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existing patients with type 1 SMA to access Spinraza in advance of NICE’s guidance, although the company has now withdrawn the EAP for newly diagnosed patients.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

997164

registered interest
date	29/10/2018
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	Cancer: Medical Treatments
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, on what date CAR-T therapy for adult cancer patients will be made available.
tabling member constituency	Newton Abbot
tabling member printed	Anne Marie Morris
uin	184984
answer	answer is ministerial correction date of answer 01/11/2018 answer text <p>NHS England is working with the manufacturers and National Health Service providers to prepare the NHS to begin delivering Chimeric Antigen Receptor T Cell (CAR-T) therapy - the first in a wave of treatments in a new era of personalised medicine and part of the NHS’s long-term plan to upgrade cancer service. The first treatment that will be available to patient is tisagenlecleucel (Kymriah) as an option for treating children and young people up to 25 years old with B cell acute lymphoblastic leukaemia that is refractory, in relapsed post-transplant or in second or later relapse.</p><p> </p><p>NHS England anticipates that the National Institute for Health and Care Excellence will recommend this treatment for entry into the Cancer Drugs Fund in mid-November. If so, funding will be made immediately available, following a successful commercial deal with the manufacturer Novartis. We anticipate the first patients will begin their treatment in late November 2018. The phased implementation required by the manufacturer and the NHS means that full capacity to treat eligible patients will take some months to achieve and a National CAR-T Clinical Panel will convene in mid-November to assure equity of access and prioritise eligible patients.</p> answering member constituency Winchester answering member printed Steve Brine grouped question UIN 184985 question first answered 01/11/2018 16:55:17 answering member 4067 label Biography information for Steve Brine
tabling member	4249 label Biography information for Anne Marie Morris

997165

registered interest
date	29/10/2018
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	Cancer: Medical Treatments
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, when CAR-T therapy for adult cancer patients will be made available for patients in Torbay and Plymouth hospitals.
tabling member constituency	Newton Abbot
tabling member printed	Anne Marie Morris
uin	184985
answer	answer is ministerial correction date of answer 01/11/2018 answer text <p>NHS England is working with the manufacturers and National Health Service providers to prepare the NHS to begin delivering Chimeric Antigen Receptor T Cell (CAR-T) therapy - the first in a wave of treatments in a new era of personalised medicine and part of the NHS’s long-term plan to upgrade cancer service. The first treatment that will be available to patient is tisagenlecleucel (Kymriah) as an option for treating children and young people up to 25 years old with B cell acute lymphoblastic leukaemia that is refractory, in relapsed post-transplant or in second or later relapse.</p><p> </p><p>NHS England anticipates that the National Institute for Health and Care Excellence will recommend this treatment for entry into the Cancer Drugs Fund in mid-November. If so, funding will be made immediately available, following a successful commercial deal with the manufacturer Novartis. We anticipate the first patients will begin their treatment in late November 2018. The phased implementation required by the manufacturer and the NHS means that full capacity to treat eligible patients will take some months to achieve and a National CAR-T Clinical Panel will convene in mid-November to assure equity of access and prioritise eligible patients.</p> answering member constituency Winchester answering member printed Steve Brine grouped question UIN 184984 question first answered 01/11/2018 16:55:17 answering member 4067 label Biography information for Steve Brine
tabling member	4249 label Biography information for Anne Marie Morris

992658

registered interest
date	22/10/2018
answering body	Department for Environment, Food and Rural Affairs
answering dept id	13
answering dept short name	Environment, Food and Rural Affairs
answering dept sort name	Environment, Food and Rural Affairs
hansard heading	Fisheries: South West
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Environment, Food and Rural Affairs, if he will make an assessment of the adequacy of spending by the EU fisheries programme in the South West.
tabling member constituency	Newton Abbot
tabling member printed	Anne Marie Morris
uin	182215
answer	answer is ministerial correction date of answer 25/10/2018 answer text <p>Demand for European Maritime and Fisheries Funding (EMFF) has been very high in the South West of England. 663 projects have been approved in the South West, with committed EMFF support totalling £16.6 million. This is compared to 325 projects for the rest of England, where the total committed EMFF support stands at £13.9 million. Therefore 67% of projects are located in the South West - and these receive 54% of the committed EMFF support for the grant scheme. It is clear that there is high local demand from industry and that the South West will gain significant benefits from this funding in terms of ensuring a long-term sustainable future for fisheries.</p><p> </p><p>In the event of no deal being reached, all EMFF projects approved before the closure date of the current programme (December 2020) will be fully funded under a Treasury guarantee. This guarantee applies across the UK. We will continue to support applications for EMFF across the UK, including the South West, until the fund is fully committed.</p><p> </p><p>The Marine Management Organisation (MMO) makes public all beneficiaries of the grant aid from EMFF through the Transparency Initiative. This data can be obtained from the MMO’s website here:</p><p> </p><p><a href="https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/746656/Transparency_Initiative_-_August_2018.xlsx" target="_blank">https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/746656/Transparency_Initiative_-_August_2018.xlsx</a></p> answering member constituency Camborne and Redruth answering member printed George Eustice question first answered 25/10/2018 13:44:15 answering member 3934 label Biography information for George Eustice
tabling member	4249 label Biography information for Anne Marie Morris

986409

registered interest
date	12/10/2018
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	NHS: Drugs
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 17 July 2018 to Question 163554 on Drugs: Prices; when his Department expects to consult with relevant stakeholders on its proposals for a new system of commissioning for special medicinal products.
tabling member constituency	Newton Abbot
tabling member printed	Anne Marie Morris
uin	178508
answer	answer is ministerial correction date of answer 17/10/2018 answer text <p>We expect to formally consult relevant stakeholders later this year.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 17/10/2018 16:35:28 answering member 4067 label Biography information for Steve Brine
tabling member	4249 label Biography information for Anne Marie Morris

971761

registered interest
date	11/09/2018
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	Medical Treatments
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 the money that would be accrued to the public purse of the introduction of charges by NICE for companies whose products are selected for technology appraisal.
tabling member constituency	Newton Abbot
tabling member printed	Anne Marie Morris
uin	173639
answer	answer is ministerial correction date of answer 09/10/2018 answer text <p>The Department published a consultation on 10 August titled ‘NICE's technology appraisal and highly specialised technology work programmes – Charging and Appeal Panels’ which ran until 14 September 2018.</p><p> </p><p>Prior to the consultation, the Department and the National Institute of Health and Care Excellence (NICE) considered a number of options as well as charging. These are described in the consultation document and Impact Assessment which are published at the following link:</p><p> </p><p><a href="https://www.gov.uk/government/consultations/nice-recommendations-charging-and-appeal-panels" target="_blank">https://www.gov.uk/government/consultations/nice-recommendations-charging-and-appeal-panels</a></p><p> </p><p>The document also explains that based on current activity levels and the proposed charges, NICE expects it would generate £10 million per annum from charging and that, should charges be introduced, they would be reviewed after years one and two and periodically thereafter to ensure that there is no detrimental impact on the willingness of companies, including small companies, to launch products in the United Kingdom.</p><p> </p><p>The Government will carefully consider comments received in response to the consultation and will publish its response in due course.</p> answering member constituency Winchester answering member printed Steve Brine grouped question UIN 173640 173641 question first answered 09/10/2018 17:00:54 answering member 4067 label Biography information for Steve Brine
tabling member	4249 label Biography information for Anne Marie Morris

971763

registered interest
date	11/09/2018
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	Medical Treatments
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, whether he has made an assessment of the potential effectiveness of options available to NICE other than charging for technology appraisals to tackle changes in the level of its central Government funding; and if he will make a statement.
tabling member constituency	Newton Abbot
tabling member printed	Anne Marie Morris
uin	173641
answer	answer is ministerial correction date of answer 09/10/2018 answer text <p>The Department published a consultation on 10 August titled ‘NICE's technology appraisal and highly specialised technology work programmes – Charging and Appeal Panels’ which ran until 14 September 2018.</p><p> </p><p>Prior to the consultation, the Department and the National Institute of Health and Care Excellence (NICE) considered a number of options as well as charging. These are described in the consultation document and Impact Assessment which are published at the following link:</p><p> </p><p><a href="https://www.gov.uk/government/consultations/nice-recommendations-charging-and-appeal-panels" target="_blank">https://www.gov.uk/government/consultations/nice-recommendations-charging-and-appeal-panels</a></p><p> </p><p>The document also explains that based on current activity levels and the proposed charges, NICE expects it would generate £10 million per annum from charging and that, should charges be introduced, they would be reviewed after years one and two and periodically thereafter to ensure that there is no detrimental impact on the willingness of companies, including small companies, to launch products in the United Kingdom.</p><p> </p><p>The Government will carefully consider comments received in response to the consultation and will publish its response in due course.</p> answering member constituency Winchester answering member printed Steve Brine grouped question UIN 173639 173640 question first answered 09/10/2018 17:00:54 answering member 4067 label Biography information for Steve Brine
tabling member	4249 label Biography information for Anne Marie Morris

929364

registered interest
date	22/06/2018
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	Lumacaftor/ivacaftor
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 23 April 2018 to Question 135633, on Orkambi, whether his Department has also written to NHS England in similar terms to encourage them to treat negotiations with urgency.
tabling member constituency	Newton Abbot
tabling member printed	Anne Marie Morris
uin	156625
answer	answer is ministerial correction date of answer 27/06/2018 answer text <p>The Department has not written to NHS England separately. NHS England are in full agreement with the Department regarding the urgency of negotiations. Officials from NHS England are meeting frequently with Vertex.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 27/06/2018 16:04:59 answering member 4067 label Biography information for Steve Brine
tabling member	4249 label Biography information for Anne Marie Morris

929365

registered interest
date	22/06/2018
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	Rare Diseases: 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 assessment his Department has made of the suitability of processes of the National Institute for Health and Care Excellence for assessing rare disease medicines that do not meet the Highly Specialised Technology criteria.
tabling member constituency	Newton Abbot
tabling member printed	Anne Marie Morris
uin	156626
answer	answer is ministerial correction date of answer 27/06/2018 answer text <p>The National Institute for Health and Care Excellence (NICE) is the independent 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.</p><p> </p><p>NICE’s methods and processes for the assessment of drugs have been carefully developed over time and are internationally respected. NICE continues to keep its procedures under periodic review to ensure that they remain fit for purpose.</p><p> </p><p>All topics, including drugs for rare diseases, are considered through a rigorous topic selection process before formal referral to NICE to ensure that NICE guidance is appropriate and will add value. NICE assesses most significant new drugs through its technology appraisal programme and has been able to recommend a number of drugs licensed for the treatment of rare diseases for routine use on the NHS.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 27/06/2018 16:05:56 answering member 4067 label Biography information for Steve Brine
tabling member	4249 label Biography information for Anne Marie Morris

929366

registered interest
date	22/06/2018
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	Drugs: Cost-Effectiveness
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 the National Institute for Health and Care Excellence on updating its cost-effectiveness analysis methodology.
tabling member constituency	Newton Abbot
tabling member printed	Anne Marie Morris
uin	156627
answer	answer is ministerial correction date of answer 02/07/2018 answer text <p>Departmental officials regularly discuss a range of issues with colleagues in the National Institute for Health and Care Excellence (NICE), including its plans to update its methodology for the development of guidance. NICE’s methods and processes for the assessment of drugs have been carefully developed over time and are internationally respected. NICE continues to keep its procedures under periodic review to ensure that they remain fit for purpose.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 02/07/2018 14:21:29 answering member 4067 label Biography information for Steve Brine
tabling member	4249 label Biography information for Anne Marie Morris