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767576

	registered interest
	date	09/10/2017
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	HIV Infection: Clinical Trials
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health, with reference to the NHS and Public Health England HIV PrEP impact trial, what steps his Department is taking to ensure that the revised start date for the trial is not missed.
	tabling member constituency	Washington and Sunderland West
	tabling member printed	Mrs Sharon Hodgson
	uin	106653
	answer	answer is ministerial correction date of answer 17/10/2017 answer text <p>NHS England will enrol 10,000 participants over three years at clinics across the country in the pre-exposure prophylaxis (PrEP) IMPACT trial. The trial will provide data on implementation of PrEP and its impact on HIV transmission among high-risk groups, not those at any risk.</p><p> </p><p>Individuals for enrolment to the trial will be assessed against inclusion and exclusion criteria in order to target those at high risk of getting HIV and therefore most likely to benefit. National Health Service funded access to PrEP drugs is only available through the IMPACT trial.</p><p> </p><p>NHS England and Public Health England have been actively supporting the PrEP IMPACT trial sponsor in accelerating ethical approval and trial site recruitment. It was not possible to complete all the necessary steps to achieve a September 2017 start because of the large number of trial sites. Trial sites have to assure the trial co-ordination centre has ethical approval, drug procurement, trial site feasibility assessments, trial site training, local commissioner approval and local research governance approval in place before permission to recruit is given. This is dependent on local processes and is variable. Trial opening dates will be staggered to reflect this.</p><p> </p><p>The first clinics began be enrolling patients in October and a number of clinics will be opening within weeks of each other, both in and outside London. The trial sponsor anticipates that up to 70 sites will be enrolling patients by the end of November. All clinics should be enrolling patients by April 2018.</p><p> </p><p>As the largest single study of its type in the world, the PrEP trial is complex, involving well in excess of 100 organisations ranging from sexual health clinics, local authority commissioners, research bodies, and a drug manufacturer. The aim is to ensure multiple clinics across the country can provide geographical access and avoid surges to individual clinics. As trial sites open, information will be uploaded to the trial website enabling individuals who wish to participate in the trial to identify their nearest local clinic.</p><p> </p><p>Of the 10,000 trial places, an initial 2,000 places are being reserved for groups at high HIV risk other than gay men. The trial co-ordinating team will monitor PrEP uptake and keep this initial ring-fence under review.</p><p> </p><p>Further information on the trial can be found at the following link:</p><p> </p><p>https://www.prepimpacttrial.org.uk/</p> answering member constituency Winchester answering member printed Steve Brine grouped question UIN 106543 106651 106652 106654 106655 question first answered 17/10/2017 16:48:49 answering member 4067 label Biography information for Steve Brine
	tabling member	1521 label Biography information for Mrs Sharon Hodgson

767579

	registered interest
	date	09/10/2017
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	HIV Infection: Clinical Trials
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health, with reference to the NHS and Public Health England HIV PrEP impact trial, what steps his Department has taken to ensure that some trial places are reserved for under-represented groups.
	tabling member constituency	Washington and Sunderland West
	tabling member printed	Mrs Sharon Hodgson
	uin	106652
	answer	answer is ministerial correction date of answer 17/10/2017 answer text <p>NHS England will enrol 10,000 participants over three years at clinics across the country in the pre-exposure prophylaxis (PrEP) IMPACT trial. The trial will provide data on implementation of PrEP and its impact on HIV transmission among high-risk groups, not those at any risk.</p><p> </p><p>Individuals for enrolment to the trial will be assessed against inclusion and exclusion criteria in order to target those at high risk of getting HIV and therefore most likely to benefit. National Health Service funded access to PrEP drugs is only available through the IMPACT trial.</p><p> </p><p>NHS England and Public Health England have been actively supporting the PrEP IMPACT trial sponsor in accelerating ethical approval and trial site recruitment. It was not possible to complete all the necessary steps to achieve a September 2017 start because of the large number of trial sites. Trial sites have to assure the trial co-ordination centre has ethical approval, drug procurement, trial site feasibility assessments, trial site training, local commissioner approval and local research governance approval in place before permission to recruit is given. This is dependent on local processes and is variable. Trial opening dates will be staggered to reflect this.</p><p> </p><p>The first clinics began be enrolling patients in October and a number of clinics will be opening within weeks of each other, both in and outside London. The trial sponsor anticipates that up to 70 sites will be enrolling patients by the end of November. All clinics should be enrolling patients by April 2018.</p><p> </p><p>As the largest single study of its type in the world, the PrEP trial is complex, involving well in excess of 100 organisations ranging from sexual health clinics, local authority commissioners, research bodies, and a drug manufacturer. The aim is to ensure multiple clinics across the country can provide geographical access and avoid surges to individual clinics. As trial sites open, information will be uploaded to the trial website enabling individuals who wish to participate in the trial to identify their nearest local clinic.</p><p> </p><p>Of the 10,000 trial places, an initial 2,000 places are being reserved for groups at high HIV risk other than gay men. The trial co-ordinating team will monitor PrEP uptake and keep this initial ring-fence under review.</p><p> </p><p>Further information on the trial can be found at the following link:</p><p> </p><p>https://www.prepimpacttrial.org.uk/</p> answering member constituency Winchester answering member printed Steve Brine grouped question UIN 106543 106651 106653 106654 106655 question first answered 17/10/2017 16:48:48 answering member 4067 label Biography information for Steve Brine
	tabling member	1521 label Biography information for Mrs Sharon Hodgson

767578

	registered interest
	date	09/10/2017
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	HIV Infection: Clinical Trials
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health, with reference to the NHS and Public Health England HIV PrEP impact trial, what steps he is taking to ensure that people in areas that are not included in that trial can access this treatment.
	tabling member constituency	Washington and Sunderland West
	tabling member printed	Mrs Sharon Hodgson
	uin	106651
	answer	answer is ministerial correction date of answer 17/10/2017 answer text <p>NHS England will enrol 10,000 participants over three years at clinics across the country in the pre-exposure prophylaxis (PrEP) IMPACT trial. The trial will provide data on implementation of PrEP and its impact on HIV transmission among high-risk groups, not those at any risk.</p><p> </p><p>Individuals for enrolment to the trial will be assessed against inclusion and exclusion criteria in order to target those at high risk of getting HIV and therefore most likely to benefit. National Health Service funded access to PrEP drugs is only available through the IMPACT trial.</p><p> </p><p>NHS England and Public Health England have been actively supporting the PrEP IMPACT trial sponsor in accelerating ethical approval and trial site recruitment. It was not possible to complete all the necessary steps to achieve a September 2017 start because of the large number of trial sites. Trial sites have to assure the trial co-ordination centre has ethical approval, drug procurement, trial site feasibility assessments, trial site training, local commissioner approval and local research governance approval in place before permission to recruit is given. This is dependent on local processes and is variable. Trial opening dates will be staggered to reflect this.</p><p> </p><p>The first clinics began be enrolling patients in October and a number of clinics will be opening within weeks of each other, both in and outside London. The trial sponsor anticipates that up to 70 sites will be enrolling patients by the end of November. All clinics should be enrolling patients by April 2018.</p><p> </p><p>As the largest single study of its type in the world, the PrEP trial is complex, involving well in excess of 100 organisations ranging from sexual health clinics, local authority commissioners, research bodies, and a drug manufacturer. The aim is to ensure multiple clinics across the country can provide geographical access and avoid surges to individual clinics. As trial sites open, information will be uploaded to the trial website enabling individuals who wish to participate in the trial to identify their nearest local clinic.</p><p> </p><p>Of the 10,000 trial places, an initial 2,000 places are being reserved for groups at high HIV risk other than gay men. The trial co-ordinating team will monitor PrEP uptake and keep this initial ring-fence under review.</p><p> </p><p>Further information on the trial can be found at the following link:</p><p> </p><p>https://www.prepimpacttrial.org.uk/</p> answering member constituency Winchester answering member printed Steve Brine grouped question UIN 106543 106652 106653 106654 106655 question first answered 17/10/2017 16:48:48 answering member 4067 label Biography information for Steve Brine
	tabling member	1521 label Biography information for Mrs Sharon Hodgson

767577

	registered interest
	date	09/10/2017
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	HIV Infection: Clinical Trials
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health, with reference to the NHS and Public Health England HIV PrEP impact trial, what assessment he has made of the reasons why the target trial start date of September 2017 was not met.
	tabling member constituency	Washington and Sunderland West
	tabling member printed	Mrs Sharon Hodgson
	uin	106654
	answer	answer is ministerial correction date of answer 17/10/2017 answer text <p>NHS England will enrol 10,000 participants over three years at clinics across the country in the pre-exposure prophylaxis (PrEP) IMPACT trial. The trial will provide data on implementation of PrEP and its impact on HIV transmission among high-risk groups, not those at any risk.</p><p> </p><p>Individuals for enrolment to the trial will be assessed against inclusion and exclusion criteria in order to target those at high risk of getting HIV and therefore most likely to benefit. National Health Service funded access to PrEP drugs is only available through the IMPACT trial.</p><p> </p><p>NHS England and Public Health England have been actively supporting the PrEP IMPACT trial sponsor in accelerating ethical approval and trial site recruitment. It was not possible to complete all the necessary steps to achieve a September 2017 start because of the large number of trial sites. Trial sites have to assure the trial co-ordination centre has ethical approval, drug procurement, trial site feasibility assessments, trial site training, local commissioner approval and local research governance approval in place before permission to recruit is given. This is dependent on local processes and is variable. Trial opening dates will be staggered to reflect this.</p><p> </p><p>The first clinics began be enrolling patients in October and a number of clinics will be opening within weeks of each other, both in and outside London. The trial sponsor anticipates that up to 70 sites will be enrolling patients by the end of November. All clinics should be enrolling patients by April 2018.</p><p> </p><p>As the largest single study of its type in the world, the PrEP trial is complex, involving well in excess of 100 organisations ranging from sexual health clinics, local authority commissioners, research bodies, and a drug manufacturer. The aim is to ensure multiple clinics across the country can provide geographical access and avoid surges to individual clinics. As trial sites open, information will be uploaded to the trial website enabling individuals who wish to participate in the trial to identify their nearest local clinic.</p><p> </p><p>Of the 10,000 trial places, an initial 2,000 places are being reserved for groups at high HIV risk other than gay men. The trial co-ordinating team will monitor PrEP uptake and keep this initial ring-fence under review.</p><p> </p><p>Further information on the trial can be found at the following link:</p><p> </p><p>https://www.prepimpacttrial.org.uk/</p> answering member constituency Winchester answering member printed Steve Brine grouped question UIN 106543 106651 106652 106653 106655 question first answered 17/10/2017 16:48:49 answering member 4067 label Biography information for Steve Brine
	tabling member	1521 label Biography information for Mrs Sharon Hodgson

767575

	registered interest
	date	09/10/2017
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	HIV Infection: Clinical Trials
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health, with reference to NHS and Public Health England HIV PrEP impact trial, what steps his Department is taking to (a) manage demand to participate in the trial and (b) ensure that no one at risk of HIV is excluded from accessing this treatment.
	tabling member constituency	Washington and Sunderland West
	tabling member printed	Mrs Sharon Hodgson
	uin	106655
	answer	answer is ministerial correction date of answer 17/10/2017 answer text <p>NHS England will enrol 10,000 participants over three years at clinics across the country in the pre-exposure prophylaxis (PrEP) IMPACT trial. The trial will provide data on implementation of PrEP and its impact on HIV transmission among high-risk groups, not those at any risk.</p><p> </p><p>Individuals for enrolment to the trial will be assessed against inclusion and exclusion criteria in order to target those at high risk of getting HIV and therefore most likely to benefit. National Health Service funded access to PrEP drugs is only available through the IMPACT trial.</p><p> </p><p>NHS England and Public Health England have been actively supporting the PrEP IMPACT trial sponsor in accelerating ethical approval and trial site recruitment. It was not possible to complete all the necessary steps to achieve a September 2017 start because of the large number of trial sites. Trial sites have to assure the trial co-ordination centre has ethical approval, drug procurement, trial site feasibility assessments, trial site training, local commissioner approval and local research governance approval in place before permission to recruit is given. This is dependent on local processes and is variable. Trial opening dates will be staggered to reflect this.</p><p> </p><p>The first clinics began be enrolling patients in October and a number of clinics will be opening within weeks of each other, both in and outside London. The trial sponsor anticipates that up to 70 sites will be enrolling patients by the end of November. All clinics should be enrolling patients by April 2018.</p><p> </p><p>As the largest single study of its type in the world, the PrEP trial is complex, involving well in excess of 100 organisations ranging from sexual health clinics, local authority commissioners, research bodies, and a drug manufacturer. The aim is to ensure multiple clinics across the country can provide geographical access and avoid surges to individual clinics. As trial sites open, information will be uploaded to the trial website enabling individuals who wish to participate in the trial to identify their nearest local clinic.</p><p> </p><p>Of the 10,000 trial places, an initial 2,000 places are being reserved for groups at high HIV risk other than gay men. The trial co-ordinating team will monitor PrEP uptake and keep this initial ring-fence under review.</p><p> </p><p>Further information on the trial can be found at the following link:</p><p> </p><p>https://www.prepimpacttrial.org.uk/</p> answering member constituency Winchester answering member printed Steve Brine grouped question UIN 106543 106651 106652 106653 106654 question first answered 17/10/2017 16:48:49 answering member 4067 label Biography information for Steve Brine
	tabling member	1521 label Biography information for Mrs Sharon Hodgson

767547

	registered interest
	date	09/10/2017
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	Medical Treatments: Innovation
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health, whether the six technologies undergoing Commissioning through Evaluation for which a positive commissioning policy is developed will be (a) required to be assessed by the Clinical Priorities Advisory Group for funding and (b) funded through the Innovation and Technology Payment.
	tabling member constituency	Ellesmere Port and Neston
	tabling member printed	Justin Madders
	uin	106469
	answer	answer is ministerial correction date of answer 17/10/2017 answer text <p>NHS England’s Commissioning through Evaluation (CtE) programme provides the opportunity for a limited number of treatments which show promise, but where there is currently insufficient evidence to take a routine commissioning decision, to gain ‘real world’ evidence as part of a formal evaluation programme.</p><p> </p><p>The six procedures undergoing Commissioning through Evaluation are:</p><p> </p><p>- Selective Dorsal Rhizotomy (SDR);</p><p> </p><p>- Selective Internal Radiation Therapy (SIRT);</p><p> </p><p>- Mitraclip™ ;</p><p> </p><p>- Patent Foramen Ovale (PFO) Closure;</p><p> </p><p>- Left Atrial Appendage Occlusion (LAAO); and</p><p> </p><p>- Stereotactic Ablative Body Radiotherapy (SABR).</p><p> </p><p>NHS England has not made an assessment of the cost of continuing to fund the treatments currently in the CtE programme once recruitment has closed as, until the evaluation is complete, the clinical commissioning policy to ‘not routinely commission’ remains in place. However, NHS England recognises the importance of minimising the gap between a CtE scheme closing to new recruits, the updating of its clinical commissioning policy in light of the new evidence and taking final funding decisions.</p><p> </p><p>Similarly, given that treatments that have entered the CTE programme for evaluative purposes are currently covered by a 'not routinely commissioned' clinical policy, no formal assessment has been made of the number of patients who might have accessed this treatment had a 'routinely commissioned’ policy been in place at the point the scheme completed recruitment.</p><p> </p><p>Through the collection and evaluation of data, NHS England is better able to reconsider its clinical commissioning policy for these treatments. Where the evidence generated by the scheme supports a routine commissioning recommendation, final funding decisions are taken in line with NHS England’s published Service Development Policy. This could result in the policy being entered into NHS England’s biannual clinical prioritisation process for funding or, if the relevant criteria are met, being introduced as an ‘in year service development’. Both these routes are supported by advice from NHS England’s Clinical Priorities Advisory Group.</p><p> </p><p>Entry into the CtE programme does not, therefore, signal the start of routine commissioning. Rather, it is a mechanism for generating clinical evidence for innovative new treatments, which are often experimental, that would not normally be selected for National Institute for Health Research funded research.</p><p> </p><p>NHS England supports clinicians who might consider a treatment that is not currently routinely funded by the National Health Service due to insufficient evidence of clinical and / or cost effectiveness and is covered by a time limited CtE scheme. This includes ethics approval where appropriate (for example in the handling of evaluative data), scheme-specific patient information leaflets and formal consenting arrangements so that patients are aware in advance about the questions remaining about the treatment’s effectiveness. Clinicians will be able to guide patients and their families through any available routinely funded NHS treatment options alongside any potentially accessible via the CtE programme.</p><p> </p><p>The timetable for the completion of evaluation reports takes into account the patient follow up period specific to each scheme. For example, the scheme may require data to be submitted at one and two years post treatment to assess whether clinical improvements achieved by a procedure are maintained over a given time period.</p><p> </p><p>The timetable for the six procedures undergoing CtE (which includes issues like access to treatment) are:</p><p> </p><p>- SDR – The National Institute for Health Care and Excellence (NICE) evaluation report expected to be available for publication September 2018;</p><p> </p><p>- SIRT - NICE evaluation report published October 2017. A review of the clinical commissioning policy is already underway and will be informed by the NICE evaluation report;</p><p> </p><p>- Mitraclip™ - NICE evaluation report expected to be available for publication in March 2018;</p><p> </p><p>- PFO Closure - Patient recruitment completed March 2016. NICE evaluation report expected to be available for publication November 2017. A review of the clinical commissioning policy is already underway and will be informed by the NICE evaluation report once published;</p><p> </p><p>- LAAO - NICE evaluation report expected to be available for publication November 2017. A review of the clinical commissioning policy is already underway and will be informed by the NICE evaluation report once published; and</p><p> </p><p>- SABR – Patient recruitment planned to be completed March 2019. NICE evaluation report expected to be available thereafter.</p> answering member constituency Winchester answering member printed Steve Brine grouped question UIN 106470 106471 106472 106473 106474 question first answered 17/10/2017 16:36:24 answering member 4067 label Biography information for Steve Brine
	tabling member	4418 label Biography information for Justin Madders

767548

	registered interest
	date	09/10/2017
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	Medical Treatments: Innovation
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health, whether his Department has made funds available to the six procedures undergoing Commissioning through Evaluation to be used when a formal commissioning policy for them is in place.
	tabling member constituency	Ellesmere Port and Neston
	tabling member printed	Justin Madders
	uin	106470
	answer	answer is ministerial correction date of answer 17/10/2017 answer text <p>NHS England’s Commissioning through Evaluation (CtE) programme provides the opportunity for a limited number of treatments which show promise, but where there is currently insufficient evidence to take a routine commissioning decision, to gain ‘real world’ evidence as part of a formal evaluation programme.</p><p> </p><p>The six procedures undergoing Commissioning through Evaluation are:</p><p> </p><p>- Selective Dorsal Rhizotomy (SDR);</p><p> </p><p>- Selective Internal Radiation Therapy (SIRT);</p><p> </p><p>- Mitraclip™ ;</p><p> </p><p>- Patent Foramen Ovale (PFO) Closure;</p><p> </p><p>- Left Atrial Appendage Occlusion (LAAO); and</p><p> </p><p>- Stereotactic Ablative Body Radiotherapy (SABR).</p><p> </p><p>NHS England has not made an assessment of the cost of continuing to fund the treatments currently in the CtE programme once recruitment has closed as, until the evaluation is complete, the clinical commissioning policy to ‘not routinely commission’ remains in place. However, NHS England recognises the importance of minimising the gap between a CtE scheme closing to new recruits, the updating of its clinical commissioning policy in light of the new evidence and taking final funding decisions.</p><p> </p><p>Similarly, given that treatments that have entered the CTE programme for evaluative purposes are currently covered by a 'not routinely commissioned' clinical policy, no formal assessment has been made of the number of patients who might have accessed this treatment had a 'routinely commissioned’ policy been in place at the point the scheme completed recruitment.</p><p> </p><p>Through the collection and evaluation of data, NHS England is better able to reconsider its clinical commissioning policy for these treatments. Where the evidence generated by the scheme supports a routine commissioning recommendation, final funding decisions are taken in line with NHS England’s published Service Development Policy. This could result in the policy being entered into NHS England’s biannual clinical prioritisation process for funding or, if the relevant criteria are met, being introduced as an ‘in year service development’. Both these routes are supported by advice from NHS England’s Clinical Priorities Advisory Group.</p><p> </p><p>Entry into the CtE programme does not, therefore, signal the start of routine commissioning. Rather, it is a mechanism for generating clinical evidence for innovative new treatments, which are often experimental, that would not normally be selected for National Institute for Health Research funded research.</p><p> </p><p>NHS England supports clinicians who might consider a treatment that is not currently routinely funded by the National Health Service due to insufficient evidence of clinical and / or cost effectiveness and is covered by a time limited CtE scheme. This includes ethics approval where appropriate (for example in the handling of evaluative data), scheme-specific patient information leaflets and formal consenting arrangements so that patients are aware in advance about the questions remaining about the treatment’s effectiveness. Clinicians will be able to guide patients and their families through any available routinely funded NHS treatment options alongside any potentially accessible via the CtE programme.</p><p> </p><p>The timetable for the completion of evaluation reports takes into account the patient follow up period specific to each scheme. For example, the scheme may require data to be submitted at one and two years post treatment to assess whether clinical improvements achieved by a procedure are maintained over a given time period.</p><p> </p><p>The timetable for the six procedures undergoing CtE (which includes issues like access to treatment) are:</p><p> </p><p>- SDR – The National Institute for Health Care and Excellence (NICE) evaluation report expected to be available for publication September 2018;</p><p> </p><p>- SIRT - NICE evaluation report published October 2017. A review of the clinical commissioning policy is already underway and will be informed by the NICE evaluation report;</p><p> </p><p>- Mitraclip™ - NICE evaluation report expected to be available for publication in March 2018;</p><p> </p><p>- PFO Closure - Patient recruitment completed March 2016. NICE evaluation report expected to be available for publication November 2017. A review of the clinical commissioning policy is already underway and will be informed by the NICE evaluation report once published;</p><p> </p><p>- LAAO - NICE evaluation report expected to be available for publication November 2017. A review of the clinical commissioning policy is already underway and will be informed by the NICE evaluation report once published; and</p><p> </p><p>- SABR – Patient recruitment planned to be completed March 2019. NICE evaluation report expected to be available thereafter.</p> answering member constituency Winchester answering member printed Steve Brine grouped question UIN 106469 106471 106472 106473 106474 question first answered 17/10/2017 16:36:24 answering member 4067 label Biography information for Steve Brine
	tabling member	4418 label Biography information for Justin Madders

767568

	registered interest
	date	09/10/2017
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	Strokes: Medical Equipment
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health, when the Butterfly Health Device Mobius HD to prevent strokes will be available on the NHS.
	tabling member constituency	Strangford
	tabling member printed	Jim Shannon
	uin	106789
	answer	answer is ministerial correction date of answer 17/10/2017 answer text <p>According to the available information the product is currently undergoing clinical trials to determine safety and performance. We understand that so far there has just been one study in humans, a proof of concept study on 30 patients.</p><p>Once these trials have been completed and the manufacturer is able to meet all the other requirements of the medical device directives, they may use the “CE” mark on their product as a medical device. The Medicines and Healthcare products Regulatory Agency is not in a position to advise how long this process will take, as this will be dependent on the manufacturers’ data and their ability to meet the requirements of the relevant regulations.</p><p>Before treatments can be made available for patients careful assessments of the evidence for clinical effectiveness and cost effectiveness are needed in order to ensure that the treatment will give patients benefit in clinical practice, with acceptable risk and within established cost effectiveness thresholds. The National Institute for Health and Care Excellence (NICE) will normally review such treatments and make a recommendation on whether they should be used in the National Health Service, by publishing a Technology Appraisal. Commissioners will not usually develop a commissioning policy on treatments in advance of NICE Technology Appraisal.</p><p>Although stroke is one of a number of potential complications associated with untreated hypertension, the manufacturer of this device states it is intended to be used to treat resistant hypertension (hypertension which does not respond to drug treatment) and not for stroke prevention.</p><p><strong> </strong></p> answering member constituency Winchester answering member printed Steve Brine question first answered 17/10/2017 16:41:20 answering member 4067 label Biography information for Steve Brine
	tabling member	4131 label Biography information for Jim Shannon

767551

	registered interest
	date	09/10/2017
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	Medical Treatments: Innovation
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health, what the timetable is for the Commissioning through Evaluation process for (a) Selective Dorsal Rhizotomy, (b) Selective Internal Radiation Therapy, (c) Percutaneuous Mitral Valve Leaflet Repair, (d) Patent Foramen Ovale Closure, (e) Left Atrial Appendage Occlusion and (f) Stereotactic Ablative Radiotherapy.
	tabling member constituency	Ellesmere Port and Neston
	tabling member printed	Justin Madders
	uin	106474
	answer	answer is ministerial correction date of answer 17/10/2017 answer text <p>NHS England’s Commissioning through Evaluation (CtE) programme provides the opportunity for a limited number of treatments which show promise, but where there is currently insufficient evidence to take a routine commissioning decision, to gain ‘real world’ evidence as part of a formal evaluation programme.</p><p> </p><p>The six procedures undergoing Commissioning through Evaluation are:</p><p> </p><p>- Selective Dorsal Rhizotomy (SDR);</p><p> </p><p>- Selective Internal Radiation Therapy (SIRT);</p><p> </p><p>- Mitraclip™ ;</p><p> </p><p>- Patent Foramen Ovale (PFO) Closure;</p><p> </p><p>- Left Atrial Appendage Occlusion (LAAO); and</p><p> </p><p>- Stereotactic Ablative Body Radiotherapy (SABR).</p><p> </p><p>NHS England has not made an assessment of the cost of continuing to fund the treatments currently in the CtE programme once recruitment has closed as, until the evaluation is complete, the clinical commissioning policy to ‘not routinely commission’ remains in place. However, NHS England recognises the importance of minimising the gap between a CtE scheme closing to new recruits, the updating of its clinical commissioning policy in light of the new evidence and taking final funding decisions.</p><p> </p><p>Similarly, given that treatments that have entered the CTE programme for evaluative purposes are currently covered by a 'not routinely commissioned' clinical policy, no formal assessment has been made of the number of patients who might have accessed this treatment had a 'routinely commissioned’ policy been in place at the point the scheme completed recruitment.</p><p> </p><p>Through the collection and evaluation of data, NHS England is better able to reconsider its clinical commissioning policy for these treatments. Where the evidence generated by the scheme supports a routine commissioning recommendation, final funding decisions are taken in line with NHS England’s published Service Development Policy. This could result in the policy being entered into NHS England’s biannual clinical prioritisation process for funding or, if the relevant criteria are met, being introduced as an ‘in year service development’. Both these routes are supported by advice from NHS England’s Clinical Priorities Advisory Group.</p><p> </p><p>Entry into the CtE programme does not, therefore, signal the start of routine commissioning. Rather, it is a mechanism for generating clinical evidence for innovative new treatments, which are often experimental, that would not normally be selected for National Institute for Health Research funded research.</p><p> </p><p>NHS England supports clinicians who might consider a treatment that is not currently routinely funded by the National Health Service due to insufficient evidence of clinical and / or cost effectiveness and is covered by a time limited CtE scheme. This includes ethics approval where appropriate (for example in the handling of evaluative data), scheme-specific patient information leaflets and formal consenting arrangements so that patients are aware in advance about the questions remaining about the treatment’s effectiveness. Clinicians will be able to guide patients and their families through any available routinely funded NHS treatment options alongside any potentially accessible via the CtE programme.</p><p> </p><p>The timetable for the completion of evaluation reports takes into account the patient follow up period specific to each scheme. For example, the scheme may require data to be submitted at one and two years post treatment to assess whether clinical improvements achieved by a procedure are maintained over a given time period.</p><p> </p><p>The timetable for the six procedures undergoing CtE (which includes issues like access to treatment) are:</p><p> </p><p>- SDR – The National Institute for Health Care and Excellence (NICE) evaluation report expected to be available for publication September 2018;</p><p> </p><p>- SIRT - NICE evaluation report published October 2017. A review of the clinical commissioning policy is already underway and will be informed by the NICE evaluation report;</p><p> </p><p>- Mitraclip™ - NICE evaluation report expected to be available for publication in March 2018;</p><p> </p><p>- PFO Closure - Patient recruitment completed March 2016. NICE evaluation report expected to be available for publication November 2017. A review of the clinical commissioning policy is already underway and will be informed by the NICE evaluation report once published;</p><p> </p><p>- LAAO - NICE evaluation report expected to be available for publication November 2017. A review of the clinical commissioning policy is already underway and will be informed by the NICE evaluation report once published; and</p><p> </p><p>- SABR – Patient recruitment planned to be completed March 2019. NICE evaluation report expected to be available thereafter.</p> answering member constituency Winchester answering member printed Steve Brine grouped question UIN 106469 106470 106471 106472 106473 question first answered 17/10/2017 16:36:24 answering member 4067 label Biography information for Steve Brine
	tabling member	4418 label Biography information for Justin Madders

767583

	registered interest
	date	09/10/2017
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	Plastic Surgery: Heart Diseases
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health, what steps he is taking to investigate the connection between breast implants and heart problems.
	tabling member constituency	Strangford
	tabling member printed	Jim Shannon
	uin	106706
	answer	answer is ministerial correction date of answer 17/10/2017 answer text <p>The Medicines and Healthcare products Regulatory Agency is not currently conducting any regulatory activity concerning heart, or other cardiovascular disease, in respect of these medical devices. No reports of adverse events related to these devices and the diagnosis of cardiac or other cardiovascular disease have been received. The Agency is not aware of any concerns being voiced by the patients or healthcare professionals; or of action being undertaken by any other regulator either in the European Union or worldwide.</p><p> </p><p>The Agency is aware of recent media coverage of a very small study regarding the interpretation of electrocardiographs in women who have breast implants. We will continue to monitor the situation and will take action if necessary.</p><p> </p><p>We encourage anyone who suspects they have had a complication after having a medical device implanted to discuss this with their clinician and report to us via the Yellow Card scheme regardless of how long ago the implant was inserted.</p><p><strong> </strong></p><p><strong> </strong></p> answering member constituency Winchester answering member printed Steve Brine question first answered 17/10/2017 16:33:27 answering member 4067 label Biography information for Steve Brine
	tabling member	4131 label Biography information for Jim Shannon