1% of total allocation. While ambitious, NHS England has provided detailed efficiency and productivity support during 2025/26 planning and will continue to do so through a new finance improvement programme to ensure efficiency and financial plans are met without adversely impacting service delivery or patient care. As of the second month, the trust reports that it is on track to deliver the efficiencies set out in their plan for 2025/26.

What steps his Department is taking to improve access to NHS occupational therapists involved in Disabled Facilities Grants for (a) children and (b) other people.

Occupational therapists play an important role in delivering the Disabled Facilities Grant at a local level by assessing older and disabled people’s needs, recommending home adaptations, and ensuring the suitability of proposed solutions.Decisions about recruitment are matters for individual National Health Service trusts. NHS trusts manage their recruitment at a local level ensuring they have the right number of staff in place and with the right skills mix, to deliver safe and effective care. These staff include Allied Health Professionals such as occupational therapists.The Government is committed to making the NHS the best place to work, to ensure that we retain more of our skilled and dedicated staff. NHS England is leading work nationally through its retention programme to drive a consistent, system-wide approach to staff retention across NHS trusts. This ensures trusts have access to proven retention strategies, data-driven monitoring, and can foster a more stable, engaged, productive, and supported workforce.

Pursuant to the Answer of 30 June 2025 to Question 62450 on Vamorolone, which NHS Trusts have submitted prior approval forms.

The National Health Service trusts which have submitted prior approval forms are as follows:Alder Hey Children's NHS Foundation Trust;Cambridge University Hospitals NHS Foundation Trust;Great Ormond Street Hospital for Children NHS Foundation Trust;Guy's and St Thomas' NHS Foundation Trust;Nottingham University Hospitals NHS Trust;The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust;University Hospital Southampton NHS Foundation Trust;University Hospitals Birmingham NHS Foundation Trust; andUniversity Hospitals Bristol and Weston NHS Foundation Trust.

On what date he expects the final report of the independent ADHD taskforce to be published.

The ADHD taskforce's final report is expected to be published later this year.

How many patients have accessed Vamorolone since it was given NICE approval for Duchenne Muscular Dystrophy; what assessment he has made of the adequacy of availability of Vamorolone to patients with DMD in that period; and whether the NHS had fully implemented the NICE recommendation by the April 2025 deadline.

The National Institute for Health and Care Excellence (NICE) published its technology appraisal, titled Vamorolone for treating Duchenne muscular dystrophy in people 4 years and over, on 16 January 2025. NHS England routinely commissioned vamorolone in line with the guidance, from 16 April 2025.When a patient is started on vamorolone, the prescribing clinician submits an electronic prior approval form, confirming that NICE’s recommendation criteria are met. NICE’s costing report, included in the technology appraisal, suggested that 1,390 people expected to receive vamorolone in 2025/26. The NICE’s technology appraisal is available at the following link:https://www.nice.org.uk/guidance/ta1031/resources/resource-impact-summary-report-15239352925/chapter/Resource-impact-summary-reportThere is only 10 full weeks of data available since routine commissioning commenced in mid-April, and over this period there have been 32 prior approval forms submitted. Whilst submission of a form is not confirmation that treatment has begun, this is used as a proxy indication for the number of patients starting treatment.