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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

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

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

1016324

registered interest
date	28/11/2018
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	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 estimate he has made of NHS expenditure on medicines with an orphan designation in England in each of the last three financial years.
tabling member constituency	Leicester South
tabling member printed	Jonathan Ashworth
uin	196813
answer	answer is ministerial correction date of answer 07/12/2018 answer text <p>The Department has made no such estimate. The information requested is not held centrally and could only be obtained at disproportionate cost.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 07/12/2018 13:08:04 answering member 4067 label Biography information for Steve Brine
tabling member	4244 label Biography information for Jonathan Ashworth

1015082

registered interest
date	26/11/2018
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	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, if he will list the 10 orphan medicines assessed by NICE in the last five years through its single technology appraisal process as having the highest base case incremental cost effectiveness ratio (ICER); and what the (a) indication, (b) base case ICER and (c) recommendation from NICE was for each of those medicines; and if he will make a statement.
tabling member constituency	Leicester South
tabling member printed	Jonathan Ashworth
uin	195627
answer	answer is ministerial correction date of answer 29/11/2018 answer text <p>The information requested is not held centrally and could only be obtained at disproportionate cost.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 29/11/2018 16:17:49 answering member 4067 label Biography information for Steve Brine
tabling member	4244 label Biography information for Jonathan Ashworth

964512

registered interest
date	03/09/2018
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, what plans NHS England has of introducing a revised decision-making process for ultra-orphan medicines, as introduced in Scotland following the publication of the Montgomery Review of Access to Medicines.
tabling member constituency	Alyn and Deeside
tabling member printed	Mark Tami
uin	169118
answer	answer is ministerial correction date of answer 11/09/2018 answer text <p>The level of funding for products undergoing review by NHS England will be determined during the 2019/20 planning process.</p><p> </p><p>In 2016/17 and 2017/18, £25 million was set aside for discretionary investment in new specialised services. This was determined by NHS England, who considered it an appropriate level of investment in the context of NHS England’s Specialised Commissioning functioning having to achieve overall efficiency savings of approximately 2.5% and 2.7% in 2016/17 and 2017/18 respectively in order to meet the financial pressures resulting from demographic growth and the legal requirement to fund all positive National Institute for Health and Care Excellence technology appraisals.</p><p> </p><p>The split in the overall funding available between the November and May prioritisation rounds is not fixed but determined each year based on the number and estimated cost of treatments being considered by the independently chaired Clinical Priorities Advisory Group (CPAG) in each round. Revealing the split risks revealing commercial in confidence information around pricing. Anything that is not prioritised in the November round has the opportunity to be considered at the May round therefore ensuring consideration against the full funding envelope for the financial year.</p><p> </p><p>Where manufacturers have requested the cover sheets of the policy propositions, they have received the CPAG summary report as presented at the May 2018 meeting from NHS England.</p><p> </p><p>The full scoring methodology that is used at all prioritisation meetings is published on the NHS England website. This can be found at the following link:</p><p> </p><p><a href="https://www.england.nhs.uk/commissioning/wp-content/uploads/sites/12/2016/06/prioritisation-method-cons-response.pdf" target="_blank">https://www.england.nhs.uk/commissioning/wp-content/uploads/sites/12/2016/06/prioritisation-method-cons-response.pdf</a></p><p> </p><p>The outcome of the May 2018 prioritisation process through use of this methodology has been published as a ranked list of five prioritisation Levels. This can be found at the following link:</p><p> </p><p><a href="https://www.england.nhs.uk/2017/12/nhs-england-announces-new-specialised-treatments-for-patients/" target="_blank">https://www.england.nhs.uk/2017/12/nhs-england-announces-new-specialised-treatments-for-patients/</a></p><p> </p><p>The impact assessments for all the treatments include a narrative about the estimated forecast financial implications for each item, based on the list price. These are published as part of the public consultation pack. The detailed costings are not shared as in many cases these are based on discount prices provided on a commercial in confidence basis.</p><p> </p><p>The methodology for relative prioritisation has been subject to legal advice as part of its development and implementation, and NHS England believes it complies with equalities legislation, the NHS Constitution and human rights legislation.</p><p> </p><p>NHS England routinely publishes the stakeholder engagement response report as part of consultation through policy development, but does not routinely publish any responses that arise as a result of public consultation.</p><p> </p><p>NHS England has no plans to introduce a revised decision-making process for ultra-orphan medicines as introduced in Scotland following the Montgomery Review. NHS England will continue to use the methodology for prioritisation that has previously been publicly consulted on.</p> answering member constituency Winchester answering member printed Steve Brine grouped question UIN 169109 169110 169111 169112 169113 169114 169115 169116 169117 question first answered 11/09/2018 16:26:11 answering member 4067 label Biography information for Steve Brine
tabling member	1383 label Biography information for Mark Tami

846086

registered interest
date	21/02/2018
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, if he will take steps to ensure that NHS England and NICE revise their appraisal criteria for the NICE Highly Specialised Technologies as a result of the Scottish Medicines Consortium’s review of the definition of orphan and ultra-orphan designation route to include condition prevalence criteria; and if he will ensure that they publish those prevalence criteria.
tabling member constituency	Linlithgow and East Falkirk
tabling member printed	Martyn Day
uin	128793
answer	answer is ministerial correction date of answer 01/03/2018 answer text <p>The Government and the National Institute for Health and Care Excellence (NICE) have no plans to review the criteria for the selection of topics for referral to NICE’s Highly Specialised Technologies (HST) programme. The topic selection criteria for HST are published at:</p><p> </p><p><a href="https://www.nice.org.uk/about/what-we-do/our-programmes/topic-selection" target="_blank">https://www.nice.org.uk/about/what-we-do/our-programmes/topic-selection</a></p> answering member constituency Winchester answering member printed Steve Brine question first answered 01/03/2018 15:09:31 answering member 4067 label Biography information for Steve Brine
tabling member	4488 label Biography information for Martyn Day

833048

registered interest
date	29/01/2018
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, with reference to the Office of Health Economics Report, Comparing Access to Orphan Medicinal Products (OMPs) in the United Kingdom and other European countries, published in March 2017, what steps he is taking to develop the Highly Specialised Technology appraisal process at NICE.
tabling member constituency	Cambridge
tabling member printed	Daniel Zeichner
uin	125364
answer	answer is ministerial correction date of answer 06/02/2018 answer text <p>The National Institute for Health and Care Excellence (NICE) is an independent body and is responsible for the methods and processes it uses in the development of its guidance and recommendations, including through its Highly Specialised Technologies (HST) programme. NICE periodically reviews its methods and processes to ensure that they remain fit for purpose for the National Health Service in England and introduced changes to its methods for the evaluation of technologies through its HST programme in April 2017 following a public consultation.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 06/02/2018 16:18:10 answering member 4067 label Biography information for Steve Brine
tabling member	4382 label Biography information for Daniel Zeichner