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HTA Funding Committee Public Minutes 18-19 January 2022

Contents

Published: 04 March 2022

Version: 1

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Meeting

NIHR HTA Funding Committee (Commissioning)

Day 1 - Tuesday 18 January 2022

Venue

Virtual via Microsoft Teams

Present members

  • Professor Marian Knight (Chair)
  • Professor Catherine Hewitt (Deputy Chair)
  • Professor Andrew Farmer (Programme Director)
  • Professor Joy Adamson
  • Mr Mike Bradburn
  • Professor Monica Busse
  • Dr Laurentiu Craciunas
  • Dr Nathan Davies
  • Dr Rui Duarte
  • Dr Emilio Fernandez-Egea
  • Dr David Gillespie
  • Dr Pollyanna Hardy
  • Professor Angela Hassiotis
  • Mr Rakesh Heer
  • Mr Trevor Jones (Public Committee Member)
  • Ms Debby Lennard (Public Committee Member)
  • Professor Nick Maskell
  • Associate Professor Antonieta Medina-Lara
  • Professor Jane Nixon
  • Professor Ben Ollivere
  • Professor Daniel Perry
  • Professor Greta Rait
  • Professor Rebecca Reynolds
  • Dr Beth Stuart
  • Dr Chris Sutton
  • Associate Professor Lyvonne Tume
  • Professor Galina Velikova
  • Professor Nefyn Williams

NETSCC, HTA Secretariat

  • Dr Jason Horsely (Consultant Advisor)
  • Karen Williams (Senior Research Manager)
  • Kathy Tier (Research Manager)
  • Cristina Barroso (Research Manager)
  • Louisa Saunders (Assistant Research Manager)
  • Nicola McCardle (Assistant Research Manager)

Apologies

  • Professor Saul Faust
  • Professor Andrew Shennan
  • Dr Claire Rothery

Observers

None

Quoracy Information

Voting members: 29 Quorum = 19
Voting members present on Day 1: 24 (83%)

Stage 2 Applications

21/20 Lipid-modifying therapy in children with familial hypercholesterolaemia

Chair: Professor Marian Knight
Conflicts: Professor Catherine Hewitt

NIHR134993: Lipid-modifying therapy in children with familial hypercholesterolemia
(Professor Nadeem Qureshi, The University of Nottingham)
Decision: Programme Oversight Committee to consider fund with changes

21/28 Maintenance therapy for lichen sclerosus

Chair: Professor Catherine Hewitt
Conflicts: Associate Professor Beth Stuart, Mr Trevor Jones, Ms Pollyanna Hardy, Professor Andrew Farmer, Professor Marian Knight, Professor Rebecca Reynolds

NIHR135121: Proactive against reactive therapy for the prevention of lichen sclerosus exacerbation and progression of disease – a pragmatic, parallel group randomised controlled trial with embedded economic evaluation and process evaluation (PEARLS).
(Dr Rosalind Simpson, The University of Nottingham)
Decision: Programme Oversight Committee to consider fund with changes

NIHR135205: Clinical and cost effectiveness of LIchen sclerosus MAintenance with Topical stEroidS (CLIMATES): A phase III multicentre study
(Dr Jason Yap, Sandwell and West Birmingham Hospitals NHS Trust)
Decision: Decline

20/131 Corticosteroid induction regimens for children and young people with juvenile idiopathic arthritis

Chair: Professor Catherine Hewitt
Conflicts: Dr David Gillespie, Professor Andrew Farmer, Professor Daniel Perry, Professor Monica Busse, Professor Nefyn Williams

NIHR134350: Steroid TreAtment TRial in JIA (STAR-JIA): a randomised trial to compare effectiveness, safety and cost-effectiveness of intravenous versus oral corticosteroid induction regimens for children and young people with juvenile idiopathic arthritis
(Dr Clare Pain, Alder Hey Children's NHS Foundation Trust)
Decision: Programme Oversight Committee to consider fund with changes

21/30 Non-conservative treatments for major low anterior resection syndrome (LARS)

Chair: Professor Marian Knight
Conflicts: Ms Debby Lennard, Professor Galina Velikova, Professor Jane Nixon, Professor Rakesh Heer

NIHR134937:
Pathway Of Low Anterior Resection syndrome relief after Surgery (POLARiS) trial
(Mrs Julie Cornish, Cardiff and Vale University Health Board)
Decision: Programme Oversight Committee to consider fund with changes

21/21 Percutaneous thermal ablation of benign thyroid nodules

Chair: Professor Catherine Hewitt
Conflicts: Ms Pollyanna Hardy, Professor Andrew Farmer, Professor Greta Rait, Professor Marian Knight
Left meeting: Jane Nixon

NIHR134998: Thermal Ablation versus Thyroid Surgery for benign thyroid Nodules (TASNO trial)
(Dr Steve Bandula, University College London Hospitals NHS Foundation Trust)
Decision: Decline

NIHR135261: peRcutaneous thermal ABlation of Benign Intrathyroidal Tumours
(Dr Neil Sharma, University of Birmingham)
Decision: Programme Oversight Committee to consider fund with changes

21/25 Use of biologic drugs around the time of orthopaedic surgery

Chair: Professor Nick Maskell
Conflicts: Dr Antonieta Medina-Lara, Dr Christopher Sutton, Professor Andrew Farmer, Professor Ben Ollivere, Professor Catherine Hewitt, Professor Jane Nixon, Professor Joy Adamson, Professor Marian Knight, Professor Monica Busse
Left meeting: Debby Lennard

NIHR134800: SCOOBY DOO (Stoppage or COntinuation Of Biologic therapY During Orthopaedic Operations)
(Professor Hemant Pandit, University of Leeds)
Decision: Programme Oversight Committee to consider fund with changes

NIHR135281: A randomised, multi-centre trial comparing continuation with stopping of biologic drugs in patients with rheumatoid arthritis undergoing orthopaedic surgery
(Mr Geraint Thomas, The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust)
Decision: Decline

21/18 Lumbar fusion for low back pain

Chair: Professor Catherine Hewitt
Conflicts: Associate Professor Beth Stuart, Dr Christopher Sutton, Dr Rui Duarte, Mr Mike Bradburn, Professor Andrew Farmer, Professor Ben Ollivere, Professor Daniel Perry, Professor Marian Knight, Professor Nefyn Williams, Professor Rebecca Reynolds
Rejoined meeting: Jane Nixon, Debby Lennard

NIHR134859: The clinical and cost-effectiveness of lumbar fusion surgery for patients with persistent, severe low back pain: Short: FusiOn veRsus bEst coNServatIve Care (the FORENSIC trial)
(Professor David Beard, University of Oxford, NDORMS)
Decision: Programme Oversight Committee to consider fund with changes

NIHR135284: A randomised, international multi-centre trial comparing lumbar fusion with best care multidisciplinary rehabilitation in the management of non-specific low back pain in adults.
Back COMparison of Fusion & bEst Rehabilitation Treatments (Back COMFERT)
(Mr Birender Balain, The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust)
Decision: Decline

21/27 Endoscopic versus open surgery for the treatment of cubital tunnel syndrome

Chair: Professor Greta Rait
Conflicts: Dr Christopher Sutton, Dr David Gillespie, Professor Andrew Farmer, Professor Catherine Hewitt, Professor Jane Nixon, Professor Marian Knight

NIHR135252: ROVER: Randomised trial of Open versus Endoscopic Release for cubital tunnel syndrome
(Mr Lionel Bainbridge, Derby Hospitals NHS Foundation Trust)
Decision: Decline

NIHR135260: Prospective randomised controlled trial comparing endoscopic decompression of the ulnar nerve at the cubital tunnel with open surgery.
(The UNDER Study: Ulnar Nerve Decompression Endoscopic Randomisation Study)
(Mr Dominic Power, University Hospitals Birmingham NHS Foundation Trust)
Decision: Programme Oversight Committee to consider fund with changes

21/22 Stretching programme for ambulant children with cerebral palsy

Chair: Professor Catherine Hewitt
Conflicts: Mr Mike Bradburn, Ms Pollyanna Hardy, Professor Andrew Farmer, Professor Daniel Perry, Professor Marian Knight, Professor Nefyn Williams

NIHR135131: Clinical effectiveness of a child-specific dynamic stretching exercise programme, compared to usual care, for ambulant children with spastic cerebral palsy - the SPELL trial.
(Associate Professor Tim Theologis, Oxford University Hospitals NHS Trust)
Decision: Programme Oversight Committee to consider fund with changes

21/23 Strengthening programme for ambulant adolescents with cerebral palsy

Chair: Professor Catherine Hewitt
Conflicts: Mr Mike Bradburn, Ms Pollyanna Hardy, Professor Andrew Farmer, Professor Daniel Perry, Professor Marian Knight, Professor Nefyn Williams
Left meeting: Ben Ollivere

NIHR135150: Clinical effectiveness of an adolescent-specific strengthening programme, compared to usual care, for ambulant adolescents with spastic cerebral palsy - the ROBUST trial
(Associate Professor Sally Hopewell, University of Oxford)
Decision: Programme Oversight Committee to consider fund with changes

21/24 Intrauterine insemination versus in vitro fertilisation for unexplained infertility

Chair: Professor Marian Knight
Conflicts: Associate Professor Beth Stuart, Dr Christopher Sutton, Dr Laurentiu Craciunas, Ms Pollyanna Hardy, Professor Andrew Farmer, Professor Galina Velikova, Professor Greta Rait, Professor Nefyn Williams, Professor Rakesh Heer, Professor Rebecca Reynolds

NIHR135258: The UnICORn Trial - UNexplained Infertility: Cost and Outcomes RatioNale
(Dr Jackson Kirkman-Brown, University of Birmingham)
Decision: Programme Oversight Committee to consider fund with changes

NIHR135140: A randomised controlled trial evaluating the clinical and cost-effectiveness of intrauterine insemination (IUI) versus in vitro fertilisation (IVF) for unexplained infertility (UNI trial)
(Dr Sesh Sunkara, King's College London)
Decision: Decline

 

Day 2 - Wednesday 19 January 2022

Venue

Virtual via Microsoft Teams

Present members

  • Professor Marian Knight (Chair)
  • Professor Catherine Hewitt (Deputy Chair)
  • Professor Andrew Farmer (Programme Director)
  • Professor Joy Adamson
  • Mr Mike Bradburn
  • Professor Monica Busse
  • Dr Laurentiu Craciunas
  • Dr Nathan Davies
  • Dr Rui Duarte
  • Dr Emilio Fernandez-Egea
  • Dr David Gillespie
  • Dr Pollyanna Hardy
  • Mr Rakesh Heer
  • Mr Trevor Jones (Public Committee Member)
  • Ms Debby Lennard (Public Committee Member)
  • Associate Professor Kamal Mahtani (Co-opted for call 21/540)
  • Professor Nick Maskell
  • Associate Professor Antonieta Medina-Lara
  • Professor Jane Nixon
  • Professor Ben Ollivere
  • Professor Daniel Perry
  • Professor Greta Rait
  • Professor Rebecca Reynolds
  • Dr Claire Rothery
  • Dr Beth Stuart
  • Dr Chris Sutton
  • Associate Professor Lyvonne Tume
  • Professor Galina Velikova
  • Professor Nefyn Williams

NETSCC, HTA Secretariat

  • Dr Jason Horsely (Consultant Advisor)
  • Karen Williams (Senior Research Manager)
  • Kathy Tier (Research Manager)
  • Cristina Barroso (Research Manager)
  • Louisa Saunders (Assistant Research Manager)
  • Nicola McCardle (Assistant Research Manager)

Apologies

  • Professor Saul Faust
  • Professor Andrew Shennan
  • Professor Angela Hassiotis

Observers

  • Rachel Wilson (Her Majesty’s Prison and Probation Service HMPPS)
  • Mark Farmer (Her Majesty’s Prison and Probation Service HMPPS)

Quoracy Information

Voting members: 29 Quorum = 19
Voting members present on Day 2: 24 (83%)

Stage 1 Applications

21/535 - Follow-up strategy after radical treatment for prostate cancer

Chair: Professor Marian Knight
Conflicts: Professor Nick Maskell, Professor Greta Rait, Dr Beth Stuart, Professor Galina Velikova, Mr Rakesh Heer, Dr Nathan Davies

NIHR150376 - The FOLLOW UP study - a natural experiment comparing the clinical and cost-effectiveness of follow-up strategies after radical treatment for prostate cancer.
(Professor Mr Rakesh Heer, University of Newcastle upon Tyne)
Decision: Shortlist

NIHR151653 - A randomised evaluation of pro-active, technology supported prostate cancer specific patient led community follow-up compared with current care pathways for patients who have undergone radical treatment for prostate cancer.
(Mr Greg Shaw, Queen Mary University of London)
Decision: Decline

21/532 – Intensive Interaction for children and young people with profound and multiple learning disabilities

Chair: Professor Nick Maskell
Conflicts: Professor Marian Knight, Professor Andrew Farmer, Professor Catherine Hewitt, Professor Joy Adamson, Professor Monica Busse, Dr David Gillespie, Professor Angela Hassiotis, Professor Ben Ollivere, Dr Beth Stuart, Dr Christopher Sutton

NIHR151571 - Intensive Interaction for children and young people with profound and multiple learning disabilities
(Miss Catherine Hagan, Royal Berkshire NHS Foundation Trust)
Decision: Decline

NIHR151154 - A cluster Randomised Controlled Trial of Intensive Interaction plus standard practice vs standard practice alone for children with PMLD: Communication Skills Intensive Interaction trial (CoSii)
(Dr Rachel McNamara, Cardiff University)
Decision: Shortlist

NIHR151428 - Intensive Interaction for children and young people with profound and multiple learning disabilities: INTERACT trial
(Dr Jill Bradshaw, University of Kent)
Decision: Shortlist

21/534 - Surgical management of successfully reduced incarcerated inguinal hernia in children

Chair: Professor Catherine Hewitt
Conflicts: Professor Marian Knight, Dr Rui Duarte, Dr Pollyanna Hardy, Associate Professor Lyvonne Tume, Dr Beth Stuart

NIHR151196 - Emergent vs Urgent Elective Repair of Reduced Incarcerated Inguinal Hernia in Children
(Mr Nigel Hall, University of Birmingham)
Decision: Decline Return to POC

21/540 - Pharmacological treatments for low back pain or sciatica

Chair: Professor Catherine Hewitt
Conflicts: Professor Marian Knight, Dr Rui Duarte, Dr Pollyanna Hardy
Introduced by Kamal Mahtani (Chair of the HTA Integrated Community health and Social Care Prioritisation Committee)

NIHR150898 - The pharmacological treatment of adults presenting with low back pain to the Emergency Department.The REMEDY Trials (REMEDY-1, -2 and -3). REMedies for low back pain in the Emergency Department studY.
(Dr Christopher Smith, University Hospitals Coventry & Warwickshire NHS Trust)
Decision: Decline

NIHR151008 - The Medal Trial - MEDications in Acute Low back pain
(Honorary Professor Adrian Gardner, The Royal Orthopaedic Hospital NHS Foundation Trust)
Decision: Shortlist

21/542 - Medication to manage sexual preoccupation in sex offenders

Chair: Professor Marian Knight
Conflicts: Professor Joy Adamson, Professor Monica Busse, Laurentiu Craciunas, Dr Nathan Davies, Dr Rui Duarte, Dr Pollyanna Hardy, Professor Angela Hassiotis, Professor Daniel Perry, Professor Greta Rait, Professor Rebecca Reynolds, Professor Nefyn Williams
Arrived at meeting: Rachel Wilson and Mark Farmer
Introduced by Rachel Farmer (HMPPS)

NIHR150371 - Randomised Controlled Trial on Effectiveness of Medication to Manage Sexual Preoccupation in Adult Prisoners Convicted of Sexual Offences (TEMMPASO)
(Dr Artemis Igoumenou, University College London)
Decision: Shortlist

NIHR151130 - A randomised controlled trial of medication to manage sexual preoccupation in men who have sexually offended
(Dr Steven Gillespie, University of Liverpool)
Decision: Decline

NIHR151549 - Randomised Controlled Trial (RCT) of Medication to Manage Problematic Sexual Arousal
(Professor Belinda Winder, Nottingham Trent University)
Decision: Shortlist

21/537 - Neuroendoscopic lavage for preterm babies with post-haemorrhagic ventricular dilatation

Chair: Professor Catherine Hewitt
Conflicts: Professor Marian Knight, Dr Pollyanna Hardy, Professor Nick Maskell, Professor Greta Rait, Professor Rebecca Reynolds

NIHR151288 - Developmental Optimisation using Lavage in Preterm intraventricular Haemorrhage in Neonates (DOLPHIN-UK).
(Mr Kristian Aquilina, University College London)
Decision: Shortlist

21/536 - Sodium bicarbonate in neonatal care

Chair: Professor Catherine Hewitt
Conflicts: Professor Marian Knight, Professor Andrew Farmer, Dr Pollyanna Hardy, Professor Rebecca Reynolds, Associate Professor Lyvonne Tume, Mr Mike Bradburn

NIHR151000 - NEOMEC – NEOnatal Metabolic ACidosis trial: The clinical effectiveness and safety of intravenous sodium bicarbonate in critically ill babies with metabolic acidosis: a pragmatic randomised controlled multicentre trial.
(Dr Mark Johnson, University Hospital Southampton NHS Foundation Trust)
Decision: Shortlist

NIHR151086 - Bicarbonate for AcidosiS in very pretErm babies: a randomised clinical trial: The BASE Trial
(Dr Sabita Uthaya, University of Oxford)
Decision: Shortlist

21/538 - Benefits and harms of reduced dose oral isotretinoin in the management of acne vulgaris

Chair: Professor Marian Knight
Conflicts: Professor Andrew Farmer, Professor Catherine Hewitt, Mr Trevor Jones, Professor Ben Ollivere, Dr Beth Stuart

NIHR151318 - Investigating the benefits and harms of reduced daily dose oral isotretinoin in the treatment of acne: A pragmatic, parallel group, assessor blind, non-inferiority, multicentre randomised controlled trial, with an internal pilot
(Dr Esther Burden-Teh, The University of Nottingham)
Decision: Shortlist