The Department has made no such estimate. The information requested is not held centrally and could only be obtained at disproportionate cost.<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/4067", "label" : {"_value" : "Biography information for Steve Brine"} } , "answeringMemberConstituency" : {"_value" : "Winchester"} , "answeringMemberPrinted" : {"_value" : "Steve Brine"} , "dateOfAnswer" : {"_value" : "2018-12-07", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2018-12-07T13:08:04.04Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "17"} , "answeringDeptShortName" : {"_value" : "Health and Social Care"} , "answeringDeptSortName" : {"_value" : "Health and Social Care"} , "date" : {"_value" : "2018-11-28", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Orphan Drugs"} , "houseId" : {"_value" : "1"} , "legislature" : [{"_about" : "http://data.parliament.uk/terms/25259", "prefLabel" : {"_value" : "House of Commons"} } ], "questionText" : "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.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/4244", "label" : {"_value" : "Biography information for Jonathan Ashworth"} } , "tablingMemberConstituency" : {"_value" : "Leicester South"} , "tablingMemberPrinted" : [{"_value" : "Jonathan Ashworth"} ], "uin" : "196813"} , {"_about" : "http://data.parliament.uk/resources/1015082", "AnsweringBody" : [{"_value" : "Department of Health and Social Care"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/1015082/answer", "answerText" : {"_value" : "
The information requested is not held centrally and could only be obtained at disproportionate cost.<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/4067", "label" : {"_value" : "Biography information for Steve Brine"} } , "answeringMemberConstituency" : {"_value" : "Winchester"} , "answeringMemberPrinted" : {"_value" : "Steve Brine"} , "dateOfAnswer" : {"_value" : "2018-11-29", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2018-11-29T16:17:49.027Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "17"} , "answeringDeptShortName" : {"_value" : "Health and Social Care"} , "answeringDeptSortName" : {"_value" : "Health and Social Care"} , "date" : {"_value" : "2018-11-26", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Orphan Drugs"} , "houseId" : {"_value" : "1"} , "legislature" : [{"_about" : "http://data.parliament.uk/terms/25259", "prefLabel" : {"_value" : "House of Commons"} } ], "questionText" : "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.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/4244", "label" : {"_value" : "Biography information for Jonathan Ashworth"} } , "tablingMemberConstituency" : {"_value" : "Leicester South"} , "tablingMemberPrinted" : [{"_value" : "Jonathan Ashworth"} ], "uin" : "195627"} , {"_about" : "http://data.parliament.uk/resources/964512", "AnsweringBody" : [{"_value" : "Department of Health and Social Care"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/964512/answer", "answerText" : {"_value" : "
The level of funding for products undergoing review by NHS England will be determined during the 2019/20 planning process.<\/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\u2019s 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>
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>
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>
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>
https://www.england.nhs.uk/commissioning/wp-content/uploads/sites/12/2016/06/prioritisation-method-cons-response.pdf<\/a><\/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>
Guidance<\/p><\/td> | Estimated patient population<\/p><\/td> | Recommended<\/p><\/td><\/tr> |
Asfotase alfa for treating paediatric-onset hypophosphatasia<\/p><\/td> | Not known<\/p><\/td> | Yes<\/p><\/td><\/tr> |
Eliglustat for treating type 1 Gaucher disease<\/p><\/td> | 50 to 100<\/p><\/td> | Yes - for long-term treatment in adults who are cytochrome P450 2D6 poor, intermediate or extensive metabolisers.<\/p><\/td><\/tr> |
Migalastat for treating Fabry disease<\/p><\/td> | 142<\/p><\/td> | Yes \u2013 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> |
Ataluren for treating Duchenne muscular dystrophy with a nonsense mutation in the dystrophin gene<\/p><\/td> | Not known<\/p><\/td> | Yes<\/p><\/td><\/tr> |
Elosulfase alfa for treating mucopolysaccharidosis type Iva<\/p><\/td> | 74-77<\/p><\/td> | Yes<\/p><\/td><\/tr> |
Eculizumab for treating atypical haemolytic uraemic syndrome<\/p><\/td> | Not known<\/p><\/td> | Yes<\/p><\/td><\/tr><\/tbody><\/table> <\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/4545", "label" : {"_value" : "Biography information for Lord O'Shaughnessy"} } , "answeringMemberPrinted" : {"_value" : "Lord O'Shaughnessy"} , "dateOfAnswer" : {"_value" : "2018-02-05", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2018-02-05T12:12:36.58Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "17"} , "answeringDeptShortName" : {"_value" : "Health and Social Care"} , "answeringDeptSortName" : {"_value" : "Health and Social Care"} , "date" : {"_value" : "2018-01-22", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Orphan Drugs"} , "houseId" : {"_value" : "2"} , "legislature" : [{"_about" : "http://data.parliament.uk/terms/25277", "prefLabel" : {"_value" : "House of Lords"} } ], "questionText" : "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.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/1850", "label" : {"_value" : "Biography information for Baroness Masham of Ilton"} } , "tablingMemberPrinted" : [{"_value" : "Baroness Masham of Ilton"} ], "uin" : "HL4941"} , {"_about" : "http://data.parliament.uk/resources/796020", "AnsweringBody" : [{"_value" : "Department of Health"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/796020/answer", "answerText" : {"_value" : " 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> - There is likely to be significant benefit to patients in terms of administration, efficacy or improved side effect profile;<\/p> - The new formulation or technology is at, or likely to be at a significantly different price;<\/p> - There is appropriate evidence, such as would enable evaluation, either available or anticipated to be available in the near future;<\/p> - The timing is right. NICE is committed to publishing timely guidance within six months of the marketing authorisation; and<\/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> 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> - 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> - The target patient group is distinct for clinical reasons;<\/p> - The condition is chronic and severely disabling;<\/p> - The technology is expected to be used exclusively in the context of a highly specialised service;<\/p> - The technology is likely to have a very high acquisition cost;<\/p> - The technology has the potential for life long use; and<\/p> - The need for national commissioning of the technology is significant.<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/4545", "label" : {"_value" : "Biography information for Lord O'Shaughnessy"} } , "answeringMemberPrinted" : {"_value" : "Lord O'Shaughnessy"} , "dateOfAnswer" : {"_value" : "2017-12-11", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2017-12-11T14:21:57.437Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "17"} , "answeringDeptShortName" : {"_value" : "Health"} , "answeringDeptSortName" : {"_value" : "Health"} , "date" : {"_value" : "2017-11-28", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Orphan Drugs"} , "houseId" : {"_value" : "2"} , "legislature" : [{"_about" : "http://data.parliament.uk/terms/25277", "prefLabel" : {"_value" : "House of Lords"} } ], "questionText" : "To ask Her Majesty's Government what consideration has been given by NICE to appraisal criteria for ultra-orphan conditions.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/1850", "label" : {"_value" : "Biography information for Baroness Masham of Ilton"} } , "tablingMemberPrinted" : [{"_value" : "Baroness Masham of Ilton"} ], "uin" : "HL3669"} , {"_about" : "http://data.parliament.uk/resources/760898", "AnsweringBody" : [{"_value" : "Department of Health"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/760898/answer", "answerText" : {"_value" : " 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> 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>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/4067", "label" : {"_value" : "Biography information for Steve Brine"} } , "answeringMemberConstituency" : {"_value" : "Winchester"} , "answeringMemberPrinted" : {"_value" : "Steve Brine"} , "dateOfAnswer" : {"_value" : "2017-10-09", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2017-10-09T11:22:20.147Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "17"} , "answeringDeptShortName" : {"_value" : "Health"} , "answeringDeptSortName" : {"_value" : "Health"} , "date" : {"_value" : "2017-09-14", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Orphan Drugs"} , "houseId" : {"_value" : "1"} , "legislature" : [{"_about" : "http://data.parliament.uk/terms/25259", "prefLabel" : {"_value" : "House of Commons"} } ], "questionText" : "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.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/1511", "label" : {"_value" : "Biography information for Lord Austin of Dudley"} } , "tablingMemberConstituency" : {"_value" : "Dudley North"} , "tablingMemberPrinted" : [{"_value" : "Ian Austin"} ], "uin" : "105408"} , {"_about" : "http://data.parliament.uk/resources/658703", "AnsweringBody" : [{"_value" : "Department of Health"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/658703/answer", "answerText" : {"_value" : " The National Institute for Health and Care Excellence has no plans to develop a new assessment service specifically for orphan medicines.<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/127", "label" : {"_value" : "Biography information for Lord Prior of Brampton"} } , "answeringMemberPrinted" : {"_value" : "Lord Prior of Brampton"} , "dateOfAnswer" : {"_value" : "2016-12-19", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2016-12-19T15:59:13.96Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "17"} , "answeringDeptShortName" : {"_value" : "Health"} , "answeringDeptSortName" : {"_value" : "Health"} , "date" : {"_value" : "2016-12-14", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Orphan Drugs"} , "houseId" : {"_value" : "2"} , "legislature" : [{"_about" : "http://data.parliament.uk/terms/25277", "prefLabel" : {"_value" : "House of Lords"} } ], "questionText" : "To ask Her Majesty\u2019s 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.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/2024", "label" : {"_value" : "Biography information for Lord Hunt of Kings Heath"} } , "tablingMemberPrinted" : [{"_value" : "Lord Hunt of Kings Heath"} ], "uin" : "HL4121"} , {"_about" : "http://data.parliament.uk/resources/657938", "AnsweringBody" : [{"_value" : "Department of Health"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/657938/answer", "answerText" : {"_value" : " 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\u2019s technology appraisal and highly specialised technologies programmes.<\/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>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/4080", "label" : {"_value" : "Biography information for David Mowat"} } , "answeringMemberConstituency" : {"_value" : "Warrington South"} , "answeringMemberPrinted" : {"_value" : "David Mowat"} , "dateOfAnswer" : {"_value" : "2016-12-20", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2016-12-20T15:42:05.52Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "17"} , "answeringDeptShortName" : {"_value" : "Health"} , "answeringDeptSortName" : {"_value" : "Health"} , "date" : {"_value" : "2016-12-13", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Orphan Drugs"} , "houseId" : {"_value" : "1"} , "legislature" : [{"_about" : "http://data.parliament.uk/terms/25259", "prefLabel" : {"_value" : "House of Commons"} } ], "questionText" : "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.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/4382", "label" : {"_value" : "Biography information for Daniel Zeichner"} } , "tablingMemberConstituency" : {"_value" : "Cambridge"} , "tablingMemberPrinted" : [{"_value" : "Daniel Zeichner"} ], "uin" : "57383"} ], "itemsPerPage" : 10, "next" : "http://eldaddp.azurewebsites.net/answeredquestions.text?_page=1&max-date=2018-11-28&hansardHeading=Orphan+Drugs", "page" : 0, "startIndex" : 1, "totalResults" : 15, "type" : ["http://purl.org/linked-data/api/vocab#ListEndpoint", "http://purl.org/linked-data/api/vocab#Page"]} } |