Asked by: Cheryl Gillan (Conservative - Chesham and Amersham)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, with reference to the situation relating to covid-19, what advice his Department is providing to parents of young children with chronic lung conditions; and whether those children can be removed from schooling.
Answered by Jo Churchill - Minister of State (Department for Work and Pensions)
Schools in the United Kingdom closed on Friday 20 March 2020. Only children of key workers, and some children that attend special schools, may continue to attend school after this date.
People who have been identified by their general practice as being high risk from COVID-19 infection will receive a letter from the National Health Service this week telling them what additional precautions they need to take. Guidance on social distancing and vulnerable people is available to view here at the following link:
The stay at home guidance is available to view here at the following link: https://www.gov.uk/government/publications/covid-19-stay-at-home-guidance/stay-at-home-guidance-for-people-with-confirmed-or-possible-coronavirus-covid-19-infection
Local Health Protection Teams from PHE will work with the Local Education Authority, headteachers, principals or management teams, to advise on the management of children, pupils, students or staff in relation to COVID-19.
General PHE advice on COVID-19 is updated regularly and can be viewed here at the following link:
https://www.gov.uk/guidance/coronavirus-covid-19-information-for-the-public
Asked by: Cheryl Gillan (Conservative - Chesham and Amersham)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what plans he has to make Tildacerfont available on the NHS.
Answered by Jo Churchill - Minister of State (Department for Work and Pensions)
Tildacerfont does not have a Marketing Authorisation for use in the United Kingdom and is not routinely available on the National Health Service. Tildacerfront is still in early development and is being studied for use in the treatment of patients with classic congenital adrenal hyperplasia. Once the trials with the product are complete, the drug manufacturer will be able to apply for a Marketing Authorisation.
Most new medicines are assessed by the National Institute for Health and Care Excellence (NICE) through its technology appraisal or highly specialised technologies programmes which make recommendations for the NHS on whether treatments represent an effective use of NHS resources. NHS commissioners are legally required to fund treatments recommended by NICE. If the manufacturer seeks a Marketing Authorisation for Tildacerfont, it will be considered through the established topic selection process to determine whether it should be assessed by NICE.
If Tildacerfont receives a Marketing Authorisation, funding decisions will be the responsibility of NHS commissioners, taking into account the available evidence and any relevant NICE recommendations.
Asked by: Cheryl Gillan (Conservative - Chesham and Amersham)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what plans he has to reduce or eliminate hospital car parking charges for nurses, doctors and essential healthcare workers.
Answered by Stephen Hammond
The level and appropriateness of car parking charges at National Health Service sites is the responsibility of the local NHS trust. We have published the NHS Car Parking Principles which clearly state that concessions should be offered to groups who most need help, such as staff who cannot travel by public transport due to their shift pattern.
However, given it is the responsibility of the local NHS trust, the Department has no jurisdiction to reduce or eliminate hospital car parking charges for nurses, doctors and essential healthcare workers.
Asked by: Cheryl Gillan (Conservative - Chesham and Amersham)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment he has made of the suitability of the Single Technology Appraisal process for new treatments for patients with Duchenne Muscular Dystrophy.
Answered by Steve Brine
The National Institute for Health and Care Excellence (NICE) is the independent body responsible for developing authoritative, evidence-based guidance for the National Health Service on whether drugs and other treatments represent an effective use of NHS resources.
NICE assesses most significant new drugs through its technology appraisal programme and has been able to recommend a number of drugs licenced for the treatment of rare diseases for routine use on the NHS. NICE also operates a separate highly specialised technology (HST) evaluation programme for the assessment of very high cost drugs for the treatment of very small numbers of patients. Decisions on the most appropriate programme for individual drugs and other treatments are made through an established topic selection process that includes a public consultation and thorough consideration against a set of published criteria.
NICE published HST guidance recommending ataluren for treating Duchenne muscular dystrophy with a nonsense mutation in the dystrophin gene in July 2016 and is currently developing guidance, through its technology appraisal and HST programmes, on other drugs for the treatment of Duchenne muscular dystrophy.
Asked by: Cheryl Gillan (Conservative - Chesham and Amersham)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment he has made of the potential merits of increasing flexibility within NICE's Single Technology Appraisal process for medicines for rare diseases.
Answered by Steve Brine
The Department has made no such assessment. The National Institute for Health and Care Excellence (NICE) is the independent body responsible for developing authoritative, evidence-based guidance for the NHS on whether drugs and other treatments represent an effective use of National Health Service resources.
NICE assesses most significant new drugs through its technology appraisal programme and has been able to recommend a number of drugs licenced for the treatment of rare diseases for routine use on the NHS. NICE also operates a separate highly specialised technology evaluation programme for the assessment of very high cost drugs for the treatment of very small numbers of patients.
NICE’s methods and processes for the assessment of drugs have been carefully developed over time and are internationally respected. NICE continues to keep its procedures under periodic review to ensure that they remain effective.
Asked by: Cheryl Gillan (Conservative - Chesham and Amersham)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what representations his Department and its agencies have received on the resources necessary to improve patient safety and engage with health professionals to raise awareness of the potential health risks for women of child-bearing age taking Sodium Valproate; and if he will make a statement.
Answered by Jackie Doyle-Price
The Medicines and Healthcare products Regulatory Agency (MHRA) is working in partnership with the Department, professional bodies and the healthcare system to deliver a package of measures to raise awareness of the significant risks associated with sodium valproate in pregnancy and to support healthcare professionals in reducing the harms from valproate in women of child-bearing age and improving patient safety in line with the strengthened regulatory position. Educational materials for healthcare professionals and patients are being sent to general practitioners (GP) and specialist prescribers. The National Institute for Health and Care Excellence has updated its guidelines which mention valproate to reflect the new regulatory measures. GP electronic system providers have provided a search and audit function to facilitate the identification of women of childbearing age on valproate and are updating the alerts for valproate.
All parties involved are fully committed to this important work using the resources available from each relevant organisation. In addition, since 2016 the MHRA has been working with a network of over 40 stakeholder organisations (termed the Valproate Stakeholders’ Network) to foster cross-sector support for the new measures and leverage their collective communications reach.
The effectiveness of the new measures in reducing prescribing of valproate in women of childbearing potential will be closely monitored. Relevant data will be published and there will be ongoing follow-up to ensure that the harms to the child from valproate in pregnancy are minimised.
I would particularly like to thank the families involved in the Valproate Stakeholder Network who have shared their experiences and expertise. Their dedication, support and altruism will help to keep future generations of children safe.
Asked by: Cheryl Gillan (Conservative - Chesham and Amersham)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what plans he has to reduce the time between EU marketing authorisation and NICE appraisal of treatments for serious and progressive conditions and improve the timeliness of making such treatments available to patients.
Answered by Steve Brine
The National Institute for Health and Care Excellence (NICE) routinely aims to publish draft technology appraisal guidance on new non-cancer drugs within six months of licensing, and to publish draft guidance on new cancer drugs before licensing.
National Health Service commissioners are legally required to make funding available for treatments recommended in NICE technology appraisal guidance within three months of the publication of guidance. In April 2017, NICE introduced a new fast track appraisal process that is designed to bring forward patient access to drugs where the company can demonstrate clear cost-effectiveness by around five months compared with the standard timescales.
The Government has also published the response to the Accelerated Access Review which includes the introduction of a new Accelerated Access Pathway and £86 million of funding to support medical innovations get to patients faster. This will streamline regulatory and market access decisions, getting breakthrough products that we believe will be truly transformative to patients more quickly, and will be operational from April 2018. All products including medical technologies, devices and diagnostics will be eligible for selection.
Asked by: Cheryl Gillan (Conservative - Chesham and Amersham)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what timeline is for NHS England to complete commercial negotiations with pharmaceutical companies after a treatment has met the NICE budget impact test; and what steps he is taking to ensure that those treatments are available to patients in a timely manner.
Answered by Steve Brine
The timescales for the commercial negotiations for products that trigger the budget impact test are set out in the ‘Procedure for varying the funding requirement to take account of net budget impact’ which is published at:
The process has been designed to ensure that, wherever possible, the commercial negotiation takes place in parallel with the technology appraisal and does not affect patient access.
Asked by: Cheryl Gillan (Conservative - Chesham and Amersham)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, when the first treatments and technologies chosen for the Accelerated Access Pathway will be available for the NHS to use.
Answered by Steve Brine
As set out in the response to the Accelerated Access Review, the Accelerated Access Pathway was established with the purpose of getting those innovations that we believe will be truly transformative to patients more quickly. The pathway will open in April for product selection. Exact timing of when the first products will reach the National Health Service will depend on those products selected. The Pathway will be open to medicines, devices, diagnostics and digital products.
Asked by: Cheryl Gillan (Conservative - Chesham and Amersham)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment he has made of the accuracy of the coding of diagnoses of Mast Cell Activation Syndrome on NHS systems.
Answered by Steve Brine
NHS England does not have any current plans to assess the coding of National Health Service care for patients with Mast Cell Activation Syndrome.
In response to the commitments outlined in the UK Strategy for Rare Diseases, NHS England published the Rare Diseases Implementation Plan in which it proposed to monitor the development of International Classification of Diseases (ICD)-11 and support the accurate characterisation of patients through Human Phenotype Ontology terms as being developed through the 100,000 Genomes Project.
More information about the NHS England Rare Diseases Implementation Plan can be found here:
https://www.england.nhs.uk/publication/implementation-plan-for-the-uk-strategy-for-rare-diseases/