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1142736

registered interest
date	02/09/2019
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	Nusinersen
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, what recent assessment he has made of the appropriateness of the NICE criteria for assessing a patient's access to Spinraza.
tabling member constituency	Wolverhampton South West
tabling member printed	Eleanor Smith
uin	284289
answer	answer is ministerial correction date of answer 09/09/2019 answer text <p>It has not proved possible to respond to the hon. Member in the time available before Prorogation.</p> answering member constituency Bury St Edmunds answering member printed Jo Churchill question first answered 09/09/2019 17:25:25 answering member 4380 label Biography information for Jo Churchill
tabling member	4609 label Biography information for Eleanor Smith

1127499

registered interest
date	20/05/2019
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	Nusinersen
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, what discussions his Department has held with (a) NICE, (b) NHS England and (c) Biogen on a Managed Access Agreement for SMA treatment Spinraza.
tabling member constituency	West Lancashire
tabling member printed	Rosie Cooper
uin	256254
answer	answer is ministerial correction date of answer 29/05/2019 answer text <p>Discussions about managed access agreements for technologies undergoing assessment by the National Institute for Health and Care Excellence (NICE) are rightly held between NHS England as an independent body and the manufacturer concerned. Departmental officials play no role in such discussions, but are in regular contact with NICE and NHS England colleagues about a range of issues, including progress in discussions about a potential managed access agreement for Spinraza (nusinersen) for the treatment of spinal muscular atrophy. Ministers have also held meetings with Biogen, NICE and NHS England on a number of occasions, at which the availability of Spinraza was discussed.</p><p> </p><p>NHS England and NICE have made stakeholders and the public aware of the outcome of its appraisal committee meeting of 8 May and NICE is now able to recommend the use of Spinraza for NHS patients in England, subject to a managed access agreement agreed between NHS England and Biogen which makes Spinraza available to children with the most severe form of spinal muscular atrophy available with immediate effect. NICE’s Appraisal Committee’s considerations and recommendations will be contained in the final appraisal document which will be published in due course, with final guidance expected in June 2019.</p> answering member constituency South Ribble answering member printed Seema Kennedy grouped question UIN 256255 question first answered 29/05/2019 10:38:01 answering member 4455 label Biography information for Seema Kennedy
tabling member	1538 label Biography information for Rosie Cooper

1124901

registered interest
date	07/05/2019
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	Nusinersen
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government what discussions they have had with (1) NICE, (2) NHS England, and (3) Biogen, on a Managed Access Agreement for Spinal Muscular Atrophy treatment, Spinraza.
tabling member printed	Baroness Thomas of Winchester
uin	HL15576
answer	answer is ministerial correction date of answer 17/05/2019 answer text <p>Departmental officials are in regular contact with colleagues in the National Institute for Health and Care Excellence (NICE) and NHS England about a range of issues, including progress in discussions about a potential managed access agreement for Spinraza (nusinersen). Ministers have also held meetings with Biogen, NICE and NHS England on a number of occasions, at which the availability of Spinraza was discussed.</p><p>NHS England and NICE have made stakeholders and the public aware of the outcome of its appraisal committee meeting and NICE is now able to recommend the use of Spinraza for National Health Service patients in England, subject to a managed access agreement agreed between NHS England and Biogen. The final appraisal document will be published in due course.</p><p> </p> answering member printed Baroness Blackwood of North Oxford grouped question UIN HL15577 question first answered 17/05/2019 11:07:46 answering member 4019 label Biography information for Baroness Blackwood of North Oxford
tabling member	3785 label Biography information for Baroness Thomas of Winchester

1077279

registered interest
date	25/02/2019
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	Nusinersen
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, what discussions his Department has held with NICE on the cost-flexibility effectiveness calculations for the treatment Spinraza.
tabling member constituency	West Lancashire
tabling member printed	Rosie Cooper
uin	225455
answer	answer is ministerial correction date of answer 05/03/2019 answer text <p>The National Institute for Health and Care Excellence (NICE) is an independent body and develops its technology appraisal recommendations in accordance with its published methods and processes, including consultation with stakeholders. The Department is a stakeholder in all NICE technology appraisals and has the opportunity to provide input at set points in the process, in common with other stakeholders.</p><p>NHS England and NICE have been in discussions with the manufacturer of Spinraza, Biogen, to explore whether there are commercial flexibilities that might enable NICE to recommend the drug as a clinically and cost-effective use of National Health Service resources. Biogen has now submitted a revised submission and a meeting of NICE’s independent appraisal committee has been arranged for 6 March 2019 to consider the recommendations.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 05/03/2019 17:13:30 answering member 4067 label Biography information for Steve Brine
tabling member	1538 label Biography information for Rosie Cooper

1077280

registered interest
date	25/02/2019
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	Nusinersen
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, what steps his Department is taking to ensure that the cost of spinal muscular atrophy treatment Spinraza is not a barrier in the appraisal process.
tabling member constituency	West Lancashire
tabling member printed	Rosie Cooper
uin	225456
answer	answer is ministerial correction date of answer 05/03/2019 answer text <p>The Government wants National Health Service patients to be able to benefit from effective new medicines in a way that represents value for money to the taxpayer. The National Institute for Health and Care Excellence (NICE) is currently developing technology appraisal guidance on the use of Spinraza for the treatment of spinal muscular atrophy.</p><p>Discussions have been taking place between the manufacturer of Spinraza, Biogen, and NHS England to explore whether there are commercial flexibilities that might enable NICE to recommend the drug as a clinically and cost-effective use of NHS resources. Biogen has now submitted a revised submission for NICE’s independent Appraisal and a meeting has been arranged for 6 March to consider the recommendations.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 05/03/2019 17:14:34 answering member 4067 label Biography information for Steve Brine
tabling member	1538 label Biography information for Rosie Cooper

1064472

registered interest
date	20/02/2019
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	Nusinersen
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, what the planned timescale is for patients to access Spinraza treatment for muscular atrophy types 2 and 3.
tabling member constituency	West Bromwich West
tabling member printed	Mr Adrian Bailey
uin	224024
answer	answer is ministerial correction date of answer 28/02/2019 answer text <p>The National Institute for Health and Care Excellence (NICE) is currently developing guidance on the use of Spinraza (nusinersen) for the treatment of spinal muscular atrophy, including types 2 and 3.</p><p> </p><p>NHS England and NICE have been in discussions with the manufacturer of Spinraza, Biogen, to explore whether there are commercial flexibilities that might enable NICE to recommend the drug as a clinically and cost effective use of NHS resources. Biogen has now submitted a revised submission for NICE’s independent Appraisal Committee to consider and a meeting has been arranged for 6 March 2019 to consider the recommendations. In the absence of final guidance from NICE, clinicians can apply to NHS England for funding in exceptional cases through the individual funding request process.</p> answering member constituency Winchester answering member printed Steve Brine grouped question UIN 224025 question first answered 28/02/2019 11:56:53 answering member 4067 label Biography information for Steve Brine
tabling member	320 label Biography information for Mr Adrian Bailey

1064473

registered interest
date	20/02/2019
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	Nusinersen
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, what progress has been made on concluding a managed access treatment agreement for the use of Spinraza for patients with spinal muscular atrophy types 2 and 3.
tabling member constituency	West Bromwich West
tabling member printed	Mr Adrian Bailey
uin	224025
answer	answer is ministerial correction date of answer 28/02/2019 answer text <p>The National Institute for Health and Care Excellence (NICE) is currently developing guidance on the use of Spinraza (nusinersen) for the treatment of spinal muscular atrophy, including types 2 and 3.</p><p> </p><p>NHS England and NICE have been in discussions with the manufacturer of Spinraza, Biogen, to explore whether there are commercial flexibilities that might enable NICE to recommend the drug as a clinically and cost effective use of NHS resources. Biogen has now submitted a revised submission for NICE’s independent Appraisal Committee to consider and a meeting has been arranged for 6 March 2019 to consider the recommendations. In the absence of final guidance from NICE, clinicians can apply to NHS England for funding in exceptional cases through the individual funding request process.</p> answering member constituency Winchester answering member printed Steve Brine grouped question UIN 224024 question first answered 28/02/2019 11:56:53 answering member 4067 label Biography information for Steve Brine
tabling member	320 label Biography information for Mr Adrian Bailey

1027584

registered interest
date	18/12/2018
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	Nusinersen
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, what recent discussions he has had with NICE on the (a) timeframe for the publication of decision of the NICE evaluation committee meeting held on 23 October 2018 in relation to Spinraza and (b) potential availability of Spinraza on the NHS.
tabling member constituency	South Cambridgeshire
tabling member printed	Heidi Allen
uin	203346
answer	answer is ministerial correction date of answer 21/12/2018 answer text <p>Departmental Ministers and officials have spoken to colleagues at the National Institute for Health and Care Excellence (NICE) on a number of occasions to enquire about the progress of the technology appraisal of nusinersen for the treatment of spinal muscular atrophy.</p><p> </p><p>On 12 November, following NICE’s second appraisal committee meeting for nusinersen on Tuesday 23 October, NICE informed registered stakeholders that it and the manufacturer Biogen were continuing to progress discussions and as a result NICE was not in a position to provide the outcome of the committee’s deliberations.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 21/12/2018 14:17:39 answering member 4067 label Biography information for Steve Brine
tabling member	4516 label Biography information for Heidi Allen

1015562

registered interest
date	27/11/2018
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	Nusinersen
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, what discussions his Department has had with NICE on its appraised criteria to facilitate progress towards a Managed Access Arrangement for Spinraza.
tabling member constituency	Harborough
tabling member printed	Neil O'Brien
uin	196306
answer	answer is ministerial correction date of answer 05/12/2018 answer text <p>Departmental officials have had a number of discussions with colleagues in the National Institute for Health and Care Excellence (NICE) to enquire about progress of the ongoing appraisal of nusinersen (Spinraza) for the treatment of spinal muscular atrophy. Discussions between NHS England, NICE and Biogen (the company that manufactures nusinersen) are ongoing to seek to agree a commercial agreement that would enable NICE to recommend use of nusinersen as a clinically and cost effective use of National Health Service resources.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 05/12/2018 16:27:43 answering member 4067 label Biography information for Steve Brine
tabling member	4679 label Biography information for Neil O'Brien

1007767

registered interest
date	15/11/2018
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	Nusinersen
house id	1
legislature	25259 pref label House of Commons
question text	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.
tabling member constituency	Newton Abbot
tabling member printed	Anne Marie Morris
uin	191928
answer	answer is ministerial correction date of answer 22/11/2018 answer text <p>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><p> </p><p>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><p> </p><p>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’s guidance, although the company has now withdrawn the EAP for newly diagnosed patients.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 22/11/2018 15:13:09 answering member 4067 label Biography information for Steve Brine
tabling member	4249 label Biography information for Anne Marie Morris