bluuebunny/crossref_metadata_2025 huggingface dataset:
PP032 Holistic Patient Access Processes Of Medical Devices In South Korea
Authors: Lee Sang-Soo , Lee Moo Yeol , Kim Veronica , Lee Kyungja , Kwon Young-Kwan
Published: January 2018

INTRODUCTION:

Historically, patient access processes of new and innovative medical devices including in-vitro diagnostics are made in the sequence of regulatory approval, new Health Technology Assessment (nHTA) approval, reimbursement coverage and coding finally reaching the pricing approval stage in South Korea. Although the individual patient access process has its own distinct objective and perspective, there are still opportunities for the authorities or agencies in charge to streamline their processes by working together to promote earlier patient access of new and innovative medical devices to patients without impacting their own decision making.

METHODS:

This research examined and analyzed the current policies about: patient access processes with a holistic viewpoint, industry-wide survey about patient access practices; case studies of two innovative medical devices for patient access in South Korea and also proposed new or alternative programs which can contribute to patient access harmonization efforts with a holistic approach.

RESULTS:

Historically, health authorities play defensive strategies by delaying the adoption of new and innovative medical devices and implementing certain periods (that is, 2 to 5 years) for a patient's out-of-pocket payment scheme. It is well illustrated with the statistic that only twenty-nine percent of new and innovative medical technologies which have successfully gone through the nHTA process were determined for reimbursement coverage in the past 7 years.

The survey by the medical device industry to determine the patient access lead-time of innovative medical devices with a holistic perspective indicated significantly delayed patient access even considerabley exceeding the legally required decision-making lead time. The in-depth case studies with two innovative devices indicated the disadvantageous patient access processes to the innovator in terms of both final approval timing and the price level.

CONCLUSIONS:

The concurrent review process for reimbursement coverage decision making for medical procedures, medical devices and reimbursement coverage payment guidelines committed within the Health Insurance Review and Assessment Service shall be created. New programs to deal with uncertainty in reimbursement coverage decision making shall be considered such as coverage with evidence development, performance-based risk-sharing arrangement, multi-criteria decision analysis and economic evaluation.
PP033 Patient And Public Involvement In Health Technology Assessment: The Brazilian Experience
Authors: Mega Tacila , Silva Aline , Petramale Clarice , Rabelo Roberta
Published: January 2018

INTRODUCTION:

The National Committee for Health Technology Incorporation (CONITEC) (1) was created in 2011, when the participation of civil society in the Health Technology Assessment (HTA) process was formalized in Brazil. According to legislation, patient and public involvement (PPI) in HTA occurs through: public consultations (PC); representation of SUS (Brazilian Public Health System) users in the plenary of CONITEC and by public hearings in relevant cases. Due the incipient culture of social participation in Brazil, strategies involving better communication, direct participation and popular education were developed to broaden and qualify this participation.

METHODS:

•

Case study about PPI strategies developed in 5 years of CONITEC

•

Analysis of documents and official records from the Brazilian Ministry of Health.

RESULTS:

Since its creation, the innovations of CONITEC regarding PPI were: creation of specific PC form to reproduce or represent the perspectives of patients and caregivers; summarized versions of technical reports written in a simplified language to improve users involvement; surveys prior to elaborating clinical guidelines, a bi-weekly educational program transmitted by streaming, and the recent launch of an HTA Users Guide and a mobile app.

After the implementation of these strategies (which started in 2014), there was an increase of annual contributions, from 2,584 in 2014 to 13,619 in 2015. Most participants were patients, family members or caregivers. Surveys concerning clinical guidelines received about 3,000 contributions. There were thirty-seven published society reports until December 2016. The publication of the HTA Users Guide and other related actions increased the number of accesses to the CONITEC website and its subsection for social participation. The educational program had more than 800 online accesses in five months.

CONCLUSIONS:

These actions allowed expanding and qualifying PPI beyond what is legally defined, and it is possible to predict an increasingly favorable scenario regarding the patient and public participation in HTA in Brazil.
PP046 Screening In Women Vaccinated Against Human Papillomavirus: Governing Innovation
Authors: Rossi Paolo Giorgi , Carozzi Francesca , Federici Antonio , Ronco Guglielmo , Zappa Marco , Franceschi Silvia
Published: January 2018

INTRODUCTION:

In Italy, the cohorts of women who were offered Human papillomavirus (HPV) vaccination in 2007/08 will reach the age for cervical cancer (CC) screening from 2017. According to the National Prevention Plan 2014–18, HPV-based screening must be implemented for women ≥30 years old, following the Italian Health Technology Assessment (HTA) report recommendations (1). The simultaneous shift from cytology-based screening to HPV test-based screening gives the opportunity for unprecedented reorganisation of CC prevention.

METHODS:

The National Screening Monitoring Centre and the Italian Group for Cervical Screening, following a commitment by the Italian the Ministry of Health (MoH), identified the consensus conference as the most suitable method for addressing this topic. The objective was defining the best screening methods in girls vaccinated against HPV and the knowledge needs for defining evidence-based screening strategies. During the consensus celebration (24 November 2015) a jury made recommendations about questions and proposals formulated by a panel of experts representative of Italian scientific societies involved in CC prevention and based on systematic reviews (2).

RESULTS:

The jury considered changing the screening protocols for girls vaccinated in their 12th year as appropriate. Tailored screening protocols based on vaccination status could be replaced by “one size fits all” protocols only when a herd immunity effect has been reached. Vaccinated women should start screening at age 30, instead of 25, with the HPV test. Furthermore, there is a strong rationale for applying longer intervals for re-screening HPV negative women than the currently recommended 5 years, but research is needed to determine the optimal screening time points. For non-vaccinated women and for women vaccinated in their 15th year or later, the current protocol should be kept.

CONCLUSIONS:

As further action, in 2016 the Ministry of Health funded a Health Technology Assessment program of the new screening protocol proposed by the consensus conference and a cohort study for determining a safe interval in vaccinated women.
PP075 Has A Drug Replacement An Impact On Hospital Treatment? A Health Technology Assessment-debate
Authors: Riedel Rainer
Published: January 2018

INTRODUCTION:

Drug product changes occur in hospitals for different reasons: improved efficacy or tolerance of a drug, reduced costs, new pharmaceutical innovations or drug shortage (1). The aim of this analysis is to develop a process model for drug product changes and to determine a hospital specific threshold when product change is reasonable, provided that the efficacy and safety of the new product is economically reasonable (2).

METHODS:

The individual process steps at the Klinikum rechts der Isar in Munich (MRI) were recorded to develop a process model. The required expenditure of time for the different process modules was documented and a process cost calculation undertaken.

RESULTS:

Product changes can be divided into three groups: generic changes, identical active ingredient but different brand name, and complex drug changes with different active ingredients or changed drug formulation. The later change is associated with a higher demand for information, which is reflected in higher process costs. Relevant costs arise during the process of product purchase and on the ward. The cost per product change inclusive operating expenses at the MRI range (3) from EUR2,300 to EUR6,420 and depend on the frequency of prescription and the complexity of the product.

CONCLUSIONS:

This Health Technology Assessment (HTA) shows that main costs for a drug product change arise due to additional staff costs on the ward. Reasonable thresholds can aid in decision making when considering cost effectiveness and potential risks of the medication or patient safety.
PP076 Research On Drug Policy Change In China Since 2009 New Medical Reform
Authors: Ye Yingfeng , Ying XiaoHua
Published: January 2018

INTRODUCTION:

Drugs are a special commodity for treating diseases and protecting health. There are problems in China's drug research, production, distribution and use (1) thus the national drug policies, including government long-term frameworks and specific policies, play an important role (2). This study summarized and analyzed drug policies in China since the New Medical Reform, to determine patterns of policy change, and aiming to provide theoretical support for drug policy making for the world.

METHODS:

We downloaded all drug policies issued between April 2009 to December 2016 on State Council, National Development and Reform Commission, National Health and Family Planning Commission, China Food and Drug Administration websites. These documents were combined with academic articles to extract data, which was processed in Microsoft Excel 2013. We also use the Advocacy Coalition Framework to analyze dynamic factors for drug policy change in China.

RESULTS:

There are 113 drug policies during last 8 years on 4 websites; 76 of them are released by a single ministry. Thirteen, ten, ten, fifteen, seven, fourteen, twenty-six and eighteen policies are issued each year, respectively. Fifteen are classified in long-term frameworks, while the other ninety-eight are specific policies. And fourteen of ninety-eight policies are focusing on basic drug systems, while six are on centralized purchases, nine on public hospitals reform, seven on drug safety, sixteen on prices, fourteen on distribution, twelve on administration, five on traditional medicine, and fifteen on specific drugs.

CONCLUSIONS:

After the basic drug system was built in 2009, the government started to focus on its distribution over the next 7 years. Policies on centralized purchases are mainly issued in 2010 and 2015, and creative modes have been coming up since 2015. The Government cares not only about production safety, but also safety in sales. Prices were decided by government at first but then follow the market forces. Work focus shifted from the above contents to drug distribution, price, management and traditional medicine after 2012. The peak of policy releases occurred when the great reform took place, such as 2009 when reform began, and in 2012 the Twelfth Five-year plan began. There was a decrease in 2013 due to national leadership change (3). Overall, dynamic factors for policy change mainly are social conditions, public issues and opinions, and feedback on former policy effects.
PP090 Reducing Low-Value Practices In Catalonia: Essencial Project
Authors: Almazan Cari , Caro Johanna
Published: January 2018

INTRODUCTION:

In 2013 the Essencial Project launched in Catalonia promotes the identification of low-value practices (LVP) by healthcare professionals and elaborates recommendations to avoid them. This project aims to reduce unnecessary care of health care services which harm outweighs the benefits, resulting in physical, psychological to the patients and wasteful healthcare services. The main objectives are to describe the implementation process at the primary care level and to evaluate the impact of recommendations on general practitioners (GPs) practice.

METHODS:

The implementation process consists in:

(i) Nomination of clinical leaders to promote the project among their primary care teams (PCT) and to lead the implementation activities by identification of barriers and enablers for change in clinical practice towards avoiding LVP.

(ii) Selection of recommendations to be implemented and definition of corresponding activities to be carried out by each PCT according to the specific characteristics of their organizations.

(iii) Development of related indicators and comparison between baseline status

RESULTS:

One hundred and sixteen PCT (covering 30 percent of the Catalan population) participated in the pilot experience of implementation. Twenty-one recommendations were selected such as: bisphosphonates in post-menopausal women with low risk of fracture, PSA screening and statins for primary prevention of cardiovascular disease, among others. At 12 month follow-up, use of bisphosphonates were reduced by 21 percent (p = .0005), PSA was reduced by 14 percent (p = .0009). The use of other treatments such as antidepressants, benzodiazepines for some specific clinical conditions decreases with no statistically significant changes.

CONCLUSIONS:

This is the first experience in Catalonia and Spain of implementation of the recommendations to avoid LVP with early involvement of target professionals. Follow-up results provide information about the early impact of recommendations at primary care level. Our challenge is to implement the recommendations at hospital level.
PP115 Patient And Public Involvement In Health Technology Assessment: Update Of A Systematic Review
Authors: Tantchou Mylène , Gagnon Marie-Pierre , Poder Thomas
Published: January 2018

INTRODUCTION:

There is a general consensus on the need to involve patients and the public in Health Technology Assessment (HTA) but questions remain about the best strategies for involving them into HTA structures and activities. The aim of this study was to update a systematic review (published in 2011) on patient and public engagement in HTA.

METHODS:

We searched papers published between January 2009 (end of the initial search) and November 2016 in eight databases and HTA journals using specific search strategies. We identified other publications through citation tracking, Internet search engines, HTA agencies websites, and discussion with experts in the field. Studies in English or French were included if they met the following criteria: (i) qualitative, quantitative or mixed-methods study; (ii) describing patients or public involvement; and (iii) in the HTA field. We extracted information using a pre-established grid including: characteristics of studies, type of activities for involving patients or public, effects on decisions, and factors facilitating or limiting involvement.

RESULTS:

We identified a total of 4,762 new publications from the main search strategy. Among them, twenty-eight articles (reporting on twenty-three studies) met the inclusion criteria, whereas seventeen articles were included in the previous systematic review. Research designs are qualitative (18/23), quantitative (3/23) or mixed (2/23). Two main strategies for involving patients and public are generally described. The first is when public representatives participate directly in decision-making processes (participation) and the second is when patient or public input is sought to inform decisions (consultation or indirect participation).

CONCLUSIONS:

The number of studies on patient and public involvement in HTA has increased in recent years. Findings from this update are mainly consistent with those of the previous systematic review. However, studies are still needed to assess the effectiveness of different strategies for involving patients and the public in HTA.
PP120 Health Technology Assessment Framework To Capture The Full Value Of Value Added Medicines
Authors: Toumi Mondher , Remuzat Cecile , Plich Adam
Published: January 2018

INTRODUCTION:

Value added medicines (VAM) are medicines based on known molecules that address healthcare needs and deliver relevant improvements for patients, healthcare professionals and/or payers through drug repositioning, drug reformulation or drug combination (1-3). Recently, the European Commission, through the Safe and Timely Access to Medicines for Patients (STAMP) program, considered the issue of VAM development and regulatory process. Current Health Technology Assessment (HTA) tools may not fully capture the benefits of VAM, which could lead to obstacles for patient access to VAM in several European countries (1). The study objective was to identify how HTA frameworks should evolve to reflect VAM value.

METHODS:

HTA expert interviews were performed as a preparatory step to an advisory board meeting. The following topics were addressed: (i) Eligibility for HTA and early HTA dialogues; (ii) Attributes that should be considered in HTA; (iii) HTA methodology; and (iv) Involvement of stakeholders in HTA.

RESULTS:

VAMs bring additional benefit to patients and society. Therefore, the possibility for VAM assessment on a voluntary basis and within the appropriate assessment patterns/tools should be, in principle, included into HTA frameworks, as well as into early HTA dialogues. HTA should be patient-centric, and attributes such as patient preference, adherence, and patient reported outcomes should be considered where relevant. Unmet patient needs and disease burden should be used in a transparent and reproducible deliberative process. All these attributes should be used as explicitly and meaningfully weighted appraisal modifiers. HTA methodology should be comprehensive and should integrate societal perspectives. Patient representatives should take part in the decision-making process.

CONCLUSIONS:

Current HTA frameworks should evolve to enhance VAM value recognition and encourage industry investment in medicines with high potential value for society.
PP126 MEA In Italy: Correlation Between Time To Payment By Result And Time To Off Treatment Curve
Authors: Vittoria Gabriele , Fascì Antonio , Ferrario Matteo , Giuliani Giovanni
Published: January 2018

INTRODUCTION:

Payment by result agreements have been quite widely used in Italy to provide access for high costs oncologic drugs and minimize uncertainties of real life benefits (1). The aim of this analysis was to overview the Roche experience in terms of Payment by Result (Pbr) in oncology and investigate the relation between timing for the evaluation of treatment failures and observed Time to Off Treatment (TTOT) from Phase III clinical trials (2).

METHODS:

A retrospective analysis of the Roche payment by results schemes in place in Italy was conducted. For each drug included in the analysis it was collected: (i) the negotiated timing to assess the treatment failure for payment by result, (ii) the median time to off treatment curve observed in clinical trials for the experimental drug, (iii) the median time to off treatment observed in clinical trials for the control arm. The mean ratios between timing to assess the treatment failure for payment by result and the time to off treatment observed for the experimental drug or the median time to off treatment observed in the control arm were calculated to identify potential correlations. High level of correlation was expected if ratio was close to 1 (±.2).

RESULTS:

Roche products or different indications of the same product were identified as candidates for the analysis from 2008 to 2016. The timing for the evaluation of treatment failures for Pbr varies between 2 and 9 months, depending on the type of tumor and line of therapy. The mean Time to Payment By Result (TTPbr) / Control arm Time To Off Treatment (cTTOT) ratio was 1.16 (±.37) while the mean Time to Payment By Result (TTPbr) / Experimental arm Time To Off Treatment (eTTOT) ratio was .71 (±.13). Data analysis according to different time periods shows that the mean TTPbr/cTTOT and TTPbr/eTTOT for drugs negotiated from 2008 to 2015 were respectively 1.07 and 1.39 whereas for drugs negotiated in 2016 were respectively and .63 and 1.

CONCLUSIONS:

Good level of correlation between TTPbr and cTTOT was found. This finding is in line with the methodology used by Italian Medicines Agency so far, leveraging the cTTOT as the most appropriate proxy to assess any incremental effect of a new drug compared to the previous Standard of Care. The analysis over time of TTPbr shows that in the first years of payment by result negotiation TTPbr is more correlated to the cTTOT whereas in the last years is moving closer to the experimental one.
PP128 Regional Guidance On Spinal Cord Stimulation For Chronic Pain
Authors: Cavazzana Anna , Redomi Anna , Poerio Elena , Bassotto Francesca , Mottola Rita , Andretta Margherita , Scroccaro Giovanna
Published: January 2018

INTRODUCTION:

Chronic Pain (CP) is the uncontrolled pain that affects patients for a long time. CP can be caused by many conditions, sometimes still poorly understood, and its levels can vary from moderate to intense. The management of resistant CP requires a stepwise approach and spinal cord stimulation (SCS) could be considered an extreme strategy. With the aim of ensuring the economic sustainability, the Veneto Region usually establishes rigorous access criteria to high-cost medical devices through its Regional Technical Committee on Medical Devices (CTRDM) and a Health Technology Assessment (HTA) procedure.

METHODS:

The Regional Health Technology Assessment Unit (CRUF) conducted through Pubmed a literature review of randomized controlled trials, systematic reviews, meta-analysis on SCS published from March 2006 to February 2016. International and national clinical guidelines were included in the analysis as well. The regional multidisciplinary Working Group on CP, which involved local clinicians, pharmacists, clinical engineer and health economist, discussed the collected evidence by consensus. Final recommendations on the appropriate use were submitted to the CTRDM for final approval.

RESULTS:

The regional guidance describes the type of pain that can be treated with spinal neurostimulators and the criteria which determine the success of the test procedure. A comparative analysis of spinal neurostimulators available on the market and related patients eligibility criteria have been also included. Moreover, the guidelines stated a list of compulsory requirements in order to become a regional center authorized in performing spinal neurostimulation procedure. Finally, the document describes some indicators for appropriateness monitoring. The CTRDM approved the final version in October 2016.

CONCLUSIONS:

The regional guidance on SCS aims at ensuring the appropriate use of neurostimulators in patients affected by resistant CP. The strict monitoring of agreed indicators is essential for appropriateness and consequently the sustainability of medical devices expenditure throughout the Regional Health Service.
PP138 Italian Medicines Agency Registries Distribution By Managed Entry Agreements And By Anatomical Therapeutic Area
Authors: Vittoria Gabriele , Fascì Antonio , Ferrario Matteo , Giuliani Giovanni
Published: January 2018

INTRODUCTION:

In a budget constrained environment characterized by an increasing number of high-cost medicines, manufacturers need to demonstrate that their drugs can provide value-for-money. In this complex environment Managed Entry Agreements (MEAs) have been developed with the aim of sharing the risk between the National Health Service (NHS) and manufacturers (1). The objective of this analysis was to identify a correlation between Anatomical Therapeutic Chemical Classification (ATC) and different type of agreements assigned taking into consideration the distribution of Italian Medicines Agency registries by ATC and by kind of agreement negotiated (financial or performance based) (2).

METHODS:

This analysis takes into account all drugs under monitoring AIFA registries in place in Italy from 2006. For each registry included in the analysis it was collected the status of the registry (active, closed or incoming), the disease area that the registry covers and the monitored drugs with or without an associated Managed Entry Agreements. Considering the high weight of oncology drugs, a sub-analysis was done to investigate registries distribution for each specific form of cancer.

RESULTS:

The majority of drugs monitored are under a registry with no associated risk sharing agreement according to AIFA (60 percent). For what concerned monitored drugs with an associated agreement, performance-based agreement is the most diffused type of MEA. In terms of therapeutic area involved in the monitoring registries activity, oncology was the most common area. Financial based agreements characterize principally medicines used for Leukemia and Hepatitis C, whereas drugs administrated for Melanoma, Breast and Ovarian Cancer and Ophthalmology diseases follow performance based agreements.

CONCLUSIONS:

MEAs represent a way to guarantee a sustainable access for innovative medicines. It is proven that oncology products are most likely to have a MEA since they represent some of the most expensive drugs launched in recent years. From this study appear a correlation between the therapeutic disease area of the monitored drugs and MEA assigned by AIFA which is influenced also by other factors like budget impact, risk-benefit ratio and the presence of appropriate endpoints to evaluate the treatment response.
PP155 The Impact Of Lawsuits In The Brazilian Public Health System
Authors: Biella Carla , Pereira Viviane , Raynal Fabiana , Barreto Jorge , Canuto Vania , Petramale Clarice
Published: January 2018

INTRODUCTION:

The increase of litigation in Brazil on the right to health, and the Brazilian Public Health System (SUS) targets of litigation, are phenomena that generate discussions both in the judiciary, and among researchers and managers of health. The lawsuits are based on the integrality that includes the right to any health technology. Our aim was to gather information on the use of scientific evidence by judges and other law professionals to support their decisions in lawsuits involving health care in Brazil.

METHODS:

A narrative review by literature search using key terms of legalization in specific databases was conducted.

RESULTS:

Twenty-five studies showed litigation matters relating to health care which were focused on legal claims about drugs. In general, law operators used the scientific evidences in a limited way when making decisions, by considering the medical report and medication label indications and disregarding therapeutic alternatives contemplated in the SUS list. The access to health technologies, by litigation, reveals that the gap between scientific knowledge and legal practice are similar to those found between science and decision-making in the formulation and implementation of health policies. The Health Technology Assessment studies have high potential for use by the judiciary as a reference source to support technical and scientific decisions in lawsuits on health care.

CONCLUSIONS:

For the judiciary to ensure not only access to health technologies, but also the efficacy and safety of technologies to system users, their decisions must be substantiated by scientific evidence. The National Committee for Health Technology Incorporation (CONITEC) in SUS has established actions in conjunction with law operators and society, such as a communication using e-mail, aiding the decision for the injunction and elaboration of technical reports and a policy brief, with the intention that the decisions are taken with the greatest possible knowledge about technologies provided by SUS, and based on scientific evidence.
VP01 Effect Of Early Life Socioeconomic Status On Trajectories Of Chinese Elders Health
Authors: Hu Xiaoqian , Zhen Xuemei , Dong Hengjin
Published: January 2018

INTRODUCTION:

China, with the largest aging population which is fast increasing, faces great challenges. Increasingly, researchers are looking at the relationship between whole life conditions from birth to death and health status in old age using a life-course approach. Few researchers have paid attention to developing countries like China where early life conditions were worse than those in western countries in the early twentieth century. China has had a complex social and political history in the twentieth century. This study investigates trajectories of aging and the effects of childhood and adulthood Socioeconomic Status (SES) encompassing education, job and family condition, on oldest-elders physical health in China.

METHODS:

The data used in this study was from all seven waves (1998-2014) of the Chinese Longitudinal Healthy Longevity Survey and covered 6,483 respondents aged 80 to105 years in baseline. Measuring the limitation in activities of daily living represents physical health. Group-based trajectory modeling is used to identify groups of individuals with statistically similar developmental characteristics or trajectories. Multinomial logistic regression is used to compare the differences among trajectory groups.

RESULTS:

Three-group models best fit the data for males and females. Along with increasing age, there was an increase in the limitation in activities of daily living. Some groups changed gradually, while others rose rapidly. Some childhood and adulthood socioeconomic status characteristics influenced trajectory-group membership. For both genders, group one and two had similar childhood socioeconomic status, while higher adulthood socioeconomic status like jobs were associated with less favorable health status. For group three of males suffering the hardest childhood in regard to education, had stable health status instead.

CONCLUSIONS:

Diversity exists among aging procedure. Childhood and adulthood socioeconomic status influence health conditions of the oldest-elders in complex ways. Education is a remarkably positive factor significantly contributing to better health status.
VP13 Relation Between Magnetic Resonance Imaging Use And Hip Or Knee Replacements In The Organisation For Economic Co-operation And Development
Authors: Emprechtinger Robert
Published: January 2018

INTRODUCTION:

A high degree of geographic variation in the use of medical interventions is usually considered as a sign for inappropriate use. However, the plain geographic variation has the disadvantage that the variation might also be appropriate due to differences in the regions. Hence, we conducted a more comprehensive analysis on Magnetic Resonance Imaging (MRI) use and the relationship to hip or knee replacements. We evaluated whether there is evidence that guideline recommendations regarding hip replacements and total knee replacements are being followed. Additionally, we tried to assess whether the use of MRI is related to subsequent interventions.

METHODS:

We extracted recommendations of the American College of Radiology (ACR) on the use of MRI relevant to hip replacements and total knee replacements. Subsequently, we created three hypotheses on MRI for hip or total knee replacements on what to expect from the data when these recommendations are being followed.

For each hypothesis we calculated a multiple linear regression to analyze Organisation for Economic Co-operation and Development (OECD) data. This was necessary to control for other important variables that might have had an influence on the number of interventions despite the MRI use (for example, healthcare spending, or Computed Tomography (CT) use).

RESULTS:

The initial results on (primary) hip replacement and secondary hip replacement were heavily influenced by outliers. After the exclusion of the outliers (Turkey and Belgium), (primary) hip replacements were related to MRI use but not secondary hip replacements. The results on MRI and (primary) hip replacement suggest that the relationship between MRI and hip replacement in Turkey is lower than in the other OECD nations.

Regarding knee replacements, we detected a relationship between the MRI use and total knee replacement. An increase of 10 MRI examinations per 1,000 population would, according to our model, result in 9.8 additional total knee replacements per 100,000 population.

CONCLUSIONS:

The relationship of MRI and (primary) hip replacement hints to inappropriate use of MRI in Turkey since the data shows a substantial deviation in the relationship compared to the other OECD nations. Apart from this, we found no evidence for inappropriate use of MRI in connection with hip replacements.

However, our results suggest that MRI is inappropriately used in relation to total knee replacements. This might contribute to potentially unnecessary total knee replacements.
VP14 Screening Recommendations For Socioeconomic Disadvantages In Pregnancy
Authors: Rosian Katharina
Published: January 2018

INTRODUCTION:

In 2015, 18.3 percent of the Austrian population were at risk of poverty and social exclusion - about 211,000 (20 percent) women aged 20–39 years were affected. International studies report that poverty may lead to an increased risk of complications and pathologies during pregnancy. Further, children who grow up in poverty often have poorer long-term health outcomes.

METHODS:

In order to identify recent guidelines (2011-2016) a comprehensive handsearch was conducted in the guideline databases National Guideline Clearinghouse (NGC) and Guidelines International Network (GIN). Moreover, a handsearch for systematic reviews and primary studies was conducted in PubMed.

RESULTS:

Two guidelines, the British National Institute for Health and Clinical Excellence (NICE) Guideline “Pregnancy and Complex Social Factors”, as well as the Australian Health Ministers' Advisory Council (AHMAC) Guideline “Antenatal Care”, address socioeconomic disadvantages of women during antenatal care. The recommendation of the AHMAC is that pregnancy care should be offered to all pregnant women. In addition, an individual approach will help to pay particular attention to socioeconomic factors and to incorporate them in routine examinations. NICE recommends in its guideline, affected women should be supported in order to ensure adequate prenatal care. NICE also defines criteria which are used to identify pregnant women who are in greater need of support. The only identified study developed and tested a tool for the identification of patients affected by poverty. The authors of this Canadian pilot study concluded that the defined questions helped to identify socioeconomically disadvantaged persons during anamnesis without stigmatizing.

CONCLUSIONS:

Due to the proven link between poverty and health risks, special attention must be paid to socioeconomically disadvantaged pregnant women. Research on non-stigmatizing instruments, which can identify vulnerable women, is of great importance. In addition to social policy measures, it is necessary to ensure that low-threshold services are available for socioeconomic disadvantaged women and their children.
VP16 Interventional Management Of Hyperhidrosis: A Systematic Review
Authors: Wade Ros , Llewellyn Alexis , Jones-Diette Julie , Wright Kath , Rice Stephen , Moloney Eoin , Stoniute Julija , Layton Alison , Levell Nick , Stansby Gerard , Craig Dawn , Woolacott Nerys
Published: January 2018

INTRODUCTION:

Hyperhidrosis is characterized by uncontrollable excessive sweating, which occurs at rest, regardless of temperature, and can significantly affect quality of life. There is substantial variation in the availability of treatments in secondary care and uncertainty regarding optimal patient management. A systematic review was undertaken to assess the clinical effectiveness of treatments prescribed by dermatologists (iontophoresis, anticholinergic medications, botulinum toxin injections) and minor surgical treatments (curettage and newer energy based technologies) for primary hyperhidrosis and identify areas for further research.

METHODS:

Fifteen databases and trial registers were searched to July 2016. Pairwise meta-analyses were conducted for comparisons between botulinum toxin injections and placebo for axillary hyperhidrosis. For other treatments data were synthesised narratively due to limited and heterogeneous data.

RESULTS:

Fifty studies were included in the review; thirty-two randomized controlled trials (RCTs), seventeen non-RCTs and one case series. There was substantial variation between the studies in terms of country of origin (indicating climate and population differences), interventions and methods of outcome assessment. Most studies were small, at high risk of bias and poorly reported. There was moderate quality evidence of a large statistically significant effect of botulinum toxin injections on axillary hyperhidrosis symptoms in the short to medium term (up to 16 weeks), compared with placebo. There was weak but consistent evidence for iontophoresis for palmar hyperhidrosis. Evidence for other interventions was low or very low quality. Combining the evidence and patient advisor input, we established that further research on the clinical and cost-effectiveness of botulinum toxin injections (with anesthesia) versus iontophoresis for palmar hyperhidrosis would be useful.

CONCLUSIONS:

The evidence for the effectiveness and safety of treatments for primary hyperhidrosis is limited overall and few firm conclusions can be drawn. However, there is moderate quality evidence to support the use of botulinum toxin injections for axillary hyperhidrosis. A trial comparing botulinum toxin injections with iontophoresis for palmar hyperhidrosis is warranted.
VP18 Early Awareness And Alert System In Sweden: History And Current Status
Authors: Eriksson Irene , Wettermark Björn , Persson Marie , Edström Morgan , Godman Brian , Lindhé Anna , Malmström Rickard , Ramström Helena , von Euler Mia , Bergkvist-Christensen Anna
Published: January 2018

INTRODUCTION:

Over the past decades, early awareness and alert (EAA) activities and systems have gained importance and become a key early Health Technology Assessment (HTA) tool. While a pioneer in HTA, Sweden had no national level EAA activities until recently. We describe the evolution and current status of the Swedish EAA System.

METHODS:

This was a historical analysis based on the knowledge and experience of the authors supplemented by a targeted review of published and grey literature, as well as documents produced by or relating to the Swedish EAA System. Key milestones and a description of the current state of the Swedish EAA System are presented.

RESULTS:

Initiatives to establish a system for the identification and assessment of emerging health technologies in Sweden date back to the 1980s. Since the 1990s, the Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU) supported the development of EuroScan and was one of its founding members. In the mid-2000s, an independent regional initiative, driven by the Stockholm Drug and Therapeutics Committee, resulted in the establishment of a regional horizon scanning unit. By 2009, this work had expanded to a collaboration between the four biggest regions in Sweden. The following year it was further expanded to the national level. Today, the Swedish EAA System carries out identification, filtration and prioritization of new drugs, early assessment of the prioritized drugs, and dissemination of the information. Its outputs are used to select new drugs for inclusion in the Swedish national process for managed introduction and follow-up.

CONCLUSIONS:

The Swedish EAA System started as a regional initiative and rapidly grew to become a national level activity. An important feature of the system today is its complete integration into the national process for managed introduction and follow-up of new drugs. The system will continue to evolve as a response both to the changing landscape of health innovations and to new policy initiatives at the regional, national and international levels.
VP30 Research And Analysis Of European Health Technology Assessment Processes
Authors: Sus Julia , Garrett Zoe
Published: January 2018

INTRODUCTION:

As part of the European Network for Health Technology Assessment (EUnetHTA) Joint Action 3, the National Institute for Health and Care Excellence (NICE) in collaboration with forty-nine Health Technology Assessment (HTA) agencies and payer organizations, is leading on research to gain a high level understanding of HTA processes across Europe. This will help to facilitate improved collaboration and use of EUnetHTA HTA reports and tools across member states and decrease the duplication of work.

To analyze the similarities and differences in HTA processes and decision making on the reimbursement of pharmaceuticals and medical devices across Europe.

METHODS:

National agencies involved in the HTA and reimbursement processes shared data on HTA and decision-making processes. Data provided was extracted into an excel workbook including information relating to pharmaceuticals, medical devices, inpatient and outpatient care and assessments that inform reimbursement, pricing and other processes.

RESULTS:

Thirty-one countries provided fifty-eight sets of HTA process and procedural documents for both medical devices and pharmaceuticals. This information was translated into the workbook which consisted of eleven sections (general information, capacity, overview of the process, topic selection, assessment process, advice and decision making, legal and procedural issues, reassessment, stakeholders engagement, HTA information used and HTA information held).

The first stage of data analysis is a descriptive write up of existing processes from horizon scanning and topic selection up to decision making. The second stage is an analysis showing how collaboration and use of EUnetHTA outputs can be implemented into existing processes. An additional questionnaire will be developed to gain further understanding of EUnetHTA partners views on national engagement in the EUnetHTA procedures, implications of joint production, what EUnetHTA products are most valued and what mechanism might support better information sharing and more efficient use of HTA reports between jurisdictions.

CONCLUSIONS:

The analysis of the above data will provide detailed information on how EUnetHTA products or HTA products from other jurisdictions could be introduced into HTA and reimbursement processes across member states and at what point could EUnetHTA partners best engage in joint and cooperative work.
VP31 Health Technology Assessment Evidence On E-Health/M-Health Technologies: Fields For Improvement
Authors: Vukovic Vladimir , Favaretti Carlo , de Waure Chiara
Published: January 2018

INTRODUCTION:

Evaluation is crucial for integration of e-Health/m-Health applications into healthcare systems and their further sustainability. However, evaluation of these technologies is often challenged by poor quality of research design, lack of common outcome indicators and no consensus on appropriate methodology. Health Technology Assessment (HTA) could offer a sound methodological basis for these evaluations (1). The aim of this study was to look for HTA reports on e-Health/m-Health technologies and to describe their characteristics and analyze transparency, consistency and thoroughness, with the goal to detect fields for improvements.

METHODS:

A literature search was performed on PubMed, ISI WOS and University of York – Centre for Reviews and Dissemination (CRD) electronic databases, in order to identify reports that had evaluated e-Health/m-Health technologies, published until 1 April 2016. We used the International Network of Agencies for Health Technology Assessment (INAHTA) checklist (2) to evaluate transparency and consistency of included reports. We also assessed thoroughness of reports by checking the presence of the domains suggested by European Network for HTA (EUnetHTA) HTA Core Model (3).

RESULTS:

Twenty-eight reports published between 1999 and 2015 were included. Most of reports (71.4 percent) were delivered by non-European countries and only 35.7 percent were classified as full reports. E-Health/m-Health technologies from several fields of medicine, mostly cardiology (21.4 percent) and psychiatry (17.9 percent) were evaluated. Policy question was clearly defined in 32.1 percent of reports, whereas ethical (21.4 percent) and legal implications (3.6 percent) were domains with the least presence. With respect to the EUnetHTA Core Model, around 70 percent of reports dealt with effectiveness and economic evaluation, more than 50 percent described health problem and around 40 percent organizational and social aspects. Remaining domains were evaluated in very few reports.

CONCLUSIONS:

E-Health/m-Health technologies are increasingly present in the field of HTA. Our work identified a number of elements not being included in the available reports. Several reports missed to respond to relevant assessment elements especially ethical, social and organizational implications. There is a need for strengthening and standardizing methods used for the evaluation of these technologies.
VP40 Comprehensive Evaluation Of Islet Transplantation For Type I Diabetes
Authors: Chen Danni , Xiong Kun , Xue Di
Published: January 2018

INTRODUCTION:

Despite several therapeutic options existing for the patients with type I diabetes, the patients are still at high risk for severe acute and chronic complications (1). Pancreatic islet transplantation is a promising therapy to achieve good glycemic control with no or little additional insulin (2). This study was to evaluate the effectiveness, safety, economics and social ethics of islet transplantation (IT) for the patients with type I diabetes.

METHODS:

We searched PubMed, Cochrane Library, CNKI and CBM to retrieve eligible literatures. The values of H1bAc before and after transplantation, the rates of insulin independence and functional islet graft at the last follow-up, and the insulin dose per patient-day were analyzed. Descriptive statistics, t tests and random effects meta-analyses were used in the study.

RESULTS:

Totally 21 original papers with 488 cases from 9 different countries were reviewed and analyzed. The studies showed that the H1bAc was decreased from 7.7 percent (95 percent Confidence Interval, CI: 7.4, 8.1) before IT to 6.2 percent (95 percent CI: 5.9, 6.4) after IT. At the last follow-up, the rate of insulin independence was 48.96 percent (95 percent CI: 31.32, 66.73) and the rate of functional islet graft was 65.79 percent (95 percent CI: 47.06, 82.21). The daily insulin requirement dropped from 0.52U/kg/d to 0.21 U/kg/d. The main adverse events of islet transplantation were bleeding (7.01 percent) and the complications related to immunosuppression therapy (6.37 percent), but they were less than those of whole pancreas transplantation.

Another study with a 20-year follow-up also showed that the cost-effectiveness of islet transplantation (USD47,800 per QALY) was better than that of insulin therapy (USD71,000 per QALY). In spite of the better evidences of islet transplantation, the insufficient organ donation and issues of cell purification and immunological rejection limited islet transplantation's widespread utilization (1).

CONCLUSIONS:

The islet transplantation therapy for the patients with type I diabetes has a potential to achieve insulin independence and better cost-effectiveness, and is relatively safe. But there are some obstacles for its wide utilization.