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1024698

	registered interest
	date	13/12/2018
	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	Orphan Drugs
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, whether he is taking steps to introduce a revised definition for ultra-orphan medicine.
	tabling member constituency	Linlithgow and East Falkirk
	tabling member printed	Martyn Day
	uin	202090
	answer	answer is ministerial correction date of answer 20/12/2018 answer text <p>Currently, rare diseases are defined as conditions affecting no more than five in 10,000 people in the European Union. The new European Clinical Trial Regulation (Regulation (EU) No 536/2014) will introduce an ‘ultra-rare’ condition and states that clinical trials for the development of orphan medicinal products and those of medicines affecting no more than one person in 50,000 in the EU (ultra-rare diseases) should be fostered, and in such areas, a rapid yet in-depth assessment is of particular importance. The new clinical trials regulation is expected to be implemented in the EU in late 2020. The Government has confirmed that United Kingdom law will remain aligned with the parts of the new EU clinical trials Regulation that are within the UK’s control.</p> answering member constituency Thurrock answering member printed Jackie Doyle-Price question first answered 20/12/2018 17:10:46 answering member 4065 label Biography information for Dame Jackie Doyle-Price
	tabling member	4488 label Biography information for Martyn Day

1035245

	registered interest
	date	04/01/2019
	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	Orphan Drugs
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, with reference to the Scottish Medicines Consortium’s announcement on 8 October 2018 of the introduction of a revised definition for an ultra-orphan medicine, what assessment his Department has made of the potential merits of adopting the same definition.
	tabling member constituency	Alyn and Deeside
	tabling member printed	Mark Tami
	uin	205210
	answer	answer is ministerial correction date of answer 14/01/2019 answer text <p>The Department has made no such assessment. The National Institute for Health and Care Excellence (NICE) makes recommendations for the National Health Service in England on the use of most new medicines through its technology appraisal programme and also operates a separate highly specialised technologies programme for the evaluation of very high cost drugs for the treatment of very small numbers of patients. NICE operates a topic selection process that includes consideration of individual topics against published criteria and engagement with stakeholders to determine whether topics are suitable for assessment by NICE and, if so, which programme is most appropriate.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 14/01/2019 16:19:01 answering member 4067 label Biography information for Steve Brine
	tabling member	1383 label Biography information for Mark Tami

1186527

	registered interest
	date	19/03/2020
	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	Orphan Drugs
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, what assessment he has made of the potential merits of establishing a new orphan medicines pathway at NICE to enable orphan medicines which do not qualify for the highly specialised technology evaluation programme to be appraised.
	tabling member constituency	Reigate
	tabling member printed	Crispin Blunt
	uin	32035
	answer	answer is ministerial correction date of answer 27/04/2020 answer text <p>There are no current plans to establish a further National Institute for Health and Care Excellence (NICE) assessment programme for orphan medicines. Where companies are willing to price their drugs fairly in a way that reflects the benefits they bring to patients, NICE has been able to recommend a number of orphan medicines for routine NHS funding through its technology appraisal programme. NICE is reviewing its methods for the development of technology appraisal and highly specialised technology recommendations, including the methods for the assessment of medicines licensed for rare diseases. The creation of an Innovative Medicines Fund will also build on the success of the Cancer Drugs Fund and support access to the most advanced medicines for patients with rare diseases.</p><p> </p><p> </p><p> </p><p> </p><p> </p> answering member constituency Bury St Edmunds answering member printed Jo Churchill question first answered 27/04/2020 13:01:11 answering member 4380 label Biography information for Jo Churchill
	tabling member	104 label Biography information for Crispin Blunt

1186529

	registered interest
	date	19/03/2020
	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	Orphan Drugs
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, what assessment he made of the effect of the (a) introduction of the ultra-orphan pathway by the Scottish Medicines Consortium and (b) additional factors and modifiers for orphan medicines and medicines that have evidence of achieving a substantial improvement in life expectancy and/or quality of life considered by the Scottish Medicines Consortium in relation to informing methods and processes at the National Institute for Health and Care Excellence.
	tabling member constituency	Reigate
	tabling member printed	Crispin Blunt
	uin	32036
	answer	answer is ministerial correction date of answer 27/04/2020 answer text <p>The National Institute for Health and Care Excellence (NICE) is responsible for the review of the methods it uses in the development of its technology appraisal and highly specialised technology recommendations in England. NICE has advised that additional factors and modifiers that may affect NICE’s decisions, including factors relevant to orphan medicines and medicines that substantially improve health and/or life expectancy, are being considered within its methods review. This review will give consideration to approaches in other health technology assessment bodies, including the devolved administrations.</p> answering member constituency Bury St Edmunds answering member printed Jo Churchill question first answered 27/04/2020 13:36:50 answering member 4380 label Biography information for Jo Churchill
	tabling member	104 label Biography information for Crispin Blunt

1365661

	registered interest
	date	02/11/2021
	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	Orphan Drugs
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, which medicines with an EMA Orphan Medicines Product designation have been appraised by NICE through a Single Technology Appraisal process; and what category of recommendation, (a) recommended, (b) optimised, (c) Cancer Drugs Fund, (d) not recommended and (e) only in research, was made in each case.
	tabling member constituency	Leeds North West
	tabling member printed	Alex Sobel
	uin	68424
	answer	answer is ministerial correction date of answer 10/11/2021 answer text <p>The attached table lists medicines with a European Medicines Agency orphan designation appraised by the National Institute for Health and Care Excellence through the single technology appraisal process and the category of recommendation made in each case.</p> answering member constituency Charnwood answering member printed Edward Argar question first answered 10/11/2021 16:31:43 answering member 4362 label Biography information for Edward Argar attachment 1 file name FORMATTED TABLE FOR MINISTERIAL CLEARANCE PQ68424 - EMA Orphan Meds Appraisal table (1).docx title EMA Orphan Meds Appraisal table
	tabling member	4658 label Biography information for Alex Sobel