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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existing patients with type 1 SMA to access Spinraza in advance of NICE’s guidance, although the company has now withdrawn the EAP for newly diagnosed patients.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

851702

registered interest
date	28/02/2018
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	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 and Biogenon have made in discussions on a managed access agreement for the use of Spinraza for the treatment of spinal muscular atrophy.
tabling member constituency	North Tyneside
tabling member printed	Mary Glindon
uin	130465
answer	answer is ministerial correction date of answer 05/03/2018 answer text <p>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> answering member constituency Winchester answering member printed Steve Brine question first answered 05/03/2018 15:54:12 answering member 4067 label Biography information for Steve Brine
tabling member	4126 label Biography information for Mary Glindon

797688

registered interest
date	29/11/2017
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Nusinersen
house id	1
legislature	25259 pref label House of Commons
question text	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.
tabling member constituency	South Leicestershire
tabling member printed	Alberto Costa
uin	116651
answer	answer is ministerial correction date of answer 07/12/2017 answer text <p>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’s 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> answering member constituency Winchester answering member printed Steve Brine question first answered 07/12/2017 15:10:28 answering member 4067 label Biography information for Steve Brine
tabling member	4439 label Biography information for Alberto Costa