The Newcastle EAG – a collaboration between Newcastle Hospitals and Newcastle University – is commissioned by NICE to provide independent assessment of clinical evidence for innovative medical technologies and associated analysis of the economic impact of adopting the technology in the NHS.
Health technology assessment
The health technology assessment team at the Freeman Hospital has been involved in the national programme of medical device assessment for over 40 years. As an EAG for NICE, the team’s work complements other activities in medical physics, including developing innovative devices and bioinformatics.
Collaboration with Newcastle University brings additional expertise in literature searching, systematic review, meta-analysis, health economics and horizon scanning. This range of skills ensures the team’s work as an EAG is well-placed to support the medical technologies evaluation programme (MTEP) at NICE.
Team members from Newcastle hospitals:
- Andrew Sims, centre director
- Kim Keltie, centre manager
- James Blake, head of service, clinical measurement
- Michael Drinnan, head of service , clinical engineering
- Emma Belilios, project co-ordinator
- Derek Bousfield, senior clinical technologist
- Julie Burn, clinical bioinformatician
- Humayra Dervin (née Abdul-Razakq), clinical scientist
- Rachel O’Leary, clinical scientist
- Rosalyn Parker, evaluation healthcare scientist
- Paula Leslie, clinical scientist
- David Muir, clinical scientist
From Evidence Synthesis Group (ESG), Newcastle University
- Dawn Craig, ESG lead and director of NIHR Innovation Observatory
- Teresa Fortune NIHR IO chief operating officer
- Fiona Beyer, senior research associate
- Sheila Wallace, research fellow and information specialist
- Hannah O’Keefe, research assistant/information specialist
- Sonia Garcia Gonzalez Moral, research assistant / information specialist
- Oleta Williams, research assistant/information specialist
- Claire Eastaugh, research assistant, information specialist
- Louise Tanner, research associate
- Nick Meader, principal research associate
- Fiona Pearson, principal research associate
- Ryan Kenny, research associate
- Katie Thomson, senior research associate
- Aalya Al- Assaf, research associate
- Oluwatomi Arisa, research assistant
From Health Economics Group (HEG), Newcastle University
- Luke Vale, HEG lead and professor of health economics
- Gurdeep Sagoo, senior lecturer, health economics
- Stephen Rice, senior lecturer, health economics
- Hosein Shabanineiad, senior research associate, health economist
- Tara Homer, senior research associate, health economist
- Ashleigh Kernohan, senior research associate, health economist
- Tomos Robinson, senior research associate, health economist
- Matthew Breckons, senior research associate
- Cristina Fernandez-Garcia, senior research associate, health economist
- Diarmuid Coughlan, senior research associate, health economist
- Gioyany Orozco-Leal, research associate, health economist
- Sedighe Hosseinijebeli, research associate, health economist
- Tumi Sotire, research associate, health economist
- Naimeh Moradi, research associate, health economist
- Yaneth Gil Rojas, research associate, health economist
Early Value Assessments (EVAs): EVAs are a new approach to the assessment of digital products, devices and diagnostics. They offer a rapid assessment based on clinical effectiveness and value for money, allowing patients and services to benefit sooner from promising technologies where the evidence base is still developing.
|GID-MT590 ProKnow Cloud-based system for radiotherapy data archiving, communications and management||Rosalyn Parker, Kim Keltie, Rachel O’Leary, Emma Belilios, Sonia Garcia Gonzalez Moral, Fiona Beyer, Sedighe Hosseinijebeli, Gurdeep Sagoo, Luke Vale, Andrew Sims||March 2023|
|GID-HTE10007 Digital products for diet and activity support alongside prescription of weight loss medication||Kim Keltie, Humayra Dervin, Paula Leslie, David Muir, Rosalyn Parker, Emma Belilios, Susan Reece, Alex Inskip, Sheila Wallace, Cristina Fernandez-Garcia, Tomos Robinson, Gurdeep Sagoo, Luke Vale, Andrew Sims||Guidance in development – expected publication September 2023|
Evidence Generation Plans: Following publication of an EVA, NICE may commission an EAG to develop a plan of how best to generate the evidence required to support future assessment and guidance development.
|RX328 ProKnow Cloud-based |
system for radiotherapy data
archiving, communications and management
evidence generation plan & delivery
|Kim Keltie, Rosalyn Parker, Paula Leslie, Matthew Breckons, Emma Belilios, Luke Vale, Andrew Sims||Ongoing|
The EAG prepares assessment reports to support NICE’s medical technologies advisory committee.
Companies notifying their technologies to NICE for guidance development, submit summaries of the clinical and economic evidence supporting the adoption of their technology.
The EAG independently assesses this submission, and the wider evidence base, and summarises findings in an assessment report to enable the committee to formulate provisional recommendations in national guidance.
|GID-MT562 FibroScan for assessing liver fibrosis and cirrhosis in primary or community care||Kim Keltie, Rachel O’Leary, Rosalyn Parker, Emma Belilios, Alex Inskip, Fiona Beyer, Andrew Sims.|
Additional supporting documentation: Kim Keltie, Cristina Fernandez-Garcia, Rosalyn Parker, Matthew Reiling, Emma Belilios, Andrew Sims
|GID-MT564 GreenLight XPS for treating benign prostatic hyperplasia [update]||Kim Keltie, Rosalyn Parker, Rachel O’Leary, Emma Belilios, Humayra Abdul-Razakq, Sonia Garcia Gonzalez Moral, Sheila Wallace, Andrew Sims||November 2022|
|MTG72 Magtrace and Sentimag for locating sentinel lymph nodes||Kim Keltie, Rosalyn Parker, Emma Belilios, Joanne Davison, Humayra Abdul-Razakq, Catherine Richmond, Fiona Beyer, Andrew Sims||October 2022|
|MTG64 KardiaMobile for detecting atrial fibrillation||Kim Keltie, Michael Drinnan, Alex Inskip, Fiona Beyer, Rachel O’Leary, Grace Fairlamb, Julie Burn, Derek Bousfield, Andrew Sims||January 2022|
|MTG59 Plus Sutures for preventing surgical site infection||Iain Willits, Kim Keltie, Rachel O’Leary, Catherine Richmond, Fiona Beyer, Andrew Sims||June 2021|
|MTG54 The VAC Veraflo Therapy system for acute infected or chronic wounds that are failing to heal||Iain Willits, Kim Keltie, Catherine Richmond, Fiona Beyer, Helen Cole, Andrew Sims||January 2021|
|MTG49 Rezum for treating lower urinary tract symptoms secondary to benign prostatic hyperplasia||Iain Willits, Kim Keltie, Neil Watson, Jo Mullen, Mark Chambers, Joyce Craig, Helen Cole, Andrew Sims||June 2020|
The EAG reports on changes that may affect the validity of published guidance, including additional published evidence and costing updates.
|MTG43 PICO negative pressure wounddressings for closed surgical incisions||Rachel O’Leary, Kim Keltie, Humayra Dervin, Emma Belilios, Michael Drinnan||Awaiting publication|
|MTG40 Mepilex Border Heel and Sacrum dressings for preventing pressure ulcers||Rachel O’Leary, Kim Keltie, Matthew Reiling, Humayra Dervin, Rosalyn Parker, Emma Belilios, Andrew Sims||Awaiting publication|
|MTG41 Senza spinal cord stimulation system for delivering HF10 therapy to treat chronic neuropathic pain||Rachel O’Leary, Kim Keltie, Matthew Reiling, Humayra Dervin, Emma Belilios, Michael Drinnan||Awaiting publication|
|MTG13 WatchBP Home A or opportunistically detecting atrial fibrillation during diagnosis and monitoring of hyper tension||Kim Keltie, Rosalyn Parker, Matthew Reiling, Emma Belilios, James Blake, Andrew Sims||January 2023|
|MTG8 MiraQ for assessing graft flow during coronary artery bypass graft surgery||Kim Keltie, Rosalyn Parker, Emma Belilios, Rachel O’Leary, Humayra Abdul-Razakq, Joanne Davison, Andrew Sims||June 2022|
|MTG38 Neuropad for detecting preclinical diabetic peripheral neuropathy||Rachel O’Leary, Kim Keltie, Emma Belilios, Andrew Sims||September 2022|
|MTG34 SecurAcath for securing percutaneous catheters||Rachel O’Leary, Kim Keltie, Andrew Sims||August 2022|
|MTG31 HumiGard for preventing inadvertent perioperative hypothermia||Iain Willits, Kim Keltie, Andrew Sims||December 2020|
Costing Updates: Costing updates may be required as part of the guidance review process if the cost of the device or other relevant resources are likely to have changed significantly. The cost model parameters are updated to reflect current values and the results used to estimate current savings associated with the use of the technology.
|MTG40 Mepilex Border Heel and Sacrum dressings for preventing pressure ulcers||Tumi Sotire, Kim Keltie, Luke Vale, Stephen Rice||Awaiting publication|
Meta-analysis: Meta-analysis may be required (or updated) as part of the guidance review process.
|MTG43 PICO negative pressure wound dressings for closed surgical incisions||Kim Keltie, Akvile Stoniute, David Muir, Humayra Dervin, Emma Belilios, Susan Reece, Nick Meader, Andrew Sims||Awaiting publication|
MIBs are designed to support NHS and social care commissioners and staff who are considering using new medical devices and other medical or diagnostic technologies. They are designed to be fast, flexible and responsive to the need for information on innovative technologies.
|Contrast Enhanced Spectral Mammography (CESM)||Rachel O’Leary, Kim Keltie, Rosalyn Parker, Derek Bousfield, Catherine Richmond, Fiona Beyer, Matthew Reiling, Emma Belilios, Andrew Sims||August 2022|
|MIB242 Artificial Intelligence in mammography||Rachel O’Leary, Kim Keltie, Helen Cole, Derek Bousfield, Sonia Garcia Gonzalez-Moral, Fiona Beyer, Andrew Sims||January 2021|
|MIB232 KardiaMobile for the ambulatory detection of atrial fibrillation||Kim Keltie, Rachel O’Leary, Dor Wilson, Sheila Wallace, Andrew Sims||October 2020|
Real World Evidence (RWE) support for Managed Access: Managed Access Agreements allow earlier access to promising technologies while evidence is collected to support their routine adoption into the NHS.
|Reviewing the statistical analysis plans and technical support for two SMA topics||Kim Keltie, Ryan Kenny, Rosalyn Parker, Humayra Dervin, David Muir, Paula Leslie, Emma Belilios, Nick Meader, Andrew Sims||Ongoing|
NICE guidance often recommends research to address identified evidence gaps before a positive recommendation can be made. The EAG works with NICE teams (including the NICE observational data unit) to facilitate further research on promising technologies where current evidence is limited.
The EAG has a particular interest in observational data collection and analysis. This includes setting up national clinical registries to collect data about particular technologies or treatments where additional knowledge is needed.
The team also undertakes data analysis based on routinely collected health data to assess safety and efficacy and to study patient pathways. A main source for this work is hospital episodes statistics (HES) data which covers NHS hospital activity in England.
Examples of observational research conducted by the team:
Other work for NICE
Newcastle EAG provides a variety of other services for NICE, including:
- regulatory advice to the interventional procedures (IP) programme on CE marking, including the new UKCA marking of medical technologies
- research ethics advisory service to the NICE science policy and research team
- feasibility assessment of further research to address uncertainties in NICE guidance
- methodological support across all NICE programmes.
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Northern Medical Physics and Clinical Engineering, Freeman Hospital
Evidence Synthesis Group and Health Economics Group