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1138242
star this property registered interest false more like this
star this property date less than 2019-07-10more like thismore than 2019-07-10
star this property answering body
Department of Health and Social Care more like this
unstar this property answering dept id 17 more like this
star this property answering dept short name Health and Social Care more like this
star this property answering dept sort name Health and Social Care more like this
star this property hansard heading Spinal Muscular Atrophy: Nusinersen more like this
star this property house id 1 more like this
star this property legislature
25259
star this property pref label House of Commons more like this
star this property question text To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 8 July 2019 to Question 369611 on Spinal Muscular Atrophy (SMA), what the evidential basis is that Spinraza does not work effectively on people with SMA that are excluded from access to that drug following the announcement of 15 May 2019 by NICE on that drug; and if he will make a statement. more like this
star this property tabling member constituency Christchurch more like this
star this property tabling member printed
Sir Christopher Chope remove filter
star this property uin 275653 more like this
star this property answer
answer
unstar this property is ministerial correction false more like this
unstar this property date of answer less than 2019-07-15more like thismore than 2019-07-15
star this property answer text <p>The National Institute for Health and Care Excellence (NICE) is currently developing recommendations for the National Health Service on the use of Spinraza for the treatment of spinal muscular atrophy (SMA) through its technology appraisal programme. NICE recommends technologies for use in the NHS when the evidence demonstrates that they are clinically effective and represent a cost-effective use of NHS resources.</p><p>There are several subtypes of SMA and, in the case of Spinraza, NICE has advised that it was not presented with evidence in SMA type 0 and SMA type 4. Evidence presented for the SMA type 3 population, who had lost the ability to walk, was limited and immature and resulted in its independent Appraisal Committee concluding that the size and nature of the benefits of Spinraza for this population were uncertain. Therefore, they were not included in the managed access arrangement (MAA) agreed by NHS England and Biogen.</p><p>Following publication of the initial MAA, the company presented further clinical evidence and the MAA was extended to include paediatric patients, who have recently (in the previous 12 months) lost the ability to walk independently.</p><p>Uniquely for this type of arrangement, during the five-year course of the MAA, should evidence become available on the potential benefits of Spinraza for type 3 SMA patients that are currently not included in the MAA, NICE will review that evidence to see whether it would support a change in the MAA inclusion criteria.</p><p> </p>
star this property answering member constituency South Ribble more like this
star this property answering member printed Seema Kennedy remove filter
star this property question first answered
less than 2019-07-15T16:42:57.43Zmore like thismore than 2019-07-15T16:42:57.43Z
star this property answering member
4455
star this property label Biography information for Seema Kennedy more like this
star this property tabling member
242
unstar this property label Biography information for Sir Christopher Chope more like this
1136673
star this property registered interest false more like this
star this property date less than 2019-07-03more like thismore than 2019-07-03
star this property answering body
Department of Health and Social Care more like this
unstar this property answering dept id 17 more like this
star this property answering dept short name Health and Social Care more like this
star this property answering dept sort name Health and Social Care more like this
star this property hansard heading Spinal Muscular Atrophy: Drugs more like this
star this property house id 1 more like this
star this property legislature
25259
star this property pref label House of Commons more like this
star this property question text To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 1 July 2019 to Question 269609 on Spinal Muscular Atrophy, if he will place in the Library a copy of the managed access agreement. more like this
star this property tabling member constituency Christchurch more like this
star this property tabling member printed
Sir Christopher Chope remove filter
star this property uin 272723 more like this
star this property answer
answer
unstar this property is ministerial correction false more like this
unstar this property date of answer less than 2019-07-08more like thismore than 2019-07-08
star this property answer text <p>The Managed Access Agreement for nusinersen for the treatment of spinal muscular atrophy which has been approved by NHS England, Biogen, the National Institute for Health and Care Excellence, the three main patient groups (Muscular Dystrophy UK, Spinal Muscular Atrophy UK, Treat SMA) and clinicians can be found at the following link:</p><p><a href="https://www.nice.org.uk/guidance/gid-ta10281/documents/committee-papers-2" target="_blank">https://www.nice.org.uk/guidance/gid-ta10281/documents/committee-papers-2</a></p> more like this
star this property answering member constituency South Ribble more like this
star this property answering member printed Seema Kennedy remove filter
star this property question first answered
less than 2019-07-08T15:43:56.353Zmore like thismore than 2019-07-08T15:43:56.353Z
star this property answering member
4455
star this property label Biography information for Seema Kennedy more like this
star this property tabling member
242
unstar this property label Biography information for Sir Christopher Chope more like this
1136680
star this property registered interest false more like this
star this property date less than 2019-07-03more like thismore than 2019-07-03
star this property answering body
Department of Health and Social Care more like this
unstar this property answering dept id 17 more like this
star this property answering dept short name Health and Social Care more like this
star this property answering dept sort name Health and Social Care more like this
star this property hansard heading Spinal Muscular Atrophy: Drugs more like this
star this property house id 1 more like this
star this property legislature
25259
star this property pref label House of Commons more like this
star this property question text To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 1 July 2019 to Question 269610 on Spinal Muscular Atrophy: Drugs, what the maximum length of time is for the period of further data collection. more like this
star this property tabling member constituency Christchurch more like this
star this property tabling member printed
Sir Christopher Chope remove filter
star this property uin 272725 more like this
star this property answer
answer
unstar this property is ministerial correction false more like this
unstar this property date of answer less than 2019-07-08more like thismore than 2019-07-08
star this property answer text <p>The Managed Access Agreement (MAA) for nusinersen for treating spinal muscular atrophy states that the data collection will be in place for a minimum of three years and up to the automatic expiry of the MAA on the fifth anniversary, unless the MAA expires earlier as a result of the publication of the National Institute for Health and Care Excellence’s reappraisal of nusinersen.</p> more like this
star this property answering member constituency South Ribble more like this
star this property answering member printed Seema Kennedy remove filter
star this property question first answered
less than 2019-07-08T15:49:09.58Zmore like thismore than 2019-07-08T15:49:09.58Z
star this property answering member
4455
star this property label Biography information for Seema Kennedy more like this
star this property tabling member
242
unstar this property label Biography information for Sir Christopher Chope more like this
1136683
star this property registered interest false more like this
star this property date less than 2019-07-03more like thismore than 2019-07-03
star this property answering body
Department of Health and Social Care more like this
unstar this property answering dept id 17 more like this
star this property answering dept short name Health and Social Care more like this
star this property answering dept sort name Health and Social Care more like this
star this property hansard heading Spinal Muscular Atrophy: Drugs more like this
star this property house id 1 more like this
star this property legislature
25259
star this property pref label House of Commons more like this
star this property question text To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 1 July 2019 to Question 369611 on Spinal Muscular Atrophy: Drugs, what estimate he has made of the number of patients affected by the NICE announcement of 15 May 2019. more like this
star this property tabling member constituency Christchurch more like this
star this property tabling member printed
Sir Christopher Chope remove filter
star this property uin 272726 more like this
star this property answer
answer
unstar this property is ministerial correction false more like this
unstar this property date of answer less than 2019-07-08more like thismore than 2019-07-08
star this property answer text <p>NHS England and NHS Improvement have estimated that circa 630 patients will access nusinersen over a period of five years, which is the maximum period of the Managed Access Agreement.</p> more like this
star this property answering member constituency South Ribble more like this
star this property answering member printed Seema Kennedy remove filter
star this property question first answered
less than 2019-07-08T15:47:32.413Zmore like thismore than 2019-07-08T15:47:32.413Z
star this property answering member
4455
star this property label Biography information for Seema Kennedy more like this
star this property tabling member
242
unstar this property label Biography information for Sir Christopher Chope more like this
1135042
star this property registered interest false more like this
star this property date less than 2019-06-26more like thismore than 2019-06-26
star this property answering body
Department of Health and Social Care more like this
unstar this property answering dept id 17 more like this
star this property answering dept short name Health and Social Care more like this
star this property answering dept sort name Health and Social Care more like this
star this property hansard heading Spinal Muscular Atrophy: Drugs more like this
star this property house id 1 more like this
star this property legislature
25259
star this property pref label House of Commons more like this
star this property question text To ask the Secretary of State for Health and Social Care, what estimate he has made of the annual cost to the public purse of (a) the decision by NICE in May 2019 to enable people with spinal muscular atrophy to access new drugs and (b) enabling all people with relevant conditions to access those drugs; and if he will make a statement. more like this
star this property tabling member constituency Christchurch more like this
star this property tabling member printed
Sir Christopher Chope remove filter
star this property uin 269609 more like this
star this property answer
answer
unstar this property is ministerial correction false more like this
unstar this property date of answer less than 2019-07-01more like thismore than 2019-07-01
star this property answer text <p>The National Institute for Health and Care Excellence has advised that the total budget impact for the National Health Service at list prices to make nusinersen available for the total population with spinal muscular atrophy has been projected to be £156 million. The actual budget impact is subject to a managed access agreement and a confidential commercial agreement between NHS England and NHS Improvement and the company.</p> more like this
star this property answering member constituency South Ribble more like this
star this property answering member printed Seema Kennedy remove filter
star this property question first answered
less than 2019-07-01T15:49:02.907Zmore like thismore than 2019-07-01T15:49:02.907Z
star this property answering member
4455
star this property label Biography information for Seema Kennedy more like this
star this property tabling member
242
unstar this property label Biography information for Sir Christopher Chope more like this
1135043
star this property registered interest false more like this
star this property date less than 2019-06-26more like thismore than 2019-06-26
star this property answering body
Department of Health and Social Care more like this
unstar this property answering dept id 17 more like this
star this property answering dept short name Health and Social Care more like this
star this property answering dept sort name Health and Social Care more like this
star this property hansard heading Spinal Muscular Atrophy: Drugs more like this
star this property house id 1 more like this
star this property legislature
25259
star this property pref label House of Commons more like this
star this property question text To ask the Secretary of State for Health and Social Care, how many and what proportion of people with spinal muscular atrophy will be eligible for access to NHS drugs for treatment following the 15 May 2019 announcement by NICE; what his policy is on people who have been excluded from that access; and if he will make a statement. more like this
star this property tabling member constituency Christchurch more like this
star this property tabling member printed
Sir Christopher Chope remove filter
star this property uin 269610 more like this
star this property answer
answer
unstar this property is ministerial correction false more like this
unstar this property date of answer less than 2019-07-01more like thismore than 2019-07-01
star this property answer text <p>NHS England, NHS Improvement, the National Institute for Health and Care Excellence (NICE) and Biogen have worked together extensively to reach an arrangement that allows access to nusinersen for most people with spinal muscular atrophy types 1, 2 and 3 along with pre-symptomatic patients.</p><p>NICE has advised that because of the difficulties in being confident about the clinical evidence and the cost-effectiveness of nusinersen, it was necessary to agree access criteria for a period of further data collection to try and better understand how nusinersen affects people with spinal muscular atrophy. Therefore a managed access agreement has been reached, which should not only help answer these questions but also address the financial risk and challenges for implementation in the National Health Service.</p><p> </p><p> </p><p> </p><p> </p> more like this
star this property answering member constituency South Ribble more like this
star this property answering member printed Seema Kennedy remove filter
star this property question first answered
less than 2019-07-01T15:54:43.597Zmore like thismore than 2019-07-01T15:54:43.597Z
star this property answering member
4455
star this property label Biography information for Seema Kennedy more like this
star this property tabling member
242
unstar this property label Biography information for Sir Christopher Chope more like this
1135044
star this property registered interest false more like this
star this property date less than 2019-06-26more like thismore than 2019-06-26
star this property answering body
Department of Health and Social Care more like this
unstar this property answering dept id 17 more like this
star this property answering dept short name Health and Social Care more like this
star this property answering dept sort name Health and Social Care more like this
star this property hansard heading Spinal Muscular Atrophy: Drugs more like this
star this property house id 1 more like this
star this property legislature
25259
star this property pref label House of Commons more like this
star this property question text To ask the Secretary of State for Health and Social Care, for what reason the announcement by NICE on 15 May 2019 that it would facilitate access by people with spinal muscular atrophy to a new drug for prescription on the NHS was followed several weeks later by an announcement that the drug would be available only to a specific group of those people; and if he will make a statement. more like this
star this property tabling member constituency Christchurch more like this
star this property tabling member printed
Sir Christopher Chope remove filter
star this property uin 269611 more like this
star this property answer
answer
unstar this property is ministerial correction false more like this
unstar this property date of answer less than 2019-07-01more like thismore than 2019-07-01
star this property answer text <p>The National Institute for Health and Care Excellence (NICE) has advised that on 15 May 2019 it confirmed that it was able to recommend nusinersen for the treatment of spinal muscular atrophy. In the announcement, NICE said the treatment would be made available under the terms of the managed access agreement between NHS England and NHS Improvement and Biogen. However, the full detail of the agreement was not given in the announcement and NICE accepts this was misleading for some of the patient population. NICE provided clarification at the earliest opportunity and has apologised to individuals affected.</p> more like this
star this property answering member constituency South Ribble more like this
star this property answering member printed Seema Kennedy remove filter
star this property question first answered
less than 2019-07-01T15:53:48.517Zmore like thismore than 2019-07-01T15:53:48.517Z
star this property answering member
4455
star this property label Biography information for Seema Kennedy more like this
star this property tabling member
242
unstar this property label Biography information for Sir Christopher Chope more like this
1127107
star this property registered interest false more like this
star this property date less than 2019-05-16more like thismore than 2019-05-16
star this property answering body
Department of Health and Social Care more like this
unstar this property answering dept id 17 more like this
star this property answering dept short name Health and Social Care more like this
star this property answering dept sort name Health and Social Care more like this
star this property hansard heading Chemical Weapons: Salisbury more like this
star this property house id 1 more like this
star this property legislature
25259
star this property pref label House of Commons more like this
star this property question text To ask the Secretary of State for Health and Social Care, if he will commission a review of the public health response to the Salisbury and Amesbury Novichok incidents in 2018 to inform future policy on the protection of public health. more like this
star this property tabling member constituency Christchurch more like this
star this property tabling member printed
Sir Christopher Chope remove filter
star this property uin 255256 more like this
star this property answer
answer
unstar this property is ministerial correction false more like this
unstar this property date of answer less than 2019-05-21more like thismore than 2019-05-21
star this property answer text <p>Public Health England, NHS England and the Department have carried out post-incident reviews into their response to the Salisbury and Amesbury Novichok incidents. These were subsequently discussed within the Department in September of last year.</p> more like this
star this property answering member constituency South Ribble more like this
star this property answering member printed Seema Kennedy remove filter
star this property question first answered
less than 2019-05-21T16:24:19.94Zmore like thismore than 2019-05-21T16:24:19.94Z
star this property answering member
4455
star this property label Biography information for Seema Kennedy more like this
star this property tabling member
242
unstar this property label Biography information for Sir Christopher Chope more like this