Sadik Al-Hassan

The Government is taking decisive steps to secure the future of life sciences research in the United Kingdom and to ensure we remain internationally competitive. The upcoming Life Sciences Sector Plan sets out a bold vision to strengthen our world-class research and development, attract global investment, and accelerate healthcare innovation.

The National Health Service seeks the best value in its commercial deals for patients and taxpayers. The recent NHS Commercial Framework consultation clarified the circumstances in which indication specific pricing will be considered in England. The framework now provides further guidance relating to the time period over which revenue loss is considered and the components included in its calculation, referencing the potential to include future indications where there is a high degree of confidence of regulatory approval, a National Institute for Health and Care Excellence recommendation, and forecast volumes and prices. This will help companies better understand the circumstances in which indication specific pricing may be available to support patient access to new medicines.

The 10-Year Health Plan will describe a shared vision for the health and care system in 2035, drawing directly from the extensive engagement that has been undertaken with the public, patients, and staff. The plan will set out how care models and pathways will need to change or evolve to better meet their needs, and the cultural and behavioural changes we want to see. The plan’s shift from sickness to prevention will help ensure the National Health Service uses its relationship with patients to help patients improve and protect their own health.

Under the Enhanced health in care homes framework, every care home must be aligned to a primary care network (PCN) and must have established protocols between the PCN, the care home, and system partners, such as local general practices and pharmacies, for information sharing, shared care planning, use of shared care records, and clear clinical governance.

Pharmacies are expected to maintain a reasonable stock holding to meet their legal obligations to dispense all prescriptions, including to patients in care homes, with reasonable promptness, recognising that it is not feasible for a pharmacy to maintain stock of every medicine. The Pharmacy Quality Scheme rewards community pharmacy contractors that deliver quality criteria, one of which is the Palliative and End of Life Care scheme. Participating pharmacy contractors must declare if they intend to routinely stock 16 critical end of life medicines, including controlled drugs such as morphine and midazolam and/or parenteral haloperidol, and must have an action plan in place to support local access. This enables palliative medicines to be quickly sourced when prescribed.

Most care homes with nursing can hold stocks of controlled drugs and will not require a licence to access medicines containing controlled drugs for patients who need them. This is because care homes run by public authorities or charities are exempt from the need for a Home Office controlled drug licence. Care homes without nursing cannot store controlled drugs unless they are prescribed for individual residents.

Under the Enhanced health in care homes framework, every care home must be aligned to a primary care network (PCN) and must have established protocols between the PCN, the care home, and system partners, such as local general practices and pharmacies, for information sharing, shared care planning, use of shared care records, and clear clinical governance.

Pharmacies are expected to maintain a reasonable stock holding to meet their legal obligations to dispense all prescriptions, including to patients in care homes, with reasonable promptness, recognising that it is not feasible for a pharmacy to maintain stock of every medicine. The Pharmacy Quality Scheme rewards community pharmacy contractors that deliver quality criteria, one of which is the Palliative and End of Life Care scheme. Participating pharmacy contractors must declare if they intend to routinely stock 16 critical end of life medicines, including controlled drugs such as morphine and midazolam and/or parenteral haloperidol, and must have an action plan in place to support local access. This enables palliative medicines to be quickly sourced when prescribed.

Most care homes with nursing can hold stocks of controlled drugs and will not require a licence to access medicines containing controlled drugs for patients who need them. This is because care homes run by public authorities or charities are exempt from the need for a Home Office controlled drug licence. Care homes without nursing cannot store controlled drugs unless they are prescribed for individual residents.

We have committed to develop a 10-Year Health Plan to deliver a National Health Service fit for the future. The plan, and the refreshed Long Term Workforce Plan that follows it, will ensure that we have the right number of staff, with the right skill mix so that patients, including those with rare diseases like myasthenia gravis, can be promptly diagnosed and treated.

On 7 March 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) approved the medicine rozanolixizumab, marketed as Rystiggo, to treat adults with generalised myasthenia gravis.

The National Institute for Health and Care Excellence (NICE) evaluates all new licensed medicines and makes recommendations for the National Health Service on whether they should be routinely funded by the NHS based on their clinical and cost effectiveness. NICE aims to publish guidance as close as possible to the time of licensing.

NICE published draft guidance on the use of rozanolixizumab for consultation in September 2024 and was unable to recommend it as a clinically and cost-effective use of NHS resources due to uncertainties in the long-term effectiveness of the treatment, as well as uncertainties in the economic model and the cost-effectiveness at the price proposed by the company. NICE has not yet published final guidance, and it will keep stakeholders informed about next steps as soon as possible.

The Government is committed to improving the lives of those living with rare diseases, such as myasthenia gravis. The UK Rare Diseases Framework sets out four priorities collaboratively developed with the rare disease community: these include improving access to specialist care, treatments, and drugs. We remain committed to delivering under the Framework and published the annual England action plan in February 2025.

In the 2023 England Rare Disease Action Plan, action 25 was introduced to review the effectiveness of Innovative Medicines Fund (IMF), Early Access to Medicines Scheme (EAMS) and Innovative Licensing and Access Pathway (ILAP) in improving access to treatments for people living with rare diseases.

NHS England, the National Institute for Health and Care Excellence and the Medicines and Healthcare products Regulatory Agency will meet annually to continue to discuss progress and the role of EAMS, ILAP and IMF in supporting access to treatments for people living with rare diseases. These meetings will include representatives from patient advocacy groups, industry and clinical researchers. Further progress on action 25 has been reported in the 2025 action plan, which is available at the following link:

https://www.gov.uk/government/publications/england-rare-diseases-action-plan-2025

Decisions on whether medicines should be evaluated by the National Institute for Health and Care Excellence (NICE) through its highly specialised technologies (HST) programme are taken by NICE itself against a set of published criteria that have been developed through public and stakeholder engagement.

NICE is currently reviewing its HST criteria and has recently closed its public consultation on proposed changes. NICE will discuss the updated criteria at its Public Board Meeting on 19 March 2025.

The purpose of the review is not to change the number or nature of the topics that are evaluated through the HST programme, but to ensure that the criteria are sufficiently clear and predictable for companies and patient groups and are aligned to the HST vision. The aims of the HST programme will remain unchanged. It is intended to: encourage research on, and innovation for, very rare conditions when there are challenges in generating an evidence base that is robust enough to bring the product to market; secure fairer and more equitable treatment access for very small populations with very rare diseases; and recognise that an approach that maximises health gain for the NHS may not always be acceptable; it could deliver results that are not equitable.

Since 2022/23, NICE has been able to recommend 13 out of 14 medicines that it has appraised through its HST programme.

Decisions on whether medicines should be evaluated by the National Institute for Health and Care Excellence (NICE) through its highly specialised technologies (HST) programme are taken by NICE itself against a set of published criteria that have been developed through public and stakeholder engagement.

NICE is currently reviewing its HST criteria and has recently closed its public consultation on proposed changes. NICE will discuss the updated criteria at its Public Board Meeting on 19 March 2025.

The purpose of the review is not to change the number or nature of the topics that are evaluated through the HST programme, but to ensure that the criteria are sufficiently clear and predictable for companies and patient groups and are aligned to the HST vision. The aims of the HST programme will remain unchanged. It is intended to: encourage research on, and innovation for, very rare conditions when there are challenges in generating an evidence base that is robust enough to bring the product to market; secure fairer and more equitable treatment access for very small populations with very rare diseases; and recognise that an approach that maximises health gain for the NHS may not always be acceptable; it could deliver results that are not equitable.

Since 2022/23, NICE has been able to recommend 13 out of 14 medicines that it has appraised through its HST programme.

Decisions on whether medicines should be evaluated by the National Institute for Health and Care Excellence (NICE) through its highly specialised technologies (HST) programme are taken by NICE itself against a set of published criteria that have been developed through public and stakeholder engagement.

NICE is currently reviewing its HST criteria and has recently closed its public consultation on proposed changes. NICE will discuss the updated criteria at its Public Board Meeting on 19 March 2025.

The purpose of the review is not to change the number or nature of the topics that are evaluated through the HST programme, but to ensure that the criteria are sufficiently clear and predictable for companies and patient groups and are aligned to the HST vision. The aims of the HST programme will remain unchanged. It is intended to: encourage research on, and innovation for, very rare conditions when there are challenges in generating an evidence base that is robust enough to bring the product to market; secure fairer and more equitable treatment access for very small populations with very rare diseases; and recognise that an approach that maximises health gain for the NHS may not always be acceptable; it could deliver results that are not equitable.

Since 2022/23, NICE has been able to recommend 13 out of 14 medicines that it has appraised through its HST programme.

Integrated care board (ICB) allocations for 2025/26 were published on 30 January alongside the 2025/26 NHS Planning Guidance, with further information available at the following link:

https://www.england.nhs.uk/allocations/

The pre-requisite for multi-year settlements for ICBs is a multi-year settlement for the Department, and phase two of the Spending Review is currently underway. There have not yet been discussions with Cabinet colleagues on what the Department’s settlement in the Spending Review will then mean for ICB allocations beyond 2025/26.

The Elective Reform Plan, published in January 2025, sets out the reform efforts needed to return to the 18-week constitutional standard, including the need to put the patient front and centre and reform elective pathways. In recognition of the unacceptably long waits experienced at present, the plan commits a particular focus on respiratory health, as one of five initial specialties where a clinically led process will agree on the reforms needed to improve waiting times and re-design pathways in order to improve patient experience and outcomes, and make best use of clinical time.

The Elective Reform Plan commits to giving patients more choice and control over their follow up care. This includes through increasing the use of Patient Initiated Follow-Ups (PIFU), which empowers patients to book their own follow up appointments when they need them, preventing appointments that are low value to patients and to clinicians. Many respiratory patients will be appropriate for a PIFU pathway, including patients with asthma, depending upon their circumstances.

We are also committed to helping support the self-management of conditions so that patients are better equipped to recognise changes in their condition and take control of their own care. NHS England has developed a national bundle of care for children and young people with asthma, including accredited asthma training courses, alongside education and self-management resources for schools, families, and carers.

NHS England has also introduced the adult asthma best practice tariff to improve the proportion of patients who receive a specialist review of their care within 24 hours of emergency admission for an asthma attack and receive a discharge bundle before leaving hospital.

The data below is based on figures published in the Prescription Cost Analysis. It includes all community dispensing in England, regardless of where they were prescribed, where the prescriptions have been submitted to the NHS Business Service Authority (NHSBSA) for payment. The list of inhaler products is derived from products in the NHSBSA’s dictionary of medicines and devices database with a pharmaceutical formulation of inhalation powder.

In the 12 months from December 2023 to November 2024, 14.4 million such prescription items were dispensed. The term items refers to the number of times an inhalation product appears on a prescription form, not the quantity prescribed. Some prescriptions may be for multiple inhalers, whilst other may be for refills of a previously supplied inhalation device. These made up 27.9% of the total 51.6 million items of the three commonly prescribed inhaler formulations, namely: pressurised inhalation; inhalation powder: and inhalation solution.

The Government is working towards introducing legislation to enable hub and spoke dispensing between different legal entities in 2025. This change will be enabled via amendments to both primary and secondary legislation, and is subject to the usual parliamentary processes.

The independent Joint Committee for Vaccination and Immunisation (JCVI) advises the Department on the approach to vaccination and immunisation. On 13 November 2024, the JCVI published advice on the COVID-19 vaccination programme, covering vaccination in 2025 and spring 2026. This advice is available at the following link:

https://www.gov.uk/government/publications/covid-19-vaccination-in-2025-and-spring-2026-jcvi-advice/jcvi-statement-on-covid-19-vaccination-in-2025-and-spring-2026

The Government is considering the JCVI’s advice on autumn 2025 carefully and will respond in due course.