bluuebunny/crossref_metadata_2025 huggingface dataset:
OP35 Integrated Knowledge Translation In Policy Development
Authors: Laing Glenna , Djebah Rume , Hoff Judy , Shaffer Robert , Harding Sheila Rutledge , Moga Carmen , Kletke Stefanie , Scott Ann
Published: January 2019

Introduction:

Immune globulin (IG) is a publicly funded blood product with high utilization rates and rapidly rising costs. Inappropriate use of IG, particularly in dose and treatment duration, is observed in about 10 percent of cases, and the national guidelines for IG treatment are outdated. To develop a utilization management policy for IG, the Alberta, Manitoba and Saskatchewan Ministries of Health collaborated with health technology assessment (HTA) researchers and clinicians to develop evidence-based guideline recommendations for IG treatment to inform an authorization policy for IG utilization in the provinces.

Methods:

A multidisciplinary committee comprising HTA researchers and 22 physicians from seven medical specialties adapted recommendations from 43 “seed” guidelines into one locally contextualized IG guideline. HTA methods and rapid review products were used extensively to update gaps in the evidence base. The guideline recommendation document was used to develop a provincial IG utilization management policy. The challenges of achieving a methodologically rigorous guideline development process will be discussed.

Results:

The guideline contained over 60 recommendations for IG use in different medical specialties. The health ministries used the guideline recommendations to develop an IG authorization policy. The clinician-sanctioned review criteria were used to construct a conditional reimbursement system for generating outcome data from controlled off-label IG use for conditions where evidence gaps existed, and were built into policies for benchmarking compliance.

Conclusions:

Three provinces successfully collaborated to develop an IG utilization management policy. The unique approach involved a credible and transparent process that incorporated key review elements for compliance benchmarking and reimbursement, promoted clinician buy-in, and created a cadre of clinical champions willing to assist in policy development and implementation. The proactive, rather than retroactive, incorporation of clinician-sanctioned benchmarking and review criteria into policy will help bridge the know-do gap and foster a stronger, more direct link between health policy and evidence.
OP39 Evaluation Of Discharge Planning And Transitional Care For The Elderly
Authors: Wassef Maggy , Trepanier Marc-Olivier , Beauchamp Sylvie
Published: January 2019

Introduction:

According to our local data, elderly patients accounted for 14 percent of the population yet, represent 58 percent of hospitalization and, they are more likely to return after discharge. These patients are more likely to return to the hospital following discharge. In order to meet ministerial target for length of stay of patient on a stretcher, the UETMIS-SS was requested to evaluate interventions aiming to improve the fluidity of patient trajectories in the acute care services. The objective of this health technology assessment is to evaluate the effectiveness of discharge planning and transitional care interventions aiming at reducing the readmission rate of the elderly.

Methods:

An umbrella review was conducted following the PRISMA statement to summarize the scientific evidence. The search was conducted in five databases along with the grey literature search. Two reviewers independently performed the study selection, the quality assessment and the data extraction. To better illustrate the activities and the healthcare professionals (HCP) involved in the interventions, an analytical framework was developed. Results were summarized in a narrative synthesis. The contextual and experiential data were collected through interviews with HCP and directorates from different settings. The level of evidence was and a committee was then held to elaborate the recommendations.

Results:

In the nine systematic reviews included in the narrative synthesis, three models were identified: Post-discharge planning and follow-up by the same HCP was established to be effective in reducing the readmission rate. Discharge planning interventions with follow-up by non-specific HCP have been shown to be promising, while discharge planning without follow-up after the hospital discharge has shown to be ineffective in reducing the readmission rate.

Conclusions:

An individualized discharge plan, coordination of services and follow-up performed by the same HCP is established to be effective in reducing readmission rate.
OP43 Robotic Or Conventional Gait Training Rehabilitation? A Health Technology Assessment Study
Authors: Andellini Martina , Faggiano Francesco , di Mauro Roxana , Derrico Pietro , Ritrovato Matteo
Published: January 2019

Introduction:

The purpose of this study is to gather evidence on safety and overall effectiveness of three alternative technologies for gait rehabilitation in diplegic children with Cerebral Palsy: robotic, conventional and joint conventional and robotic gait training.

Methods:

A new methodology, decision-oriented health technology assessment (DoHTA), was applied to assess the technology on clinical, technical, organizational, economic, social and ethical, legal and safety domains. This method, conceived as a hospital-based HTA tool for supporting the introduction of innovative technologies, has been implemented merging the EUnetHTA Core Model® with the Multi-Criteria Decision Analysis. In particular, the general items of the EUnetHTA Core Model® are re-formulated as performance indicators and re-placed along a decision tree structure that, from the one hand, respects the original top-down design of the EUnetHTA model (growing level of detail from domains to issues) and, from the other hand, allows obtaining a quantitative evaluation of each identified performance indicator.

Results:

The multiple indicators, which have been identified for the seven domains, play important and different roles in the alternative technologies evaluation. DoHTA results showed that robotic system offers the possibility to control more accurately the exerted forces and movement trajectories than the traditional therapy. It gives the possibility to measure the task performances parameters and to receive the patient feedback simultaneously. To carry out robotic gait rehabilitation fewer therapists are required compared with the conventional therapy, resulting in lower therapists’ physical workload.

Conclusions:

Despite the great perspectives that robotics offer to motor rehabilitation, it seems that robotic gait training could not provide greater benefits in terms of motor and functional recovery compared to the conventional therapy. Preliminary results, supported by most recent literature evidence, lead to the hypothesis that joint use of robotic and conventional therapy can produce better clinical outcomes than the separate use of the two rehabilitation techniques.
OP44 HTA Of 3D Videolaparoscopy: Follow-up 12 Months After Introduction
Authors: di Mauro Roxana , Andellini Martina , Faggiano Francesco , Derrico Pietro , Ritrovato Matteo
Published: January 2019

Introduction:

In 2016, a health technology assessment (HTA) was conducted to gather evidence on the safety and overall effectiveness of performing laparoscopic surgery by using 3D videolaparoscopy (3DVL) versus 2D videolaparoscopy (2DVL) display systems in a variety of pediatric surgical procedures in order to efficiently support the final investment decision on video system to be acquired. Results showed that 3DVL might be a good alternative to 2DVL. Moreover, sensitivity analysis has also confirmed that the results associated to the best technology (3DVL) are robust; this has led to a confident decision for recommending it in Bambino Gesù Children's Hospital (OPBG). The objective of this work is to evaluate the impact of 3DVL within the hospital setting after 12 months its introduction in clinical practice.

Methods:

After 12 months since the technology's introduction, clinical data, identified in previous HTA study, were extracted from surgery registries; data concerning the number of surgeries, duration of intervention, blood loss and surgery complications were analyzed. Statistical analyses on these data, between pre and post 3D system implementation period were carried out.

Results:

Results confirmed the 2016 HTA results, highlighting clinical advantages identified a priori. The percentage of the number of laparoscopic procedures significantly increased from 12 percent in pre-3D system installation period to the 20 percent in post 3D system installation (p=7,35E-6). No statistical differences in length of hospital stay, operative time, incidence of perioperative blood loss and surgery complication, between pre- and post- 3D installation period were identified.

Conclusions:

This study highlighted the importance of a HTA process before the acquisition of a technology for which the investment decision is not obvious, because benefits and drawbacks of the new technology are unclear. Preliminary results showed that 3D video laparoscopy system seems to be better than the 2D laparoscopy system. However, more data has to be examined to be able to establish the final judgement.
OP48 A Contextual Model For Evaluating The Value Of Multi-Indication Drugs
Authors: Wu Elise , Pellissier James , Bellanca Leana , Normand Raphael , Hughes Robert , Ratciffe Aran
Published: January 2019

Introduction:

An increasing number of anti-cancer medications are indicated for multiple tumors. Existing pharmacoeconomic evaluations routinely examine the cost-effectiveness (CE) and budget impact (BI) of such drugs by indication, as and when each indication is reviewed. The impact of indication-specific conclusions on the holistic value of such medications across all indicated patients is not currently evaluated, yet is important to stakeholders including health technology assessment (HTA) agencies, payers and patients. We introduce a holistic framework that considers the value of multiple indications together at a product level. Application of this approach is illustrated via an example across multiple indications for a novel, targeted anti-cancer therapy (pembrolizumab) in Canada.

Methods:

Previously-HTA-evaluated indication-specific CE and BI models serve as the foundation for this multi-indication model. Comparing to standard of care (SoC) per indication, the model evaluates the potential BI, clinical outcomes and CE of pembrolizumab among the individual indications along with the overall multi-indication patient population from the perspective of a third-party payer. For the contextual model, incremental costs and quality-adjusted life years (QALYs) were weighted using indication populations derived from national incidence rates.

Results:

The indication-specific incremental cost-effectiveness ratios (ICER) from CE analyses of ipilimumab-treated advanced melanoma, ipilimumab-naïve advanced melanoma, second-line non-small cell lung cancer (NSCLC), first-line NSCLC and fourth-line classical Hodgkin lymphoma range from USD 52 K to USD 163 K per QALY. Accounting for the relative contributions of the various sizes of indication-specific patient populations results in an overall ICER for pembrolizumab vs. SoC of USD 100 K.

Conclusions:

A holistic model can provide stakeholders with a tool to evaluate the overall value of multi-indication drugs. Results enable an understanding of the outcomes and economic consequences of treatment with pembrolizumab versus SoC by both individual indications and across all indications. Insights from this contextual approach will enable data from less-developed clinical trials to be considered when previously they might have gone unevaluated by decision-makers.
OP79 A Meta-Framework To Inform Health Inequalities In Systematic Reviews
Authors: Maden Michelle
Published: January 2019

Introduction:

Recent equity review guidance encourages reviewers to consider whether it is likely that their findings may impact on health inequalities. Much of the guidance assumes that health inequalities have either already been identified as the focus of the review, or that reviewers are able to recognize if and how health inequalities matter. However, our experience is that this is not necessarily true. Furthermore, theorizing if and how health inequalities matter is not normally integrated into the HTA review process. This presentation describes a novel approach to the development of a theory-led meta-framework to inform health inequality considerations in systematic reviews. The meta-framework aims to increase the usefulness of systematic reviews in informing and implementing changes to practice.

Methods:

Following the best-fit framework synthesis approach, a meta-framework was generated by ‘deconstituting’ concepts from theories relating to complex interventions and socio-economic health inequalities into a single framework. Feedback was sought from health inequality experts and reviewers.

Results:

Complex intervention theories identify four domains and key factors that may influence effectiveness; intervention design, implementation, context and participant response. Applying an equity lens, socio-economic health inequality theories identify key factors and mechanisms associated with these domains that may lead to differential effects across disadvantaged populations.

Conclusions:

The meta-framework has the potential to i) facilitate the identification and understanding of when, why and how interventions may impact on socio-economic health inequalities, ii) promote a theory-led approach to incorporating health inequalities in systematic reviews iii) help reviewers identify data to extract and inform a priori analysis on what factors are associated with differential effects, iv) help reviewers to decide whether it is likely that their review findings may have the potential for an intervention to indirectly widen or narrow socio-economic health inequalities, even when evidence of an impact in the primary research is lacking.
OP83 Thinking Explicitly About Ethical Issues In Health Technology Assessment: Lessons From The Canadian Agency For Drugs And Technologies In Health
Authors: Bond Ken , Duthie Katherine
Published: January 2019

Introduction:

While methods for ethics analysis in health technology assessment (HTA) exist, there have been relatively few applications and assessments of these methods. The Canadian Agency for Drugs and Technologies in Health (CADTH) began to include an explicit analysis of ethical issues within its HTAs in 2015. To examine some of the differences among ethics analyses, we critically compared the conduct and contribution of the analysis of ethical issues for four CADTH HTAs.

Methods:

Two experts in ethics in HTA examined ethics analyses conducted by CADTH for four technologies: DNA mismatch repair testing for colorectal cancer, treatments for obstructive sleep apnea, dialysis for end-stage liver disease, and human papillomavirus screening for cervical cancer. The methods of analysis and presentation of results, extent to which the ethics analysis was used in committee deliberations was gathered via meeting notes, recommendation documents, and discussion, and were summarized narratively.

Results:

The amount of literature explicitly discussing ethical issues pertaining to particular technologies varied and was not predicted by the age and maturity of a technology. The axiological approach proved a helpful starting point for ethical reflection, but other methods were used for analysis and presentation. Explicit discussion of ethical issues identified the need for additional information to ensure robust deliberation. Committee members expressed the belief that ethics analysis “brought together” individual sections of the HTA.

Conclusions:

While many methods exist for ethics analysis, ethics expertise is required to identify and explicitly discuss the complete range of ethical issues relevant to a particular HTA. Ethics analyses create space to challenge assumptions underlying the clinical and economic evidence, raise issues about the value of technologies, and help to integrate the HTA results.
OP95 Are Patient-Reported Outcome Measures Meeting Today's Standards?
Authors: Oehrlein Elisabeth , Perfetto Eleanor , Rose Love T. , Chung Yujin , Ghafoori Parima
Published: January 2019

Introduction:

Over the past decade, health technology assessment (HTA) agencies have become interested in improving the patient-centeredness of their assessments. A common approach has been to prioritize patient-reported outcomes (PROs), often describing PROs as patient-relevant or patient-oriented. However, it is often unclear whether and to what degree PRO measures (PROMs) truly reflect what is important to patients. This review examined the pedigree of a sample of measures used as primary or secondary endpoints in trials and discussed in Food and Drug Administration (FDA) approved product labels between 2003 and 2014.

Methods:

We examined all 26 PROs included in chapters 1 (Office of Microbial Products) and 2 (Office of Drug Evaluation I) of the FDA's Pilot Clinical Outcome Assessment (COA) Compendium. Three reviewers independently searched PubMed and Google to identify publications or other relevant materials related to method and stage of measure development where patient engagement took place.

Results:

Among 26 evaluated PROMs, we were unable to locate any information on development or validation for 12 (patient diary=9; rating scale=3). Among the remaining 14 PROMs, 5 did not include any evidence of patient engagement (questionnaire=1; patient diary=2; rating scale=2); 3 engaged patients during concept elicitation or psychometric validation only (disease-specific questionnaires=3); and 6 engaged patients during both concept elicitation and cognitive interviewing (disease-specific questionnaires=6). PROMs either previously qualified or submitted for qualification by FDA were more likely to include patient engagement.

Conclusions:

PROs can provide patient-centered data useful for HTA; however, patient-reported information is not inherently patient-centered. This study found that only a minority of sampled PROMs engaged patients during both concept elicitation and cognitive interviewing. To facilitate patient-centered HTA, manufacturers should ensure that PROMs incorporated into clinical trials measure concepts important to patients. Similarly, HTAs should request data on development and validation of all outcome measures incorporated into trials.
OP96 Standardizing Collection Of Patient-Reported Experience Measures To Drive Service Improvement In Wales
Authors: Withers Kathleen , Puntoni Sarah , Palmer Robert , O'Connell Susan , Carolan-Rees Grace
Published: January 2019

Introduction:

Co-production relates to patients and health professionals working in equal partnership with shared decision-making. Patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) are increasingly being used to involve patients and measure healthcare quality. We set out to develop a set of universal experience questions for use across Wales. These will be used in various settings, including the national electronic PROMs and PREMs platform, which is already collecting outcome data across Wales and has received over 7,000 responses to date.

Methods:

Patient experience leads and clinical leads were invited to a workshop to discuss standardized PREMs collection in Wales, with all health boards and trusts represented. It was agreed that quantitative patient experience data collection, while limited, would be a pragmatic way to collect responses from a large cohort. It was agreed that a previously developed set of PREMs questions could be adapted for use in all healthcare settings. Patient focus groups reduced the number of questions to a shortlist of those considered most important by patients. Wording was improved and an additional question was added.

Results:

In partnership with stakeholders we developed and agreed on a set of universal PREMs questions. These have been added to the national electronic platform, with collection commencing imminently. This will allow patients accessing secondary care in Wales to provide PREMs and PROMs responses.

Conclusions:

Development of a standardized set of PREMs has allowed us to initiate collection on a national basis. Addition of PREMs to the national electronic platform provides a unique means of collecting large volumes of data consistently, allowing us to benchmark across and within organizations. It will also allow experience teams to target improvement initiatives and identify good practice. Together with outcomes responses, the data will be used to measure experience of care in Wales.
OP102 Multiple Criteria Decision Analysis In The Field Of Hospital-Based Health Technology Assessment
Authors: Avdeyev Andrey , Tabarov Adlet , Akhetov Amir , Shanazarov Nasrulla , Kaptagayeva Aigul , Hailey David
Published: January 2019

Introduction:

One of the main tools for Hospital-Based Health Technology Assessment (HB HTA) is the preparation of a mini-health technology assessment (HTA) report. Despite the high value of the results of mini-HTA reports for hospital decision-makers, the classical mini-HTA report does not allow a direct comparison of several health technologies among themselves.

Methods:

Based on the analysis of international experience of using the principles of multiple-criteria decision analysis (MCDA) in the field of HB HTA, we created and approved our own managerial decision-making model which includes five standardized multiple criteria. The value (weight) of each criterion was defined as the arithmetic mean obtained as a result of interviewing hospital decision-makers and an HTA expert group.

Results:

Five standardized multiple criteria were included in the structure of our mini-HTA report. These criteria presented the main results of assessment of the viability of implementing new health technologies (HTs) in hospital practice and contain the following: i) Novelty/innovation; ii) Comparative clinical effectiveness and safety; iii) Relevance (demand); iv) Economic effectiveness; and, v) Payback period. We conducted the modeling of various options of HTA results by using multiple criteria, which allowed us to determine the threshold values of the evaluated HTs corresponding to their priority for implementation: i) High priority - HTs are recommended for implementation; ii) Medium priority - HTs can be recommended only if there are sufficient financial resources in hospital; and, iii) Low priority - HTs may be recommended only if there are strong reasons for their need.

Conclusions:

Integration of the principles of MCDA in the structure of mini-HTA reports gives the opportunity to i) make comparative assessments of implementing new health technologies based on standardized criteria; ii) determine the priority for implementation of newly evaluated health technologies; iii) avoid the influence of subjective factors on the managerial decision-making in hospitals.
OP107 The Stakeholder Involvement Strategy For Horizon Scanning In Korea
Authors: Park Jooyeon , Park Eunjung , Shin Chaemin
Published: January 2019

Introduction:

As science advances the number of newly developed health technologies increases, but the lifecycles of health technologies becomes shorter. Thus, the importance of horizon scanning systems for identifying promising new health technologies and evaluating their potential impact is increasing. Engaging and collecting opinions from various stakeholders in this search process is very important. The purpose of this study was to develop a strategy for involving various stakeholders in all steps of the horizon scanning system in Korea.

Methods:

The horizon scanning system consists of five steps: identification, filtration, prioritization, assessment, and dissemination. We identified the stakeholders to be considered at each stage, and examined who would be involved and how. In addition, we planned how to synthesize and apply stakeholder opinions and to test the feasibility of these methods by using them in a horizon scanning system.

Results:

In the identification stage, developers, health professionals, and consumers suggested new and emerging health technologies to investigate. In the filtration stage, the person in charge of licensing judged the technologies based on appropriateness, innovativeness, and potential of market entry. In the prioritization phase, experts from eight to ten related fields (clinical, health technology and drugs, policy, methodology, patient organizations, etc.) participated and judged the technologies according to seven criteria (burden of disease, clinical impact, innovativeness, economic impact, acceptability, social impact, and evidence). In the assessment stage, between one and four clinical and methodological experts assessed the potential impact of the selected promising health technologies using seven evaluation items (unmet needs, improved patient health, health equity, change in medical behaviors, acceptability with respect to the patient and clinical condition, change in medical costs, and social, ethical, political, and cultural aspects). Before its dissemination, the final report was delivered to relevant industries for feedback (with particular emphasis on accuracy of data on the technology).

Conclusions:

There are many stakeholders in the horizon scanning system for new and emerging health technologies, depending on the healthcare system, policy, environment, etc. This study confirmed that stakeholder opinions on new technologies can vary. In addition, standards of social value judgment may change over time. It is therefore very important for horizon scanning systems to engage various stakeholders, collect their opinions, and make rational scientific decisions.
OP122 Applications For Research Funding: How Many Peer Reviewers Do We Need?
Authors: Turner Sheila , McArdle Nicola , Bull Abby , Chinnery Fay , Hinks Jeremy , Moran Rebecca , Payne Helen , Guegan Eleanor Woodford , Worswick Louise , Wyatt Jeremy
Published: January 2019

Introduction:

The National Institute for Health Research (NIHR) is a major funder of health research in the United Kingdom. Selecting the most promising studies to fund is crucial, and external expert peer review is used to inform the funding boards. Our aim was to evaluate the influence of different kinds and numbers of peer review and reviewer scores on Board funding decisions, and how we might modify the process to reduce the workload for stakeholders.

Methods:

Our mixed method study included i) retrospective cross sectional analysis of funding board and external reviewer scores for second stage applications for research funding, using Receiver Operator Characteristic (ROC) curves to quantify the influence of reviewer scores on funding decisions and ii) qualitative interviews with thirty stakeholders (funding board members, applicants, external peer reviewers and NIHR staff).

Results:

Analysis of ROC area for reviewers indicated that areas changed very little with increasing numbers of reviewers from four to seven or more. External reviewers with clinical, methodological or patient expertise all appeared to influence Board funding decisions to a similar extent. The stakeholders interviewed valued peer review but felt it was important to develop a more proportionate process, to better balance its benefit with the workload of obtaining, preparing, reading and responding to reviews. Reviews are of most value when they fill gaps in expertise on the Board. Less than four reviews was felt to be insufficient but more than six, excessive. Workload could be reduced by making reviews more focused on the strengths and weaknesses of applications and identifying flaws which are potentially “fixable”.

Conclusions:

Stakeholders supported the need for peer review in evaluating funding applications. Our results suggest that four to six peer reviews per application is optimum, depending on the expertise needed to complement that of advisory boards.
OP149 Survival Rates And Costs In Hepatocellular Carcinoma With Cirrhosis
Authors: Yang Jangmi , Shin Sangjin , Choi Insun
Published: January 2019

Introduction:

Early detection of primary hepatocellular carcinoma (PHC) patients with cirrhosis is critical to enhance PHC patients’ survival rates and to save medical costs. The study aimed to generate real world evidence to support the importance for early detection of PHC patients, and this evidence will contribute to a cost effectiveness analysis of the national liver cancer surveillance program.

Methods:

A retrospective analysis was performed on 98,275 PHC patients with cirrhosis in the National Center Cancer Registry from 2005 to 2014, linked to the Korea National Health Insurance claims database. The hazard ratio (HR) of mortality within five years and medical costs for the patients were compared by surveillance, epidemiology, and end results (SEER) stage.

Results:

There were differences in survival rates and medical costs depending on their characteristics including sex, age at diagnosis, SEER stage and types of initial treatment of cancer. The HR of mortality within five years of the PHC patients with distant stage versus local stage was 3.36 with 95% Confidence Interval (95% CI: 3.33–3.38) which is higher than those of the patients with regional stage (HR 1.93, 95% CI: 1.92–1.95). The estimated annual medical cost was USD 38,208 with standard deviation (SD) 54,399 for localized stage but USD 16,345 (SD 42,377) for distant stage.

Conclusions:

If PHC patients with cirrhosis were detected at early stage, their survival rates would be clinically better with a big saving for medical costs than if they were detected at distant stage. This result itself highlights that importance of the national liver cancer surveillance program. Future studies are indicated to apply these quantitative results into the cost-effectiveness analysis of the Korean national liver cancer surveillance program.
OP173 Eligibility Criteria For “Accelerated Access” Approval: A Global Survey
Authors: Efthymiadou Olina , Mills Mackenzie , Tzouma Victoria , Kanavos Panos
Published: January 2019

Introduction:

Several early access schemes (EAS) exist, which aim to accelerate patient access to new, potentially life-saving therapies. While some information exists on key schemes and their modalities, the determinants that drive adoption of a new medicine under an EAS remain unclear. We aimed to map eligibility criteria for inclusion of new medicines into the different EAS available across countries.

Methods:

Health technology assessment (HTA) stakeholders across 23 countries globally were invited via email to complete a web-survey with questions on (i) items that define product eligibility for EAS designation, (ii) standards for minimum level of evidence, monitoring, and additional evidence generation for early access products, and (iii) funding arrangements for these products across settings and types of schemes. Anonymized responses were analysed using descriptive statistics.

Results:

Fourteen responses from 10 countries (including Belgium, England, France, Japan and Mexico, among others) demonstrated that “unmet clinical need” was paramount for EAS designation across all countries and types of schemes. The next most important factors were “phase-III trials underway” and “serious condition” for Compassionate Use Programme (CUP) and Named Patient Programme (NPP) inclusion (21 percent and 20 percent of respondents, respectively). “Measures in place to monitor risk” was key for CUP and NPP designation (43 percent and 27 percent of respondents, respectively), followed by “innovative product designation” for CUP and “scientific opinion” for NPP eligibility (14 percent and 23 percent of respondents, respectively). “No specific monitoring requirements” exist in Germany and Austria, whereas “reporting of adverse events” is crucial in France, England, Japan and Spain. NPP eligible products are mainly funded at a negotiated price and CUP designated products are largely provided by manufacturers free-of-charge (i.e. England, Scotland, Germany).

Conclusions:

Eligibility criteria/requirements and funding arrangements for early access vary considerably across settings and their respective EAS. Information from a larger sample of countries is required for an all-encompassing mapping of the early access products’ characteristics.
OP177 Identification Of Technologies Of No Or Low Added Value
Authors: Esandi Maria Eugenia , Gutiérrez-Ibarluzea Iñaki , Ibargoyen-Roteta Nora , Godman Brian
Published: January 2019

Introduction:

Health technology has no or low added value when it is harmful and/or is deemed to deliver limited health gain relative to its cost, representing inefficient health resource allocation. A joint effort by the Health Technology Assessment International (HTAi) interest group (IG) on disinvestment and early awareness, the IG on ethics, the EuroScan network and the International Network of Agencies for Health Technology Assessment (INAHTA) is aiming to design a toolkit that could aid organizations and individuals considering disinvestment activities. We synthesized state of the art methods for identifying candidate technologies for disinvestment, and propose a framework for executing this task.

Methods:

We searched systematic reviews on disinvestment and compared the methods used for identifying potential candidates. A descriptive analysis was performed including sources of evidence used and methods for selection / filtration.

Results:

Ten systematic reviews were retrieved, and the methods of 29 disinvestment initiatives were compared. A new framework for identifying potential candidates was proposed which comprises seven basic approaches based on the wide definition of evidence provided by Lomas et al.; 11 triggers for disinvestment were adapted from Elshaug's proposal, and 13 methods for applying these triggers that were grouped in embedded and ad-hoc methods.

Conclusions:

Identification methods have been described in the literature, and have been tested in different contexts. Context is crucial in determining the ‘not to do’ practices as they are described in different sources.
PP02 Cost Effectiveness Of Tamoxifen For Breast Cancer Treatment In Ghana
Authors: Addo Rebecca , Goodall Stephen , Haas Jane Hall Marion
Published: January 2019

Introduction:

In recent years, unlike developing countries, developed countries have seen an increase in the survival of women diagnosed with breast cancer and this has been attributed to early detection through screening and best treatments such as adjuvant systemic therapies with medications like Tamoxifen. The burden of breast cancer in Africa, including Ghana, lies among premenopausal women, with mean age of diagnosis being 46 years. However, survival among these women is low due to reasons such as inability to afford treatment including Tamoxifen, an older but cheaper and effective adjuvant therapy. This study therefore sought to assess the cost effectiveness of Tamoxifen compared to nothing for the adjuvant treatment of early breast cancer among pre- and peri-menopausal women in Ghana to inform funding decisions.

Methods:

A Markov model was developed using TreeAge pro to incorporate effectiveness, costs and utility data. Effectiveness of Tamoxifen, rate of events and utility weights were derived from published literature. Resource utilization and costs were estimated from Ghanaian clinical expert, national health insurance scheme tariffs and medicines. The analysis was conducted from the perspective of the payer.

Results:

Patients on Tamoxifen incurred additional costs compared to those who received nothing. The key driver of costs was the cost of Tamoxifen. However, these costs were offset by the QALY gained: 3.51. The incremental cost effectiveness ratio (ICER) was GHC 666.15 (USD 150) per QALY gained. In line with the effective measure commonly used in developing countries, the ICER per DALYs averted was GHC 219.96 (USD 50). The results were sensitive to variations in the utility weights and the cost of Tamoxifen. There were no significant differences between the ICERs of premenopausal and peri-menopausal women in a subgroup analysis.

Conclusions:

Compared to no treatment, Tamoxifen therapy is highly cost-effective for the adjuvant treatment of breast cancer among pre- and peri-menopausal women in Ghana. The results can be applied to other African countries with similar resource use and treatment protocols
PP04 Co-Constructing Recommendations With Patients And Health Professionals
Authors: Lambert Laurie , Boothroyd Lucy , Azzi Leila , Collette Caroline , Brouillard Philippe , Pomey Marie-Pascale , Fournier Monique , Grégoire Alexandre , Ganache Isabelle , Brière Anabèle , Bogaty Peter , de Guise Michèle
Published: January 2019

Introduction:

Decision-making about replacement or modification of an implantable cardioverter defibrillator (ICD) must be patient-centered and clinically appropriate. We engaged both patients and health care professionals in a multi-method approach in order to recommend structures and processes that facilitate informed and shared decision-making.

Methods:

A systematic literature review (2000 to 2017) was performed focusing on the patient's perspective and the optimal organization of structures and processes for decision-making. A province-wide field evaluation based on medical chart review was carried out to provide ‘real world’ evidence in Québec's six ICD implanting centers (1 July to 31 December, 2016; N = 418). Patients and health care professionals reviewed the findings of the review and field evaluation, and deliberated recommendations in an anonymous manner by electronic mail. A joint meeting focused on proposed recommendations concerning shared decision-making.

Results:

The patients provided feedback on the literature review based on their ICD experience, and highlighted the need for better and more interactive decision aids, clinical information and time, and a private space for sensitive discussions. The field evaluation underlined the variability of treatment choices at the time of replacement and that more than one in ten patients had undergone ICD deactivation. Proposed recommendations focus on multi-disciplinary, integrated follow-up of patients and outline best practice for incorporating patient wishes and life objectives when discussing treatment options. The multi-round consultation process allowed both patients and professionals to co-construct recommendations with our evaluation team.

Conclusions:

This multi-method approach enriched our interpretation of literature and ‘real world’ data and facilitated identification and prioritization of important themes. Partnership with both patients and clinicians added a new and energizing dynamic to our evaluation and recommendation processes. We acknowledge the contribution of the members of the patient committee and the clinical experts committee.
PP20 Assessment Of The First Software Combined With Telemonitoring Support
Authors: Piotto Estelle , Marguerite Camille , Collignon Corinne , Galmiche Hubert , Belorgey Chantal
Published: January 2019

Introduction:

More and more software programs, including those with medical device status, are coming into the market that aim to facilitate management of diabetic patients. In France, their coverage requires a positive opinion from the French National Health Agency (HAS) dedicated committee. To understand the utility of these products for patients, real-life experiments are in progress. Since the evaluation principles are similar for all medical devices, it was important to find out with this first connected software if specific methods or evaluation criteria are necessary.

Methods:

After obtaining CE marking, the manufacturer submitted a dossier to HAS outlining the clinical data and technical performance of the software. HAS assessed the dossier and the opinion of stakeholders (i.e. professionals and patient associations) in order to determine the actual clinical benefit of this software. At the same time, HAS set technical features in particular to secure patient data and limit access to only those involved in telemonitoring. Terms of prescription and use of this connected software had also been defined.

Results:

Two feasibility studies and one randomized controlled trial were analyzed. Specific clinical data demonstrated that the risk-benefit balance was positive in type 1 diabetic patients.

Conclusions:

In addition to the need to keep personal data confidential and to integrate the technology in the organization of healthcare, this assessment shows that randomized clinical trials are feasible and necessary to demonstrate the clinical benefit of connected software; however, specificities exist regarding data collection methods and the scope of healthcare organization that should be taken into account. A specific guide to connected medical devices for industry has been developed by HAS to help them build their application dossier for reimbursement. The second step for HAS is to develop guidelines on the specificities of the assessment of these connected devices.
PP21 Reassessment Of Cochlear Implantation For Children In Kazakhstan
Authors: Kosherbayeva Lyazzat , Medeulova Aigul , Hailey David
Published: January 2019

Introduction:

Cochlear implantation (CI) is a standard technology for the management of children with sensorineural hearing loss. In the Republic of Kazakhstan (RK), CI was introduced in 2007. In 2012, a report for the Ministry of Health (MoH) of the RK considered the effectiveness of CI, age of implantation, use of clinical protocols, and availability of audiological screening and rehabilitation services. We assessed the influence of the report findings on the provision of medical care in the RK for children with sensorineural hearing loss.

Methods:

Information was collected in a survey of all RK health regions on issues related to CI, audiological screening and rehabilitation. Administrative data relevant to the provision of CI in the RK were obtained from the MoH. Data obtained were compared with those available for preparation of the 2012 report.

Results:

The proportion of medical organizations with equipment to provide audiological screening had improved, from 29 percent in 2012 to 90 percent in 2018. The proportion of children under two receiving CI increased from 12 percent to 36 percent, while that for children over five years decreased from 48 percent to 17 percent. A clinical protocol for CI in children was developed by a center in the MoH. Progress with post-CI rehabilitation of children was limited by a lack of specialists in the health regions. The proportion of school-age children with implants who have attended general schools remains low.

Conclusions:

The findings of the HTA report had a positive influence on availability of screening services and a protocol for CI. The average age of children receiving an implant has decreased, though it is still higher than in other countries. The need for improvements in post-CI rehabilitation and placement of children with implants in general schools is recognized but these await further resources.
PP27 A Prototype Patient Advocate Decision Aid For Oncology HTA
Authors: Thomas Samuel , Paddock Silvia , Shortenhaus Scott , Zummo Jacqueline
Published: January 2019

Introduction:

Patient advocates need to process vast amounts of information to accurately and effectively represent heterogeneous patient groups and make meaningful contributions to HTA decisions. Although a wealth of data is available from a variety of sources, it is not often curated in user-friendly ways. Patient representatives have frequently requested tailored resources that allow them to mine the existing literature in preparation for their engagements. Developing such resources constitutes a complex challenge that requires contributions and scrutiny from multiple stakeholders.

Methods:

We previously developed the Continuous Innovation Indicators™ (CII), an evidence-based tool to assess treatments for twelve solid tumors (freely available at www.scoringprogress.com). The foundation of the CII is a rigorous assessment of published evidence for increased overall survival. Based on feedback from patient advocates, we are expanding the framework to include information on adverse events and other patient-centered outcomes for selected prototype indications.

Results:

We present a novel, flexible framework that combines evidence of efficacy with published results on other outcomes that matter to patients. Menus and outputs are designed to facilitate dialogue between advocates, clinicians, and HTA professionals. By allowing the user to adjust settings based on known heterogeneity among subpopulations, the tool's output can be used to inform discussions about the value of new interventions for defined patient segments.

Conclusions:

Patient representatives must frequently identify knowledge gaps in the literature before their HTA engagements and leverage this information to conduct surveys among their constituents. Our new patient advocate decision aid can support this process and facilitate a better understanding of the value of new innovations for diverse subgroups. A better definition of target populations will help to achieve balance between patient access and budget impact of new treatments. We seek feedback on our prototype from all stakeholders to further improve and maximize utility of this tool.
PP35 The National Oral Health Policy In Brazil: A Review Of The Literature
Authors: Horbach Aurea , Baldisserotto Julio
Published: January 2019

Introduction:

The National Oral Health Policy (NOHP) “Smiling Brazil” was launched in 2004, with the goal of reorienting the model of oral health care in the Unified Health System. Up to then, this area was impaired by limited access and curative procedures. The NOHP aims to reorganize Primary Health Care in Oral Health, expand and qualify Specialized Care and add fluoride in the public water supply. This review will bring a reflective view of NOHP evaluation.

Methods:

This review work searched for evidence on the Bireme and Google Academic databases, with the keywords “Evaluation” and “National Oral Health Policy” in October 2017. The search was limited to full texts in Portuguese, English and Spanish. After reading the titles, the abstracts and finally the complete texts, the articles that did not correspond to the evaluation objective of the NOHP were excluded.

Results:

Of the 381 initial articles found, fifteen were selected for inclusion in this study. The majority reported advances in the quality and scope of oral health care with expanded access and provision of services, such as preventive actions, health education, fluoridation of the public water supply and an increase in population coverage. There was also an improvement in the main indicators, in resolution, financial investments and epidemiological surveys. Moreover, few studies showed improvement in user satisfaction. Conversely, difficulties were identified in overcoming the traditional care model, in training and professional appreciation. Challenges included the need to expand access to fluoridated water, increase coverage, build a more comprehensive care network and reduce regional disparities.

Conclusions:

After 13 years, advances and challenges can be observed in the quality and comprehensiveness of oral health care in Brazil. There is evident improvement in indicators; however there remains a lack of access and resolution in the actions, with a large number of regional discrepancies.