scholarly journals Application of Health Technology Assessment (HTA) to Evaluate New Laboratory Tests in a Health System: A Case Study of Bladder Cancer Testing

2020 ◽  
Vol 7 ◽  
pp. 237428952096822
Author(s):  
Erik J. Landaas ◽  
Ashley M. Eckel ◽  
Jonathan L. Wright ◽  
Geoffrey S. Baird ◽  
Ryan N. Hansen ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Pilot Study ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Real World ◽  
Health Technology ◽  
Test System ◽  
Real World Data ◽  
World Data

We describe the methods and decision from a health technology assessment of a new molecular test for bladder cancer (Cxbladder), which was proposed for adoption to our send-out test menu by urology providers. The Cxbladder health technology assessment report contained mixed evidence; predominant concerns were related to the test’s low specificity and high cost. The low specificity indicated a high false-positive rate, which our laboratory formulary committee concluded would result in unnecessary confirmatory testing and follow-up. Our committee voted unanimously to not adopt the test system-wide for use for the initial diagnosis of bladder cancer but supported a pilot study for bladder cancer recurrence surveillance. The pilot study used real-world data from patient management in the scenario in which a patient is evaluated for possible recurrent bladder cancer after a finding of atypical cytopathology in the urine. We evaluated the type and number of follow-up tests conducted including urine cytopathology, imaging studies, repeat cystoscopy evaluation, biopsy, and repeat Cxbladder and their test results. The pilot identified ordering challenges and suggested potential use cases in which the results of Cxbladder affected a change in management. Our health technology assessment provided an objective process to efficiently review test performance and guide new test adoption. Based on our pilot, there were real-world data indicating improved clinician decision-making among select patients who underwent Cxbladder testing.

R WE ready for reimbursement? A round up of developments in RWE relating to health technology assessment: part 2

2021 ◽  
Author(s):  
Alex Simpson ◽  
Sreeram V Ramagopalan
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Real World ◽  
Health Technology ◽  
Health Inequity ◽  
Real World Data ◽  
World Data

In this round up, we cover how COVID-19 has been beneficial for improved access to real-world data, as well as how real-world data can be used to address health inequity, an area of increasing interest for health technology assessment.

VP08 Real-World Data Use In Health Technology Assessments: A Comparison Of Five Health Technology Assessment Agencies

2017 ◽  
Vol 33 (S1) ◽  
pp. 149-150
Author(s):  
Amr Makady ◽  
Ard van Veelen ◽  
Anthonius de Boer ◽  
Hans Hillege ◽  
Olaf Klunger ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Real World ◽  
Relative Effectiveness ◽  
Internal Validity ◽  
Health Technology ◽  
Real World Data ◽  
World Data ◽  
The Impact

INTRODUCTION:Reimbursement decisions are usually based on evidence from randomized controlled trials (RCT) with high internal validity but lower external validity. Real-World Data (RWD) may provide complimentary evidence for relative effectiveness assessments (REA's) and cost-effectiveness assessments (CEA's) of treatments. This study explores to which extent RWD is incorporated in REA's and CEA's of drugs used to treat metastatic melanoma (MM) by five Health Technology Assessment (HTA) agencies.METHODS:Dossiers for MM drugs published between 1 January 2011 and 31 December 2016 were retrieved for HTA agencies in five countries: the United Kingdom (NICE), Scotland (SMC), France (HAS), Germany (IQWiG) and the Netherlands (ZIN). A standardized data-extraction form was used to extract data on RWD mentioned in the assessment and its impact on appraisal (for example, positive, negative, neutral or unknown) for both REA and CEA.RESULTS:In total, fourty-nine dossiers were retrieved: NICE = 10, SMC = 13, IQWiG = 16, HAS = 8 and ZIN = 2. Nine dossiers (18.4 percent) included RWD in REA's for several parameters: to describe effectiveness (n = 5) and/or the safety (n = 2) of the drug, and/or the prevalence of MM (n = 4). CEA's were included in 25/49 dossiers (IQWiG and HAS did not perform CEA's). Of the twenty-five CEA's, twenty (80 percent) included RWD to extrapolate long-term effectiveness (n = 19), and/or identify costs associated with treatments (n = 7). When RWD was included in REA's (n = 9), its impact on the appraisal was negative (n = 4), neutral (n = 2), unknown (n = 1) or was not discussed in the appraisal (n = 2). When RWD was included in CEA's (n = 11), its impact on the appraisal varied between positive (n = 2), negative (n = 5) and unknown (n = 4).CONCLUSIONS:Generally, RWD is more often included in CEA's than REA's (80 percent versus 18.4 percent, respectively). When included, RWD was mostly used to describe the effectiveness of the drug (REA) or to predict long-term effectiveness (CEA). The impact of RWD on the appraisal varied greatly within both REA's and CEA's.

scholarly journals Policies for Use of Real-World Data in Health Technology Assessment: A Comparative Study of 6 HTA Agencies

2016 ◽  
Vol 19 (7) ◽  
pp. A501-A502 ◽  
Author(s):  
A Makady ◽  
R ten Ham ◽  
A de Boer ◽  
JL Hillege ◽  
O Klungel ◽  
...  
Keyword(s):  
Comparative Study ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Real World ◽  
Health Technology ◽  
Real World Data ◽  
World Data

scholarly journals Using Real-World Data in Health Technology Assessment (HTA) Practice: A Comparative Study of Five HTA Agencies

2017 ◽  
Vol 36 (3) ◽  
pp. 359-368 ◽  
Author(s):  
Amr Makady ◽  
Ard van Veelen ◽  
Páll Jonsson ◽  
Owen Moseley ◽  
Anne D’Andon ◽  
...  
Keyword(s):  
Comparative Study ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Real World ◽  
Health Technology ◽  
Real World Data ◽  
World Data

OP13 2017 Health Technology Assessment International Asia Policy Forum: The Perspective Of Not-For-Profit Members

2018 ◽  
Vol 34 (S1) ◽  
pp. 6-6
Author(s):  
Raoh-Fang Pwu ◽  
Rebecca Trowman
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Real World ◽  
Health Technology ◽  
The Philippines ◽  
Real World Data ◽  
World Data ◽  
For Profit ◽  
Not For Profit ◽  
Policy Forum

Introduction:The fifth Health Technology Assessment International (HTAi) Asia Policy Forum (APF) was held in Beijing, November 2017. The topic of the meeting was ‘Universal Health Care in the Asia Region: Overcoming the Barriers using HTA and Real World Data’. This presentation will focus on the use of real world data (RWD) as a mechanism of informing HTA in the Asia region – from the perspective of the not-for-profit HTA agencies that were represented at the APF.Methods:The 2017 HTAi APF had senior representatives from government and HTA agencies from 11 countries in the Asia region. This included first-time attendees from Iran, Indonesia and the Philippines. A keynote presentation on the lessons learnt from Taiwan on the use of RWD was delivered, and there were guided breakout group discussions.Results:There are a number of registries and sources of RWD available to the HTA agencies across the Asia region. However it was noted that the databases are resource intensive to maintain, and there are noted time lags in the data collection and release. There are examples where the data from these sources have been used to evaluate local utilization of treatments and post-market surveillance, but it has not yet been used in pricing/reimbursement decisions.Conclusions:Although RWD could be a good tool for healthcare decision-making in the Asia region, it is still unclear how to do so properly. Infrastructure and human capacity, as well as law, are key factors to the successful use of RWD. Standardized methodologies, increased transparency, quality control and capacity building are essential elements to better implementing RWD in HTA.

scholarly journals Policies for Use of Real-World Data in Health Technology Assessment (HTA): A Comparative Study of Six HTA Agencies

2017 ◽  
Vol 20 (4) ◽  
pp. 520-532 ◽  
Author(s):  
Amr Makady ◽  
Renske ten Ham ◽  
Anthonius de Boer ◽  
Hans Hillege ◽  
Olaf Klungel ◽  
...  
Keyword(s):  
Comparative Study ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Real World ◽  
Health Technology ◽  
Real World Data ◽  
World Data

PP162 Digital Medication Health Service Platforms Of Pharmaceutical Companies As Novel Sources Of Real-World Data For Health Technology Assessment

2020 ◽  
Vol 36 (S1) ◽  
pp. 18-18
Author(s):  
Jian Li ◽  
He Wang ◽  
Carolina Oi Lam Ung ◽  
Hao Hu
Keyword(s):  
Health Service ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Real World ◽  
Health Technology ◽  
Therapeutic Drug ◽  
Pharmaceutical Companies ◽  
Real World Data ◽  
World Data

IntroductionDigital medication health service (DMHS) platforms are increasingly used by pharmaceutical companies to provide direct medication health services through digital methods like apps, hotlines, and web services, etcetera. However, the implications of such platforms in supporting health technology assessment (HTA) are rarely discussed in the literature. This presentation sets out the opportunities for using the DMHS platforms of pharmaceutical companies as real-world data sources for HTA.MethodsA mixed-method qualitative study combining literature review and case study was conducted. Relevant literature was identified by searching the Web of Science and PubMed databases. A case study on current DMHS platforms in China was carried out using an inductive approach to identify the key elements emerging from these platforms.ResultsDMHS platforms of pharmaceutical companies can identify multiple attributes of medication information needs regarding medical products, including effectiveness, safety, and economic factors. The platforms can respond to different stakeholders, including patients and their carers, doctors, nurses, pharmacists, etcetera. As one kind of interactive process, DMHS platforms can provide further services, including patient education, consultation, and evaluation, follow-up visits, chronic disease management, promotion of the rational use of drugs, therapeutic drug monitoring, and adverse drug reaction surveillance and reporting.ConclusionsThe DMHS platforms of pharmaceutical companies provide a unique and valuable real-world data source for HTA. These types of self-reported outcomes have not gained enough attention in HTA. Collective efforts by HTA agencies and pharmaceutical companies are needed to set strategies for integrating DMHS platforms into HTA.

scholarly journals Real-world data for health technology assessment for reimbursement decisions in Asia: current landscape and a way forward

2020 ◽  
Vol 36 (5) ◽  
pp. 474-480
Author(s):  
Jing Lou ◽  
Sarin KC ◽  
Kai Yee Toh ◽  
Saudamini Dabak ◽  
Amanda Adler ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Health Systems ◽  
Technology Assessment ◽  
Real World ◽  
New Technologies ◽  
Health Technology ◽  
Guidance Document ◽  
Real World Data ◽  
World Data ◽  
Relevant Evidence

There is growing interest globally in using real-world data (RWD) and real-world evidence (RWE) for health technology assessment (HTA). Optimal collection, analysis, and use of RWD/RWE to inform HTA requires a conceptual framework to standardize processes and ensure consistency. However, such framework is currently lacking in Asia, a region that is likely to benefit from RWD/RWE for at least two reasons. First, there is often limited Asian representation in clinical trials unless specifically conducted in Asian populations, and RWD may help to fill the evidence gap. Second, in a few Asian health systems, reimbursement decisions are not made at market entry; thus, allowing RWD/RWE to be collected to give more certainty about the effectiveness of technologies in the local setting and inform their appropriate use. Furthermore, an alignment of RWD/RWE policies across Asia would equip decision makers with context-relevant evidence, and improve timely patient access to new technologies. Using data collected from eleven health systems in Asia, this paper provides a review of the current landscape of RWD/RWE in Asia to inform HTA and explores a way forward to align policies within the region. This paper concludes with a proposal to establish an international collaboration among academics and HTA agencies in the region: the REAL World Data In ASia for HEalth Technology Assessment in Reimbursement (REALISE) working group, which seeks to develop a non-binding guidance document on the use of RWD/RWE to inform HTA for decision making in Asia.

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