Assessments
PATIENT WEB PORTALS AND PATIENT–PROVIDER RELATIONSHIPS: A SUMMARY PERSPECTIVE
- Hannah D. Caldwell, Neil B. Minkoff, Kalyani Murthy
-
- Published online by Cambridge University Press:
- 24 April 2017, pp. 63-68
-
- Article
- Export citation
-
Objectives: Patient Web portals (PWPs) have been gaining traction as a means to collect patient-reported outcomes and maintain quality patient care between office visits. PWPs have the potential to impact patient–provider relationships by rendering additional channels for communication outside of clinic visits and could help in the management of common chronic medical conditions. Studies documenting their effect in primary care settings are limited. This perspective aims to summarize the benefits and drawbacks of using PWPs in the management of chronic conditions, such as diabetes mellitus, hypertension, and asthma, focusing on communication, disease management, compliance, potential barriers, and the impact on patient–provider dynamic. After a review of these topics, we present potential future directions.
Methods: We conducted an exploratory PubMed search of the literature published from inception through December 2015, and focused our subsequent searches specifically to assess benefits and drawbacks of using PWPs in the management of diabetes mellitus, hypertension, and asthma.
Results: Our search revealed several potential benefits of PWP implementation in the management of chronic conditions with regards to patient–provider relationships, such as improved communication, disease management, and compliance. We also noted drawbacks such as potentially unreliable reporting, barriers to use, and increased workload.
Conclusions: PWPs offer opportunities for patients to report symptoms and outcomes in a timely manner and allow for secure online communication with providers. Despite the drawbacks noted, the overall benefits from successful PWP implementation could improve patient–provider relationships and help in the management of chronic conditions, such as diabetes mellitus, hypertension, and asthma.
Methods
A SYSTEMATIC APPROACH FOR ASSESSING, IN THE ABSENCE OF FULL EVIDENCE, WHETHER MULTICOMPONENT INTERVENTIONS CAN BE MORE COST-EFFECTIVE THAN SINGLE COMPONENT INTERVENTIONS
- Part of:
- Janne C. Mewes, Lotte M.G. Steuten, Maarten J. IJzerman, Wim H. van Harten
-
- Published online by Cambridge University Press:
- 11 September 2017, pp. 444-453
-
- Article
- Export citation
-
Objectives: Multicomponent interventions (MCIs), consisting of at least two interventions, are common in rehabilitation and other healthcare fields. When the effectiveness of the MCI versus that of its single interventions is comparable or unknown, evidence of their expected incremental cost-effectiveness can be helpful in deciding which intervention to recommend. As such evidence often is unavailable this study proposes an approach to estimate what is more cost-effective; the MCI or the single intervention(s).
Methods: We reviewed the literature for potential methods. Of those identified, headroom analysis was selected as the most suitable basis for developing the approach, based on the criteria of being able to estimate the cost-effectiveness of the single interventions versus that of the MCI (a) within a limited time frame, (b) in the absence of full data, and (c) taking into account carry-over and interaction effects. We illustrated the approach with an MCI for cancer survivors.
Results: The approach starts with analyzing the costs of the MCI. Given a specific willingness-to-pay-value, it is analyzed how much effectiveness the MCI would need to generate to be considered cost-effective, and if this is likely to be attained. Finally, the cost-effectiveness of the single interventions relative to the potential of the MCI for being cost-effective can be compared.
Conclusions: A systematic approach using headroom analysis was developed for estimating whether an MCI is likely to be more cost effective than one (or more) of its single interventions.
Assessments
CASE STUDY ON AN IPILIMUMAB COST-CONTAINMENT STRATEGY IN AN ITALIAN HOSPITAL
- Alberto Russi, Vanna Chiarion-Sileni, Vera Damuzzo, Francesca Di Sarra, Jacopo Pigozzo, Angelo Claudio Palozzo
-
- Published online by Cambridge University Press:
- 13 July 2017, pp. 199-205
-
- Article
- Export citation
-
Objectives: Ipilimumab is the first licensed immune checkpoint inhibitor for treatment of melanoma. The promising results of the registration clinical study need confirmation in real practice and its clinical success comes together with a relevant budget impact due to the high price of this drug. The aim of this work is to describe a new model of economical sustainability of ipilimumab developed in an Italian reference center for melanoma treatment.
Methods: This retrospective, observational, and monocentric study was carried out at the Veneto Institute of Oncology. Ipilimumab was administered to fifty-seven patients with advanced melanoma. Overall survival, progression free survival, and toxicity were evaluated. A local management procedure was evaluated together with the cost-saving strategies implemented by the Italian Medicines Agency (AIFA).
Results: We demonstrated that the use of ipilimumab for metastatic melanoma in real practice had an efficacy and toxicity similar to that reported in the literature. In this scenario, our management model (centralization of compounding + drug-day) permitted savings up to the 11.1 percent of the gross cost for the drug (calculated assuming that no cost saving procedures were applied) while the policy of cost containment designed by AIFA produced an additional 6.2 percent of savings.
Conclusions: In real practice conditions, the centralized administration of ipilimumab allows to replicate the results of clinical studies and in the meantime to contain the cost associated with this drug. The local strategy of management can be readily applied to most of the high cost drugs compounded in the hospital pharmacy. Impact of findings on practice: (i) We describe a new model of economic sustainability (drug-day, centralization of compounding, payback systems) of an expensive and innovative drug, ipilimumab, for treatment of melanoma within an Italian cancer center. (ii) This pivotal study demonstrated that a cost containment strategy is feasible and it needs the cooperation of all healthcare providers (oncologists, pharmacists, nurses, and technicians) to guarantee the full efficiency of the process.
Theme Submissions
INTEGRATE-HTA: A LOW- AND MIDDLE-INCOME COUNTRY PERSPECTIVE
- Leon Bijlmakers, Debjani Mueller, Rabia Kahveci, Yingyao Chen, Gert Jan van der Wilt
-
- Published online by Cambridge University Press:
- 06 November 2017, pp. 599-604
-
- Article
- Export citation
-
Objectives: The INTEGRATE-HTA project recommends that complexity be taken into account when conducting health technology assessments (HTAs) and suggests a five-step process for doing that. This study examines whether the approach suggested by INTEGRATE-HTA could be useful, appropriate, and feasible in the context of low- and middle-income countries (LMIC) given some of the typical challenges that healthcare systems face in those countries.
Methods: A nonexhaustive literature review was performed on the implementation in low and middle income countries of the five aspects recommended by the INTEGRATE-HTA project, using the following search terms: national health planning, health sector strategy, health sector performance, assessment criteria, health (management) information, complexity, context, stakeholder consultation.
Results: HTA is being practiced in LMIC in various ways and through different mechanisms, for example in health sector reviews, even though it is usually not referred to as HTA. It does not necessarily follow the five steps distinguished in the INTEGRATE-HTA model (scoping; defining the initial logic model; providing concepts and methods to identify, collect, and synthesize evidence in relation to various dimensions; extracting and presenting evidence in respect of agreed assessment criteria; providing guidance to draw conclusions and formulate recommendations).
Conclusions: The conditions for functional HTA are not always fulfilled in LMICs. At least four aspects would require special attention: (a) the scope and quality of routine health information that can support and be fed into health technology assessments and strategic planning; (b) consensus on health system performance assessment frameworks and their main criteria, in particular the inclusion of social disparities/equity and sustainability; (c) institutional capacity to set evidence-based priorities based on a variety of explicit criteria; (d) political will to engage with stakeholders in a transparent and inclusive consultation process about health priorities.
Methods
METHODOLOGICAL QUALITY OF ECONOMIC EVALUATIONS ALONGSIDE TRIALS OF KNEE PHYSIOTHERAPY
- Part of:
- Lidia García-Pérez, Renata Linertová, Alejandro Arvelo-Martín, Carolina Guerra-Marrero, Carlos Enrique Martínez-Alberto, Leticia Cuéllar-Pompa, Antonio Escobar, Pedro Serrano-Aguilar
-
- Published online by Cambridge University Press:
- 31 August 2017, pp. 454-462
-
- Article
- Export citation
-
Objectives: The methodological quality of an economic evaluation performed alongside a clinical trial can be underestimated if the paper does not report key methodological features. This study discusses methodological assessment issues on the example of a systematic review on cost-effectiveness of physiotherapy for knee osteoarthritis.
Methods: Six economic evaluation studies included in the systematic review and related clinical trials were assessed using the 10-question check-list by Drummond and the Physiotherapy Evidence Database (PEDro) scale.
Results: All economic evaluations were performed alongside a clinical trial but the studied interventions were too heterogeneous to be synthesized. Methodological quality of the economic evaluations reported in the papers was not free of drawbacks, and in some cases, it improved when information from the related clinical trial was taken into account.
Conclusions: Economic evaluation papers dedicate little space to methodological features of related clinical trials; therefore, the methodological quality can be underestimated if evaluated separately from the trials. Future economic evaluations should follow more strictly the recommendations about methodology and the authors should pay special attention to the quality of reporting.
Assessments
DOSAGE AND DURATION OF ETANERCEPT THERAPY FOR ANKYLOSING SPONDYLITIS: A META-ANALYSIS
- Heeyoung Lee, Younjoo Jung, Seungyeon Song, Jihyung Lee, Hyunjun Shim, Wonku Kang, Eunyoung Kim
-
- Published online by Cambridge University Press:
- 24 April 2017, pp. 69-75
-
- Article
- Export citation
-
Objectives: We conducted a meta-analysis of recently published randomized controlled trials (RCTs) to identify the most effective and safe etanercept dosing regimen and duration of therapy for the treatment of patients with ankylosing spondylitis (AS).
Methods: We systematically reviewed PubMed, Embase, Cochrane Library, and Web of Science databases for RCTs. The proportion of patients attaining 20 percent improvement (according to the Spondyloarthritis International Society response criteria [ASAS 20]) was evaluated as a primary outcome. Secondary outcomes included 50 percent increase in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI 50) used for evaluating efficacy, as well as the BASDAI/Bath Ankylosing Spondylitis Functional Index (BASFI) scores and adverse events.
Results: ASAS 20 indicated that the efficacy of etanercept did not differ amongst dosing regimens (25 mg twice-weekly versus 50 mg once-weekly: relative risk [RR], 2.18, 95 percent confidence interval [CI], 1.78–2.67 versus RR, 2.00, 95 percent CI, 1.70–2.37). The ASAS 20 reported subgroup differences among treatment durations of less than 12 weeks (RR, 2.70; 95 percent CI, 2.09–3.49); 12 weeks (RR, 1.74; 95 percent CI, 1.37–2.22); and more than 12 weeks (RR, 2.56; 95 percent CI, 1.88–3.48). Other outcomes included BASDAI, BASDAI 50, and BASFI. Drug safety differed according to the treatment regimen and duration.
Conclusion: Our meta-analysis found that there was no significant efficacy difference between 50 mg once-weekly and 25 mg twice-weekly dosing for the treatment of AS, and a dosing duration of less than 12 weeks was more effective for treating AS patients.
Policies
LEGITIMACY OF MEDICINES FUNDING IN THE ERA OF ACCELERATED ACCESS
- Jessica Pace, Sallie-Anne Pearson, Wendy Lipworth
-
- Published online by Cambridge University Press:
- 12 September 2017, pp. 700-707
-
- Article
- Export citation
-
Objectives: In recent years, numerous frameworks have been developed to enhance the legitimacy of health technology assessment processes. Despite efforts to implement these “legitimacy frameworks,” medicines funding decisions can still be perceived as lacking in legitimacy. We, therefore, sought to examine stakeholder views on factors that they think should be considered when making decisions about the funding of high-cost breast cancer therapies, focusing on those that are not included in current frameworks and processes.
Methods: We analyzed published discourse on the funding of high-cost breast-cancer therapies. Relevant materials were identified by searching the databases Google, Google Scholar, and Factiva in August 2014 and July 2016 and these were analyzed thematically.
Results: We analyzed fifty published materials and found that stakeholders, for the most part, want to be able to access medicines more quickly and at the same time as other patients and for decision makers to be more flexible with regards to evidence requirements and to use a wider range of criteria when evaluating therapies. Many also advocated for existing process to be accelerated or bypassed to improve access to therapies.
Conclusions: Our results illustrate that a stakeholder-derived conceptualization of legitimacy emphasizes principles of accelerated access and is not fully accounted for by existing frameworks and processes aimed at promoting legitimacy. However, further research examining the ethical, political, and clinical implications of the stakeholder claims raised here is needed before firm policy recommendations can be made.
Assessments
ASSESSMENT OF UNIVERSAL NEWBORN HEARING SCREENING AND INTERVENTION IN SHANGHAI, CHINA
- Xiuzhi Chen, Min Yuan, Jun Lu, Qi Zhang, Mei Sun, Fengshui Chang
-
- Published online by Cambridge University Press:
- 06 June 2017, pp. 206-214
-
- Article
- Export citation
-
Objectives: The aim of this study was to evaluate the universal newborn hearing screening (UNHS) and intervention program in Shanghai, China.
Methods: This study included the quantitative analyses of the UNHS-Shanghai database in 2002–12 and qualitative assessment of the program. The Otoacoustic Emissions and the Automated Auditory Brainstem Evoked Responses tests were conducted in screening. The costs and benefits were calculated based on the number of participants in each stage. The short-term and long-term periods were defined as from birth to 15 years of age or to death (82-year-olds), respectively. Sensitivity analyses were conducted.
Results: A total 1,574,380 newborns were included, representing 93.6 percent of all eligible babies in Shanghai during the study period. The prevalence of newborn hearing loss was 1.66‰. The short-term/long-term program costs were ¥488.5 million (US$75.52 million)/¥1.08 billion (US$167.12 million), and the short-term/long-term program benefit was ¥980.1 million (US$151.53 million)/¥8.13 billion (US$1.26 billion). The program benefit was greater than its cost if the proportion of hearing-loss children enrolled in regular schools was no less than 41.4 percent of all hearing impaired children, as well as if the wage growth rate ranged from 3 percent to 8 percent. Qualitative results also suggested that stakeholders strongly supported this program.
Conclusions: The universal newborn hearing screening and intervention program in Shanghai is justified in terms of the resource input in the long run, although there is still room for further improvement with respect to educational rehabilitation and a better infrastructure system.
Oral Presentations
OP16 A Patient-centered Value Framework For Healthcare In Hemophilia
- Brian O'Mahony, Gerard Dolan, Diane Nugent, Clifford Goodman
-
- Published online by Cambridge University Press:
- 12 January 2018, pp. 8-9
-
- Article
-
- You have access Access
- Export citation
-
INTRODUCTION:
Hemophilia is a rare, inherited bleeding disorder affecting an estimated 400,000 people worldwide (1). Characterized by spontaneous bleeding and long-term, irreversible joint damage, persons with hemophilia are often limited in normal day-to-day activities, including work/school, and require comprehensive care at specialized treatment centers. With replacement therapies extending survival by decades and vastly improving quality of life (QoL), routine prophylaxis is considered the standard-of-care in developed countries. However, due to the cost of replacement factor, access to treatment remains a challenge, and increased scrutiny over funding has been augmented by growing demands on healthcare budgets (2). Thus, the hemophilia community shares a unified goal of objectively defining patient-centered value in hemophilia care.
METHODS:Using a three-tiered outcomes hierarchy model initially described by Porter (3), an international, multidisciplinary panel of health economics outcomes researchers and hemophilia experts developed a value framework for decision makers to assess value of various healthcare interventions in hemophilia.
RESULTS:The three tiers for assessing value are: (i) Health status achieved/retained; (ii) Process of recovery; and (iii) Sustainability of health. Tier one measures survival, quality of life (QoL), and hemophilia-specific outcomes of bleeding frequency, musculoskeletal complications, and severe bleeds, as well as function/activity (that is, lifestyle impairment). Tier two measures time to initial treatment or recovery and time missed at education/work, as well as disutility of care (that is, inhibitor development, pathogen transmission/infections, orthopedic intervention, and venous access). Tier three measures avoidance of bleeds, maintenance of productive lives, and long-term health, while capturing long-term consequences of insufficient therapy or age-related complications. Applicability of the framework can be demonstrated in areas of healthcare delivery, treatment regimen, and innovation for new therapies.
CONCLUSIONS:This value framework represents an initial collaboration with stakeholders to define and organize an array of patient-centric outcomes of importance in hemophilia into a practical tool that can influence treatment and funding decisions in hemophilia care.
Theme Submissions
HEALTH TECHNOLOGY ASSESSMENT IN CENTRAL, EASTERN, AND SOUTH EUROPEAN COUNTRIES: CROATIA
- Mirjana Huic, Romana Tandara Hacek, Ivan Svajger
-
- Published online by Cambridge University Press:
- 14 August 2017, pp. 376-383
-
- Article
- Export citation
-
Objectives: The aim of this study was to provide a brief, 7-year history of health technology assessment (HTA) implementation in Croatia through national and international activities.
Methods: We used retrospective descriptive analysis of key documents related to the legal framework, process of decision making, and HTA. Analysis of the Agency's plan for and experience with the implementation of a transparent HTA process in Croatia was performed by addressing seven key components of the HTA implementation scorecard framework. The main challenges and facilitating factors were also assessed.
Results: HTA is not yet fully implemented in Croatia. The main challenges are the insufficient legal framework, limited human and financial resources, and limited stakeholder involvement. Facilitating factors are active international collaboration and education through EUnetHTA and the International Society for Pharmacoeconomics and Outcomes Research and production of national and international HTA reports.
Conclusions: The HTA process is not yet sustainable in Croatia and HTA reports are still not mandatory for reimbursement/investment or disinvestment decision processes. There are still barriers to overcome.
INTEGRATE-HTA: THE PERSPECTIVE OF EUnetHTA
- Kristian Lampe, Petra Schnell-Inderst
-
- Published online by Cambridge University Press:
- 06 September 2017, pp. 605-608
-
- Article
- Export citation
-
The HTA Core Model (HTACM) of EUnetHTA and the INTEGRATE-HTA Model (IHTAM) both provide HTA experts with advanced guidance on how to assess health technologies. In this study, we examine the similarities and differences of the two models, identifying synergies and opportunities for future collaboration. We also consider how such an alignment of the HTACM and IHTAM might be done in practice and present some alternative practical approaches. Overall the two models share several similarities, primarily the perception of HTA as a multidisciplinary analysis that needs to be adjusted according to the properties of the technology under assessment.
Assessments
CARDIOVASCULAR SCREENING OF YOUNG ATHLETES: A REVIEW OF ECONOMIC EVALUATIONS
- Sophie Gerkens, Hans Van Brabandt, Anja Desomer, Christian Leonard, Mattias Neyt
-
- Published online by Cambridge University Press:
- 24 April 2017, pp. 76-83
-
- Article
- Export citation
-
Objectives: Some experts have promoted preparticipative cardiovascular screening programs for young athletes and have claimed that such programs were cost-effective without performing a critical analysis of studies supporting this statement. In this systematic review, a critical assessment of economic evaluations on these programs is performed to determine if they really provide value for money.
Methods: A systematic review of economic evaluations was performed on December 24, 2014. Web sites of health technology assessment agencies, the Cochrane database of systematic review, the National Health Service Economic Evaluation Database of the Cochrane Library, EMBASE, Medline, Psychinfo, and EconLit were searched to retrieve (reviews of) economic evaluations. No language or time restrictions were imposed and predefined selection criteria were used. Selected studies were critically assessed applying a structured data extraction sheet.
Results: Five relevant economic evaluations were critically assessed. Results of these studies were mixed. However, those in favor of screening made (methodological) incorrect choices, of which the most important one was not taking into account a no-screening alternative as comparator. Compared with no screening, other strategies (history and physical examination or history and physical examination plus electrocardiogram) were not considered cost-effective.
Conclusions: Results of primary economic evaluations should not be blindly copied without critical assessment. Economic evaluations in this field lack the support of robust evidence. Negative consequences of screening (false positive findings, overtreatment) should also be taken into account and may cause more harm than good. A mass screening of young athletes for cardiovascular diseases does not provide value for money and should be discouraged.
PHARMACOECONOMIC STUDIES IN WORLD HEALTH ORGANIZATION EASTERN MEDITERRANEAN COUNTRIES: REPORTING COMPLETENESS
- Qais Alefan, Karen Rascati
-
- Published online by Cambridge University Press:
- 05 June 2017, pp. 215-221
-
- Article
- Export citation
-
Objectives: The aim of this study was to evaluate the extent of reporting necessary information in published health economic research in World Health Organization Eastern Mediterranean Countries (WHO EMC).
Methods: A systematic literature search was conducted using PubMed and Google Scholar to identify pharmacoeconomic studies conducted in WHO EMC. The inclusion criteria for the studies were: (i) original studies, (ii) compared pharmaceutical services or drugs, (iii) conducted in WHO EMC, (iv) manuscript published in English. The articles were reviewed by two independent reviewers using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist.
Results: A total of seventeen studies were included, each of which were published in seventeen different journals. The mean CHEERS checklist score was 16 ± 4. Most studies were published in journals outside WHO EMC (n = 12; 71 percent). Cost-effectiveness (n = 5; 29 percent) and cost-utility analyses (n = 5; 29 percent) were the most frequently used methods of economic evaluation.
Conclusions: Pharmacoeconomic studies in WHO EMC are limited and sometimes incomplete. Economic evaluation of pharmaceuticals should be encouraged in WHO EMC to ensure the appropriate allocation of healthcare resources.
Theme Submissions
HEALTH TECHNOLOGY ASSESSMENT IN SERBIA
- Dragana Atanasijevic, Vladimir Zah
-
- Published online by Cambridge University Press:
- 30 June 2017, pp. 384-389
-
- Article
- Export citation
-
Objectives: This study provides an overview of the Republic of Serbia healthcare system and describes the process of developing and conducting health technology assessment (HTA).
Methods: The authors performed pragmatic, nonsystematic literature review based on available statistical data, legislation, and studies.
Results: Healthcare law creates conditions that allow implementation of the principle “value for money.” The institutions directly vested in the implementation of HTA are the National Health Insurance Fund (NHIF) and the Ministry of Health (MoH). There are some reflections of the efforts by NHIF and MoH toward achieving this goal.
Conclusions: Despite the highly set objectives, there is still a lot of work to be done to build an adequate model to support decision-making processes to bridge the discrepancies between broadly defined rights to health care and limited resources in the country.
Methods
EXPLORATION AND PREFERENTIAL RANKING OF PATIENT BENEFITS OF MEDICAL DEVICES: A NEW AND GENERIC INSTRUMENT FOR HEALTH ECONOMIC ASSESSMENTS
- Part of:
- Eva Lesén, Ingela Björholt, Anders Ingelgård, Fredrik J. Olson
-
- Published online by Cambridge University Press:
- 25 October 2017, pp. 463-471
-
- Article
-
- You have access Access
- Open access
- HTML
- Export citation
-
Objectives: For medical devices, benefits other than direct clinical effects may have a large impact on the patients’ well-being, but a standardized method for measuring these benefits is unavailable. The objective was to explore potential patient benefits provided by medical devices, and to assess the relative preferences of these benefits in the general Swedish population.
Methods: To identify attributes of patient benefit, healthcare personnel within a wide range of disease areas were interviewed. The generalized attributes were then validated among healthcare personnel, patient organizations, and manufacturers; in two pilot studies in the general population; and in two rounds of cognitive interviews. The general population's preferences of the attributes were measured with a usability-tested questionnaire in a final responding sample of 3,802 individuals, representative of the Swedish population.
Results: Twenty attributes were identified, encompassing aspects of integrity, sense of security, social participation, and convenience. When measuring the relative preferences, the response rate was 37.0 percent, and the results showed that the attributes with the highest preferences concerned reliability, reduced need for assistance, and sense of control of the illness/disability.
Conclusions: A set of twenty attributes of patient benefit relevant to users of medical devices was identified and validated. A questionnaire for patient-reported assessment of the benefits provided by a medical device was developed, based on the attributes. The questionnaire, designated MedTech20, provides a generic measurement method for the evaluation of medical devices used in a wide range of diseases/disabilities.
Policies
MEDICAL DEVICE RECALLS IN CANADA FROM 2005 TO 2015
- Anna R. Gagliardi, Julie Takata, Ariel Ducey, Pascale Lehoux, Sue Ross, Patricia L. Trbovich, Anthony Easty, Chaim M. Bell, David R. Urbach
-
- Published online by Cambridge University Press:
- 18 September 2017, pp. 708-714
-
- Article
- Export citation
-
Objectives: Medical devices are ubiquitous in modern medical care. However, little is known about the epidemiology of medical devices in the healthcare marketplace, including the rate at which medical devices are subject to recalls or other advisories. We sought to study the epidemiology of medical devices in Canada, focusing on device recalls. In Canada, a recall may signify a variety of events, ranging from relatively minor field safety notifications, to removal of a product from the marketplace.
Methods: We used data from Health Canada to study medical device recalls in Canada from 2005 to 2015. We analyzed the risks of medical device recalls according to the risk class of the device (I lowest; IV highest) and the hazard priority of the recall (Type I highest potential harm; Type III lowest potential harm).
Results: During a 10-year period, there were 7,226 medical device recalls. Most recalls were for intermediate risk class (Class II, 40.1 percent; Class III, 38.7 percent) medical devices. Among recalled devices, 5.0 percent were judged to have a reasonable probability of serious adverse health consequences or death (Type I recall Hazard Priority classification). While the number of medical devices marketed in Canada is not known, over a similar 10-year period, 24,849 new Class II, II, and IV medical device licenses were issued by Health Canada.
Conclusions: Several hundred medical device recalls occur in Canada each year. Further research is needed to characterize the nature of medical device recalls, and to explore how consumers use information about recalls.
Oral Presentations
OP19 Unlocking The Potential Of Established Products: Need For Incentives
- Gabrielle Nayroles, Sylvie Gabriel, Mondher Toumi, Åsa Kornfeld, Patrycja Jaros, Sandrine Frybourg, Fernando Antoñanzas, Jaime Espín, Claudio Jommi, Nello Martini, Gérard de Pouvourville, Keith Tolley, Jürgen Wasem
-
- Published online by Cambridge University Press:
- 12 January 2018, p. 9
-
- Article
-
- You have access Access
- Export citation
-
INTRODUCTION:
Re-purposing of established products (EPs) – defined as marketed for 8 years or more – may represent a high value for patients and society. It has been recognized by the European Commission as an important factor contributing to greater access to new therapies. Due to a lower development cost, it could also represent a cost-effective alternative and help to reduce pressure on healthcare budgets. However, it is perceived that no financial incentives exist for the pharmaceutical industry to invest in new indications for EPs. The objective of this research was to review current European regulations and propose strategies stimulating development in this field.
METHODS:We performed a targeted literature review and held two international expert panel workshops to discuss current policies and their implications, and issue recommendations for changes.
RESULTS:Within the current regulatory framework EPs face price cuts due to generic competition, reference pricing (RP), price re-negotiations or systematic price cuts, after a period of marketing presence. Extension of indications does not permit to increase or maintain the price. Generic substitution regardless of indication poses another challenge. Limited incentives in the form of an additional year of market protection exists only for new indication(s) registered within the first 8 years following initial approval. The expert panel proposed several strategies to stimulate development in this field, including: (i) extending the period in which registering a new indication results in additional market protection beyond 8 years and extending the duration of additional market protection; (ii) delaying inclusion in RP for EPs with a new value adding indication; (iii) establishing a differential pricing by indication; (iv) preventing temporarily generic substitution when an EP is prescribed for a new indication.
CONCLUSIONS:Current regulations represent a serious disincentive to develop new indications for EPs. Regulatory and pricing policy changes are needed to stimulate development in this important field.
OP21 Involving Clinical Experts In Prioritizing Topics For Health Technology Assessment: A Randomized Controlled Trial
- Andrew Cook, Elke Streit, Gill Davage
-
- Published online by Cambridge University Press:
- 12 January 2018, pp. 9-10
-
- Article
-
- You have access Access
- Export citation
-
INTRODUCTION:
The National Institute for Health Research Health Technology Assessment (NIHR HTA) Programme commissions research to inform health services in the United Kingdom. The program prioritises research ideas from literature, guidelines, patients, and clinicians, to decide which research should be funded. We get clinical input on these ideas through (i) committees of clinicians and patients and (ii) seeking written advice from multiple clinicians — a refereeing process. Chairs of our committees suggested that the material we sent to clinicians was too extensive and the method of response too burdensome. We set out to determine whether reducing the information provided or burden of response would improve the engagement of clinicians with our processes, and hence improve the quality of advice provided, and the research available to health services.
METHODS:We undertook a factorial randomized controlled trial (University of Southampton Faculty of Medicine Ethics Committee #8192, Trial registration: ACTRN12614000167662). Each participant was randomized to receive one of two types of material to comment on, and one of two means to respond. In the first allocation participants were randomised in a 1:1 ratio between receiving a ‘vignette’ (a briefing paper of up to ten pages discussing possible research = usual practice), or a ‘commissioning brief’ (a single page summarising the proposed research). In the second allocation, the method of response was randomized, between a structured form and free text email.
RESULTS:We randomized 460 clinical experts, and 356 (77.4 percent) responded. The responses were graded for quality on a scale of 0 to 4 (higher scores better). Non-response was scored as 0. Analysis using ANOVA gave results of a structured response scoring .34 points (Standard Deviation, SD .36) over a freeform response (p = .02); and the commissioning brief as .04 points over a vignette (p = .81).
CONCLUSIONS:This was the first randomized trial to take place inside the secretariat of the HTA program. The difference in quality score between the brief and the vignette allocations was neither statistically nor practically important. The difference between the structured and freeform response was statistically significant, and sufficiently large to be important in practice. While the choice of material to share with clinicians seems unimportant we have shown that it is worth sending a structured response form to experts.
Policies
EVALUATION OF PATIENT AND PUBLIC INVOLVEMENT INITIATIVES IN HEALTH TECHNOLOGY ASSESSMENT: A SURVEY OF INTERNATIONAL AGENCIES
- Laura Weeks, Julie Polisena, Anna Mae Scott, Anke-Peggy Holtorf, Sophie Staniszewska, Karen Facey
-
- Published online by Cambridge University Press:
- 10 November 2017, pp. 715-723
-
- Article
-
- You have access Access
- Open access
- HTML
- Export citation
-
Objectives: Although there is increased awareness of patient and public involvement (PPI) among health technology assessment (HTA) organizations, evaluations of PPI initiatives are relatively scarce. Our objective as members of Health Technology Assessment International's (HTAi's) Patient and Citizen Involvement Group (PCIG) was to advance understanding of the range of evaluation strategies adopted by HTA organizations and their potential usefulness.
Methods: In March 2016, a survey was sent to fifty-four HTA organizations through the International Network of Agencies for Health Technology Assessment (INAHTA) and contacts of members of HTAi's PCIG. Respondents were asked about their organizational structure; how patients and members of the public are involved; whether and how PPI initiatives have been evaluated, and, if so, which facilitators and challenges to evaluation were found and how results were used and disseminated.
Results: Fifteen (n = 15) programs from twelve countries responded (response rate 27.8 percent) that involved patients (14/15) and members of the public (10/15) in HTA activities. Seven programs evaluated their PPI activities, including participant satisfaction (5/7), process (5/7) and impact evaluations (4/7). Evaluation results were used to improve PPI activities, identify education and training needs, and direct strategic priorities. Facilitators and challenges revolved around the need for stakeholder buy-in, sufficient resources, senior leadership, and including patients in evaluations.
Conclusions: A small but diverse set of HTA organizations evaluate their PPI activities using a range of strategies that reflect the range of rationales and approaches to PPI in HTA. It will be important for HTA organizations to draw on evaluation theories and methods.
Methods
PERFORMANCE OF OVID MEDLINE SEARCH FILTERS TO IDENTIFY HEALTH STATE UTILITY STUDIES
- Part of:
- Mick Arber, Sonia Garcia, Thomas Veale, Mary Edwards, Alison Shaw, Julie M. Glanville
-
- Published online by Cambridge University Press:
- 25 October 2017, pp. 472-480
-
- Article
- Export citation
-
Objectives: This study was designed to assess the sensitivity of three Ovid MEDLINE search filters developed to identify studies reporting health state utility values (HSUVs), to improve the performance of the best performing filter, and to validate resulting search filters.
Methods: Three quasi-gold standard sets (QGS1, QGS2, QGS3) of relevant studies were harvested from reviews of studies reporting HSUVs. The performance of three initial filters was assessed by measuring their relative recall of studies in QGS1. The best performing filter was then developed further using QGS2. This resulted in three final search filters (FSF1, FSF2, and FSF3), which were validated using QGS3.
Results: FSF1 (sensitivity maximizing) retrieved 132/139 records (sensitivity: 95 percent) in the QGS3 validation set. FSF1 had a number needed to read (NNR) of 842. FSF2 (balancing sensitivity and precision) retrieved 128/139 records (sensitivity: 92 percent) with a NNR of 502. FSF3 (precision maximizing) retrieved 123/139 records (sensitivity: 88 percent) with a NNR of 383.
Conclusions: We have developed and validated a search filter (FSF1) to identify studies reporting HSUVs with high sensitivity (95 percent) and two other search filters (FSF2 and FSF3) with reasonably high sensitivity (92 percent and 88 percent) but greater precision, resulting in a lower NNR. These seem to be the first validated filters available for HSUVs. The availability of filters with a range of sensitivity and precision options enables researchers to choose the filter which is most appropriate to the resources available for their specific research.