bluuebunny/crossref_metadata_2025 huggingface dataset:
OP97 Digital Home Services: Overcoming Critical Barriers In Early Decision Making
Authors: Stome Linn Nathalie , Norrud Arne , Fjordholm Martin , Kvaerner Kari
Published: January 2019

Introduction:

There is a lack of adoption and diffusion of health innovations needed to drive the implementation of important breakthroughs in value-based health care. To stimulate organizational changes, decision-makers need to see potential benefit at an early stage. The aim of the present study was to assess the potential effects of a conceptualized intention to provide digital home-based care and compare it to the current provision of such care. The new intervention aims to strengthen the municipality's care services by offering a digital communication platform to recipients of home-based health services and their dependents. The platform is designed to be implemented nationally and is in line with home service needs identified in several white papers.

Methods:

An interdisciplinary team united to determine and quantify potential effects of the project. Effects of the digitalized service were distinguished in priced quantitative, unpriced quantitative and qualitative effects. A ten-year present value calculation with a calculation rate of four percent was used for the estimates. A risk analysis was also carried out.

Results:

The present value calculation resulted in estimated savings equal to EUR 25.8 million , with present value investments costs of EUR 5.5 million over ten years. This resulted in net present value per invested euro in the public sector equal to EUR 3.2. Overall assessment of uncertainty related to the intervention's socio-economic profitability was deemed average. Based on data quantified estimates from the conceptual phase, the project succeeded in the decision-making and funding needed to proceed into the next developmental phase of the project.

Conclusions:

The present approach to early assessment may provide much desired decision support in an early innovation phase when data are still missing. Our experience is that early stakeholder involvement and the early assessment and quantification of value gains are of utmost importance to overcome the critical barriers to organization health innovations.
OP99 Sustaining Mobile Health Interventions In Vietnam: The Challenges
Authors: Lam Jeffrey , Dang Linh , Phan Ngoc , Trinh Hue , Vu Nguyen , Nguyen Cuong
Published: January 2019

Introduction:

Mobile health (mHealth) is increasingly being seen as a promising solution to the multiple health system challenges that Vietnam faces, including inadequate health service provision. Nevertheless, there is limited published information describing the sustainability of such mHealth solutions in the Vietnamese context. This study reviewed the available projects and interventions to evaluate factors challenging sustainability of mHealth initiatives in Vietnam.

Methods:

A multimodal scoping study was designed to collect data from various sources: published literature, government reports, unpublished literature, conference presentations, online documents, and key informant interviews. Relevant mHealth initiatives were identified and selected through electronic searches and informal discussions with key stakeholders. Collected data was charted and classified by thematic analysis. Challenges to the sustainability of mHealth initiatives were discussed in the context of the strengths, weaknesses, opportunities, and threats (SWOT).

Results:

Twenty mHealth initiatives with relevant information and available data were collected, covering the period from 2010 to 2017. Fifteen (75 percent) were primarily funded by external donors, one (5 percent) was government supported, and four (20 percent) were self-funded projects. Five (25 percent) were on-going, and fifteen (75 percent) were completed at the time of data collection. Four (20 percent) out of the completed initiatives were continuing to use materials, infrastructure, and technology to engage end-users.

Conclusions:

The high percentage of external funding, complicated governmental bureaucracy and lack of government commitment, electronic medical record standardization, and legislation relating to mHealth are amongst the largest challenges to mHealth sustainability in Vietnam. In addition, findings demonstrate it is crucial for project managers of mHealth initiatives to build strong relationships with the Vietnam government and advocate for their mHealth initiatives in order to promote sustainability.
OP104 Moving Forward Hospital-Based Health Technology Assessment: Public Procurement Of Innovation
Authors: Restovic Gabriela , Sagarra Joan , Sampietro-Colom Laura , Sitges Marta
Published: January 2019

Introduction:

Innovation procurement is a key enabler to improve the quality and efficiency of public healthcare services by driving innovation from demand side to meet concrete public healthcare provider needs. Catalan Health Services (CatSalut) aims to optimize healthcare services through innovative solutions that encompass both innovative technologies and new processes of care. Answering this aim, the Hospital Clinic of Barcelona (HCB) is participating in an Innovative Pilot Program to optimize the efficiency in the management of Aortic Valve Stenosis (AVS) using an adaptation of the methods and knowledge from hospital-based health technology assessment (HB-HTA).

Methods:

The first step was to identify unmet needs, main bottlenecks and problems in the comprehensive management of aortic valve stenosis (AVS) (from primary care to hospital discharge). Innovative technologies, solutions and health care organizations were proactively scanned through literature review and professional expertise. Lists of solutions were proposed through an inclusive stakeholder participation process.

Results:

A new healthcare model was proposed to be evaluated in the next three years based on an integral, transversal and multidisciplinary management of AVS (named MITMEVA). For each new proposed solution, the management, work streams, expected impact and key performance indicators (based on stakeholder information demands) were defined. To test the potential of the proposal, a theoretical modeling of the economic, clinical and process impacts of implementation was performed based on available scientific evidence, local professional and economic data. This analysis shows more quality-adjusted life years, fewer adverse effects and lower cost with the new proposed model.

Conclusions:

HB-HTA usually recommends for/against investments. In the era of value based procurement, HB-HTA can also help in developing a Public Procurement of innovative solutions (PPI) project and in testing proactively its potential impact in healthcare, which will be later tested in real life. Therefore, adapting HB-HTA to hospital innovative procurement is another way for health technology assessment to push for the implementation and testing of high value innovative technologies.
OP118 Women's Preferences And Perspectives On Cervical Cancer Screening
Authors: Majid Umair , Kandasamy Sujane , Arora Neha , Vanstone Meredith
Published: January 2019

Introduction:

Cervical cancer screening (CCS) is conducted through multiple testing modalities including Papanicolaou smears and more recently, HPV Testing. Participation in CCS is influenced by a multitude of barriers and facilitators governed by the preferences, values, and beliefs of women. This presentation will discuss the findings from a Patient Perspectives and Experiences review for a CADTH Health Technology Assessment on HPV Testing for Primary Cervical Cancer Screening.

Methods:

A systematic literature search yielded 4864 citations published from 1 January 2002 to 1 November 2017. One hundred and six eligible studies were analyzed using the qualitative meta-synthesis methodology.

Results:

The social location, circumstances and resources available to women significantly influence how they negotiate the factors that influence their CCS participation. Some of the factors we identified are Emotions, Understanding Personal Risk, Logistics, and Multiple Roles of Women. In this presentation, we will discuss how these factors interact with a woman's social location to influence women's choices and preferences about engaging in cervical cancer screening. Specifically, we describe an analysis that conceptualizes social location as a balancing fulcrum, which changes the force exerted by factors acting as incentives and disincentives. Women who experience social and material deprivation may find that disincentives are harder to overcome than women who have access to ample social and material resources. More incentives in quantity and strength would tip the balance in favor of incentives and increase CCS participation. This presentation will also describe how incentives and disincentives were operationalized in the context of a patient perspectives and experiences review for a health technology assessment.

Conclusions:

Women's decisions to participate in CCS are influenced by many factors. The way women negotiate these factors is closely related to their personal circumstances and the availability of social, material, and financial resources.
OP125 Increasing Capacity For Utilization Of Health Technology Assessment
Authors: Amanya John Vianney , Wamboga Joshua
Published: January 2019

Introduction:

Increased capacity for utilization of Health Technology Assessment (HTA) is key to ensuring high-impact; affordable health technologies reach the people who need them most. It also enables an environment for research in access to lifesaving technologies and innovations. The number of people suffering from one or more chronic diseases is rapidly increasing and the existing systems of care are not adequately addressing this increase. Increased HTA visibility provides an opportunity for a formal connection of Health Technologies (HTs), building a new working relationship among patients and healthcare professionals, health system strengthening, engagement of patients /consumers and health care professionals for follow up on existing HTs, and assessing new Health Technology innovations.

Methods:

We reviewed existing HTA literature, and hosted a meeting of fifty participants at the first HTA meeting representing different health stakeholders including patients. The meeting explored innovative synergies that addressed best practices in health policy and technological decision making, and opportunities for integrating HTA in Uganda's Health system.

Results:

Induced practical skills in coordinating a number of uncoordinated health technologies to over forty participants, an HTA strategy developed to complement national HTA initiatives and to generate information and tools to facilitate the start of hospital-based HTA initiatives in hospitals countrywide and regionally, to improve quality and efficiency of current initiatives. An HTA association, “Uganda Association of Health Technology Assessment - UAHTA” was formed, and a work plan for piloting hospital based HTA was developed.

Conclusions:

A Health Technology Assessment (HTA) system will enable comprehensive patient-centered, integrated (as opposed to simultaneous but independent) assessment of complex health technologies. There is a need for increased capacity and partnerships towards evidence generation, and accountability measures.
OP128 Evaluating The NPS MedicineWise Medicines Information Phone Service
Authors: Humphreys Lauren , Packham Nerida , Blogg Suzanne , Gonzaga Nicole , Dickinson Scott , Granger Renee
Published: January 2019

Introduction:

The NPS MedicineWise pharmacist-delivered phone service, Medicines Line, aims to provide evidence-based medicines information to consumers. We evaluated outcomes of the Medicines Line, including common consumer inquiries and resultant decision-making, and explored consumer motivations for seeking medicines information.

Methods:

The evaluation involved conducting paper-based and telephone surveys of a sample of 200 Medicines Line callers, and semi-structured telephone interviews of a subset of twenty callers. Quantitative data were analyzed using SPSS software. Qualitative data were analyzed using content analysis.

Results:

Preliminary analysis found that the majority of callers thought the Medicines Line had improved their knowledge (ninety-six percent), confidence (eighty-two percent) and decision-making (eighty-nine percent). The most common reasons for calling the Medicines Line were inquiries about side effects or medicine compatibility. The medicines most commonly asked about were antidepressants (twenty percent), analgesics (thirteen percent) and antibiotics (nine percent). Questions about sertraline accounted for thirty-six percent of antidepressant inquiries. Interview themes regarding motivations for using the service included: trust; efficiency and convenience; specialized drug knowledge; and reporting adverse drug reactions to protect others from medicine-related harm. Medicines Line was perceived to be especially useful as an alternative to family physician or specialist consultations when consumers had a non-urgent inquiry about a medicine, and as a service to provide medicines information in remote communities.

Conclusions:

These results indicate that pharmacist-delivered medicines information telephone services are an effective and efficient way of handling medicines inquiries. Medicines information telephone services are effective in improving health literacy, by increasing callers’ knowledge and confidence to source evidence-based medicines information and improving their ability to make informed decisions about medicine use. This evaluation identified knowledge gaps in medicine side effects and antidepressant use. Identifying such knowledge gaps may be useful in informing future health professional education programs, community campaigns, and shared decision-making resources.
OP143 Conceptualizing Patients’ Experience With Atrial Fibrillation
Authors: Oehrlein Elisabeth , Perfetto Eleanor , McCall Debbe , Albrecht Jennifer , Slejko Julia , Cooke Catherine , dosReis Susan
Published: January 2019

Introduction:

Conceptual models (CMs) are useful tools for researchers and health technology assessment bodies to understand the interplay among environmental characteristics (e.g., health care system), patient characteristics, health behaviors, and patient outcomes. The objective of this pilot study was to elicit perspectives of patients with atrial fibrillation (AF) and health care providers (HCPs) to develop a patient-centered CM of the AF patient experience in a US-based sample.

Methods:

We developed two preliminary versions of the Andersen model of healthcare utilization (standard and patient-friendly versions) based on the published literature and the help of a patient advisor. For example, instead of describing “predisposing characteristics,” the patient-friendly CM describes, “what is it about me, or other afib patients that could impact disease or outcomes;” “enabling resources” is swapped for “helpful resources,” and “perceived need” is changed to “what impacts whether I believe I need to be treated”. Five patients from an online patient community and 10 HCPs from the University of Maryland Medical System provided feedback on the preliminary models. Audio recordings of interviews were transcribed verbatim, analyzed, and findings incorporated into a revised CM.

Results:

Interviewee additions under “what impacts whether I believe I need to be treated” included: absence of symptoms and fear of experiencing an AF episode; under “helpful resources” suggested additions include resources for navigating insurer formulary/benefits. Suggested additional outcomes of interest include anxiety, bruising, and shortness-of-breath. While patients found the patient-friendly version easy to understand, HCPs required explanation of standard-version headers, for example ‘predisposing characteristics’ and ‘enabling resources’, which had been adapted in the patient-friendly version.

Conclusions:

Soliciting input from stakeholders ensures CMs are pragmatic, reflect the real-world experiences of patients and HCPs, and incorporate variables or other considerations not currently described in published literature. Researchers can utilize CMs to aid in selection of variables for observational studies.
OP160 Enhancing Innovation Through HTA: Experience From South Australia
Authors: Burgess Naomi , Chen Deborah
Published: January 2019

Introduction:

A statewide health technology assessment (HTA) program was implemented to increase equity of access and support robust assessment of technologies, with a focus on those that are high-cost, high-risk, or have state-wide impact.

Methods:

Local hospital networks and clinicians refer technologies to the South Australia Policy Advisory Committee on Technology (SAPACT) for assessment. Independently produced, comprehensive HTA reports are developed using internationally recognized evidence and critical appraisal methodologies. Clinical and economic systematic analyses are utilized, with extensive clinical consultation, to develop recommendations for new technologies and their role in models of care. Feasibility of adoption and local implementation are considered, including existing service delivery and appropriate training and credentialing. For approved technologies, SAPACT may also develop audit criteria and seek implementation reports on clinical outcomes.

Results:

The HTA framework has been successfully adopted across South Australia Health, increasing the incorporation of evidence-based decision making in the use of high-cost and high-risk health technologies. Over 35 evidence evaluations for high-risk and high-cost health technologies have been conducted for a broad range of treatment interventions. SAPACT develops and utilizes HTA decision-making criteria for transparency of Committee considerations. The program recommends adoption or rejection of technologies, or it may request a re-submission due to safety concerns or a lack of proven effectiveness. SAPACT has also granted temporary approval through adoption under clinical evaluation to inform investment decisions. A key component is working with clinicians to define specific treatment criteria and patient selection. SAPACT continues to strengthen relationships with all stakeholders, increase patient input through the development of public summary documents for technologies, and improve monitoring and reporting of clinical outcomes.

Conclusions:

The HTA program has been very productive and positively received. The success of the program is underpinned by its engagement with clinicians, hospital networks, and consumers. The completion of SAPACT HTA reviews and the publication of the SAPACT decision-making criteria have increased the credibility of decisions, supporting enhancements in patient care and cost efficiency for the state government.
OP170 Regulatory And Health Technology Assessment Considerations In Alzheimer's Disease
Authors: Bouvy Jacoline , Jonsson Pall
Published: January 2019

Introduction:

There has been a move towards the development of disease-modifying agents in Alzheimer's disease (AD) and it is likely that early disease-modifying treatments will initially be offered to people who have positive AD markers and mild cognitive impairment (MCI). Consequently, disease-modifying drugs will have distinctive features as compared to currently licensed symptomatic treatments, which makes the implications of these new agents for regulatory and health technology assessment (HTA) processes unclear.

Methods:

The ROADMAP (Real-world Outcomes across the AD spectrum for better care: Multi-modal data Access Platform) project provides the foundation for a European data platform for real-world evidence in AD, and established an expert advisory group (EXAG) consisting of regulatory and HTA experts. This presentation will summarize the key lessons from the first year of ROADMAP's EXAG and identifies the next steps that are required to prepare Europe's healthcare systems for a disease-modifying drug.

Results:

The EXAG identified a need for: (i) establishing the rationale for the selection of priority outcomes in pre-clinical AD and MCI; (ii) establishing accepted outcomes for defining prevention of AD or delayed AD onset; (iii) exploring modern technology that could assist in testing cognition that could easily be used in clinical practice; and (iv) establishing caregiver-relevant outcomes (e.g. quality of life, loss of income, carer time) that are important to capture; and found that not all evidence to support modelling assumptions can be generated through RCTs, making the case for using real-world evidence.

Conclusions:

Many of the challenges that the EXAG identified can be solved by generating better real-world data in AD. There is a clear need to agree on the outcomes that will facilitate and inform regulatory and HTA decision-making. Once the gaps in the availability of outcomes in AD will be closed, we will be one step closer towards being ready for a disease-modifying drug.
OP171 Does Parallel Regulatory-Health Technology Assessment Reviews Affect Time To Health Technology Assessment Decisions?
Authors: Cai Jesmine , Wang Tina , McAuslane Neil , Liberti Lawrence
Published: January 2019

Introduction:

Timely recommendation by Health Technology Assessment (HTA) agencies for drug reimbursement is critical to ensure patient access to medicines of therapeutic value. In this study, HTA performance was examined in terms of their outcome and timing by looking at how 103 drugs, which gained regulatory approval from 2013 to 2015, were assessed by HTA agencies from 2014 to 2016.

Methods:

Products must have received regulatory approval from one of the following regulatory agencies: EMA (Europe), Health Canada (Canada) and TGA (Australia). The first HTA recommendations were then collected from PBAC (Australia), CADTH (Canada), HAS (France), IQWiG (Germany), SMC (Scotland) and TLV (Sweden). The HTA decisions were classified as positive, positive with restrictions, negative and multiple.

Results:

Eighty-four drugs were approved in Europe before Australia and Canada. Of the studied HTA agencies, PBAC had the highest percentage of products recommended within a year from regulatory approval (93 percent). In addition, Australia had the shortest median time between first regulatory submission by any of the three agencies and HTA recommendation (553 days) as compared to Europe (616 days) and Canada (722 days). This can be attributed to the TGA/PBAC parallel process. However, Australia has the highest proportion of products receiving a negative PBAC recommendation (62 percent).

Conclusions:

The majority of drugs were first submitted for reimbursement in Europe, but the time from regulatory submission to HTA decision was the fastest in Australia. This can be attributed to the TGA/PBAC parallel review process, which showed its benefit in reducing the overall time. A parallel review process is also available in Canada; however, it is not utilized as frequently by companies as in Australia.
OP172 Do Expedited Regulatory Pathways Affect Time To Health Technology Assessment Decision?
Authors: Cai Jesmine , Wang Tina , McAuslane Neil , Liberti Lawrence
Published: January 2019

Introduction:

In an effort to speed the assessment of new medicines while maintaining the quality of the regulatory review, facilitated regulatory pathways (FRPs) have been introduced in many countries. In this study, the effects of FRPs (expedited and conditional reviews) were investigated in terms of their influence on HTA outcomes and timing.

Methods:

HTA recommendations issued between 2014 and 2016 were collected from CADTH (Canada), HAS (France), IQWIG (Germany), SMC (Scotland) and TLV (Sweden) for 90 internationalized medicines (new active substances approved between 2012 and 2016 by all regulatory agencies in the five jurisdictions). The HTA decisions were then classified into the following categories: positive, positive with restrictions, negative and multiple.

Results:

Of this cohort of internationalized medicines that received an HTA recommendation, 31 percent in Canada and 28 percent in Europe were approved via a FRP. With the exception of Scotland, expedited medicines were more likely to be appraised within a year from regulatory approval and had a shorter median time between regulatory approval to HTA recommendation than standard medicines. The largest difference was seen in Sweden, where medicines were 66.5 days faster than standard pathways when it underwent the expedited pathways. Compared to standard pathways, there were generally a higher proportion of positive and positive with restrictions recommendations when expedited pathways were used. Germany reported the largest proportional difference (31 percent) between the two pathways.

Conclusions:

Medicines being designated for an expedited review pathway show a reduced time from regulatory approval to HTA decision. This finding suggests there is an alignment between regulators and HTA agencies on which medicines require expedited HTA pathways; however, from this data it cannot be assessed whether the reduced time from approval to HTA decision is attributed to the company strategy, HTA review time or both. Further investigation is required.
OP174 Development Of A Formal Priority-Setting For The Philippine Government
Authors: Wong John , Reyes Katherine Ann , Ho Beverly Lorraine
Published: January 2019

Introduction:

The lack of institutional mechanisms in the Philippine Health Insurance Corporation (PhilHealth) for rationalizing spending has led to a less than optimal allocation of financial resources. The study's objective is an explicit and systematic priority setting process of selecting new interventions for PhilHealth through identification of relevant literature evidence on the themes under study, then subjecting these to stakeholder and expert consultations.

Methods:

The qualitative study followed a problem solving approach to policy analysis. Bardach's Eightfold Path, supplemented by a World Health Organization (WHO) guideline on policy analysis, provided the framework. Eightfold path recommends that the analysis proceed by (i) defining the problem, (ii) assembling the evidence, (iii) constructing the alternatives, (iv) selecting the criteria for identifying the best alternative, (v) projecting the outcomes, (vi) confronting the tradeoffs, (vii) making the decision, and (viii) disseminating the results.

Results:

A six-step priority setting process to facilitate the assessment of new interventions for PhilHealth coverage was developed. The process is governed by seven accountability-based principles and four explicit criteria to evaluate interventions. Additionally, the study provided proof-of-concept for conducting local cost-effectiveness and budget impact analyses as key inputs to a national systematic priority-setting process.

Conclusions:

This study recommended four criteria and a seven-step process for priority setting to be adopted and an overarching set of principles that will guide the conduct of such activities. The proposed priority-setting process was approved by the PhilHealth. The same process was adopted by the Department of Health in the draft administrative order for health technology assessment. This study stimulated research projects for economic evaluations of health interventions.
PP08 Health Technology Assessment Of Autologous Chondrocyte Implantation
Authors: Mistry Hema , Connock Martin , Royle Pamela , Waugh Norman
Published: January 2019

Introduction:

Microfracture (MF) has been the main intervention in symptomatic articular cartilage knee defects. Autologous chondrocyte implantation (ACI) has looked promising, but was not recommended by the UK National Institute for Health and Care Excellence (NICE) in 2015 due to the short-term follow-up data from trials.

Methods:

Most long-term data comes from observational studies. We provided new unpublished analyses to NICE based on survival data of these studies, with appropriate caveats. They included: a large ACI study by Nawaz with useful subgroup data by osteoarthritis Kellgren-Lawrence stage and previous repair attempts; a very large MF study by Layton, and a small RCT by Knutsen indicating MF was as ‘good’ as ACI. A Markov model explored the cost-effectiveness of ACI vs. MF. Different scenarios were explored: ACI or MF as a first procedure, followed by ACI or MF in those needing a second repair. A NHS England perspective was adopted. Health outcomes were expressed as quality-adjusted life-years (QALYs).

Results:

The revised base-case analysis, used a list price of £16,000 (EUR 17,380 in 2013 prices) for cells, used ACI failure data from Nawaz with no previous procedures for ACI, and pooled MF failure data from two studies-Saris and Knutsen. ACI was more expensive but provided more QALYs. The incremental cost-effectiveness ratio comparing ACI then MF with MF then ACI was £8,000 (EUR 8,690) per QALY. Various sensitivity analyses were conducted assuming a threshold of £20,000 (EUR 21,730) per QALY: previous repair attempts reduced success of ACI (£22,000 (EUR 23,900) per QALY); reducing cell costs, ACI improved its cost-effectiveness; and limiting intervention to patients with higher Kellgren-Lawrence score did not appear cost-effectiveness.

Conclusions:

The final NICE guidance published in October 2017 approved the use of ACI for patients who had no previous knee repairs, for people with minimal osteoarthritic damage to the knee, and for people with articular defects of over 2cm2.
PP15 Incorporating Participatory Design Approaches Into HTA
Authors: Peddie David , Small Serena , Wickham Maeve , Badke Katherin , Woo Stephanie , Hohl Corinne , Balka Ellen
Published: January 2019

Introduction:

To address local workability, cross-setting variation, and clinician and patient perspectives, health technology assessment (HTA) practitioners and health system decision-makers incorporate varying forms of qualitative evidence into evaluations of novel health technologies. Employing principles and methods from long-established sociotechnical fields such as participatory design (PD) may help HTA teams in the production of formal, rigorous ‘practice-based evidence’.

Methods:

We draw on a theoretical review of foundational PD literature and experiences using PD for a large-scale health information technology project to summarize principles and strategies for the effective introduction and evaluation of new technologies in healthcare.

Results:

HTA may benefit from observing some of the core commitments of PD: (i) Ensuring that technologies enhance rather than detract from the quality of working life; (ii) Fostering democratic engagement in the implementation and evaluation of technologies; and (iii) Proceeding via direct partnership with technology users. These are practical commitments stemming from the recognition that technology implementation entails re-configuring existing practices and social arrangements. The experts of this existing milieu are the people on the ground, who may reject or underutilize technologies that they perceive as impractical, ill-adapted to their needs, or having negative consequences on their work. At the same time, PD recognizes that local activities occur within larger systems and that effective technology introduction also requires attention to macro-politics (e.g. governance challenges, competing priorities). PD employs a diversity of methods (e.g. participant observation, focus groups, workshops, interviews) to develop evidence that is holistically informed.

Conclusions:

Many of the challenges that HTA faces, both in terms of evidence production and translation, have been encountered before in PD. Given that decision-making around health technologies necessarily involves consideration of many forms of qualitative evidence, there is value in producing and evaluating such evidence in carefully designed manner – a challenge to which fields like PD can lend a wealth of experience.
PP16 Turning The Tide On Antibiotic Use With Consumers And Health Professionals
Authors: Wu Jianyun , Taylor Daniel , Dartnell Jonathan , Heaney Aine , Weekes Lynn , Blogg Suzanne , Sterling Kirsten , Carr Anthony
Published: January 2019

Introduction:

Many countries have a national antimicrobial resistance strategy. In Australia, primary care is especially important because this setting encompasses a high proportion of antibiotic use. While antibiotic use decreased during the 1990s, it began to increase again in the mid-2000s. In response to this, in 2009 NPS MedicineWise implemented a series of nationwide educational interventions for consumers, family physicians (general practitioners), and community pharmacies that aimed to reduce excessive antibiotic use.

Methods:

For consumers a social marketing approach was used, including strategies that leveraged collectivism, nudge theory, celebrity endorsement, and co-creation. Channels included social, print, radio, and other media as well as practice waiting rooms and pharmacies. For health professionals, interventions included face-to-face education, audits, comparative prescribing feedback, case studies, and point-of-care materials. Surveys of consumers and family physicians were conducted periodically to evaluate changes in knowledge and behavior. National Pharmaceutical Benefits Scheme claims data were analyzed using a Bayesian structural time-series model to estimate the cumulative effect of interventions by comparing the observed and expected monthly dispensing volumes if the interventions had not occurred.

Results:

The consumer survey results indicated that more people were aware of antibiotic resistance (seventy-four percent in 2017 versus seventy percent in 2014), with the minority requesting or expecting antibiotics for upper respiratory tract infections (URTIs) (twenty-two percent in 2017). People underestimated the usual duration of symptoms for URTIs and were more inclined to expect antibiotics beyond that timeframe. Compared with non-participants, family physicians who participated in the program reported more frequent discussions about hand hygiene (ninety percent versus eighty-two percent) and proper use of antibiotics with patients (ninety-five percent versus eighty-eight percent). Between 2009 and 2015 there was an estimated fourteen percent reduction in prescriptions dispensed to concessional patients for antibiotics commonly prescribed for URTIs.

Conclusions:

Family physicians and consumers have responded positively to national programs. Sustaining and building on these improvements will require continued education and further innovation.
PP40 HTA Evaluations Of Combination Drugs: Positive Reimbursement Solutions
Authors: Solaman Dilani Angela , Walker Andrew , Alba Salus , Edoo Hanim , Jommi Claudio , Ratcliffe Mark
Published: January 2019

Introduction:

Health technology assessments (HTA) for combination drug therapies in oncology are increasingly common. Companies face multiple challenges when determining their economic value due to their complexity and high cost, while payers must balance the need for these vital innovations with sensitivity to rising costs. The study objective was to evaluate the current HTA frameworks in Europe and identify the potential barriers/solutions to reimbursement of brand-on-brand (BoB) combination therapy.

Methods:

A targeted literature review of HTA agency websites was undertaken to identify any literature/guidance relating to HTA decision-making for combination oncology therapies in France, Germany, Sweden, and the UK.

Results:

In France and the UK, BoB HTA decisions reflect clinical- and cost-effectiveness. Combination therapies have been accepted for use in France and the UK, for example, dabrafenib plus trametinib, are assessed through standard HTA processes, exemplifying that positive reimbursement is not unattainable where there is an unmet need and high clinical value. Despite this flexibility, many therapies will fail to prove their cost-effectiveness, resulting in delays or arbitrary pricing decisions. Potential solutions are the use of the ‘efficiency frontier’, as typified by the German HTA system, giving more ‘scope‘ to expensive innovations; or the Swedish HTA approach, which applies variable cost-effectiveness thresholds according to therapeutic area, disease severity, and social criteria. Other possibilities include indication-specific pricing, multiple-criteria decision analysis, and net monetary benefit with willingness-to-trade weights. One likely issue to arise is when different companies are involved, necessitating co-operation. In this scenario, a simplistic solution would be arbitration of the division of the combined price, circumventing the need for HTA agencies to make changes to decision-making criteria.

Conclusions:

Constructive debates and collaboration between industry and decision-makers are vital to achieve a harmonized HTA process for high-cost combination therapies which offer advanced benefits and improved safety outcomes, whilst satisfying HTA bodies and providing better access for patients.
PP46 When Composite Measures Or Indices Fail: Data Processing Lessons
Authors: Chao Yi-Sheng , Wu Chao-Jung
Published: January 2019

Introduction:

Index mining is a new discipline that aims to search for the composite measures or indices most relevant to the contexts or outcomes. After reviewing three frailty indices and principal component (PC)-based indices, we hereby show certain occasions that can lead to ineffective indices, which consist of bias or fail to represent the theories.

Methods:

We reproduced and reviewed the three frailty indices and the 134,689 PC (principal component) -based indices from previous publications. The impact of aggregating the input variables on the final indices was analyzed using forward stepwise regression.

Results:

Several methods to combine the input variables were related to ineffective projection of information onto the indices. The most common causes leading to ineffective summation of input variables were shown in three examples involving different types of input variables, which were positively or negatively correlated or uncorrelated to the outcome. Ineffective indices were created often because of the summation of redundant information or uncorrelated variables.

Conclusions:

The creation of ineffective indices can be avoided if the relationships between input variables and outcomes are properly scrutinized. The creation of composite measures and indices is still a discipline under active development. The three examples we identified are the mistakes that may be repeated unintentionally and need to be addressed with explicit rules. A reporting guide for the creation of composite measures has been proposed. A proper review of index objectives, data characteristics, and data limitations before creating composite measures or indices is recommended.
PP60 Producing Qualitative Syntheses In Health Technology Assessment: Challenges From The Canary Islands
Authors: Toledo-Chávarri Ana , Booth Andrew
Published: January 2019

Introduction:

With heightened awareness of the value of patient and provider perspectives to decision making, Qualitative Evidence Synthesis (QES) is increasingly used within a health technology assessment (HTA) context. Acceptability, feasibility and implementation can all be addressed by synthesis of qualitative research. Concerns have been raised about the quality of the synthesis product, especially when conducted within a constrained time window. How can we test the validity of qualitative studies and assess confidence in synthesized qualitative findings, particularly when time is tight?

Methods:

A brief examination of issues relating to production and use of QES identified from within the Canary Islands HTA agency will identify practical and methodological challenges. How can existing approaches address wider patient, social, organizational and ethical considerations that inform HTA? The potential for use of Evidence To Decision frameworks and approaches such as GRADE CERQual (a transparent method for assessing the confidence of evidence from reviews of qualitative research) will be briefly examined.

Results:

This presentation will identify potential gaps between the needs of a small HTA agency and the methodological support and tools required to address these gaps, based on experience of conducting QES to date. Issues identified are particularly relevant to other small HTA agencies but are also generalizable to larger agencies and guideline producers worldwide. Pragmatic solutions are suggested. A future research agenda for potential methodological and applied research is outlined and current GRADE-CERQual development initiatives briefly shared.

Conclusions:

Despite significant progress in developing methodologies for integrating QES within HTA decision making, substantive challenges remain. Observations derived from this small HTA agency can inform further developments across all HTA organizations. Research is required to examine the impact of potential dissemination bias, application of tools across a wider HTA decision making framework and use of rigorous approaches within a time-limited evaluation window.
PP62 A Guide To Report And Review Innovative Indices Or Composite Measures
Authors: Chao Yi-Sheng , Wu Chao-Jung
Published: January 2019

Introduction:

Composite measures and indices are used in medical research to represent certain concepts that cannot be measured with one variable. They can be used to predict outcomes or serve as outcomes in trials. The creation of innovative indices is important to increase publications and secure research funding. However, some assumptions and problems are prevalent among indices. We aim to develop a reporting guide and an appraisal tool for indices based on the issues we identified.

Methods:

We reproduced the three frailty indices from a previous publication and 134,689 principal component-based indices. We reviewed the index assumptions, bias introduced by data processing, relationships between input variables. We interpreted the indices with input variables.

Results:

We identified four major issues to be addressed in a reporting guide: constraints imposed by index creation on the input variables; data processing without evidence base; indices poorly linked to input variables; and, relatively inferior predictive power. We demonstrated a flow diagram and a checklist to report and review these four issues related to innovative indices.

Conclusions:

A reporting and critical appraisal tool for innovative indices is lacking and needed. These four issues that need to be explicitly considered are previously neglected. This guide is the first attempt to improve the quality and generalizability of innovative indices. This guide can be used to lead further discussion with other experts and review committees.
PP70 Health Technology Assessment Evaluations Of Combination Drugs: The Italian Case Study
Authors: Solaman Dilani Angela , Jommi Claudio , Walker Andrew , Edoo Hanim , Ratcliffe Mark
Published: January 2019

Introduction:

Health technology assessment (HTA) must adapt to support the changing health system landscapes and improve access to valuable innovation under budgetary constraints. This is exemplified by the pricing and reimbursement of high-cost combination therapies increasingly used in oncology. Variability exists in current HTA practices across different countries, resulting in discrepancies in reimbursement outcomes and patient access. Using Italy as a case study, the objective was to assess the challenges faced by HTA agencies in the negotiation of pricing and reimbursement of combination therapies.

Methods:

A targeted literature review of Italian HTA agency websites was undertaken to identify any literature/guidance relating to HTA decision-making for combination oncology therapies.

Results:

In Italy, there is no fixed cost-effectiveness threshold and decisions are based on multiple criteria. Managed market entry agreements are extensively used; price-volume agreements and drug registries are common. While this framework allows flexibility and avoids the rigidity of incremental cost-effectiveness ratio thresholds, it has raised concerns about transparency and budget impact. Combination therapies are not given specific concessions; however, market access for a combination of a new high-cost drug with an existing one is complex, particularly if the drugs are manufactured by different companies. The added value provided by the new drug in the combination should be rewarded while the older product benefits from the increased volume of use. The price of the older drug cannot be lowered unless the pricing and reimbursement contract is expiring or a new indication/formulation is pending, presenting a challenge to both pharmaceutical companies and HTA agencies.

Conclusions:

Combination therapies pose a challenge for HTA agencies. In the Italian system this is partially mitigated by the use of multiple criteria for decision-making and managed access agreements. However, these approaches have also led to concerns about a lack of transparency in decision-making.
PP86 Impact Of Health Technology Assessment On Drug Price Negotiations: Canada
Authors: Rocchi Angela , Mills Ferg
Published: January 2019

Introduction:

Subsequent to review by Canada's two central health technology assessment (HTA) agencies, confidential drug prices are negotiated by the pan-Canadian Pharmaceutical Alliance (pCPA) on behalf of public drug plans. This analysis is the first to examine characteristics of drugs considered for negotiation, and the duration of negotiations, from inception in 2011 to August 2017. The objectives were to identify how HTA recommendations impacted price negotiations, and in particular the role of health economics in the process.

Methods:

The dataset contained 208 drug indications from the pCPA archives: those with a decision to negotiate (n=155) or a decision not to negotiate (n=53). Data were abstracted from the publicly-maintained websites of the respective agencies; descriptive statistics were conducted.

Results:

There was close but imperfect alignment between the HTA agency listing recommendation and the pCPA's decision to negotiate. The incremental cost-effectiveness ratio (ICER) of negotiated drugs (as estimated by HTA agencies) approached CAD 200,000/QALY (i.e. USD 157,000) for oncology drugs, but was closer to CAD 100,000/QALY (i.e. USD 78,000) for non-oncology drugs, revealing that negotiations would require a substantial discount to achieve conventionally ‘acceptable’ value-for-money. ICERs were influential to non-oncology drug recommendations (and were increasingly used to set pCPA negotiation targets) but did not appear to influence oncology drug HTA recommendations. The time period required to initiate negotiations was dramatically shorter for oncology versus non-oncology drugs (53 versus 263 days), and also differed markedly between therapeutic areas. The time period for pCPA activities was surprisingly similar for drugs recommended without a price condition and for those conditional on a price reduction.

Conclusions:

These findings revealed an implicit prioritization pattern at the pCPA, as well as the evolving role of health economics in Canada's two-stage reimbursement process.