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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

48539

	registered interest
	date	25/04/2014
	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 many patients have required further operations due to complications with transvaginal mesh implants in each of the last three years; and what the cost of such procedures was.
	tabling member constituency	Livingston
	tabling member printed	Graeme Morrice
	uin	196743
	answer	answer is ministerial correction date of answer 06/05/2014 answer text <p>The Department of Health does not hold information on the number of patients who have required further operations due to complications with transvaginal mesh implants in each of the last three years or the costs of these operations.</p><p> </p><p>The Department has had two meetings in which polypropylene transvaginal mesh implants were either discussed or on the agenda.</p><p> </p><p>NHS England manages the National Reporting and Learning System (NRLS) for patient safety incident reports from the NHS. NHS England shares incident reports concerning harms arising from medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA).</p><p> </p><p>Manufacturers of medical devices such as transvaginal mesh implants are legally required to report adverse incidents (ie death, serious injury or potential serious injury) involving their devices to the MHRA. General Medical Guidance published in February 2013 makes it clear that clinicians should report medical device incidents to the MHRA, and make information available to patients about how they can report side effects to the MHRA. The MHRA also encourages voluntary reporting of adverse incidents by healthcare workers, carers, patients and members of the public and participates in monthly telephone meetings with regulators in other European Union member states to share information about medical device safety.</p><p> </p><p>The Department is currently engaged in work to assess the effectiveness of existing arrangements for reporting complications relating to transvaginal mesh implants. NHS England is leading this work, which also involves the MHRA, the Royal College of Obstetricians and Gynaecologists, and the relevant professional societies (the British Society of Urogynaecology and the British Association of Urological Surgeons).</p><p> </p><p>Finished Consultant Episodes for women who have received a primary or secondary operative procedure for the insertion of Transvaginal Mesh, Transobturator Tape, Transvaginal Slings and Transvaginal Tape.</p><p> </p><table><tbody><tr><td><p>Procedure</p></td><td><p>2010-11</p></td><td><p>2011-12</p></td><td><p>2012-13</p></td></tr><tr><td><p>Insertion of Transvaginal Mesh</p></td><td><p>1,636</p></td><td><p>1,524</p></td><td><p>1,310</p></td></tr><tr><td><p>Insertion of Transobturator Tape</p></td><td><p>5,426</p></td><td><p>4,885</p></td><td><p>4,476</p></td></tr><tr><td><p>Insertion of Transvaginal Sling</p></td><td><p>130</p></td><td><p>134</p></td><td><p>135</p></td></tr><tr><td><p>Insertion of Transvaginal Tape</p></td><td><p>8,087</p></td><td><p>8,172</p></td><td><p>7,627</p></td></tr></tbody></table><p> </p><p><em>Source</em>: Hospital Episode Statistics (HES), Health and Social Care Information Centre.</p><p><em>Note</em>: Activity in English NHS Hospitals and English NHS commissioned activity in the independent sector.</p><p> </p><p> </p><p>Adverse events reported to MHRA by Health Professionals concerning Vaginal tape and mesh implants are as follows</p><p> </p><table><tbody><tr><td> </td><td><p>Vaginal Tapes for Stress Urinary Incontinence</p></td><td><p>Vaginal Mesh for Pelvic Organ Prolapse</p></td><td><p>Vaginal Mesh for unknown* indication</p></td></tr><tr><td><p>2011</p></td><td><p>3</p></td><td><p>1</p></td><td><p>0</p></td></tr><tr><td><p>2012</p></td><td><p>23</p></td><td><p>31</p></td><td><p>2</p></td></tr><tr><td><p>2013</p></td><td><p>27</p></td><td><p>20</p></td><td><p>0</p></td></tr><tr><td><p>Up to March 2014</p></td><td><p>16</p></td><td><p>7</p></td><td><p>0</p></td></tr></tbody></table><p>*The reporter did not provide enough information on what type of mesh it was</p><p> </p><p> </p><p>Number of patient safety incidents relating to mesh used in gynaecological procedures reported to the NRLS (Year of occurrence by reported degree of harm)</p><p> </p><table><tbody><tr><td><p> </p></td><td><p>No Harm</p></td><td><p>Low</p></td><td><p>Moderate</p></td><td><p>TOTAL</p></td></tr><tr><td><p>2011</p></td><td><p>0</p></td><td><p>2</p></td><td><p>4</p></td><td><p>6</p></td></tr><tr><td><p>2012</p></td><td><p>7</p></td><td><p>4</p></td><td><p>3</p></td><td><p>14</p></td></tr><tr><td><p>2013</p></td><td><p>4</p></td><td><p>1</p></td><td><p>1</p></td><td><p>6</p></td></tr><tr><td><p>TOTAL</p></td><td><p>11</p></td><td><p>7</p></td><td><p>8</p></td><td><p>26</p></td></tr></tbody></table><p>Search strategy: All incidents from gynaecological specialties in the NRLS were searched on 2 December 2013 for the keyword ‘mesh'</p><p> </p><p> </p><p> </p><p>Adverse events reported to MHRA by patients/members of the public concerning Vaginal tape and mesh implants are as follows</p><p> </p><table><tbody><tr><td> </td><td><p>Vaginal Tapes for Stress Urinary Incontinence</p></td><td><p>Vaginal Mesh for Pelvic Organ Prolapse</p></td><td><p>Vaginal Mesh for unknown* indication</p></td></tr><tr><td><p>2011</p></td><td><p>33</p></td><td><p>7</p></td><td><p>3</p></td></tr><tr><td><p>2012</p></td><td><p>26</p></td><td><p>2</p></td><td><p>0</p></td></tr><tr><td><p>2013</p></td><td><p>30</p></td><td><p>10</p></td><td><p>3</p></td></tr><tr><td><p>Up to March 2014</p></td><td><p>7</p></td><td><p>0</p></td><td><p>0</p></td></tr></tbody></table><p>*The reporter did not provide enough information on what type of mesh it was</p><p> </p><p>No incidents relating to transvaginal mesh have been reported to the NRLS by patients.</p><p> </p><p>The Department has answered 11 previous Parliamentary Questions, 27 letters from hon. Members and Peers and 17 letters from members of the public since 1 September 2011. The Chief Executive of the MHRA has replied to six letters from hon. Members since 1 September 2011.</p><p> </p> answering member constituency North Norfolk answering member printed Norman Lamb grouped question UIN 196738 196739 196740 196741 196742 196744 question first answered 06/05/2014 12:00:00 answering member 1439 label Biography information for Norman Lamb
	tabling member	4012 label Biography information for Graeme Morrice

48540

	registered interest
	date	25/04/2014
	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 criteria his Department uses to decide whether to prescribe Kadcyla using funds from the Cancer Drugs Fund.
	tabling member constituency	Newport West
	tabling member printed	Paul Flynn
	uin	196787
	answer	answer is ministerial correction date of answer 06/05/2014 answer text <p>NHS England is responsible for administering the Cancer Drugs Fund. Its national Cancer Drugs Fund clinical panel added Kadcyla (trastuzumab emtansine) for the treatment of HER2-positive locally advanced/unresectable or metastatic breast cancer to its national cohort policies list in February 2014. Further information on how the panel made its decision is available at:</p><p> </p><p>www.england.nhs.uk/ourwork/pe/cdf/</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	545 label Biography information for Paul Flynn

48546

	registered interest
	date	25/04/2014
	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 systems are in place for recording and publication of children's deaths in psychiatric hospitals who had been either forcefully detained or voluntary in-patients; and to which authority such deaths are reported.
	tabling member constituency	Feltham and Heston
	tabling member printed	Seema Malhotra
	uin	196780
	answer	answer is ministerial correction date of answer 06/05/2014 answer text <p>From 1 April 2008, all Local Safeguarding Children Boards (LSCBs) have had a statutory responsibility to review the deaths of all children from birth (excluding still born babies) up to 18 years, who are normally resident within their area. This is known as the Child Death Review Process. Their responsibilities include setting up a Child Death Overview Panel which reviews child deaths on behalf of the LSCB. This would include deaths in psychiatric in-patient settings. The following link presents data collected from LSCBs in England to the year ending 31 March 2013.</p><p> </p><p>www.gov.uk/government/publications/child-death-reviews-year-ending-31-march-2013</p><p> </p><p>The Care Quality Commission (CQC) is currently developing a system of Intelligent Monitoring for Mental Health services; it is considering which indicators, including those that relate to Serious Untoward Incidents to include in it. This will include children and young people.</p><p> </p><p>The CQC is the official source of information on deaths of patients subject to the Mental Health Act. A link to the CQC's <em>Monitoring the Mental Health Act 2012/13</em> is:</p><p>www.cqc.org.uk/sites/default/files/media/documents/cqc_mentalhealth_2012_13_07_update.pdf</p><p> </p><p>Further information can be obtained from:</p><p> </p><p>The Care Quality Commission (CQC)</p><p> </p><p>public.affairs@cqc.org.uk</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	4253 label Biography information for Seema Malhotra

48547

	registered interest
	date	25/04/2014
	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 many (a) meetings, (b) items of written correspondence, (c) phone calls, (d) consultation responses, (e) tenders and (f) other individual communications and contacts his Department has had with (i) Johnson & Johnson, (ii) Ethicon and (iii) BARD.
	tabling member constituency	Livingston
	tabling member printed	Graeme Morrice
	uin	196778
	answer	answer is ministerial correction date of answer 06/05/2014 answer text <p>Within the last 12 months, the Department has had regular communication with a number of pharmaceutical, device and diagnostic manufacturers, on a wide range of topics. However, the information requested could only be provided at disproportionate cost.</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	4012 label Biography information for Graeme Morrice

48548

	registered interest
	date	25/04/2014
	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 many children of each (a) age and (b) gender have died while in-patients (i) at psychiatric hospitals in total as either forcefully detained or voluntary in-patients and (ii) in each institution in each year since 2000.
	tabling member constituency	Feltham and Heston
	tabling member printed	Seema Malhotra
	uin	196781
	answer	answer is ministerial correction date of answer 06/05/2014 answer text <p>Since April 2008 all Local Safeguarding Children Boards have had a statutory duty to review the death of all children from birth to age 18. Statistics on these Child Death Reviews are collated and published by the Care Quality Commission (CQC) and are available on the CQC's website:</p><p> </p><p>www.gov.uk/government/collections/statistics-child-death-reviews.</p><p> </p><p>Statistics on the location of child deaths are available from 2010 onward and show that in this time, no child has died in an inpatient mental health unit.</p><p> </p><p>According to data from the Mental Health Act Commission, six females and one male under 18 died between 2003 and 2008. Owing to patient confidentiality these figures cannot broken down to each institution.</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	4253 label Biography information for Seema Malhotra

48549

	registered interest
	date	25/04/2014
	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 systems and controls are in place for recording, monitoring and oversight of the use of force and restraint against children receiving psychiatric in-patient care.
	tabling member constituency	Feltham and Heston
	tabling member printed	Seema Malhotra
	uin	196782
	answer	answer is ministerial correction date of answer 06/05/2014 answer text <p>The Department does not currently collect data on restraint.</p><p> </p><p>The Department is planning on categorising physical restraint as a patient safety incident. All incidents of restraint against children receiving psychiatric in-patient care will need to be reported to the National Reporting and Learning System.</p><p> </p><p>Mental Health Commissioners visit patients detained under the Mental Health Act, including children and review all aspects of their care including restraint.</p><p> </p><p>Plans for the monitoring and oversight of restraint in psychiatric in-patient services will form part of the Care Quality Commission's (CQC's) new inspection approach for all hospitals. The CQC is currently consulting on its handbooks for all sectors and has set out its planned approach to assessing services against five questions: Are they safe? Are they effective? Are they caring? Are they responsive? Are they well-led? Restraint will be reviewed in services against the question of whether the service is safe and the CQC is developing guidance for both providers and inspection teams that will draw upon good practice guidance and tools. For children's psychiatric services specifically, this would require specific key lines of enquiry to be used.</p><p> </p><p>The CQC is planning to work with NHS Confederation to look at how the CQC expects providers to implement the guidance as set out in <em>Positive and Safe</em> and how this will be used in our monitoring and oversight approaches. <em>Positive and Safe</em> is a two year programme with the principal aim to radically reduce all restrictive interventions, including ending the deliberate use of face down restraint and – outside the Mental Health Act – seclusion. The work group will be preparing guidance on restraint in the light of <em>Positive and Safe</em> and using this to inform CQC tools and inspection methodology. The CQC always considers providers' approaches to restraint when carrying out comprehensive inspections. Mental Health Act monitoring visits to inpatient units will also look at individual concerns relating to restraint practices. The methodology for all reviews and inspections which the CQC carries out is informed by the available guidance and the Mental Health Act Code of Practice.</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	4253 label Biography information for Seema Malhotra