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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

827891

registered interest
date	22/01/2018
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	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government how many treatments with an orphan designation have been subject to a Highly Specialised Technology evaluation by the National Institute for Health and Care Excellence since 2013; what was the recommendation for each assessment; and what was the estimated populated size for each treatment.
tabling member printed	Baroness Masham of Ilton
uin	HL4941
answer	answer is ministerial correction date of answer 05/02/2018 answer text <p>The National Institute for Health and Care Excellence (NICE) has evaluated six treatments with an orphan designation through its Highly Specialised Technology (HST) programme since 2013. The table below details the guidance, patient population size and the recommendation for each evaluation.</p><table><tbody><tr><td><p>Guidance</p></td><td><p>Estimated patient population</p></td><td><p>Recommended</p></td></tr><tr><td><p>Asfotase alfa for treating paediatric-onset hypophosphatasia</p></td><td><p>Not known</p></td><td><p>Yes</p></td></tr><tr><td><p>Eliglustat for treating type 1 Gaucher disease</p></td><td><p>50 to 100</p></td><td><p>Yes - for long-term treatment in adults who are cytochrome P450 2D6 poor, intermediate or extensive metabolisers.</p></td></tr><tr><td><p>Migalastat for treating Fabry disease</p></td><td><p>142</p></td><td><p>Yes – for people over 16 years of age with an amenable mutation, only if migalastat is provided with the discount agreed in the patient access scheme, and only if enzyme replacement therapy would otherwise be offered.</p></td></tr><tr><td><p>Ataluren for treating Duchenne muscular dystrophy with a nonsense mutation in the dystrophin gene</p></td><td><p>Not known</p></td><td><p>Yes</p></td></tr><tr><td><p>Elosulfase alfa for treating mucopolysaccharidosis type Iva</p></td><td><p>74-77</p></td><td><p>Yes</p></td></tr><tr><td><p>Eculizumab for treating atypical haemolytic uraemic syndrome</p></td><td><p>Not known</p></td><td><p>Yes</p></td></tr></tbody></table><p> </p> answering member printed Lord O'Shaughnessy question first answered 05/02/2018 12:12:36 answering member 4545 label Biography information for Lord O'Shaughnessy
tabling member	1850 label Biography information for Baroness Masham of Ilton

796020

registered interest
date	28/11/2017
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Orphan Drugs
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government what consideration has been given by NICE to appraisal criteria for ultra-orphan conditions.
tabling member printed	Baroness Masham of Ilton
uin	HL3669
answer	answer is ministerial correction date of answer 11/12/2017 answer text <p>For treatments to be considered by the National Institute for Health and Care Excellence (NICE) for the Highly Specialised Technologies (HST) programme, including ultra-orphan treatments, they are subject to the elimination and prioritisation criteria set by NICE. The elimination criteria remove any unsuitable topics from potential consideration for guidance development through the HST programme, and the criteria are as follows:</p><p> </p><p>- There is likely to be significant benefit to patients in terms of administration, efficacy or improved side effect profile;</p><p>- The new formulation or technology is at, or likely to be at a significantly different price;</p><p>- There is appropriate evidence, such as would enable evaluation, either available or anticipated to be available in the near future;</p><p>- The timing is right. NICE is committed to publishing timely guidance within six months of the marketing authorisation; and</p><p>- The relevant clinical question(s) can be addressed by the application of the highly specialised technologies evaluation methodology. This would exclude topics on which guidance to NHS England would be of inadequate value in the absence of broader guidelines on the clinical pathway within which the technology should be contextualised.</p><p> </p><p>The importance of each topic is considered against the prioritisation criteria that help the Department decide which topics should be referred to NICE for guidance development through the HST programme. The prioritisation criteria are as follows:</p><p> </p><p>- The target patient group for the technology in its licensed indication is so small that treatment will usually be concentrated in very few centres in the NHS;</p><p>- The target patient group is distinct for clinical reasons;</p><p>- The condition is chronic and severely disabling;</p><p>- The technology is expected to be used exclusively in the context of a highly specialised service;</p><p>- The technology is likely to have a very high acquisition cost;</p><p>- The technology has the potential for life long use; and</p><p>- The need for national commissioning of the technology is significant.</p> answering member printed Lord O'Shaughnessy question first answered 11/12/2017 14:21:57 answering member 4545 label Biography information for Lord O'Shaughnessy
tabling member	1850 label Biography information for Baroness Masham of Ilton

760898

registered interest
date	14/09/2017
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Orphan Drugs
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health, what assessment he has made of the ability of NICE to assess orphan treatments as part of its (i) single technology appraisal and (ii) highly specialised technology programmes; and if he will make a statement.
tabling member constituency	Dudley North
tabling member printed	Ian Austin
uin	105408
answer	answer is ministerial correction date of answer 09/10/2017 answer text <p>The National Institute for Health and Care Excellence (NICE) is the independent, expert body responsible for developing authoritative, evidence-based guidance for the National Health Service on whether drugs and other treatments represent an effective use of NHS resources. The methods and processes it uses in the development of its guidance are internationally respected have been developed through extensive engagement with a full range of stakeholders, including the Department, and are periodically reviewed to ensure that they remain fit for purpose.</p><p> </p><p>NICE has assessed, and been able to recommend, a number of orphan medicines through its technology appraisal and highly specialised technology programmes. NHS commissioners are legally required to fund drugs and treatments recommended in NICE technology appraisal and highly specialised technology guidance.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 09/10/2017 11:22:20 answering member 4067 label Biography information for Steve Brine
tabling member	1511 label Biography information for Lord Austin of Dudley

658703

registered interest
date	14/12/2016
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Orphan Drugs
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty’s Government whether the National Institute for Health and Care Excellence intends to develop a new assessment process to evaluate orphan medicines for use in the NHS.
tabling member printed	Lord Hunt of Kings Heath
uin	HL4121
answer	answer is ministerial correction date of answer 19/12/2016 answer text <p>The National Institute for Health and Care Excellence has no plans to develop a new assessment service specifically for orphan medicines.</p> answering member printed Lord Prior of Brampton question first answered 19/12/2016 15:59:13 answering member 127 label Biography information for Lord Prior of Brampton
tabling member	2024 label Biography information for Lord Hunt of Kings Heath

657938

registered interest
date	13/12/2016
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Orphan Drugs
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health, if NHS England will consider the potential merits of developing a new assessment process to evaluate orphan medicines for use in the NHS.
tabling member constituency	Cambridge
tabling member printed	Daniel Zeichner
uin	57383
answer	answer is ministerial correction date of answer 20/12/2016 answer text <p>NHS England is waiting for the outcome of the current joint National Institute for Health and Care Excellence/NHS England consultation on proposed changes to arrangements for evaluating and funding drugs and other health technologies which are appraised through NICE’s technology appraisal and highly specialised technologies programmes.</p><p> </p><p>The consultation is due to close on 13 January. Once the responses to the consultation have been reviewed, NHS England and NICE will consider whether any changes to the way orphan drugs are evaluated should be made.</p> answering member constituency Warrington South answering member printed David Mowat question first answered 20/12/2016 15:42:05 answering member 4080 label Biography information for David Mowat
tabling member	4382 label Biography information for Daniel Zeichner