Pre-reimbursement: early assessment for coverage decisions

Grössmann, N.; Wolf, Sarah; Rosian, Katharina; Wild, Claudia

doi:10.1007/s10354-019-0683-1

Cited by 9 publications

(7 citation statements)

References 29 publications

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“…The situation is similar for coverage of services within the hospital, where different processes exist for hospital inpatient (separate for devices and drugs) and for hospital outpatient services. While benefit assessment of devices has gained considerable importance and has been increasingly standardized [29–31], cost-effectiveness evidence is not used in any steps of the process in a systematic way. One area where economic evaluations have played some role are coverage decisions for vaccination and for screening programs, although again, no standardized processes are in place.…”

Section: Resultsmentioning

confidence: 99%

The status of health economic evaluation within decision making in Austria

Zechmeister‐Koss

Stanak

Wolf

2019

Wien Med Wochenschr

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Summary Background Given limited resources compared to the demand for them, spending resources efficiently is important. Key methods applied for supporting efficient resource allocation are health economic evaluations. Methods Based on secondary literature, we analyze international challenges for using two types of economic evaluations—cost-effectiveness analysis and cost-utility analysis—in reimbursement decisions and reflect on them for the Austrian case. Results The main challenges with the application of economic evaluations are related to the methods, the decision-making culture, and the respective system. The challenges also apply to the Austrian Bismarck system, where almost no formal requirements for using economic evaluations exist, except on a case-by-case basis. Resource allocation in Austria hence occurs, for the most part, implicitly. Conclusion One way forward towards more explicit efficiency considerations may be to consider more descriptive study types and foster capacity building, standardization of methods and presentation of results, and a mandatory detailed guideline.

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Section: Resultsmentioning

confidence: 99%

The status of health economic evaluation within decision making in Austria

Zechmeister‐Koss

Stanak

Wolf

2019

Wien Med Wochenschr

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“…The results of this analysis complement older analyses of the evidence-based reimbursement process of hospital medical services in Austria. A descriptive analysis [13] regarding reimbursement processes in Austria (early assessment for coverage decisions) found 95 HTA assessments between 2008 and 2018. Their unit of analysis were HTA assessments (instead of recommendations as chosen in our analysis).…”

Section: Discussionmentioning

confidence: 99%

“…In Austria, the introduction of new medical services and medical devices into the hospital individual services catalogue, as well as the amendment or deletion of already included services, has been supported by comparative evaluations of the clinical evidence since 2008. These comparative evaluations take the form of evidence syntheses of comparative effectiveness and safety conducted by the by the Austrian Institute for Health Technology Assessment (AIHTA; Former: Ludwig Boltzmann Institute for HTA) [13]. An interdisciplinary steering committee coordinated by the Ministry of Health is responsible for the maintenance of the hospital individual services catalogue and uses the evidence syntheses for an annual update of the catalogue, including new interventions, but also excluding (disinvesting) interventions of uncertain clinical value [14,15].…”

Section: Introductionmentioning

confidence: 99%

“…for reimbursed hospital individual services with increased uncertainty around their clinical value [13,[15][16][17]. This system has been described and partly evaluated in earlier publications, concluding that clinical evidence is being well considered in decisions on in-/exclusion of services in the hospital catalogue, but proposing that other factors seem to in uence the nal decisions as well [13,16,17]. It is still not su ciently clear which re-imbursement decisions have been exclusively supported by clinical evidence and which further factors in uenced the decisions besides clinical evidence.…”

Section: Introductionmentioning

confidence: 99%

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Reimbursement Decisions for Medical Services in Austria: An Analysis of Influencing Factors for the Hospital Individual Services Catalogue Between 2008 and 2020

Goetz

Пантели

Busse

et al. 2021

Preprint

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ObjectivesTo (1) describe the (evidence-based) reimbursement process of hospital individual services, (2) evaluate the accordance between evidence-based recommendations and reimbursement decision of individual services and (3) elaborate potential aspects that play a role in the decision-making process in Austria.Method:The reimbursement process is described based on selected relevant sources such as official documents. Evidence-based recommendations and subsequent reimbursement decisions for the annual maintenance of the hospital individual service catalogue in Austria between 2008 and 2020 were analysed using a mixed methods approach, encompassing descriptive statistics and a focus group with Austrian decision makers. Results:118 evidence-based recommendations were analysed. There were 93 (78.8%) negative and 25 (21.2%) positive evidence-based recommendations. In total, 107 out of 118 evidence-based recommendations (90.1%) did not lead to a deviating reimbursement decision. We identified six aspects that may have played a role in the decision-making process for the annual maintenance of the hospital individual service catalogue, with clinical evidence being the most notable. Further aspects included quality assurance/organisational aspects (i.e., structural quality assurance), costs (if comparable to already existing medical services, not: cost-effectiveness), procedural aspects (e.g., if certain criteria for adoption have not been met formally through the proposals), “other countries” (i.e., taking into account how other countries decided) and situational aspects (such as the COVID-19 pandemic).Conclusions:There is good accordance between evidence-based recommendations and reimbursement decisions regarding hospital individual services in Austria. Beyond clinical evidence, organizational aspects seem to be considered often with regard to quality assurance but costs do not appear to play a major role. The Austrian system has mechanisms in place that can restrict widespread adoption of novel hospital individual services with uncertain clinical benefits. Future studies could investigate how well these mechanisms work and how they compare to other health systems in Europe.

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“…The scale most widely utilized with HTA applications in cancer is the Magnitude of Clinical Benefit Scale (MCBS) of the European Society for Medical Oncology (ESMO) [ 110 , 111 ]. Validation of MCBS as a tool to harmonize regulatory decisions as well as enabling HTA decisions has been provided across multiple countries, including the UK [ 112 ], Israel [ 113 ], Austria [ 114 ], France [ 115 , 116 ], Switzerland [ 117 ] and Kazakhstan [ 9 ]. MCBS provides explicit scores based on a transparent methodology, helping to discern high- versus low-value medicines.…”

Section: What Could Be Donementioning

confidence: 99%

Implications of Oncology Trial Design and Uncertainties in Efficacy-Safety Data on Health Technology Assessments

et al. 2022

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Background: Advances in cancer medicines have resulted in tangible health impacts, but the magnitude of benefits of approved cancer medicines could vary greatly. Health Technology Assessment (HTA) is a multidisciplinary process used to inform resource allocation through a systematic value assessment of health technology. This paper reviews the challenges in conducting HTA for cancer medicines arising from oncology trial designs and uncertainties of safety-efficacy data. Methods: Multiple databases (PubMed, Scopus and Google Scholar) and grey literature (public health agencies and governmental reports) were searched to inform this policy narrative review. Results: A lack of robust efficacy-safety data from clinical trials and other relevant sources of evidence has made HTA for cancer medicines challenging. The approval of cancer medicines through expedited pathways has increased in recent years, in which surrogate endpoints or biomarkers for patient selection have been widely used. Using these surrogate endpoints has created uncertainties in translating surrogate measures into patient-centric clinically (survival and quality of life) and economically (cost-effectiveness and budget impact) meaningful outcomes, with potential effects on diverting scarce health resources to low-value or detrimental interventions. Potential solutions include policy harmonization between regulatory and HTA authorities, commitment to generating robust post-marketing efficacy-safety data, managing uncertainties through risk-sharing agreements, and using value frameworks. Conclusion: A lack of robust efficacy-safety data is a central problem for conducting HTA of cancer medicines, potentially resulting in misinformed resource allocation.

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Pre-reimbursement: early assessment for coverage decisions

Cited by 9 publications

References 29 publications

The status of health economic evaluation within decision making in Austria

The status of health economic evaluation within decision making in Austria

Reimbursement Decisions for Medical Services in Austria: An Analysis of Influencing Factors for the Hospital Individual Services Catalogue Between 2008 and 2020

Implications of Oncology Trial Design and Uncertainties in Efficacy-Safety Data on Health Technology Assessments

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