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1015562

	registered interest
	date	27/11/2018
	answering body	Department of Health and Social Care
	answering dept id	17
	answering dept short name	Health and Social Care
	answering dept sort name	Health and Social Care
	hansard heading	Nusinersen
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, what discussions his Department has had with NICE on its appraised criteria to facilitate progress towards a Managed Access Arrangement for Spinraza.
	tabling member constituency	Harborough
	tabling member printed	Neil O'Brien
	uin	196306
	answer	answer is ministerial correction date of answer 05/12/2018 answer text <p>Departmental officials have had a number of discussions with colleagues in the National Institute for Health and Care Excellence (NICE) to enquire about progress of the ongoing appraisal of nusinersen (Spinraza) for the treatment of spinal muscular atrophy. Discussions between NHS England, NICE and Biogen (the company that manufactures nusinersen) are ongoing to seek to agree a commercial agreement that would enable NICE to recommend use of nusinersen as a clinically and cost effective use of National Health Service resources.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 05/12/2018 16:27:43 answering member 4067 label Biography information for Steve Brine
	tabling member	4679 label Biography information for Neil O'Brien

1060051

	registered interest
	date	12/02/2019
	answering body	Department of Health and Social Care
	answering dept id	17
	answering dept short name	Health and Social Care
	answering dept sort name	Health and Social Care
	hansard heading	Blood: Medical Treatments
	house id	1
	legislature	25259 pref label House of Commons
	question text	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.
	tabling member constituency	Harborough
	tabling member printed	Neil O'Brien
	uin	220333
	answer	answer is ministerial correction date of answer 20/02/2019 answer text <p>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.</p><p> </p><p>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.</p><p> </p><p>The MHRA provides a scientific advice service to Marketing Authorisation Holders regarding their submissions should they request it.</p> answering member constituency Thurrock answering member printed Jackie Doyle-Price question first answered 20/02/2019 16:45:11 answering member 4065 label Biography information for Dame Jackie Doyle-Price
	tabling member	4679 label Biography information for Neil O'Brien

938464

	registered interest
	date	11/07/2018
	answering body	Department of Health and Social Care
	answering dept id	17
	answering dept short name	Health and Social Care
	answering dept sort name	Health and Social Care
	hansard heading	Prostate Cancer
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, what progress has been made on the provision of Focused Laser Ablation treatment for prostate cancer available on the NHS.
	tabling member constituency	Harborough
	tabling member printed	Neil O'Brien
	uin	163225
	answer	answer is ministerial correction date of answer 17/07/2018 answer text <p>Focused Laser Ablation treatment for prostate cancer is not within the scope of services commissioned by NHS England. We continue to encourage clinical commissioning groups and providers to offer services in line with the latest National Institute for Health and Care Excellence guidance.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 17/07/2018 15:02:13 answering member 4067 label Biography information for Steve Brine
	tabling member	4679 label Biography information for Neil O'Brien