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Book: Management im Gesundheitswesen

Busse, Reinhard / Schreyögg, Jonas / Stargardt, Tom

das Lehrbuch für Studium und Praxis

2022

Author's details	[Herausgeber] Reinhard Busse, Jonas Schreyögg, Tom Stargardt
Keywords	Gesundheitsmanagement ; Gesundheitswesen ; Gesundheitsökonomie ; Management ; Public health ; Betriebswirtschaft ; Pflegestudiengang ; Pflegemanagement ; Wirtschaftswissenschaft ; Künstliche Intelligenz ; Studium Gesundheitsmanagement ; Krankenhausmanagement ; Leistungsmangement ; Integrierte Versorgung ; Arzneimittelindustrie ; Personalmanagement im Gesundheitswesen
Subject	Unternehmen ; Unternehmensmanagement ; Unternehmensführung ; Leitung ; Gesundheitsdienst ; Gesundheitssystem ; Gesundheitswirtschaft ; Medizinalwesen ; Medizinalsystem
Language	German
Size	XXIII, 649 Seiten, Diagramme, 25.4 cm x 17.8 cm
Edition	5. Auflage
Publisher	Springer
Publishing place	Berlin
Publishing country	Germany
Document type	Book
Old title	Vorangegangen ist
HBZ-ID	HT021401132
ISBN	978-3-662-64175-0 ; 3-662-64175-5 ; 9783662641767 ; 3662641763
Database	Catalogue ZB MED Medicine, Health

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2022 A 790	available for loan (reading room)	Lesesaal EG

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Article ; Online: Harmonizing regulatory market approval of products with high safety requirements: Evidence from the European pharmaceutical market.

Grünwald, Fabian / Stargardt, Tom

Health economics

2024

Abstract: We causally analyzed whether being a member of the European Union (EU) and having access to a centralized marketing authorization procedure (centralized procedure [CP]) affects availability and time to launch of new pharmaceuticals. We employed multiple ... ...

Abstract	We causally analyzed whether being a member of the European Union (EU) and having access to a centralized marketing authorization procedure (centralized procedure [CP]) affects availability and time to launch of new pharmaceuticals. We employed multiple difference-in-differences models, exploiting the eastern enlargement of the EU as well as changes in the indications that fall within the compulsory or voluntary scope of the CP. Results showed that countries experienced a mean decrease in launch delay of 10.9 months (p = 0.004) after joining the EU. Effects were higher among pharmaceuticals that belong to indications that might voluntarily participate in the CP but are not obliged to. These are often financially less attractive to manufacturers than pharmaceuticals within the compulsory scope. Availability of new pharmaceuticals launched remained unaffected. We found signs that the magnitude of the country-specific effect of centralized marketing authorization on launch delay may be influenced by strategic decisions of manufacturers at the national level (e.g., parallel trade or reference pricing).
Language	English
Publishing date	2024-03-15
Publishing country	England
Document type	Journal Article
ZDB-ID	1135838-5
ISSN	1099-1050 ; 1057-9230
ISSN (online)	1099-1050
ISSN	1057-9230
DOI	10.1002/hec.4819
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Does health technology assessment compromise access to pharmaceuticals?

Büssgen, Melanie / Stargardt, Tom

The European journal of health economics : HEPAC : health economics in prevention and care

2023 Volume 24, Issue 7, Page(s) 1245–1248

Abstract: In response to rapidly rising pharmaceutical costs, many countries have introduced health technology assessment (HTA) as a 'fourth hurdle'. We evaluated the causal effect of HTA based regulation on access to pharmaceuticals by using the introduction of ... ...

Abstract	In response to rapidly rising pharmaceutical costs, many countries have introduced health technology assessment (HTA) as a 'fourth hurdle'. We evaluated the causal effect of HTA based regulation on access to pharmaceuticals by using the introduction of Germany's HTA system (AMNOG) in 2011. We obtained launch data on pharmaceuticals for 30 European countries from the IQVIA (formerly IMS) database. Using difference-in-difference models, we estimated the effect of AMNOG on launch delay, the ranking order of launch delays and the availability of pharmaceuticals. We then compared the results for Germany to Austria, Czechia, Italy, Portugal and the UK. Across all six countries, launch delay decreased from the pre-AMNOG period (25.01 months) to the post-AMNOG period (14.34 months). However, the introduction of AMNOG consistently reduced the magnitude of the decrease in launch delay in Germany compared to the comparator countries (staggered DiD: + 4.31 months, p = 0.05). Our logit results indicate that the availability of pharmaceuticals in Germany increased as a result of AMNOG (staggered logit: + 5.78%, p = 0.009). We provide evidence on the trade-off between regulation and access. This can help policymakers make better informed decisions to strike the right balance between cost savings achieved through HTA based regulation and access to pharmaceuticals.
MeSH term(s)	Humans ; Technology Assessment, Biomedical ; Europe ; Germany ; Costs and Cost Analysis ; Pharmaceutical Preparations
Chemical Substances	Pharmaceutical Preparations
Language	English
Publishing date	2023-06-19
Publishing country	Germany
Document type	Letter
ZDB-ID	2045253-6
ISSN	1618-7601 ; 1618-7598
ISSN (online)	1618-7601
ISSN	1618-7598
DOI	10.1007/s10198-023-01611-9
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: 10 Years of AMNOG: What is the Willingness-to-Pay for Pharmaceuticals in Germany?

Büssgen, Melanie / Stargardt, Tom

Applied health economics and health policy

2023 Volume 21, Issue 5, Page(s) 751–759

Abstract: Objectives: The German Pharmaceutical Market Restructuring Act (AMNOG, 2011) is a two-stage process to regulate the price of new pharmaceuticals in which price negotiations are conducted based on evidence-based medical benefit assessments using data ... ...

Abstract	Objectives: The German Pharmaceutical Market Restructuring Act (AMNOG, 2011) is a two-stage process to regulate the price of new pharmaceuticals in which price negotiations are conducted based on evidence-based medical benefit assessments using data from prior clinical trials. Although the act does not explicitly set a willingness-to-pay (WTP) threshold, the process itself implicitly establishes a WTP for health improvement. We evaluated the implicit WTP for prescription pharmaceuticals post-AMNOG in the German healthcare system from the decision-maker/payer perspective. Methods: We extracted data on patient-group-specific annual treatment costs and endpoints from 2011 to 2021 from the dossiers assessed by the German Federal Joint Committee (FJC; Gemeinsamer Bundesausschuss). Using incremental cost-effectiveness ratios (ICERs), we calculated a WTP for the indications (I) diabetes, (II) cardiovascular disease, and (III) psoriasis weighted according to patient group size, first from the perspective of the decision-maker (approach A), and second from the perspective of the industry (approach B). To put clinical outcome measures into relation to one another, minimum clinically important differences (MCIDs) were derived from the literature and compared. Results: The annual treatment costs of newly authorized drugs were substantially higher (both pre- and post-negotiation) than that of their comparators (e.g., psoriasis, pre-negotiation: €20,601.59, post-negotiation: €16,763.57; comparators: €5178.00). However, although newly launched drugs were more expensive than their comparators, they brought greater medical benefits and were more aligned with value (r = 0.59, P < 0.001) than older drugs. We estimated WTP to vary widely by indication group [€33,814.08 per 1 percentage point hemoglobin A1c (HbA1c) reduction for diabetes, €10,970.83 per life year gained for cardiovascular disease, and €663.46 per 1% PASI decrease for psoriasis; approach A]. WTP was converted to MCID thresholds: diabetes: €16,907.04; cardiovascular drugs: no MCID existent to convert; and psoriasis: €33,173.00. WTP remained constant over time for diabetes and cardiovascular drugs but increased for psoriasis drugs. Conclusion: This paper is one of the first to estimate the implicit WTP for prescription pharmaceuticals post-AMNOG and suggests that the WTP may vary between different therapeutic areas. Additionally, making different assumptions (approach A versus approach B) with regard to the assumed effectiveness in indication areas that had been declared as having no additional benefit by the FJC may explain the different perspectives of decision-makers and of the pharmaceutical industry on the value of a pharmaceutical.
MeSH term(s)	Humans ; Cardiovascular Diseases ; Delivery of Health Care ; Germany ; Health Care Costs ; Pharmaceutical Preparations ; Cost-Benefit Analysis
Chemical Substances	Pharmaceutical Preparations
Language	English
Publishing date	2023-05-30
Publishing country	New Zealand
Document type	Journal Article
ZDB-ID	2171420-4
ISSN	1179-1896 ; 1175-5652
ISSN (online)	1179-1896
ISSN	1175-5652
DOI	10.1007/s40258-023-00815-7
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Authors' Reply to Gandjour: "10 Years of AMNOG: What is the Willingness-to-Pay for Pharmaceuticals in Germany?"

Büssgen, Melanie / Stargardt, Tom

Applied health economics and health policy

2023 Volume 22, Issue 1, Page(s) 127–128

Language	English
Publishing date	2023-12-02
Publishing country	New Zealand
Document type	Letter
ZDB-ID	2171420-4
ISSN	1179-1896 ; 1175-5652
ISSN (online)	1179-1896
ISSN	1175-5652
DOI	10.1007/s40258-023-00851-3
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: From Health to Wellbeing: Toward a Monetary Valuation of a Wellbeing-Adjusted Life-Year.

Brinkmann, Carolin / Stargardt, Tom / Brouwer, Werner B F

Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research

2024

Abstract: Objectives: Economic evaluations using broader measures to capture benefits beyond improved health can inform policy making, but only if the monetary value of gains measured using these instruments is understood. This study explored contingent valuation ...

Abstract	Objectives: Economic evaluations using broader measures to capture benefits beyond improved health can inform policy making, but only if the monetary value of gains measured using these instruments is understood. This study explored contingent valuation as a method to estimate the monetary value of a wellbeing-adjusted life-year (WALY) as measured by ICEpop Capability Measure for Adults (ICECAP-A). Methods: In a large online survey of representative samples from 7 European countries, participants valued a change in the ICECAP-A from their current health state to a randomly assigned hypothetical state. Participants were instructed that an unspecified treatment could avoid a loss or produce a gain in wellbeing and were asked for their willingness to pay (WTP) for this treatment. WTP per WALY was calculated using an aggregated approach that used ICECAP-A tariffs from the United Kingdom. Results: We analyzed a sample of 7428 observations, focusing on avoided losses (n = 6002) because the results for gains were not theoretically valid. Different cutoff points for a marginal change were explored. Depending on the definition of a marginal change, WTP per WALY averaged between €13 323.28 and €61 375.63 for avoided losses between [0, 0.5] and [0, 0.1], respectively, for 1 month. Mean WTP per WALY varied across the countries as follows: Denmark (€17 867.93-€88 634.14), France (€10 278.35-€45 581.28), Germany (€12 119.39-€54 566.56), Italy (€11 753.69-€52 161.25), The Netherlands (€14 612.88-€58 951.74), Spain (€11 904.12-€57 909.17), and United Kingdom (€13 133.75-€68 455.85). Conclusion: Despite the inherent limitations of our study, it offers valuable insights into methods for eliciting the WTP for changes in capability wellbeing as measured with ICECAP-A.
Language	English
Publishing date	2024-03-04
Publishing country	United States
Document type	Journal Article
ZDB-ID	1471745-1
ISSN	1524-4733 ; 1098-3015
ISSN (online)	1524-4733
ISSN	1098-3015
DOI	10.1016/j.jval.2024.02.015
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Book: Management im Gesundheitswesen

Busse, Reinhard / Schreyögg, Jonas / Stargardt, Tom

das Lehrbuch für Studium und Praxis

(Lehrbuch)

2017

Author's details	Reinhard Busse, Jonas Schreyögg, Tom Stargardt (Hrsg.)
Series title	Lehrbuch
Keywords	Health Services Administration ; Gesundheitsmanagement ; Gesundheitswesen ; Gesundheitsökonomie ; Management ; Public health ; Betriebswirtschaft ; Pflegestudiengang ; Pflegemanagement ; Wirtschaftswissenschaft
Subject	Unternehmen ; Unternehmensmanagement ; Unternehmensführung ; Leitung ; Gesundheitsdienst ; Gesundheitssystem ; Gesundheitswirtschaft ; Medizinalwesen ; Medizinalsystem
Subject code	610
Language	German
Size	XVI, 521 Seiten, Diagramme
Edition	4. Auflage
Publisher	Springer
Publishing place	Berlin
Publishing country	Germany
Document type	Book
HBZ-ID	HT019426119
ISBN	978-3-662-55023-6 ; 3-662-55023-7 ; 9783662550243 ; 3662550245
Database	Catalogue ZB MED Medicine, Health

In stock of ZB MED Cologne/Königswinter

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2018 A 113	available for loan (reading room)	Lesesaal EG

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Article ; Online: Changes in launch delay and availability of pharmaceuticals in 30 European markets over the past two decades.

Büssgen, Melanie / Stargardt, Tom

BMC health services research

2022 Volume 22, Issue 1, Page(s) 1457

Abstract: Background: The timing of the launch of a new drug is an important factor that determines access for patients. We evaluated patient access to pharmaceuticals in 30 European markets over the past two decades.: Methods: Launch dates were extracted from ...

Abstract	Background: The timing of the launch of a new drug is an important factor that determines access for patients. We evaluated patient access to pharmaceuticals in 30 European markets over the past two decades. Methods: Launch dates were extracted from the IQVIA (formerly IMS) database for 30 European countries for all pharmaceuticals launched internationally between 2000 and 2017. We defined launch delay as the difference between the first international launch date and the corresponding national launch date, and calculated these for each country in our sample over time. Additionally, we ranked countries according to their launch delays and looked at changes in the ranking order over time. Lastly, we determined the availability of new pharmaceuticals in each country, calculating this as the percentage of these pharmaceuticals that were available in each country during a pre-specified interval. Results: There was a clear trend towards a decrease in launch delays across all countries from 2000 (37.2 months) to 2017 (11.8 months). Over the entire observation period, the three fastest launching countries were the Netherlands, Sweden, and Germany, whereas the three slowest were Bosnia-Herzegovina, Serbia, and Turkey. Germany had the highest availability of new pharmaceuticals with 85.7%, followed by the United Kingdom (83.1%) and Norway (82.9%). Countries with the lowest availability of pharmaceuticals were Bosnia-Herzegovina, Serbia, and Latvia. Gross domestic product per capita was negatively correlated with launch delay (-0.67, p < 0.000) and positively correlated with the availability of pharmaceuticals (+ 0.19, p < 0.000). Conclusion: Launch delay and the availability of pharmaceuticals varied substantially across all 30 European countries. Using countries with above-average availability and below-average launch delays as a benchmark, stakeholders may discuss or modify current pharmaceutical policy, if needed, to improve access to pharmaceutical care.
MeSH term(s)	Humans ; Benchmarking ; Databases, Factual ; Drug and Narcotic Control ; Serbia ; Pharmaceutical Preparations
Chemical Substances	Pharmaceutical Preparations
Language	English
Publishing date	2022-11-30
Publishing country	England
Document type	Journal Article
ZDB-ID	2050434-2
ISSN	1472-6963 ; 1472-6963
ISSN (online)	1472-6963
ISSN	1472-6963
DOI	10.1186/s12913-022-08866-7
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Does health technology assessment compromise access to pharmaceuticals?

Büssgen, Melanie / Stargardt, Tom

The European journal of health economics : HEPAC : health economics in prevention and care

2022 Volume 24, Issue 3, Page(s) 437–451

Abstract	In response to rapidly rising pharmaceutical costs, many countries have introduced health technology assessment (HTA) as a 'fourth hurdle'. We evaluated the causal effect of HTA based regulation on access to pharmaceuticals by using the introduction of Germany's HTA system (AMNOG) in 2011. We obtained launch data on pharmaceuticals for 30 European countries from the IQVIA (formerly IMS) database. Using difference-in-difference models, we estimated the effect of AMNOG on launch delay, the ranking order of launch delays, and the availability of pharmaceuticals. We then compared the results for Germany to Austria, Czechia, Italy, Portugal, and the UK. Across all six countries, launch delays decreased from the pre-AMNOG period (25.01 months) to the post-AMNOG period (14.34 months). However, the introduction of AMNOG consistently reduced the magnitude of the decrease in launch delay in Germany compared to the comparator countries (staggered DiD: + 4.31 months, p = 0.05). Our logit results indicate that the availability of pharmaceuticals in Germany increased as a result of AMNOG (staggered logit: + 5.78%, p = 0.009). We provide evidence on the trade-off between regulation and access. This can help policymakers make better-informed decisions to strike the right balance between cost savings achieved through HTA based regulation and access to pharmaceuticals.
MeSH term(s)	Humans ; Technology Assessment, Biomedical ; Europe ; Germany ; Costs and Cost Analysis ; Pharmaceutical Preparations
Chemical Substances	Pharmaceutical Preparations
Language	English
Publishing date	2022-06-16
Publishing country	Germany
Document type	Journal Article
ZDB-ID	2045253-6
ISSN	1618-7601 ; 1618-7598
ISSN (online)	1618-7601
ISSN	1618-7598
DOI	10.1007/s10198-022-01484-4
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article: Cooperation Improvement in an Integrated Healthcare Network: A Social Network Analysis.

Larrain, Nicolás / Wang, Sophie / Stargardt, Tom / Groene, Oliver

International journal of integrated care

2023 Volume 23, Issue 2, Page(s) 32

Abstract: Background: Cooperation is a core feature of integrated healthcare systems and an important link in their value-creating mechanism. The premise is that providers who cooperate can promote more efficient use of health services while improving health ... ...

Abstract	Background: Cooperation is a core feature of integrated healthcare systems and an important link in their value-creating mechanism. The premise is that providers who cooperate can promote more efficient use of health services while improving health outcomes. We studied the performance of an integrated healthcare system in improving regional cooperation. Methods: Using claims data and social network analysis, we constructed the professional network from 2004 to 2017. Cooperation was studied by analyzing the evolution of network properties at network and physician practice (node) level. The impact of the integrated system was studied with a dynamic panel model that compared practices that participated in the integrated system versus nonparticipants. Results: The regional network evolved favourably towards cooperation. Network density increased 1.4% on average per year, while mean distance decreased 0.78%. At the same time, practices participating in the integrated system became more cooperative compared to other practices in the region: Degree (1.64e-03, p = 0.07), eigenvector (3.27e-03, p = 0.06) and betweenness (4.56e-03, p < 0.001) centrality increased more for participating practices. Discussion: Findings can be explained by the holistic approach to patients' care needs and coordination efforts of integrated healthcare. The paper provides a valuable design for performance assessment of professional cooperation. Highlights: Using claims data and social network analysis, we identify a regional cooperation network and conduct a panel analysis to measure the impact of an integrated care initiative on enhancing professional cooperation.Physician practices participating in the integrated system became more cooperative and improved their influence in the regional network more than non-participating practices.Integrated healthcare systems effectively incentivize cooperation through a holistic approach to patient care needs and coordination efforts.
Language	English
Publishing date	2023-06-26
Publishing country	England
Document type	Journal Article
ZDB-ID	2119289-3
ISSN	1568-4156
ISSN	1568-4156
DOI	10.5334/ijic.6519
Database	MEDical Literature Analysis and Retrieval System OnLINE

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