It is well accepted that medical devices (MDs) and procedures have several unique characteristics compared to pharmaceuticals, such as learning curve (LC), incremental innovation (II), dynamic pricing (DP), and organizational impact (OI). The objective of this study was to determine the extent to which these MD characteristics are routinely assessed by health technology assessment (HTA) agencies and incorporated in their guidelines and reports.

Three approaches were taken. First, a review of the most recent HTA methods guidelines from 13 selected HTA agencies and five HTA networks was undertaken. Next, HTA reports from these agencies were reviewed for inclusion of MD-specific characteristics for 16 selected MDs, and finally, a narrative literature review on this topic was conducted.

Twelve of thirteen included HTA organizations and some HTA networks (2/5) have either published general or MD-specific method guidelines, while several addressed MD-specific characteristics. The National Institute for Health and Care Excellence (NICE) included all four MD characteristics in their guidelines, but this did not equate to their inclusion in published HTA evaluations. EuNetHTA described the inclusion of LC (within patient safety) and OI within their guidance. The results highlight a lack of consistency among HTA organizations. For the narrative review, 10/149 articles were reviewed. Most provided recommendations on challenges faced by HTAs, proposed steps to address uncertainties around MD characteristics and reported a lack of methodological guidance for evaluating MDs.

A lack of inclusion of MD characteristics in HTA is a complex interplay of several important factors. For these characteristics to become a formal part of HTA of MDs in the future, clear guidance and frameworks are required to enable manufacturers to develop appropriate evidence and for HTA practitioners to assess their impact more broadly.

Reducing environmental impact and ensuring sustainable practices are important to the medical technology (MedTech) industry. However, it is unclear how these factors will be formally addressed by health technology assessment (HTA). The objective of this research was to understand what sustainability measures are required and included in HTA reports on medical technologies in five European countries (France, England, Germany, Italy, and Spain).

HTA guidelines, framework papers, and published HTA reports for devices were searched from January 2022 to November 2023 for inclusion of environmental aspects. Search terms included environmental sustainability, carbon footprint, greenhouse gas, and waste generation. Data were extracted into standardized templates and analyzed both quantitively and qualitatively for the inclusion of sustainability and environmental impact measures.

HTA guidance on inclusion of sustainability and environmental measures is lacking. While some countries request the inclusion of these aspects in the HTA process, there is little detail on evidence requirements and how it will be evaluated. Of the over 450 HTA reports examined, less than 10 percent included environmental aspects, with most sustainability benefit claims made related to the reduction in waste or less resources used. Very few claims were supported by published evidence. This resulted in the exclusion of potential environmental benefits in final HTA recommendations. Costs associated with environmental impact of medical technologies were rarely assessed.

Current inclusion and evaluation of sustainability measures in MedTech HTA in Europe is nascent. While countries like England [National Institute for Health and Care Excellence (NICE)] and France [Haute Autorité de santé (HAS)] have very recently made public statements regarding the importance of environmental impact, there is a growing need for detailed guidance on environmental evidence requirements and how these will be incorporated into the evaluation and decision-making processes.

Since 2020, there has been an increase in children with mental health presentations ending up on general paediatric wards. Hospitals are identified as a place of safety for young people in crisis, though admission to a paediatric ward is not without risk for the child and staff involved in their care. Stays are often prolonged and classed as delayed discharges. This evaluation looks at 22 admissions to general paediatric wards within an acute health trust in Greater Manchester.

Local CAMHS teams identified 22 patients with a mental health presentation who had been admitted to paediatric wards and had delayed discharges between September 2021 and December 2023. Their electronic notes were analysed to identify number of bed days and CAMHS contacts, legal status, and discharge destination. Incident reports of each admission were analysed, and categorised into ‘Restraint/Rapid Tranquilisation’, ‘Assault on staff’ ‘Self harm’ ‘Abscondence’ and ‘Other’.

Of the 22 cases analyses, total bed days were 1469. The average number of bed days was 66.7. 6 admissions were over 100 days with the longest being 186 days. The majority (19) of the presenting complaints were categorised as ‘self-harm’ and /or ‘suicidal ideation’. The average number of core CAMHS contacts was 23 per admission, with an average of 9 consultant contacts, 5 Junior doctor out of hour contacts, and 32 meetings (e.g. discharge meeting, strategy meeting) requiring CAMHS attendance. 11 admissions involved assault on staff, with the highest number of assaults 48 during a single admission. 18 of the admissions required additional staffing (clinical support worker, security). Three patients required police to be called to the ward due to assault on staff. 9 of the patients were discharged to a social care placement, 8 were discharged home. The remaining were discharged to inpatient unit, day unit or to a family member.

Mental health admissions to paediatric wards are associated with a high level of CAMHS contacts provided by Tier 3 staff, which creates a previously unseen burden on the service. Admissions can be prolonged. Patients are cared for in an environment which is not designed to meet their needs. This is demonstrated by high level of patients absconding from the ward and increased restrictive measures such as restraint and 1:1 observation. Admissions are also associated with high levels or assault on staff. Further work is needed to evaluate the economic impact of additional staffing on paediatric wards, as well as the impact on paediatric nursing and security staff.

Spinal cord stimulation (SCS) is an effective and safe option for patients with refractory neuropathic pain, with positive health technology assessment (HTA) recommendations across Western Europe, yet SCS uptake remains low. Estimating target patient populations within HTAs may impact upon medical device uptake, pricing and access. However, there is a dearth of information on how this is typically conducted. This study aimed to compare the approaches of Western Europe HTA agencies for estimating the target population for SCS.

A survey was conducted among members of the Health Economics and Reimbursement function from Western Europe to collect country-specific information on how HTA agencies assess the target population of medical devices (MD). The estimations of the target population for SCS were extracted from HTA publications and compared.

Eight Health Economics and Reimbursement (HER) Analysts from France, Germany, the United Kingdom (UK), Belgium, Spain, Italy, Sweden and Norway completed the survey. HTA Agencies in France, UK and Belgium routinely ask for epidemiological data in the manufacturer submission, whereas in Germany, Sweden and Norway the request is dependent on the type of HTA submission. All HTA agencies, except NICE (UK), perform an independent estimation of the target population. HTA agencies in Germany and UK typically use epidemiological data from industry. In all countries, the estimation of the target population may indirectly impact the price of the MD, especially when budget impact analysis indicates a potential high use of healthcare resources. Only France, Belgium and UK have published HTA recommendations about SCS, however the estimated target population, nor the number of patients with refractory neuropathic pain, is not always included. Only the French and UK HTA agencies publish an approximation of the target population for SCS using the number of patients implanted every year.

This study showed there is a lack of harmonization between Western European HTA agencies’ guidelines on the inclusion and estimation of target patient populations. The new EU HTA Regulation should help to address this situation.

Medical device health technology assessment (HTA) in Australia is largely coordinated by the Medical Services Advisory Committee (MSAC). Its remit to improve the public’s health by deciding where to allocate public healthcare funding, can be enhanced by considering real world evidence (RWE). Existing data sources have limitations that can be addressed through RWE, including coverage of Australian patient populations who may not meet trial eligibility criteria, and long-term follow-up through data linkage and datasets. We partnered with a university to explore what information could be gained from an analysis of linked administrative patient data, with a view to addressing current evidence gaps and/or limitations. The findings can be used as a source of local data to define patient populations, estimate actual costs of care, and enable more comprehensive economic modeling to inform medical device HTA.

The University-developed New South Wales Cardiovascular Cohort dataset, comprising person-level longitudinal NSW administrative data for all patients admitted to hospital with a cardiovascular diagnosis from 2001 onwards, linked to national Medicare Benefits Schedule and Pharmaceutical Benefits Scheme claims data, was interrogated.

Working with RWE is resource intensive in terms of time and costs. The potential of these data was revealed as the research progressed. It was possible to continually refine the data analyzed and reported,as well as expand the data requested. Varied expertise is required to accurately analyze the administrative datasets, particularly clinical classification skills and expertise in methods for causal inference using observational data. Findings from this study will enable the refinement of information for MSAC submissions, including identifying the most relevant patient population and reporting comprehensive costs, beyond an admitted hospital setting. The data will enhance engagement with clinicians and refine messaging, for example regarding patient risk factors.

RWE enhances Australian HTA applications. Local data, extended periods of time and insights not apparent from a focus on admitted hospital episodes can be revealed. Data can be refined during the process for specificity and applicability.

Chronic pain is a debilitating condition with a high burden of disease. Neurostimulation therapy is an established modality for patients with chronic pain refractory to pharmacological based approaches and conservative interventional therapies. The therapy has evolved over the decades, based on improved understanding of the mechanisms of action, as well as technological advancement in device design.

Our objective is to conduct a review of the innovation in neurostimulation therapy for chronic pain, in the context of health technology assessment (HTA), and its implications on policies related to patient access.

A qualitative literature review was conducted to identify published HTAs, systematic reviews, clinical guidelines and other relevant articles and reports on neurostimulation therapies used in pain management. Searches were limited to the past 10 years to ensure that a contemporary analysis was conducted.

Our review indicates that there has been continuous innovation in neurostimulation therapies for chronic pain. This includes improvements in battery longevity and reduced size, advances in the design of leads, the development of novel stimulation waveforms and personalized programming using sophisticated algorithms including sensing and feedback loops, and remote management to name a few. Clinical research has also enabled an expansion in the range of neural targets and indicated subpopulations. The literature shows that apart from reduction in pain, neurostimulation therapy facilitates improvements in the quality of life, and reduction in opioid dependence, carer burden and disability, which are outcomes important to patients as well as to society at large. Clinical guidelines are largely supportive of neurostimulation for the management of chronic refractory pain in carefully selected patients.

The range and complexity of neurostimulation devices and the variety of study designs presents a challenge for evidence synthesis. HTA bodies need to ensure that the methodologies for evaluating a heterogeneous therapy such as neurostimulation for pain management are robust, and that the policies for determining access to such innovative therapies are patient-centric and fit-for-purpose.

Cardiac Implantable Electronic Device (CIED) infection is a serious complication associated with morbidity, mortality and high healthcare costs. Internationally, the published rate of CIED infection ranges from 1.0 percent to 1.6 percent. There is a lack of data on CIED infection rates in Australia; the reported range is from less than 1 percent at 30 days to 7 percent over 5 years. Due to the variability within the limited number of studies there is a need for further analyses of CIED infection rates in Australia.

This was a retrospective cohort study using secondary linked hospital (the NSW Admitted Patient Data Collection) and mortality data for patients who underwent CIED procedures between July 2017 and June 2020 in NSW. Overall and procedure-and patient-specific incidence of infection was calculated.

A total of 23,786 CIED procedures were performed among 22,404 patients and 422 CIED infections were identified, giving an overall infection rate of 1.77 percent. When infections were limited to those following a CIED procedure in the period July 2017-June 2020 (n=309), the procedure-specific CIED infection rate was 1.30 percent, ranging from 1.01 percent for permanent pacemaker (PPM) to 2.71 percent for cardiac resynchronization therapy-defibrillator (CRT-D). The proportion of patients undergoing CIED procedures in this period who had a subsequent CIED infection was 1.29 percent, ranging from 0.97 percent for permanent pacemaker (PPM) to 3.05 percent for cardiac resynchronization therapy defibrillator (CRT-D). Procedure-based infection rate in high-risk patients (generator replacement; system upgrade; revision; or CRT-D procedure) was 1.47 percent and patient-based infection rate was 1.68 percent. Infection rate was highest within the first month following the CIED procedure that dropped significantly over time.

Rates of infection were highest among patients with cardiac resynchronization therapy (CRT) devices, and those who underwent revision or upgrade procedures. Ongoing monitoring of CIED infection rates and preventative measures are necessary, especially for high-risk patients. This study highlights the important role linked secondary data has in reducing uncertainty and removing the reliance on international estimates by providing targeted, local data for health technology assessment.

Cervical artificial disc replacement (C-ADR) is not a new technology but one that has seen many technological advances in the past 10 years. Indeed, a recent review described total disc arthroplasty as the most innovative development in the history of spinal surgery. The primary goals of C-ADR are to reduce or eliminate pain, and restore normal segmental motion. The aim of this analysis was to identify, extract and examine key health outcomes and economic data from published health technology assessment (HTA) reports on C-ADR, with the aim of understanding how the evolution of this technology has influenced assessments internationally.

A comprehensive search of over 90 HTA organization websites and the INAHTA HTA database using key terms for C-ADR surgical procedures was coupled with a literature search of recent systematic reviews. No language restrictions were applied.

Twenty HTA reports of C-ADR surgery published from 2005 to 2022 were included for review. Several HTAs (4/20) were updates or reassessments by the same agency and one was an update across agencies (Italy update of Belgian HTA). While many of the HTAs concluded C-ADR is as effective as standard care and superior in certain outcomes, there was no pattern or consistency in the conclusions or recommendations from these assessments, even as the evidence base expanded over time. Our analysis found this was largely due to variations in HTA approaches among agencies including: differences in research questions asked, PICO (Population, Intervention, Comparator, Outcomes) criteria and methods performed, such as: rapid versus full systematic reviews; inclusion of economic evaluations and/or budget impact analyses.

Indeed, one of the only predictive factors for a positive HTA was a favorable cost-effectiveness analysis.

C-ADR is an established technology with extensive HTA investigation internationally. The lack of a consistent approach taken by HTA bodies made prediction of successful HTA outcomes difficult. Future alignment of key evaluation processes and methods may help address current international variations and support consistent decision making on patient access.

To evaluate the impact of increased availability of healthier options on purchasing of different types of vending snack products sold in English leisure (sports) centres.

An evaluation of an intervention using pre-post methods and interrupted time series analysis. Products within the vending machines were altered over three phases to increase the availability of healthier options, using agreed nutrition criteria – Government Buying Standards for Food and Catering Services (GBSF) for England – as a guide, as well as product availability. The primary outcome was the change in mean weekly purchased energy between the first and third phase. Secondary outcomes included changes by phase and by week in weekly number of purchases, fats, sugars and salt for all products combined and by individual product categories.

Fifteen sports centres in the city of Leeds, West Yorkshire, UK.

Snack products sold in eighteen vending machines.

Energy purchased reduced from baseline to phase 2, for all product categories combined, by 47·25 MJ (95 % CI (−61·22, −33·27)) per machine and by 279 kJ, (95 % CI (−325, −266)) per product unit. There were reductions in most nutrients purchased in all individual product categories except chocolate confectionery. Nutrients per product unit decreased for all product categories except saturated fat in chocolate confectionery. Minimal underlying trends in the baseline phase were identified, indicating changes in outcomes were likely to be due to the intervention.

Introducing standards to increase availability of healthier snack products in vending machines is feasible without substantially affecting sales.

Primary surgical resection remains the mainstay of management in locally advanced differentiated thyroid cancer. Tyrosine kinase inhibitors have recently shown promising results in patients with recurrent locally advanced differentiated thyroid cancer. This study discussed four patients with locally advanced differentiated thyroid cancer managed with tyrosine kinase inhibitors used prior to surgery in the ‘neoadjuvant’ setting.

Prospective data collection through a local thyroid database from February 2016 identified four patients with locally advanced differentiated thyroid cancer unsuitable for primary surgical resection commenced on neoadjuvant tyrosine kinase inhibitor therapy.

All cases had T4a disease at presentation. Three cases tolerated tyrosine kinase inhibitor therapy for more than 14 months while the last case failed to tolerate treatment at 1 month. All patients subsequently underwent total thyroidectomy to facilitate adjuvant radioactive iodine treatment. Disease-specific survival remains at 100 per cent currently (range, 29–75 months).

Neoadjuvant tyrosine kinase inhibitors in locally advanced differentiated thyroid cancer can be effective in reducing primary tumour extent to potentially facilitate a more limited surgical resection for local disease control.