Blood: Medical Treatments

Department of Health and Social Care written question – answered on 20th February 2019.

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Photo of Neil O'Brien Neil O'Brien Conservative, Harborough

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.

Photo of Jackie Doyle-Price Jackie Doyle-Price The Parliamentary Under-Secretary for Health and Social Care

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.

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