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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

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