bluuebunny/crossref_metadata_2025_split huggingface dataset:
PP96 Continuous Innovation In Neurostimulation Therapies For The Management Of Chronic Pain: Challenges For Health Technology Assessment Policy
Authors: Joglekar Rashmi , Strachan Liesl 
Published: December 2023

IntroductionChronic 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.MethodsA 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.ResultsOur 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.ConclusionsThe 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.
PP102 Impact Of Placing Peripherally Inserted Central Catheters At Patient Bedside Versus Radiology Suite In A Private Australian Hospital
Authors: Xian Tan Kristin Hui , Gala Smeet , Ma Yan 
Published: December 2023

IntroductionA peripherally inserted central catheter (PICC) is an important vascular access device to administer certain intravenous (IV) therapies, which is traditionally placed using fluoroscopy in radiology suites. With advancing tip-confirmation technology, PICCs can be placed at the patient bedside by nurses, without any delays arising from wait time for the radiology suite or the need of transferring patients to the radiology suite, leading to time savings and allowing prompt start to IV therapy. This study aims to estimate the cost and time impact of placing PICCs at the bedside using tip-confirmation technology led by nurses versus in the radiology suite using fluoroscopy by radiologists.MethodsA budget impact analysis was developed using Microsoft Excel to estimate the annual impact of inserting PICCs at the bedside versus in the radiology suite. The base case scenario was modelled for 1,000 PICCs placed in a private Australian hospital. Impact on bed days, labor time and overall cost was estimated by using global and local data sources for inputs. It was assumed that 100 percent PICC are placed in a radiology suite in current practice, while 95 percent are placed at the bedside and 5 percent in the radiology suite in future practice.ResultsBy shifting PICC insertion to the bedside using tip-confirmation technology, the model estimated a reduction of labor time by 221 hours and bed days by 113 days. Despite an increase in the cost of consumables by AUD34,041 (USD22,760) and reduction of Medicare Benefits Schedule rebate by AUD260,730 (USD174,328), overall cost savings of AUD1.01million (USD675,660) was observed due to significant savings due to the t reduced utilization of the radiology suite.ConclusionsPICC insertion at the patient bedside using tip-confirmation technology by nurses may lead to time and cost savings as compared to placing them in the radiology suite. This can help alleviate the burden on radiology suites and reduce their wait times, potentially leading to timely treatment initiation and discharge. Since PICCs at the bedside are typically placed by specialized vascular access nurses, these cost savings can be redirected to employ and train them.
PP109 The Use Of Health Technology Assessment In Decision Making: Evidence From The Balkan Countries
Authors: Mechili Enkeleint A. , Petelos Elena , Bucaj Jorgjia , Gallos Parisis 
Published: December 2023

IntroductionAccording to the most recent definition health technology assessment (HTA) “is a multidisciplinary process that uses explicit methods to determine the value of a health technology at different points in its lifecycle. The purpose is to inform decision-making in order to promote an equitable, efficient, and high-quality health system”. This article aimed to evaluate implementation of HTA in decision making in the Balkan countries.MethodsA scoping review of the existing literature took place to locate relevant scientific articles, policy papers and documents released by the respective Ministries. We searched data for 6 Western Balkan countries (Albania, Bosnia and Herzegovina, Kosovo, Montenegro, North Macedonia and Serbia) and didn’t focus on those countries that are part of the European Union (EU). For the literature search key words were used, while documents only in English were included in the analyses. Additionally, the search was conducted for the period January 2010 until October 2022.ResultsThe Western Balkan countries are in process of integration to the EU and based on this they are trying to make improvement in different sectors including health services. However, the use of HTA in most of the studied countries is in its preliminary phase. Most of the countries have established HTA bodies or specific authorities but with limited resources (both human and financial). Additionally, their reports are non-binding for policy makers and healthcare decisions are taken based on experts’ opinions and not an extensive HTA analyses.ConclusionsDespite their efforts, the Western Balkan countries need to improve and considerably increase the use of HTA in decision-making. Its use can help in provision of better healthcare services as well as to decrease costs. Specific attention should be put on human and financial resources that are lacking in all settings.Western Balkan countries need to put much more efforts for harmonization of their legal framework with that of the EU countries.
PP113 Common Methodological Issues In Systematic Reviews Supporting Single Technology Appraisal Submissions To The National Institute for Health and Care Excellence
Authors: Fitzgerald Anita , Wilson Katy , Wood Hannah 
Published: December 2023

IntroductionThis project aimed to identify methodological issues reported by Evidence Review Groups (ERGs) in the systematic reviews (SR) supporting single technology appraisal (STA) submissions to the National Institute for Health and Care Excellence (NICE). STA submissions contain SRs related to the clinical and cost-effectiveness of the proposed intervention and NICE require the methods for these reviews to be clearly detailed in the submission. The intention of this project was to identify methodological aspects of submissions where companies may need additional guidance or support to provide the evidence required for efficient and effective decision-making and in turn facilitate timely access to clinical innovation.MethodsFrom 2019, 61 STAs were identified from the NICE website, of which 46 were included. We extracted information about the data requests or clarification questions raised by the ERG in relation to the methodological section of both the clinical and cost effectiveness SRs reported in the STA. We then categorized these data and grouped by theme to determine the most common methodological issues faced by companies. We did not assess whether comments made by the ERG were accurate or justified.ResultsFor both clinical and cost-effectiveness SRs, the most frequent clarification questions arose from the search methods section, specifically seeking information about missing intervention or comparator terms, the use of search filters and search platforms. Clarification questions were also commonly asked about the appropriateness of interventions and comparators. There were very few clarification questions asked about screening, data extraction or risk of bias assessment.ConclusionsCompanies looking to submit an STA should align their submission methodology to established best practice guidance for systematic reviewing to ensure their methods are fit for purpose and avoid unnecessary delays to the STA process. Consistency with the PRISMA reporting standards would help ensure that the ERG is provided with the information needed to assess the appropriateness of the STA methodology and is likely to reduce the need for clarification questions.
PP130 The Effectiveness Of Extracorporeal Shock Wave Therapy For Plantar Fasciitis: A Systematic Review And Meta-analysis
Authors: Jung Youjin , Lee Seul Ki 
Published: December 2023

IntroductionExtracorporeal shock wave therapy (ESWT) has been used since the 1990s to treat various musculoskeletal disorders, but there is considerable controversy regarding the effectiveness of ESWT. Our aim was to conduct a systematic review of randomized controlled trials (RCT) to investigate the effectiveness of ESWT for plantar fasciitis.MethodsA comprehensive search was conducted via electronic databases including MEDLINE, Embase, the Cochrane Controlled trials register, and 5 Korean databases from inception date to April 2022. Two review authors independently assessed studies for inclusion and risk of bias, and extracted study data. Major outcomes were pain relief, function, and quality of life.ResultsWe identified a total of 48 RCTs comparing ESWT with corticosteroid injection (n=14), conventional therapies (n=19), and sham control (n=21). Most studies included participants with chronic heel pain diagnosed as plantar fasciitis. All trials were susceptible to bias. In terms of pain results, ESWT showed no significant difference when compared with the steroid injection group and the conventional therapy group, and significant pain relief was confirmed only compared to the sham control group (Mean Difference -1.71; 95% confidence interval [CI] -2.44,-0.98; I2=70%;). Functional outcomes were significantly improved in the ESWT group compared to the steroid injection group (standardized mean difference 0.45; 95% CI 0.27,0.63; I2=0%) and the sham control group (SMD 0.84, 95% CI 0.23,1.45; I2=91%), but no significant difference was found when compared to the conventional therapy group.ConclusionsBased upon the currently available low certainty evidence because of wide clinical diversity and varying treatment protocols of included trials, ESWT is associated with improved function and may be associated with pain reduction in plantar fasciitis. Further evidence is needed from well-designed studies with a standard dose and treatment protocol.
PP132 Health Technology Assessment Agencies’ Expectations Regarding Patient Experience Data in Australia, China, And Japan
Authors: Alonzo Carolina , Ding Ding , Poon Jiat-Ling , Zschocke Juergen , Zhang Lei , Toshihiko Aranishi , Myrick Shane , Hill Jennifer , Larkin Louise , Perez Nancy , Delbecque Laure 
Published: December 2023

IntroductionHealth technology assessment (HTA) agencies are increasingly embracing patient experience data (PED) to support reimbursement decisions. This study aimed to review HTA agencies’ expectations with regards to utilizing PED to support drug reimbursement in Australia, Japan, and China.MethodsPublished HTA guidance documents were reviewed in 2021 to identify any PED-specific information. If available, recommendations related to the type of PED (e.g., generic vs. disease-specific clinical outcomes assessment (COA)); COA validation, analyses, endpoints and interpretation; and the interest in PED beyond COA in HTA decision-making (e.g., patient preference information) were reviewed. Literature review and semi-structured interviews with key opinion leaders (KOLs) were conducted to further explore these themes and future trends with regards to PED.ResultsAustralia’s Pharmaceutical Benefits Advisory Committee guidance document includes a dedicated section on patient-reported outcomes (PRO), providing details on preferred PRO instruments; validation expectations; and recommended methods to explore score interpretation, assess and report PRO results and handle missing data. While PED derived from non-PRO sources are not discussed in the guidance, the KOL noted that they should not be ruled out. Japan’s Center for Outcomes Research and Economic Evaluation for Health guideline includes a section dedicated to PROs without details related to instrument validation, analyses and interpretation, however, is focused on the use of PRO to inform health economic assessments. In China, the HTA center of China National Health Commission drafted two disease-specific technical guidance documents recommending the inclusion of PROs in efficacy assessments and use of instruments relevant in the Chinese population; these points were echoed by the KOL interviewed.ConclusionsThere are recommendations on PED use included in country-specific guidance documents, however their level of detail varies greatly. Knowing each agency’s expectations with regards to PED is key when submitting HTA evidence dossiers and should be considered early in clinical trial design to integrate market access perspectives and optimize drug development.
PP133 What Services And Products Should A Health Technology Assessment Agency Provide?
Authors: Faraldo-Valles Maria-Jose , Maceira-Rozas Maria-Carmen , Casal-Acción Beatriz , Gomez Patricia , Trinanes Yolanda 
Published: December 2023

IntroductionHealth technology assessment (HTA) bodies support healthcare decision-making by producing different kind of products. The high speed of the healthcare innovations and the scenarios such as the COVID-19 pandemic challenge HTA organizations to adapt their services to better respond to these demands. The Spanish Network of HTA Agencies (RedETS) is redefining the services and the products in its portfolio. The first step has been conducting a review in order to identify the most relevant HTA products.MethodsA scoping review with two sections was conducted: (i) analysis of results from a bibliographic search performed in the main biomedical databases; and (ii) analysis of results from a manual review of the official websites of seven international HTA agencies: CADTH (Canada), INESSS (Canada), SBU (Sweden), NICE (United Kingdom), IQWIG (Germany), HAS (France), IECS (Argentina) and IETS (Colombia). The EUnetHTA website was also reviewed.ResultsThe search identified 1,311 references; 21 studies were considered relevant. The main topic found was about rapid responses services. The standard timeline for these should be less than six months, with even some produced in days. Transparency about methodology and involvement of decision-makers were considered key points to be included. Website analysis revealed similar HTA reports production but variation in the domains and elements considered. The timeframe for conducting a full HTA report can be up to 24 months, with a median of 12 months. Agencies also offer some kinds of rapid response services. Scientific consultation and horizon scanning systems for emerging technologies are other services performed by some agencies.ConclusionsThe review reveals that agencies have different products to address different needs throughout the life cycle of technologies: from scientific advice to full HTA. In addition, HTA agencies have incorporated rapid responses into their services. According to literature, these products could support short-term decision-making.
PP135 The Cost-Of-Illness Of The Management Of Patients Affected By Hyperparathyroidism In The Italian Healthcare Setting
Authors: Basile Michele , Antonini Debora , Fortunato Agostino , Cicchetti Americo 
Published: December 2023

IntroductionHyperparathyroidism is a medical condition characterized by an excess of parathyroid hormone (PTH) in the blood. This hormone is produced by the parathyroid glands, located behind the thyroid gland. PTH plays a crucial role in regulating calcium levels in the body, which is necessary for muscle activity, nerve transmission, and maintaining bone density. In this study, the authors aimed to determine the parameters necessary for defining the delivery process of interventions for managing hyperparathyroidism.MethodsTo achieve this, a group of Key Opinion Leaders (KOLs) was surveyed using a questionnaire to investigate specific drivers such as the duration of interventions, drug therapies employed, and materials required. The authors also estimated the indirect costs associated with patients and caregivers. The economic analysis considered the perspectives of both the Italian National Health Service (SSN) and the community. The analysis was conducted using Activity Based Costing (ABC) methods to determine the full cost sustained for a parathyroidectomy surgery and pharmacological therapies per patient treated, as well as the average resources absorbed by a patient managed through pure surveillance.ResultsThe results showed that the average annual cost of parathyroidectomy and pharmacological therapies per patient was EUR5,193.20 and EUR1,726.96, respectively. Productivity losses due to the interventions amounted to EUR858.21 and EUR66.80 for the patient and caregiver, respectively. The pure surveillance strategy incurred an average yearly cost of EUR197.42.ConclusionsThe study’s major limitation was the lack of evidence available concerning the therapies under analysis, particularly in the Italian context. Nonetheless, the survey of clinicians provided useful insights into the expenditures associated with implementing interventions for managing hyperparathyroidism. In conclusion, managing hyperparathyroidism involves considerable costs, and healthcare providers must consider the perspectives of both the SSN and the community when estimating the economic impact of interventions. The authors’ analysis provides insights into the cost of different interventions, which could help healthcare providers make informed decisions when managing hyperparathyroidism.
PP140 Burden of Illness And Health Care Costs In People with Alzheimer’s Disease
Authors: Edwards Sophie , Hahn-Pedersen Julie , Robinson Danielle , Chan Mei Sum , Bray Benjamin , Clark Alice , Ivkovic Milana , Michalak Wojciech , Wichmann Christian , Berry Sasha , Evans Marc 
Published: December 2023

IntroductionAlzheimer’s disease (AD), the most common cause of dementia, is becoming increasingly prevalent worldwide. Understanding the current burden of AD is important in health economic evaluations of new therapies. We aimed to estimate the burden of illness, and healthcare costs of people living with AD using a large, comprehensive real-world database in England.MethodsA retrospective cohort study was undertaken in the Discover-NOW dataset, a real-world database containing the linked primary and secondary care electronic health records of ˜3 million people living in North West London, England. Patients diagnosed with AD were followed from the later of 1 January 2010 or AD diagnosis date, to the earlier of 31 December 2021 or end of follow up (maximum 10 years). Baseline prevalence of 33 comorbidities, incidence of 7 outcomes (survival, cardiovascular, care home admission, hepatic and renal outcomes), healthcare resource utilisation and total direct healthcare costs (using National Health Service tariffs and unit cost approaches) were calculated.ResultsOf 18,116 patients diagnosed with AD, at baseline the mean age was 81 years, 62 percent were female, 65 percent were White, 16.5 percent Asian and 8.9 percent Black. At baseline, hypertension prevalence was 60.2 percent, chronic kidney disease 35.5 percent and Type 2 diabetes 22.4 percent. The highest incidence rates across these outcomes were 13.4 (95% confidence interval [CI]:12.2,14.7) per 1,000 person years for stroke, 7.5 (95% CI: 6.6, 8.5) for myocardial infarction, and 83.6 (95% CI: 80.1, 87.0) for care home admission. Median survival was 4.9 years from diagnosis. Their annual total direct healthcare cost was GBP4,547 per patient, of which 58 percent were from hospital admissions. The majority (75%) of healthcare contacts were from primary care. AD patients had an average length of stay of 11.5 days per inpatient admission, and spent on average one week per year as inpatients.ConclusionsAD is associated with high direct healthcare costs, with patients’ annual costs ˜1.7 times that of the UK population. The majority of these costs are associated with inpatient hospital admissions.
PP146 Seeing Eye-To-Eye on Real-World Evidence: Are Guidance from Japan and China Consistent with Recommendations from REALISE in Asia?
Authors: Wee Yan Ran , Fujita Natsumi , Evans Jennifer S 
Published: December 2023

IntroductionThe REAL World Data (RWD) In Asia for Health Technology Assessment (HTA) guidance was developed by a regional working group to facilitate the increasing acceptance of real-world evidence (RWE) in Asia. We compared the consistency of REALISE against guidance from Japan and China.MethodsCountry-specific guidance for RWE/RWD use in pharmaceutical development were identified in May 2022 through governmental websites, with validation searches via Google. Sections from local guidance were mapped onto REALISE and categorized as “agree”, “mixed”, “disagree” or “missing” based on coverage and consistency.ResultsFive Japanese and three Chinese documents were mapped. Most sections in Chinese guidance (77%) and 36 percent of sections in Japanese guidance were tagged “agree” or “mixed”, with general alignment on definitions and good practice considerations (study design, accountability); however, 63 percent of Japanese sections were tagged “missing” from REALISE. As local documents took the regulatory perspective, they lacked REALISE’s discussion of translating RWD to RWE for HTA/economic evaluations specifically. Local guidance focused on practicalities of RWD collection in local contexts, including descriptions of specific actions (e.g., evaluating RWD sources, ensuring data security) rather than overarching principles described in REALISE; specifically, Japanese guidance described how to access and analyze databases/registries, reflecting Japan’s landscape of robust sources of national healthcare data, but lacked discussion of other RWE study types, data sources and specialized analytical methods. While Chinese guidance had a broader view of RWD types (more similar to REALISE), they also contained discussions on pharmacovigilance and omics data, communication with regulatory bodies, and incorporation of RWE into the approval pathway for traditional Chinese medicines.ConclusionsDespite differing purposes (with no RWE guidance from local HTA bodies), local and regional guidance align on general principles/good practice in generating/using RWE, providing common ground for increasing usage of RWE in HTA in Asia.