The National Institute for Health and Care Excellence (NICE) is currently developing technology appraisal guidance for the National Health Service on the use of Spinraza (nusinersen) for the treatment of spinal muscular atrophy (SMA).<\/p>
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NICE is in discussion with Biogen (the company that manufactures Spinraza) to determine if there are any commercial flexibilities that could support the company in putting forward a cost-effective price in order for NICE to recommend use of the drug as a clinically and cost-effective use of NHS resources.<\/p>
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NHS England has published an Interim Policy Statement determining the circumstances in which existing patients will be supported to access Spinraza through the Expanded Access Programme (EAP) scheme sponsored by Biogen. The policy statement enables existing patients with type 1 SMA to access Spinraza in advance of NICE\u2019s guidance, although the company has now withdrawn the EAP for newly diagnosed patients.<\/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" : "2018-11-22", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2018-11-22T15:13:09.58Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "17"} , "answeringDeptShortName" : {"_value" : "Health and Social Care"} , "answeringDeptSortName" : {"_value" : "Health and Social Care"} , "date" : {"_value" : "2018-11-15", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Nusinersen"} , "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 progress NHS England, Biogen and NICE have made in discussions on a managed access agreement for the use of Spinraza for the treatment of spinal muscular dystrophy.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/4249", "label" : {"_value" : "Biography information for Anne Marie Morris"} } , "tablingMemberConstituency" : {"_value" : "Newton Abbot"} , "tablingMemberPrinted" : [{"_value" : "Anne Marie Morris"} ], "uin" : "191928"} , {"_about" : "http://data.parliament.uk/resources/851702", "AnsweringBody" : [{"_value" : "Department of Health and Social Care"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/851702/answer", "answerText" : {"_value" : "
NHS England has advised that it is continuing discussions with Biogen and the National Institute for Health and Care Excellence about the use of nusinersen (Spinraza) for the treatment of patients with spinal muscular atrophy.<\/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" : "2018-03-05", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2018-03-05T15:54:12.893Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "17"} , "answeringDeptShortName" : {"_value" : "Health and Social Care"} , "answeringDeptSortName" : {"_value" : "Health and Social Care"} , "date" : {"_value" : "2018-02-28", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Nusinersen"} , "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 progress NHS England and Biogenon have made in discussions on a managed access agreement for the use of Spinraza for the treatment of spinal muscular atrophy.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/4126", "label" : {"_value" : "Biography information for Mary Glindon"} } , "tablingMemberConstituency" : {"_value" : "North Tyneside"} , "tablingMemberPrinted" : [{"_value" : "Mary Glindon"} ], "uin" : "130465"} , {"_about" : "http://data.parliament.uk/resources/797688", "AnsweringBody" : [{"_value" : "Department of Health"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/797688/answer", "answerText" : {"_value" : "
The National Institute for Health and Care Excellence (NICE) has been asked to develop technology appraisal guidance on the use of nusinersen (Spinraza) to treat spinal muscular atrophy and this topic has been scheduled into NICE\u2019s work programme. The appraisal process is anticipated to begin in January 2018 and the deadline for an evidence submission is anticipated to be March 2018. Although no further details about timescales for the development of guidance are available at this stage, NICE take approximately nine months to develop guidance on a new drug depending on the individual product.<\/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" : "2017-12-07", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2017-12-07T15:10:28.443Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "17"} , "answeringDeptShortName" : {"_value" : "Health"} , "answeringDeptSortName" : {"_value" : "Health"} , "date" : {"_value" : "2017-11-29", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Nusinersen"} , "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 the timetable is for NICE to begin its evaluation of the spinal muscular atrophy treatment Spinraza.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/4439", "label" : {"_value" : "Biography information for Alberto Costa"} } , "tablingMemberConstituency" : {"_value" : "South Leicestershire"} , "tablingMemberPrinted" : [{"_value" : "Alberto Costa"} ], "uin" : "116651"} ], "itemsPerPage" : 10, "page" : 0, "startIndex" : 1, "totalResults" : 3, "type" : ["http://purl.org/linked-data/api/vocab#ListEndpoint", "http://purl.org/linked-data/api/vocab#Page"]} }