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767533

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	Nabiximols
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health, what medical evidence his Department has recently taken into account in its decision not to license nabiximols for use on the NHS.
tabling member constituency	Richmond Park
tabling member printed	Zac Goldsmith
uin	106691
answer	answer is ministerial correction date of answer 12/10/2017 answer text <p>Nabiximols (Sativex) is licensed in the United Kingdom for the treatment of moderate to severe spasticity in multiple sclerosis. The National Institute of Health and Care Excellence (NICE) did not recommended nabiximols in its 2014 clinical guidelines as it is not a cost-effective treatment.</p><p> </p><p>NICE develops authoritative, evidence-based guidance on best practice for the National Health Service. NICE operates with a high degree of independence from the Government and is responsible for the recommendations that it makes to the NHS. Its guidance is based on a thorough assessment of the available evidence and is developed through engagement with stakeholders.</p><p> </p><p>However, where there is an absence of final guidance recommendations from NICE, decisions on the funding of a licensed treatment on the NHS are taken by the relevant clinician and commissioner (such as NHS England or individual clinical commissioning groups) based on the individual needs of the patient.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 12/10/2017 14:33:45 answering member 4067 label Biography information for Steve Brine
tabling member	4062 label Biography information for Lord Goldsmith of Richmond Park

767535

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	Vegetables: Consumption
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 increase vegetable consumption.
tabling member constituency	Washington and Sunderland West
tabling member printed	Mrs Sharon Hodgson
uin	106542
answer	answer is ministerial correction date of answer 17/10/2017 answer text <p>The Chief Medical Officer recommends eating plenty of fruit and vegetables as part of a healthy balanced diet. The national food model the Eatwell Guide, provides a visual representation of the types and proportions of the foods needed for a healthy, balanced diet, and depicts a diet rich in fruit and vegetables.</p><p> </p><p>The Government’s 5 A DAY campaign which specifically promotes fruit and vegetable consumption and the 5 A DAY message is embedded in the Eatwell Guide. It is communicated alongside other healthy eating advice through, for example the Change4Life campaign, the One You campaign and the NHS Choices website.</p><p><strong> </strong></p><p>In addition the Department runs two schemes which contribute towards increasing vegetable consumption:</p><p> </p><p>- Healthy Start which offers support to (largely unemployed) pregnant women and children under four in families receiving one or more of the qualifying benefits and tax credits. The Healthy Start vouchers can be used for purchasing fruit and vegetables as well as milk; and</p><p>- The School Fruit and Vegetable scheme ensures all children in Key Stage 1, regardless of socio-economic background, receive a piece of fruit or vegetable every day.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 17/10/2017 16:38:45 answering member 4067 label Biography information for Steve Brine
tabling member	1521 label Biography information for Mrs Sharon Hodgson

767536

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, what recent assessment he has made of the potential of pre-exposure prophylaxis for HIV to help end the transmission of HIV among at-risk populations.
tabling member constituency	Washington and Sunderland West
tabling member printed	Mrs Sharon Hodgson
uin	106543
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 106651 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

767543

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	Alcoholism
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health, what steps his Department takes to ensure that the children of problem drinkers (a) have access to and (b) receive the support they need.
tabling member constituency	Congleton
tabling member printed	Fiona Bruce
uin	106457
answer	answer is ministerial correction date of answer 12/10/2017 answer text <p>Alcohol addiction has a devastating impact on individuals and their families and it is unacceptable that children bear the brunt of their parents’ condition. The Government is considering what further support it can provide to tackle alcohol harms, focusing on vulnerable groups including families and children.</p><p>In the meantime, Public Health England is already undertaking a programme of work to address this issue. This includes improving the evidence base; enhancing data; ensuring local authorities are given high quality advice and support in relation to alcohol treatment services, and any safeguarding implications; and social marketing.</p><p>The Government has also put in place a range of measures to help ensure children are provided with accurate information and the tools they need to make informed decisions about their relationship with alcohol. This includes the FRANK drug information and advice service; Family Nurse Partnerships to help parents within potentially vulnerable families to develop their parenting capacity; and tailored and co-ordinated support via the Troubled Families programme.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 12/10/2017 14:31:43 answering member 4067 label Biography information for Steve Brine
tabling member	3958 label Biography information for Fiona Bruce

767546

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 assessment his Department has made of the cost of funding the six procedures undergoing Commissioning through Evaluation while they are in the assessment phase.
tabling member constituency	Ellesmere Port and Neston
tabling member printed	Justin Madders
uin	106471
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 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

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

767549

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 advice his Department provides for clinicians who are managing patients who require a technology undergoing the Commissioning through Evaluation programme.
tabling member constituency	Ellesmere Port and Neston
tabling member printed	Justin Madders
uin	106472
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 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

767550

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 assessment his Department has made of the number of patients unable to access procedures which are in the assessment phase of the Commissioning through Evaluation programme.
tabling member constituency	Ellesmere Port and Neston
tabling member printed	Justin Madders
uin	106473
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 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

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