Asked by: Liz Jarvis (Liberal Democrat - Eastleigh)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps he is taking to improve (a) diagnosis and (b) treatment pathways for patients with (i) hypermobile Ehlers-Danlos Syndrome, (ii) Postural Orthostatic Tachycardia Syndrome and (iii) Mast Cell Activation Syndrome.
Answered by Andrew Gwynne
The Government is committed to improving the lives of those living with rare diseases, such as hypermobile Ehlers-Danlos syndrome (hEDS) and mast cell activation syndrome. The UK Rare Diseases Framework sets out four priorities, collaboratively developed with the rare disease community, which include helping patients get a final diagnosis faster and improving access to specialist care, treatments, and drugs. We remain committed to delivering under the framework and will publish an annual England action plan in 2025. With over 7,000 identified rare diseases, the framework and action plans focus on shared challenges across all rare diseases.
NHS England has a website page on hEDS and this notes the passing of information on to the National Congenital Anomaly and Rare Diseases Registration Service (NCARDRS) to help scientists look for better ways to prevent and treat this condition. NHS England’s website page is available at the following link:
https://www.nhs.uk/conditions/ehlers-danlos-syndromes/
Be Part of Research is a tool that can support people living with rare diseases in engaging with research. Currently on Be Part of Research there is a study recruiting those with hEDS to take part in research to help advance the understanding of diagnostic imaging in this condition. Further information is available at the following link:
https://bepartofresearch.nihr.ac.uk/trial-details/trial-detail?trialId=24730&location=&distance=
To improve awareness of postural orthostatic tachycardia syndrome (PoTS) amongst healthcare professionals, and specifically general practitioners, the Royal College of General Practitioners provides training on PoTS as part of its syncope toolkit. Further information is available at the following link:
https://elearning.rcgp.org.uk/course/view.php?id=500
In addition, the NICE has produced a clinical knowledge summary on blackouts and syncope, last updated in November 2023, which outlines how clinicians should assess and diagnose PoTS. The NICE’s clinical knowledge summary is available at the following link:
https://cks.nice.org.uk/topics/blackouts-syncope/diagnosis/assessment/
Asked by: Christopher Chope (Conservative - Christchurch)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether the NHS has commissioned research into the potential impact of (a) Covid-19 and (b) Covid-19 vaccines on the (i) diagnosis and (ii) treatment of Mast Cell Activation Syndrome.
Answered by Will Quince
The Department commissions research through the National Institute for Health and Care Research (NIHR). Vaccines must be tested in a wide range of studies, including clinical trials to establish their efficacy and safety, and have a product licence, known as a “marketing authorisation” before they can be made available for widespread use in humans. Since the start of the COVID-19 pandemic, the NIHR has allocated over £110 million in funding for COVID-19 vaccine research that has included consideration of vaccine safety and robust monitoring of adverse reactions to COVID-19 vaccines.
The NIHR welcomes funding applications for research into any aspect of human health, including vaccine side effects.
Asked by: Neil O'Brien (Conservative - Harborough, Oadby and Wigston)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps he is taking to make immunoglobulin therapy available for the treatment of Mast Cell Activation Syndrome.
Answered by Jackie Doyle-Price
Immunoglobulins are not currently licensed for the treatment of Mast Cell Activation Syndrome (MCAS). However, immunoglobulin therapy may be used ‘off-label’, if there are no other alternative licensed products available and the physician considers that immunoglobin therapy is appropriate to address the clinical need in order to manage a patient with MCAS. This decision, under the full responsibility of the physician, will need to be made following discussion between the physician and the patient.
In order to gain a licence for the use of immunoglobulin therapy for the treatment of MCAS, a Marketing Authorisation Holder would have to submit a variation to their Marketing Authorisation to the Medicines and Healthcare products Regulatory Agency (MHRA) with a dossier compiled of safety and efficacy data. Specialist assessors would review the dossier and a variation to the Marketing Authorisation would only be granted if it is determined that the benefits of the product outweigh any potential risks of using the product in its proposed indication.
The MHRA provides a scientific advice service to Marketing Authorisation Holders regarding their submissions should they request it.
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/
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, if his Department will establish a multi-disciplinary centre of excellence with leadership from a senior clinician to focus on Mast Cell Activation Syndrome.
Answered by Steve Brine
Care for patients with Mast Cell Activation Syndrome (MCAS) in an outpatient setting will typically be within local allergy clinics, available in most hospitals. These services are commissioned locally by clinical commissioning groups. There are no current plans to designate or commission the care of patients with MCAS as a prescribed national specialised clinic or service.
A list of local allergy clinics can be obtained from the British Society for Allergy and Clinical Immunology at:
http://www.bsaci.org/professionals/allergy-specialists
The Royal College of Physician’s Improving Quality in Allergy Services scheme at:
www.rcplondon.ac.uk/projects/outputs/improving-quality-allergy-services
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, if his Department will include Mast Cell Activation Syndrome (MCAS) in the 100K genome project and establish links to the MCAS Research Centre at the University of Bonn Institute of Genetics.
Answered by Jackie Doyle-Price
Mast Cell Activation Syndrome (MCAS) does not currently have a specific disease category within the 100,000 Genomes Project but patients with MCAS in the context of other medical disorders or congenital malformations suggestive of a genetic cause are eligible. In addition, a proposal for inclusion of familial MCAS in the project is currently under peer review and will be considered by the Genomics England Science Advisory Committee at their next meeting.
Genomics England will seek to establish links between the relevant Genomics England Clinical Interpretation Partnership (GeCIP) domains and the MCAS Research Centre at the University Of Bonn Institute Of Genetics.
More about GeCIP can be found here:
https://www.genomicsengland.co.uk/about-gecip/
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 allowing the use of off-label medications in the treatment of Mast Cell Activation Syndrome.
Answered by Steve Brine
We have made no such assessment. Prescribers are able to use medicinal products outside their licensed indications where they are satisfied that they best meet the individual clinical needs of their patient. This is part and parcel of normal clinical practice.
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, whether tests for mast cell activation markers, completed by the Protein Reference Unit Lab in Sheffield, are available on the NHS.
Answered by Steve Brine
A number of standard tests relevant to patients being cared for in allergy clinics are available at most hospitals. Mast cell activation marker tests are not standard tests within the National Health Service and are ordered by individual NHS clinicians using local procedures based on the assessment of individual cases.
The expertise required to investigate and manage the allergic symptoms experienced exists within allergy clinics provided by the NHS. A list of allergy clinics can be obtained from the British Society for Allergy and Clinical Immunology at:
http://www.bsaci.org/professionals/allergy-specialists
The Royal College of Physician’s Improving Quality in Allergy Services scheme at:
www.rcplondon.ac.uk/projects/outputs/improving-quality-allergy-services
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, which (a) adult and (b) paediatric NHS hospitals receive Mast Cell Activation Syndrome patients with a GP referral.
Answered by Steve Brine
Care for patients with Mast Cell Activation Syndrome in an outpatient setting is provided by local allergy clinics, available in most hospitals. These services are commissioned locally by clinical commissioning groups.
A list of allergy clinics can be obtained from the British Society for Allergy and Clinical Immunology at:
http://www.bsaci.org/professionals/allergy-specialists
The Royal College of Physician’s Improving Quality in Allergy Services scheme:
www.rcplondon.ac.uk/projects/outputs/improving-quality-allergy-services
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, if he will make it his Department’s policy to prioritise the production of NHS guidelines on the diagnosis of Mast Cell Activation Syndrome.
Answered by Steve Brine
Mast Cell Activation Syndrome is managed within local allergy clinics commissioned by clinical commissioning groups. A list of allergy clinics can be obtained from the British Society for Allergy and Clinical Immunology at:
http://www.bsaci.org/professionals/allergy-specialists
The Royal College of Physician’s Improving Quality in Allergy Services scheme at:
www.rcplondon.ac.uk/projects/outputs/improving-quality-allergy-services
Clinical guidelines are developed by the National Institute for Health and Care Excellence (NICE) or speciality based colleges and NHS England will ensure this topic is raised with NICE in relation to their consideration of future topics.