Poster Presentations
PP08 Evaluation Of The Brazilian Health Technology Assessment Network
- Cecília Menezes Farinasso, Dalila Fernandes Gomes, Betânia Ferreira Leite, Roberta Borges Silva, Daniela Fortunato Rêgo, Aurelina Aguiar de Lima, Lenilson Pereira Gonçalves, Luciana Simões, Camara Leão, Camile Giaretta Sachetti
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- Published online by Cambridge University Press:
- 31 December 2019, p. 38
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Introduction
The Brazilian Network for Health Technology Assessment (REBRATS) is a network of collaborating centers and teaching and research institutions, focused on the generation and synthesis of scientific evidence in the field of health technology assessment. Currently, the network is composed of 119 member institutions and mobilizes approximately 1,094 researchers and 4,998 relations. The objective of this study was to evaluate the member institutions of REBRATS.
MethodsThe evaluation process was developed in seven stages, including the identification of the objectives of the Network; identification of evaluation criteria; selection of performance indicators for each criterion; identification of the measures appropriate to each indicator; data collection and analysis; classification of the institutions and production of the final report.
ResultsThe evaluation of the member institutions of REBRATS mapped the capacity of these institutions to produce health technology assessment activities. The evaluation also provided information on the advances and challenges of health technology assessment in the country. In the long term, the initiative will contribute to the strengthening of the evaluation of health technology in Brazil, since the weaknesses of these institutions in the development of activities were mapped.
ConclusionsThe production of this study will contribute to the dissemination of the evaluation methodology at the national and international level. This study is one of the few initiatives that exist in the world on the evaluation of networks and will contribute to the strengthening of the evaluation of health technology in Brazil.
PP09 Cost-Effectiveness Of Chronic Obstructive Pulmonary Disease Management
- Thomas Plunkett, Paul Carty, Michelle O'Neill, Patricia Harrington, Susan M Smith, Mairin Ryan
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- Published online by Cambridge University Press:
- 31 December 2019, pp. 38-39
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Introduction
To inform the development of a national clinical guideline for Chronic Obstructive Pulmonary Disease (COPD), prioritized by the National Clinical Effectiveness Committee in Ireland, a systematic review was conducted to examine the cost-effectiveness of pulmonary rehabilitation programs (PRPs), outreach programs (OPs), and long-term oxygen therapy (LTOT), compared with usual care.
MethodsMedline, Embase, the Cochrane Library and grey literature sources were searched up to 19 June 2018. Studies evaluating cost-effectiveness published post-2008 in English were included. Screening, data extraction, and quality assessment using the Consensus Health Economic Criteria and International Society for Pharmacoeconomics questionnaires were conducted independently by two reviewers. Costs were converted to 2017 Irish Euro using consumer price indices for health and purchasing power parity.
ResultsFrom 8,661 articles identified, seven studies (one comparing both PRPs and LTOT) were included (PRPs: five; OPs: one; LTOT: two). PRP cost-utility analyses (n = 4) reported conflicting results due to considerable heterogeneity in program and study design, with incremental cost-effectiveness ratios (ICERs) ranging between EUR 12,391 and EUR 509,122 per quality adjusted life-year (QALY) gained. The remaining study investigated hospitalizations avoided and found outpatient and community-based PRPs to be dominant, while home-based PRP produced an ICER of EUR 1,913. OPs were found to be less costly, but also less effective. However, the results of the underpinning trial were neither statistically nor clinically significant. LTOT was found to be cost-effective, with ICERs of EUR 17,603 and EUR 26,936 per QALY gained.
ConclusionsApplying a willingness-to-pay threshold of EUR 45,000 per QALY gained, this systematic review found that, compared with usual care, there is inconsistent but generally favorable evidence for PRPs, no clear evidence for the cost-effectiveness of OPs, and that LTOT is likely to be cost-effective. However, there was a lack of methodologically robust studies included in the review and most were not directly transferable to the Irish context.
PP10 Quality Of Reporting Economic Evaluations In Rehabilitation Research
- Julie Flemming, Susan Armijo-Olivo, Dagmara Chojecki, Mike Paulden
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- Published online by Cambridge University Press:
- 31 December 2019, p. 39
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Introduction
Economic evaluations are a growing field of interest in the rehabilitation area. Research has questioned the quality of reporting of health economic evaluations. Poor reporting hinders the ability to provide accurate information for health care decision making. Therefore, the objectives of this study are to document on overall reporting quality of the published literature for rehabilitation economic evaluations; to identify if reporting quality has improved in health economic evaluations within the field of rehabilitation therapy since the publication of the Consolidated Health Economic Evaluation Reporting Standards (CHEERS); and to identify factors that could influence the reporting trends.
MethodsWe searched databases for economical evaluations performed in the rehabilitation area published between 2013 and 2018. Study selection was performed by two independent reviewers using Covidence software. Data extraction was conducted by one reviewer using Microsoft Excel and independently verified by another reviewer. The quality of reporting was evaluated independently by two reviewers using the CHEERS checklist.
ResultsThe search of the literature resulted in a total of 2195 published articles. Of these, 117 were considered to be potentially relevant. Independent review of these 117 articles led to the inclusion of 88 articles. This study is ongoing and complete results will be presented at the conference. Fifty papers have been analyzed in full. In general, the quality of reporting of the economical evaluations in the rehabilitation field was poor. The total mean and median for the CHEERS checklist was 17 points (out of 25) (range 8-24). Most of the analyzed studies did not report important methodological features of the economical evaluation as evaluated by the CHEERS checklist.
ConclusionsThe quality of reporting of economic evaluations in the rehabilitation field is poor and inconsistent. Commonly the methods of the analyzed studies are under reported, thereby creating challenges in determining whether the information presented is sound.
PP12 Cost-Utility Analysis Of Dolutegravir For HIV-1 Infection In Thailand
- Panida Yoopetch, Chalida Khemvaranan
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- Published online by Cambridge University Press:
- 31 December 2019, pp. 39-40
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Introduction
HIV drug resistance (HIVDR) has significantly increased in Thailand. However, a new generation integrase inhibitor, dolutegravir, has not yet been included in the country's National List of Essential Medicines (NLEM). Since these drugs are high in costs, an economic evaluation is needed to support the decision. This study aims to assess the cost-utility analysis of dolutegravir for HIV-1 infection in Thailand.
MethodsA Markov model was developed to evaluate the cost-utility as follows: (i) the current practice of darunavir/ritonavir (DRV/r) + tenofovir (TDF) + lamivudine (3TC); (ii) DRV/r + etravirine (ETR) + TDF + 3TC; (iii) DRV/r + raltegravir (RAL) + TDF + 3TC; (iv) DRV/r + RAL + ETR; and (v) DRV/r + RAL + maraviroc (MVC); (vi) DRV/r + dolutegravir (DTG) + MVC; (vii) DRV/r + DTG + ETR; (viii) DRV/r + DTG + TDF + 3TC. The model incorporated cost data adjusted for 2017 using the consumer price index, and effectiveness data from a review of published studies. Outcomes were measured in life years, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs), and future costs and outcomes were discounted at 3 percent per annum. Finally, a probabilistic sensitivity analysis was conducted to deal with uncertainties around the parameters.
ResultsAll alternative treatment regimens for HIV patients resistant to first- and second-line antiretroviral therapies (ARTs) in Thailand were found to be not cost-effective at the willingness-to-pay (WTP) of THB 160,000/QALY (USD 5,197/QALY). However, the eighth regimen of DRV/r + DTG + TDF + 3TC had the lowest lifetime cost at THB 5.3 million (USD 172,145) while increasing QALY by approximately 14 QALYs.
ConclusionsAt a societal WTP of THB 160,000 per QALY gained (USD 5,197 per QALY gained), dolutegravir for HIV patients resistant to first- and second-line ARTs in Thailand was found to be not cost-effective.
PP14 Budget Impact Of Sapropterin Dihydrochloride For Phenylketonuria
- Eduardo Mulinari, Nayara Castelano Brito, Lays Pires Marra
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- Published online by Cambridge University Press:
- 31 December 2019, p. 40
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Introduction
The National Committee for Health Technology Incorporation (CONITEC) evaluates health technologies to recommend their inclusion or exclusion within the Brazilian Public Health System (SUS), and uses the budget impact assessment to estimate costs to the system. The Ministry of Health (MS) guideline recommends treatment of phenylketonuria (PKU) with restricted phenylalanine diet and phenylalanine-free amino acid formula (PFAAf) supplementation. CONITEC evaluated the inclusion of sapropterin dihydrochloride for PKU in the SUS.
MethodsThe population eligible for treatment was evaluated by the number of patients receiving PFAAf between 2014 and 2017 registered in the SUS. Patients were stratified by age/weight and a simple linear regression was performed to estimate the future population. The costs of treatment and testing the responsiveness of sapropterin dihydrochloride were estimated according to the recommended dosage guideline of the MS, leaflet and public purchasing prices. A univariate deterministic sensitivity analysis was performed to evaluate different prices, responsiveness test methods and variations in the reduction of formula use.
ResultsThe incorporation of sapropterin dihydrochloride would generate an incremental budget impact in the SUS of around BRL 79 million (USD 21.7 million) in 2019 and BRL 300 million (USD 82.1 million) in five years (2019-2023). The univariate sensitivity analysis estimated that the incremental budget impact could be between BRL 66 and BRL 103 million (USD 18 and USD 28 million) in the first year and between BRL 251 and BRL 388 million (USD 69 and USD 106 million) in five years. Sensitivity analysis showed that the price of sapropterin dihydrochloride was the most sensitive variable in the model.
ConclusionsThe incorporation of sapropterin dihydrochloride in the SUS represents a significant budgetary impact and covers a small number of patients. Sapropterin dihydrochloride was recommended by CONITEC for the treatment of women with PKU, with a positive drug responsiveness test, and who are in the preconception period or in the gestational period.
PP20 Challenges In The Health Technology Assessment Of New/Emergent Non-Pharmacological Technologies
- Emmanuel Gimenez Garcia, Xavier Garcia, Rita Reig-Viader, Arantxa Romero-Tamarit, Iñaki Gutiérrez-Ibarluzea, Mireia Espallargues
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- Published online by Cambridge University Press:
- 31 December 2019, p. 40
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Introduction
The methodological guides for the assessment of new/emerging non-pharmacological technologies differ from the traditional health technology assessment (HTA) guidelines developed by the Spanish Network of Agencies for Assessing National Health System Technologies and Performance (RedETS). The aim of this study is to identify the special features and challenges of carrying out HTA on new/emergent non-pharmacological technologies.
MethodsThe application of traditional and new/emergent HTA guidelines is compared along the consecutive evaluation phases in four practical cases carried out at the Agency for Health Quality and Assessment of Catalonia (AQuAS) in 2017-2018.
ResultsMain learning and outstanding challenges: (i) Instead of following a defined protocol, the evaluations are carried out from a preliminary short report which generates a lack of justification and delimitation of its scope. (ii) References’ identification and data extraction are often limited due to lack of studies, and sometimes require the use of grey literature or other sources less informative, for example, trial registries. It can be challenging to exclude references related to other indications. (iii) The assessment of resource use and costs of running the technology is complicated due to the lack of public prices information and specific impacts of use. (iv) The evidence considered during the assessment usually does not meet high quality requirements (risk of bias) because of indirect evidence, lack of comparator or no having clearly defined outcomes, among others. (v) It's difficult to draw conclusions and, consequently, recommendations due to abovementioned aspects and especially for the usual evidence gap that faces this type of technology in early stages of diffusion and/or in a competition situation of manufacturer companies.
ConclusionsThe most recent innovation in non-pharmacological technologies merits a differentiated assessment approach. However, there is need to reconsider the methodology applied in order to overcome the challenges and limitations identified.
PP21 High Risk Class Medical Devices Evaluation In Germany: Another Arzneimittelmarkt-Neuordnungsgesetz?
- Elvira Müller, Ilse-Barbara Oelze, Kurt Neeser
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- Published online by Cambridge University Press:
- 31 December 2019, pp. 40-41
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Introduction
In 2011 the Arzneimittelmarkt-Neuordnungsgesetz (AMNOG) evaluation process for new drugs was implemented in Germany. Since then, the evidence requirements follow high standards and results impact reimbursement price negotiations. More recently, in 2016, a legal norm (§137h SGBV) to evaluate new treatment and diagnostic methods (MDs) of high risk classes by the Federal Joint Committee (G-BA) was introduced. The requirements, involved stakeholders, timing and results for both processes are outlined and compared.
MethodsMethodological guidelines from G-BA and Institute for Quality and Efficiency in Health Care (IQWiG), consultations and evaluations for MDs according to §137h and for drugs according to AMNOG were reviewed and compared. Published assessment results were analyzed according the decision criteria and impact on price negotiations with Statutory Health Insurance.
ResultsHospitals need to submit jointly with the manufacturer comparative evidence on clinical efficacy, safety and cost when applying for additional compensation (Neue Untersuchungs- und Behandlungsmethoden [NUB] application) for new high risk class MDs being subject to §137h. A fast track assessment by IQWiG/G-BA follows within four months resulting in benefit proven, potential benefit or no benefit compared to alternatives. The latter can lead to exclusion from reimbursement. Until now one MD was granted a benefit, two treatments were assigned a potential benefit and six MDs no benefit, while 55 percent of drugs evaluated under AMNOG were granted an additional benefit. Compared to drugs, the required evidence for MDs is similar. Whereas assessment time is shorter, manufacturers can seek advice from G-BA upfront for free and need to collaborate closely with hospitals.
ConclusionsHalf of MDs examined did not qualify for an assessment under §137h. Unlike for drugs evaluated under AMNOG, the majority of new MDs failed to be granted potential benefit as a treatment alternative and might be excluded from reimbursement. Manufacturers are challenged to generate high quality, comparative evidence within their studies.
PP26 Shift From Regional To Federal Funding: Methodological Considerations
- Skye Newton, Sharon Kessels, Arlene Vogan, Tracy Merlin
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- Published online by Cambridge University Press:
- 31 December 2019, p. 41
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Introduction
Australia has a two-tier public funding system, and many genetic tests are funded by different states and territories prior to being considered for public funding by the Federal government. In this context, health technology assessments (HTAs) of genetic tests for heritable conditions are problematic. We aimed to discuss the possible impacts on HTA methodology of a shift from regional to federal funding for genetic testing for heritable conditions.
MethodsSeveral HTA reports and economic models on genetic tests considered by the Medical Services Advisory Committee (MSAC) were reviewed and compared to ‘real world’ clinical practice.
ResultsEvery HTA of germline testing performed for the MSAC have so far compared genetic testing versus no genetic testing. However, testing for BRCA1/2 for patients with breast cancer currently occurs in Familial Cancer Centres, and testing for germline mutations for familial hypercholesterolaemia currently occurs through specialist lipid clinics. In both settings, the index patient and family members are given multidisciplinary support, including genetic counselling. The HTA comparison therefore did not reflect what the true clinical and cost-effectiveness impact of federal funding would be. Federal funding means that tests may be ordered by a broader range of specialists or general practitioners. The evidence identified was predominantly sourced from specialised centres, where knowledge regarding how to interpret the tests is high. The clinical utility of these tests largely depended on how clinicians understood and conveyed the results.
ConclusionsThe benefit of testing may have been overestimated due to the comparator and setting used (i.e. specialised and centralized care, associated with high clinical utility). Any HTA of genetic testing for heritable conditions, which could result in a shift in the delivery of testing or care for the patient, should consider the applicability of the evidence identified. Further, it should assess the subsequent impact this may have on the effectiveness and cost-effectiveness of the test and the quality of care provided for patients and their family.
PP27 Additional Capabilities In Health Technology Assessment To Support Decision Making
- Brigitte Larocque, Marc Rhainds, Martin Coulombe, Alice Nourissat
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- Published online by Cambridge University Press:
- 31 December 2019, p. 41
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Introduction
Decision-making regarding an open or a closed fluid waste management system (FWMS) in the planning of thirty operating rooms (ORs) of a new hospital at the CHU de Québec-Université-Laval was an opportunity to explore additional capabilities in health technology assessment (HTA) to support evidence-based planning.
MethodsIssues related to FWMSs in ORs were assessed from multiple data sources including: (i) systematic review in indexed databased and grey literature, (ii) waste management laws and regulations, (iii) local registry of reported incidents/accidents, (iv) occupational health and safety database, (v) electronic patient records (EPRs), (vi) field evaluation of two closed FWMSs, (vii) costs, and (viii) survey on FWMSs in ORs of other Quebec hospitals.
ResultsClosed FWMSs in ORs could reduce health care professional exposure to blood and body fluids (BBF) according to two low-quality studies. Cases of occupational and patient exposure to BBF with closed FWMSs, some of which had severe issues, were reported to the U.S. Food and Drug Administration. Depending on the volume, discharge of BBF to the sanitary sewer may be authorized upon the approval of the competent municipal authorities. Compared to an open system, a closed FWMS has the potential to reduce manipulation of canisters during the cases because of large canister capacity (24 L). However, local data showed that BBF and irrigation fluid amounts in ORs are <2 L in 84 percent of cases and >2 L in a minority of surgeries, whereas a closed FWMS is associated with higher costs for BBF volumes <12 L. Other issues were observed during field evaluation (e.g., occupational noise). Closed FWMS implementation in other hospitals was very limited in the survey.
ConclusionsAvailable evidence does not support the widespread use of a closed FWMS. Use of mixed-methods in this particular HTA allowed to assist decision makers on the choice of an FWMS in the OR planning.
PP28 Adoption Of Non-Pharmaceuticals In Galicia: Beyond Conventional Health Technology Assessment
- Leonor Varela-Lema, Maruxa Zapata-Cachafeiro, Yolanda Triñanes Pego, Maria José Faraldo Vallés
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- Published online by Cambridge University Press:
- 31 December 2019, pp. 41-42
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Introduction
The specificities of non-pharmaceuticals can require adapting classical health technology assessment (HTA) methodologies and developing additional regional approaches to support decision-making processes. However, little information exists regarding the explicit approaches used in different countries. The aim of this work is to provide an overview of the role and activities of the Galician HTA agency (avalia-t, Spain) regarding assessment, appraisal and continued evaluation across the whole life cycle of non-pharmaceutical technologies.
MethodsIn depth review and analysis of the activities undertaken by avalia-t during the past five years to support the introduction and appropriate use of non-pharmaceutical health care technologies at the regional level.
ResultsA multidisciplinary Commission judges the added value of new non-pharmaceuticals and establishes the indications and conditions for use. HTAs, which are mandatory for all relevant technologies, rely on the best available evidence on safety and effectiveness but also provide fit for purpose contextualized information based on organizational data and administrative registers. Interaction with multidisciplinary stakeholders is commonly needed to complement the evidence base (ad hoc working groups, face to face discussions), and post-launch studies can be implemented to analyze the utilization and results in real world practice. Performance indicators and other HTA based products can also be required to ensure the quality of health care (e.g., appropriate use indications, quality indicators, evidence based patient information). In addition, technical and scientific advice/support can be provided at different decision levels of the health organization to promote the quality of care and appropriate use of technologies (e.g., regional mental health program, suicide management strategy, bariatric surgery surveillance registry).
ConclusionsRigorous, comprehensive and systematic processes for supporting non-pharmaceutical technology adoption and implementation are required. Although it is acknowledged that core information does not differ substantially within countries, contextualized information is recognized as essential for establishing the conditions for use at the regional level.
PP30 Do Conditional Regulatory Pathways Affect Health Technology Assessment Recommendations?
- Jesmine Cai, Tina Wang, Neil McAuslane, Lawrence Liberti
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- Published online by Cambridge University Press:
- 31 December 2019, p. 42
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Introduction
In an effort to expedite the approval of drugs treating serious illnesses or addressing unmet medical need, conditional approvals have been used by the European Medicines Agency. In this study, the effects of conditional approvals were investigated in terms of health technology assessment (HTA) recommendations and timing in Europe.
MethodsFirst HTA recommendations of new active substances (NASs) issued between 2015 and 2017 were collected from the National Institute for Health and Care Excellence (England), Haute Autorité de Santé (France), Institute for Quality and Efficiency in Health Care (Germany), Scottish Medicine Consortium (Scotland) and Tandvårds-Läkemedelförmånsverket (Sweden). The HTA recommendations were then classified into the following categories: positive, positive with restrictions, negative and multiple and if the regulatory approval pathway had been standard or conditional.
ResultsOf this cohort of NASs that received an HTA recommendation, eight of 56 in England, 12 of 83 in France, 11 of 77 in Germany, nine of 58 in Scotland and four of 49 in Sweden were approved via a conditional review. Generally, except in England, there were a higher proportion of positive first recommendations for conditional approvals when compared to standard approvals, with Germany showing the largest proportional difference (43 percent) between the two pathways and also a faster time to recommendation. This may relate to the proportion of conditional assessments that were orphan medicines. With the exception of Germany, the time taken from regulatory approval to first HTA recommendation for products with conditional approvals is higher than those for standard approvals, with the largest difference seen in Sweden (241 days longer).
ConclusionsConditionally approved NASs showed a variable HTA outcome; although there was generally a higher proportion of positive recommendations thus enabling more likely access in conditional approvals, the timing from regulatory approval to HTA recommendation was longer compared with standard approvals. This warrants a better understanding of the factors and uncertainties underlying these recommendations, supporting timely access of NASs with conditional approval.
PP31 Medical Device Regulation: What Is New?
- Ilse-Barbara Oelze, Kurt Neeser, Elvira Müller
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- Published online by Cambridge University Press:
- 31 December 2019, pp. 42-43
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Introduction
In 2017, the European Union (EU) commission released the final versions of the Medical Device Regulation (MDR) and In-vitro Diagnostic Device Regulation. These regulations will replace the EU directives (Medical Device Directive [MDD], In-vitro Diagnostic Device [IVDD], and Active Implantable Medical Device [AIMD]). EU regulations are effective in all EU countries at date of publication. In contrast, the EU directives must be implemented in national law first.
MethodsGuidelines and respective legislation, consultation results and methods/medical device (MD) evaluations were reviewed and analyzed. Decision criteria and reasoning, assessment outcomes and potential impact on price negotiations were the main aspects for comparison.
ResultsManufacturers have to be aware of the importance of clinical data for demonstrating the compliance of their products. This applies both to the approval of the products and the “post-market activities” and particularly to the “post-market clinical follow-up” for which requirements for Class I and II products need to be further developed. The MDR requires manufacturers to collect clinical data before and after approval, which could lead to excessive documentation requirements. The term “sufficient clinical data” from the MDR is unclear. A functional Eudamed specification is necessary, which enables an automated processing of relevant data. A stronger involvement in the evaluation process is needed as well as more transparency in the Joint Federal Committee (G-BA) and faster evaluation processes.
ConclusionsThe MDR increases the burden especially for small businesses, and it is doubtable that the ultimate goal – improving patient safety – will be achieved. The increased demands and rising costs of the new EU MDR and bottlenecks at Notified Bodies can be a risk for the MD industry. Due to the general reduction in the remuneration for services with a high proportion of technical services, it is feared that products will be withdrawn from the market for economic reasons or that they will not be marketed.
PP32 Joint Early Dialogs Between Medical Device Regulation and Health Technology Assessment
- Petra Schnell-Inderst, Claudia Wild
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- Published online by Cambridge University Press:
- 31 December 2019, p. 43
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Introduction
In Europe, the new Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) that entered into force 2017 will have to be applied until 2020 and 2022, respectively. Under the old regulation, there was a large gap between evidence requirements for market approval and market access for high risk (class IIb and III) medical devices (MD). The MDR/IVDR will require appropriate clinical investigations for these MD classes. Despite the different purpose of market approval and surveillance and reimbursement decisions, there are possible synergies with regard to evidence generation, for example, design of pivotal trials and post-launch evidence generation with observational data. In the MDR, early scientific advice can be provided by expert panels of the European Commission if requested by MD developers. For medicinal products, the European network for Health Technology Assessment (EUnetHTA) has established joint early dialogs (JED) of HTA agencies with the European Medicines Agency and manufacturers. A similar approach might be possible with the Medical Device Coordination Group (MDCG). The objective was to explore possible synergies for JED with the MDCG and EUnetHTA.
MethodsIn 2018, EUnetHTA established a task force for HTA and MDR/IVDR. A workshop, which will explore possible synergies and activities on JED as well as the viewpoints of stakeholders will be held in May 2019. Participants will be Directorate-Generals GROW (Internal Market, Industry, Entrepreneurship and SME) and SANTE (Health and Food Safety), EUnetHTA members assessing MD, representatives of national competent authorities, Team Notified Bodies, MedTech Europe, patient representatives and academia.
ResultsA report on the presentations, the results of the discussion, and next steps in a possible collaboration will be presented.
ConclusionsJoint early scientific advice to manufacturers on the European level for evidence generation by HTA agencies and the MDCG has the potential to streamline evidence generation in the life cycle of high risk MD.
PP34 Costs Of Healthcare-Associated Infections In Latin America
- Ângela Bagattini, Martha Martinez-Silveira, Ana Zara, Valeska Stempliuk, Cristiana Toscano
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- Published online by Cambridge University Press:
- 31 December 2019, p. 43
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Introduction
Healthcare-associated infections (HAI) are among the most common preventable health adverse event, associated with significant burden globally. Limited data on HAI costs in lower and middle-income countries is available. The aim of this study is to assess the cost, additional length-of-stay (LOS) and extra-mortality of HAI in the Latin American and Caribbean (LAC) Region.
MethodsWe searched Medline/PubMed, Embase, Web of Science, Lilacs, Cochrane, National Health Service Economic Evaluation Database, Centre for Reviews and Dissemination, EconLit, and gray literature published in any language without restriction of date till July 2017. We included observational studies addressing the outcomes of interest, in which hospitalized patients with HAI are compared to those without HAI. The following study designs were included: quasi-experimental, controlled before-after, prospective and retrospective comparative cohort, case-control, and cross-sectional studies. We considered the following HAI-sites: surgical site infections (SSI), catheter-associated urinary-tract infections (CA-UTI), ventilator-associated pneumonia (VAP), and central line-associated bloodstream infection (CLA-BSI), as well as cross-infection (CI). Screening of citations, data extraction, and risk of bias assessment were conducted in duplicate by independent reviewers, according to the study protocol registered on PROSPERO. Reported costs were converted to USD considering official exchange rates.
ResultsWe identified 4,339 citations. After removing duplicates, a total of 3,029 citations were screened for eligibility. A total of 87 studies from 17 countries were included. The majority (27.4 percent) reported on VAP, followed by CLA-BSI (21.2 percent), SSI (16.4 percent), and CA-UTI (14.4 percent). Most studies (46.7 percent) reported on incremental LOS, with an average of 14.8 days (range 0.9-49 days). Costs were reported by 25 percent of studies, with average incremental costs of USD 3,460 (range 49-12,155). Average extra-mortality of 15.6 percent (range -2.8-45.2 percent) was reported by 12.6 percent of studies.
ConclusionsAvailable evidence from the LAC Region reports significant economic burden of HAI. This information will be useful for cost-effectiveness analysis of interventions aimed at reducing HAI economic and health burden.
PP35 Valuing Intersectoral Costs And Benefits Of Interventions
- Ruben Drost, Aggie Paulus, Dirk Ruwaard, Silvia Evers
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- Published online by Cambridge University Press:
- 31 December 2019, pp. 43-44
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Introduction
There is a lack of knowledge about methods for valuing health intervention-related costs and monetary benefits in the education and criminal justice sectors, also known as ‘inter-sectoral costs and benefits’ (ICBs). The objective of this study was to develop methods for obtaining unit prices for the valuation of ICBs.
MethodsBy conducting an exploratory literature study and expert interviews, several generic methods were developed. The methods' feasibility was assessed through application in the Netherlands. Results were validated in an expert meeting, which was attended by policy makers, public health experts, health economists and Health Technology Assessment (HTA) experts, and discussed at several international conferences and symposia.
ResultsThe study resulted in four methods, including the opportunity cost method and valuation using available unit prices, self-constructed unit prices or hourly labor costs.
ConclusionsThe methods developed can be used internationally and are valuable for the broad international field of HTA.
PP36 Inflammatory Bowel Disease: The Disability Costs Among Italian Workers
- Claudia Nardone, Simone Russo, Simone Gazzillo, Raffaele Migliorini, Marco Trabucco Aurilio, Francesco Saverio Mennini
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- Published online by Cambridge University Press:
- 31 December 2019, p. 44
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Introduction
The aim of the study is to estimate the disability insurance costs (social security system in Italy is financed by public expenditure) induced by patients with Inflammatory Bowel Disease (IBD) and specifically for Crohn's disease (CD) and Ulcerative Colitis (UC) between 2009 and 2015.
MethodsWe analyzed the database about the disability insurance awards and the mean cost per benefit of the National Institute of Social Security (INPS) for two types of social security benefits: incapacity pensions (IP - for people without workability) and disability benefits (DB - for people with reduced work ability). From this data, we have estimated the total benefit provided and the total costs for each disease. A probabilistic model with a Monte Carlo simulation was developed in order to estimate the total benefits provided and costs.
ResultsFor CD, an average of 820 beneficiaries of social security benefits were detected per year (2009-2015): the total expenditure was EUR 50 million, EUR 7 million per year (about EUR 7,900 per patient); for UC, about 1,550 beneficiaries per year were detected and the total expenditure was EUR 93 million, EUR 13 million per year (about EUR 8,600 per patient).
ConclusionsThe disability insurance costs related with the management of CD and UC showed a significant impact on the expenditure for the Italian system: the most important costs for disability for CD and UC in Italy in the analyzed period were DB (92 percent for CD and 95 percent for UC). Rapid access to innovative treatments could reduce the costs incurred by the social security system.
PP38 Productivity Loss In Patients With Chronic Diseases: A Pooled Analysis
- Omar Rashdan, Valentin Brodszky
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- Published online by Cambridge University Press:
- 31 December 2019, p. 44
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Introduction
Due to the unprecedented increase in medicine prices in recent years, the socio-economic perspective started gaining importance in health economic evaluations. Productivity loss evaluations provide a long-term economic impact visualization for a more informed reimbursed medicine decisions.
MethodsA pooled analysis of patient-level data from 11 cross-sectional, retrospective, cost-of-illness studies was performed. SPSS software was used for our statistical analysis. Analysis of variance (ANOVA) and correlation analysis were utilized to measure the effect of different variables on lost productivity hours. All costs were recalculated to account for the cumulative inflation till 2018.
ResultsThe sample size of included studies ranged between 68 (Multiple Sclerosis) and 480 (Diabetes), and the total number of patients enrolled in the analysis was 1,881 of which 956 were female. A total of 6,795 hours were reported as missed working hours per year. Overall, the female population reported a mean of 689.5 lost productive hours compared to 324.7 in males (p < 0.001). This translated into higher indirect costs at EUR 2,748 and EUR 1,530 for females and males, respectively. Patients with a college degree or higher reported lower yearly lost productive hours and indirect costs (358.4 hours and EUR 1,749) (p < 0.001) compared to patients with lower education level (845.6 hours and EUR 3,534) (p < 0.001). The average indirect cost as a percentage of gross domestic product per capita was highest in Schizophrenia patients at 97.5 percent and lowest in Benign Prostatic Hyperplasia at 1.9 percent. In patients below 65 years of age, a weak positive correlation was observed between age and lost productive hours with a Pearson value of 0.1 (p < 0.001).
ConclusionsFemale gender and older age resulted in higher productivity loss, and Schizophrenia was the disease with the highest indirect costs per patient per year.
PP39 Budget Projections And Health Impact Of PD-1/PD-L1 Inhibitors
- Alexander Roediger, Julie van Bavel, James Pellissier, Stefano Lucherini, Neil Davies, Paul Okhuoya, Boris Rachev
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- Published online by Cambridge University Press:
- 31 December 2019, pp. 44-45
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Introduction
The rapid expansion of immuno-oncology treatment options has led to concerns around their long-term affordability. Evidence on the potential budget and health impact of these new treatment options is required to inform public health policy and ensure adequate allocation of budget for the future.
MethodsThe Health Impact Projection model was developed to compare the economic impact and health outcomes observed with and without PD-1/PD-L1 inhibitors using traditional budget impact analysis. Seven types of high-incidence cancers were included: melanoma, first- and second-level non-small cell lung, bladder, head and neck, renal cell carcinoma, and triple negative breast. Inputs were based on publicly available data and literature, and over 10 key experts (oncologists, health economists) were involved in the model development. The model draws on five-year budget impact analysis.
ResultsUsing the experience of Belgium, Slovenia, Switzerland, and Italy, the model estimates budget and health impact of the PD-1/PD-L1 inhibitor class. It shows that for 2018-2022, the class will provide additional life years and avoid high-grade adverse events (AEs) with a manageable budget impact per year compared to the standard of care. The model also enables policy-makers to assess the adequacy of their budget for the near future and explore the implications of different policy decisions. Results for Belgium show that over the five-year period the PD-1/PD-L1 inhibitors will save 10,635 additional life years, avoid 7,597 AEs and have a budget impact of approximately EUR 260 million. Results for Slovenia show 1,468 additional life years gained and 869 AEs avoided with a budget impact of approximately EUR 116 million; for Switzerland, 6,775 life years gained, 6,953 AEs avoided, and EUR 106 million budget impact; and for Italy, 5,019 life years gained, 2,040 AEs avoided, and EUR 627 million budget impact.
ConclusionsAlthough limitations exist, the model informs planning by helping quantify the potential impact of immune-oncology treatments on health and budget in different scenarios.
PP41 Cost-Effectiveness Modeling Of Chimeric Antigen Receptor T-Cell Therapies
- Siguroli Teitsson, Richard Macaulay
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- Published online by Cambridge University Press:
- 31 December 2019, p. 45
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Introduction
This study has two key aims. The first is to review cost-effectiveness (CE) models for chimeric antigen receptor T-cell (CAR-T) therapies that have been appraised by health technology assessment (HTA) authorities. The second is to identify the key challenges of CE modeling of CAR-T therapies based on the main points raised in the HTA appraisals.
MethodsA targeted HTA review of published CE models for CAR-T therapies in the United Kingdom (UK) and United States (US) was undertaken.
ResultsFour relevant CE models were identified – three from the UK and one in the US. Of the three UK models, two were single technology submissions to the National Institute for Health and Care Excellence (NICE) and one was a ‘mock’ appraisal undertaken by NICE with a hypothetical evidence dataset. The one US model was published by the Institute for Clinical and Economic Review (ICER) committee. Two key model structures were adopted across the appraisals: a three-health state partitioned survival analysis model and a short-term decision tree followed by a three-health state partitioned survival model. The key modeling challenges identified can by summarized into five main categories: comparator evidence generation, estimation of long-term survival, curative benefit, health-related quality of life, and infrastructure/training requirements.
ConclusionsThere are many challenges associated with the CE modeling of CAR-T therapies, with the most critical issues related to how uncertainty for long-term efficacy and safety can be addressed and mitigated. With more mature evidence sets in the future, stakeholders will get a clearer picture for the long-term benefit and risk of CAR-T therapies, but until then it is likely that HTA authorities will take a conservative stand when appraising the comparative value of CAR-T therapies.
PP43 Decision-Making Tool In Case Of Beta-Lactam Allergy: How To Help Clinicians?
- Sylvie Bouchard, Geneviève Robitaille, Fatiha Karam, Jean-Marc Daigle, Mélanie Tardif
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- Published online by Cambridge University Press:
- 31 December 2019, p. 45
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Introduction
Beta-lactams (BLs), especially penicillins, are the most commonly used antibiotics, particularly in primary care, and one of the most reported drug allergies. Fearing cross-reactivity, clinicians refrain from prescribing another BL (e.g., cephalosporin or carbapenem) to penicillin-allergic patients. This can have significant consequences for the patients and the health-care system (e.g., exposure to broad-spectrum antibiotics, increased risk adverse effects, and increased healthcare costs).
MethodsTo assess the absolute cross-reactivity risk, two systematic reviews with meta-analysis were conducted. Then, an approach based on a knowledge mobilization framework considering scientific, contextual and experiential evidences was used. Focus groups with stakeholders, including primary care clinicians, pediatricians, infectious disease specialists and allergists/immunologists, were also held to meet the needs of all actors concerned.
ResultsFollowing this work, it appears that true allergies to penicillin are very rare. Indeed, in patients with a history of penicillin allergy, very few are truly allergic and thus the risk of cross-reaction with another BL is even lower, varying according to structural and physicochemical similarities with alleged-penicillin. Moreover, the risk of having an anaphylactic reaction after penicillin exposure is very low, especially among children. As well, in patients with confirmed penicillin allergy, the observed reactions are usually delayed non-severe skin reactions. However, with a confirmed penicillin allergy, it is important to remain cautious when administering a new BL, especially if the initial reaction was serious or severe. Based on these key messages, a decision aid including an algorithm was developed. Likewise, individualized algorithms for common infections met in primary care were produced.
ConclusionsFrom this work, health professionals non-specialized in allergology should be able to better manage the risks attributed to penicillin allergies. Therefore, patients should receive the most effective and safe antibiotics to treat their clinical conditions in primary care.