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48269

	registered interest
	date	10/04/2014
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health, what discussions officials in his Department have had with the National Institute for Health and Care Excellence (NICE) on the development of NICE's highly specialised technologies programme since 1 January 2014; what the content of those discussions was; and if he will make a statement.
	tabling member constituency	Eddisbury
	tabling member printed	Mr Stephen O'Brien
	uin	196411
	answer	answer is ministerial correction date of answer 06/05/2014 answer text <p>Departmental officials have had no such discussions. Officials may discuss individual highly specialised technology topics with the National Institute for Health and Care Excellence, including at the topic selection stage.</p> answering member constituency North Norfolk answering member printed Norman Lamb question first answered 06/05/2014 12:00:00 answering member 1439 label Biography information for Norman Lamb
	tabling member	427 label Biography information for Mr Stephen O'Brien

48276

	registered interest
	date	10/04/2014
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health, pursuant to the Answer of 24 March 2014, Official Report, column 120W, on haemolytic uraemic syndrome, what discussions NHS England has had with the National Institute for Health and Care Excellence (NICE) since 1 January 2014 on NICE's appraisal of eculizumab; and if he will make a statement.
	tabling member constituency	Eddisbury
	tabling member printed	Mr Stephen O'Brien
	uin	196426
	answer	answer is ministerial correction date of answer 06/05/2014 answer text <p>We understand that NHS England was formally consulted on the scope of the National Institute for Health and Care Excellence's (NICE) evaluation of eculizumab for atypical haemolytic uraemic syndrome. NHS England was also consulted on the evaluation consultation document, which was published on 27 February.</p><p> </p><p>Following the publication of NICE's draft guidance on eculizumab, NICE sought further advice from NHS England on what considerations relating to the management of its specialised commissioning budget it considers should be taken into account in formulating a recommendation. The response from NHS England will be considered by NICE at the next meeting of the evaluation committee.</p><p> </p> answering member constituency North Norfolk answering member printed Norman Lamb question first answered 06/05/2014 12:00:00 answering member 1439 label Biography information for Norman Lamb
	tabling member	427 label Biography information for Mr Stephen O'Brien

48280

	registered interest
	date	10/04/2014
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health, pursuant to the Answer of 31 March 2014, Official Report, column 491W, on medical treatments, what technology appraisals were conducted by the National Institute for Health and Care Excellence in the last five years; what the most plausible cost per quality adjusted life-year for each such appraisal was; what the estimated eligible patient population was for each appraised indication; on which appraisals end-of-life criteria were applied in each final appraisal determination; and on which date each such appraisal was (a) initiated and (b) concluded.
	tabling member constituency	Eddisbury
	tabling member printed	Mr Stephen O'Brien
	uin	196429
	answer	answer is ministerial correction date of answer 06/05/2014 answer text <p>National Institute for Health and Care Excellence (NICE) technology appraisal decisions published between 2000 to end of February 2014 have already been placed in the Library.</p><p> </p><p>NICE has advised that it does hold the most plausible cost per quality adjusted life-year for each technology appraisal, the estimated patient population for each appraised indication, details of appraisals where the end-of-life criteria were applied in each final appraisal determination and the dates each appraisal was initiated and concluded. However, this information could only be provided at disproportionate cost.</p><p> </p> answering member constituency North Norfolk answering member printed Norman Lamb question first answered 06/05/2014 12:00:00 answering member 1439 label Biography information for Norman Lamb
	tabling member	427 label Biography information for Mr Stephen O'Brien

48281

	registered interest
	date	10/04/2014
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health, if he will discuss with the National Institute for Health and Care Excellence (NICE) ensuring that assessments of treatments by NICE conducted through (a) normal technology appraisals and (b) highly specialised technology appraisals is consistent in its (i) engagement with stakeholders and (ii) wider methodological approaches.
	tabling member constituency	Eddisbury
	tabling member printed	Mr Stephen O'Brien
	uin	196428
	answer	answer is ministerial correction date of answer 06/05/2014 answer text <p>We have no plans to do so. As an independent body, the National Institute for Health and Care Excellence is responsible for developing its methods and processes and applying them consistently.</p> answering member constituency North Norfolk answering member printed Norman Lamb question first answered 06/05/2014 12:00:00 answering member 1439 label Biography information for Norman Lamb
	tabling member	427 label Biography information for Mr Stephen O'Brien

48282

	registered interest
	date	10/04/2014
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health, how the National Institute for Health and Care Excellence (NICE) assesses the cost-effectiveness of an intervention when the data available are uncertain; what assessment NICE has made of the average range around the most-plausible cost-per-QALY in its technology appraisals; and if he will make a statement.
	tabling member constituency	Eddisbury
	tabling member printed	Mr Stephen O'Brien
	uin	196424
	answer	answer is ministerial correction date of answer 06/05/2014 answer text <p>The National Institute for Health and Care Excellence (NICE) follows a rigorous process in the appraisal of technologies to ensure that judgements regarding the cost-effective use of NHS resources are consistently applied. This includes consideration of the uncertainty generated where available data have serious limitations.</p><p> </p><p>When making judgements on cost effectiveness, the NICE appraisal committee will consider a number of factors including the strength of the clinical-effectiveness evidence, the innovative nature of the technology, the robustness and plausibility of the economic models, the degree of certainty around the incremental cost-effectiveness ratio (ICER), the range and plausibility of the ICERs and the likelihood of decision error and its consequences. Full details of how the Committee takes uncertainty into account is contained within sections 5.8, 6.3 and 6.4 of NICE's Guide to the Methods of Technology Appraisal 2013, which is available at:</p><p>http://publications.nice.org.uk/guide-to-the-methods-of-technology-appraisal-2013-pmg9</p><p> </p><p>NICE advises that it has not carried out an assessment of the average range around the most plausible cost-per Quality Adjusted Life Year (QALY) in its technology appraisals. We understand that although NICE usually specifies the most plausible cost-per-QALY for each technology appraisal, it does not normally specify a range for this assessment.</p><p> </p> answering member constituency North Norfolk answering member printed Norman Lamb question first answered 06/05/2014 12:00:00 answering member 1439 label Biography information for Norman Lamb
	tabling member	427 label Biography information for Mr Stephen O'Brien

48283

	registered interest
	date	10/04/2014
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health, pursuant to the Answer of 24 March 2014, Official Report, column 120W, on haemolytic uraemic syndrome, for what reasons it was felt that further advice was needed on the overall cost implications, benefits and affordability of eculizumab; when it was first concluded that such further advice was needed; for what reasons the seeking of that advice was delayed until the National Institute for Health and Care Excellence took on responsibility for assessing highly specialised technologies; and if he will make a statement.
	tabling member constituency	Eddisbury
	tabling member printed	Mr Stephen O'Brien
	uin	196427
	answer	answer is ministerial correction date of answer 06/05/2014 answer text <p>Ministers concluded that further advice was needed on the overall cost implications, benefits and affordability of eculizumab as, while Advisory Group for National Specialised Services (AGNSS) members were convinced of the clinical effectiveness of the drug, they noted the very high costs of the drug and the increasing cost profile for the National Health Service.</p><p> </p><p>AGNSS was informed of this decision on 17 January 2013. On 7 February 2013, the Department conveyed its decision to the National Institute for Health and Care Excellence (NICE) so that NICE could begin preparatory work in advance of taking on formal responsibility for evaluating highly specialised technologies on 1 April 2013.</p><p> </p><p>While NICE carries out its evaluation, the current interim commissioning arrangements by NHS England in line with the ‘Clinical Commissioning Policy Statement: Eculizumab for atypical haemolytic uraemic syndrome' will remain in place. The policy statement is available at:</p><p> </p><p>www.england.nhs.uk/wp-content/uploads/2013/09/e03-hss-a.pdf</p><p> </p> answering member constituency North Norfolk answering member printed Norman Lamb question first answered 06/05/2014 12:00:00 answering member 1439 label Biography information for Norman Lamb
	tabling member	427 label Biography information for Mr Stephen O'Brien