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1135042

	registered interest
	date	26/06/2019
	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	Spinal Muscular Atrophy: 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 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.
	tabling member constituency	Christchurch
	tabling member printed	Sir Christopher Chope
	uin	269609
	answer	answer is ministerial correction date of answer 01/07/2019 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> answering member constituency South Ribble answering member printed Seema Kennedy question first answered 01/07/2019 15:49:02 answering member 4455 label Biography information for Seema Kennedy
	tabling member	242 label Biography information for Sir Christopher Chope

1135043

	registered interest
	date	26/06/2019
	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	Spinal Muscular Atrophy: Drugs
	house id	1
	legislature	25259 pref label House of Commons
	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.
	tabling member constituency	Christchurch
	tabling member printed	Sir Christopher Chope
	uin	269610
	answer	answer is ministerial correction date of answer 01/07/2019 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> answering member constituency South Ribble answering member printed Seema Kennedy question first answered 01/07/2019 15:54:43 answering member 4455 label Biography information for Seema Kennedy
	tabling member	242 label Biography information for Sir Christopher Chope

1135044

	registered interest
	date	26/06/2019
	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	Spinal Muscular Atrophy: Drugs
	house id	1
	legislature	25259 pref label House of Commons
	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.
	tabling member constituency	Christchurch
	tabling member printed	Sir Christopher Chope
	uin	269611
	answer	answer is ministerial correction date of answer 01/07/2019 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> answering member constituency South Ribble answering member printed Seema Kennedy question first answered 01/07/2019 15:53:48 answering member 4455 label Biography information for Seema Kennedy
	tabling member	242 label Biography information for Sir Christopher Chope