Kerstin Noëlle Vokinger
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View article: Therapeutic benefit of the most expensive drugs covered by Medicare and Medicaid
Therapeutic benefit of the most expensive drugs covered by Medicare and Medicaid Open
Many of the most expensive drugs were rated as having low added clinical benefit. As the US begins price negotiations under the Inflation Reduction Act, understanding the clinical value of drugs may help inform debates over drug affordabil…
View article: Generic competition and price developments in the USA, Germany and Switzerland (2007–2023): a longitudinal observational study
Generic competition and price developments in the USA, Germany and Switzerland (2007–2023): a longitudinal observational study Open
Introduction Drug expenditure has increased over the past years in the USA and Europe, mainly driven by originator drugs. Generic drugs have a substantial cost-saving potential. We analysed the number of generic competitors entering the ma…
View article: Correction to “Confidential and non-confidential drug rebates in Switzerland, 2013–2023: empirical analysis of drug rebates, trends over time and re-evaluations” [The Lancet Regional Health—Europe, volume 46, November 2024, 101094]
Correction to “Confidential and non-confidential drug rebates in Switzerland, 2013–2023: empirical analysis of drug rebates, trends over time and re-evaluations” [The Lancet Regional Health—Europe, volume 46, November 2024, 101094] Open
View article: Launch and Postlaunch Price Developments of New Drugs in the US, Germany, and Switzerland
Launch and Postlaunch Price Developments of New Drugs in the US, Germany, and Switzerland Open
Importance High prices of new drugs are concerning. What remains to be understood are price developments after entering the market because not only initial prices, but also postlaunch prices, contribute to drug spending. Objective To analy…
View article: Confidential and non-confidential drug rebates in Switzerland, 2013–2023: empirical analysis of drug rebates, trends over time and re-evaluations
Confidential and non-confidential drug rebates in Switzerland, 2013–2023: empirical analysis of drug rebates, trends over time and re-evaluations Open
View article: Why effect sizes are systematically larger for progression-free survival than overall survival in cancer drug trials: Prognostic scores as a way forward
Why effect sizes are systematically larger for progression-free survival than overall survival in cancer drug trials: Prognostic scores as a way forward Open
View article: Drug Prices After Patent Expirations in High-Income Countries and Implications for Cost-Effectiveness Analyses
Drug Prices After Patent Expirations in High-Income Countries and Implications for Cost-Effectiveness Analyses Open
Importance Understanding how patent expirations affect drug prices is crucial because price changes directly inform accurate cost-effectiveness assessments. This study investigates the association between patent expirations and drug prices…
View article: Comparative Analysis of Drug Shortages in the US and Germany (2016 – 2023)
Comparative Analysis of Drug Shortages in the US and Germany (2016 – 2023) Open
This article analyzes trends in drug shortages in the US and Germany, the largest pharmaceutical market in Europe, between 2016 and 2023. It assesses the commonalities and differences between the countries in terms of active substances in …
View article: Do Managed Entry Agreements Contribute to Lower Pharmaceutical Spending?
Do Managed Entry Agreements Contribute to Lower Pharmaceutical Spending? Open
Francesco Trotta, PhD; Maria Alessandra Guerrizio, PhD; Aurora Di Filippo, Dott; Agnese Cangini, Dott
View article: Defining ‘therapeutic value’ of medicines: a scoping review
Defining ‘therapeutic value’ of medicines: a scoping review Open
Objectives In recent years, discussions on the importance and scope of therapeutic value of new medicines have intensified, stimulated by the increase of prices and number of medicines entering the market. This study aims to perform a scop…
View article: Development Pipeline and Geographic Representation of Trials for Artificial Intelligence/Machine Learning–Enabled Medical Devices (2010 to 2023)
Development Pipeline and Geographic Representation of Trials for Artificial Intelligence/Machine Learning–Enabled Medical Devices (2010 to 2023) Open
A high number of artificial intelligence/machine learning (AI/ML)-enabled medical devices are currently in development. To understand the development pipeline and worldwide geographic distribution of clinical trials for AI/ML-enabled medic…
View article: 1705P Therapeutic value of first vs supplemental indications of drugs in the US and Europe (2011-2020): Retrospective cohort study
1705P Therapeutic value of first vs supplemental indications of drugs in the US and Europe (2011-2020): Retrospective cohort study Open
View article: 1701P Cancer premium: Explaining differences in prices for cancer vs non-cancer drugs with efficacy and epidemiological endpoints in the US, Germany, and Switzerland
1701P Cancer premium: Explaining differences in prices for cancer vs non-cancer drugs with efficacy and epidemiological endpoints in the US, Germany, and Switzerland Open
View article: Investments in Research and Development for Supplemental Drug Indications—Implications for Drug Price Negotiations
Investments in Research and Development for Supplemental Drug Indications—Implications for Drug Price Negotiations Open
This Viewpoint compares the research and development costs for a drug’s first indication with supplemental indications to demonstrate that the cost of approval for supplemental indications may be substantially lower.
View article: FDA-cleared artificial intelligence and machine learning-based medical devices and their 510(k) predicate networks
FDA-cleared artificial intelligence and machine learning-based medical devices and their 510(k) predicate networks Open
The US Food and Drug Administration is clearing an increasing number of artificial intelligence and machine learning (AI/ML)-based medical devices through the 510(k) pathway. This pathway allows clearance if the device is substantially equ…
View article: Therapeutic value of first versus supplemental indications of drugs in US and Europe (2011-20): retrospective cohort study
Therapeutic value of first versus supplemental indications of drugs in US and Europe (2011-20): retrospective cohort study Open
Objective To analyze the therapeutic value of supplemental indications compared with first indications for drugs approved in the US and Europe. Design Retrospective cohort study. Setting New and supplemental indications approved by the US …
View article: The cancer premium – explaining differences in prices for cancer vs non-cancer drugs with efficacy and epidemiological endpoints in the US, Germany, and Switzerland: a cross sectional study
The cancer premium – explaining differences in prices for cancer vs non-cancer drugs with efficacy and epidemiological endpoints in the US, Germany, and Switzerland: a cross sectional study Open
View article: Negotiating Drug Prices in the US—Lessons From Europe
Negotiating Drug Prices in the US—Lessons From Europe Open
This Viewpoint describes European drug price negotiation practices and compares them with practices in the US.
View article: Comparison of Uptake and Prices of Biosimilars in the US, Germany, and Switzerland
Comparison of Uptake and Prices of Biosimilars in the US, Germany, and Switzerland Open
Importance Biologics account for a substantial proportion of health care expenditures. Their costs have been projected to reach US $452 billion in global spending by 2022. Given recent expiration of patent protection of biologics, a shift …
View article: Reforming the World Health Organization’s Essential Medicines List
Reforming the World Health Organization’s Essential Medicines List Open
This Viewpoint proposes restructuring the WHO Essential Medicines List to remove consideration of cost and cost-effectiveness from the expert committee reviews of clinical effectiveness, safety, and public health value, and chartering a ne…
View article: Therapeutic Value of Drugs Granted Accelerated Approval or Conditional Marketing Authorization in the US and Europe From 2007 to 2021
Therapeutic Value of Drugs Granted Accelerated Approval or Conditional Marketing Authorization in the US and Europe From 2007 to 2021 Open
IMPORTANCE: The number of drugs approved through the accelerated approval or conditional marketing authorization pathways has increased with unclear evidence of their therapeutic value. OBJECTIVES: To assess the therapeutic value of drug i…
View article: Reforms to accelerated approval of new medicines: long overdue
Reforms to accelerated approval of new medicines: long overdue Open
View article: Clinical Benefit and Expedited Approval of Cancer Drugs in the United States, European Union, Switzerland, Japan, Canada, and Australia
Clinical Benefit and Expedited Approval of Cancer Drugs in the United States, European Union, Switzerland, Japan, Canada, and Australia Open
PURPOSE: Regulatory agencies have sought to speed up the review of new cancer medicines and reduce delays in approval between countries. We examined trends in regulatory review times and association with clinical benefit for new cancer med…
View article: Therapeutic Value Assessments of Novel Medicines in the US and Europe, 2018-2019
Therapeutic Value Assessments of Novel Medicines in the US and Europe, 2018-2019 Open
This economic evaluation study assesses the clinical benefit of novel drugs approved in 2018 and 2019 and examines whether drugs approved with special regulatory designations appear to provide meaningful therapeutic value.
View article: Lifecycle Regulation and Evaluation of Artificial Intelligence and Machine Learning-Based Medical Devices
Lifecycle Regulation and Evaluation of Artificial Intelligence and Machine Learning-Based Medical Devices Open
Between 2017-2018, the FDA cleared fourteen AI and ML-based software products as devices. This chapter analyzes how these products were cleared by the FDA and discusses how a lifecycle-based framework for regulating AI/ML-based software wo…
View article: Regulating AI in medicine in the United States and Europe
Regulating AI in medicine in the United States and Europe Open
View article: Mitigating bias in machine learning for medicine
Mitigating bias in machine learning for medicine Open
View article: Analysis of Launch and Postapproval Cancer Drug Pricing, Clinical Benefit, and Policy Implications in the US and Europe
Analysis of Launch and Postapproval Cancer Drug Pricing, Clinical Benefit, and Policy Implications in the US and Europe Open
During this economic evaluation study period, launch prices of cancer drugs were substantially higher in the US than in the assessed similar high-income European countries, a gap that increased in the years after approval. Cancer drug pric…
View article: Begegnungen - Beiträge von Assistierenden zum 50. Geburtstag von Thomas Gächter
Begegnungen - Beiträge von Assistierenden zum 50. Geburtstag von Thomas Gächter Open
Sozialversicherungsrecht, Gesundheitsrecht und öffentliches Recht – in diesen Rechtsgebieten prägt das wissenschaftliche Schaffen von Thomas Gächter die juristische und gesellschaftliche Diskussion. Aus Anlass seines 50. Geburtstags denken…
View article: Differenzierungen nach Immunitätsstatus und der Einsatz des Covid-Zertifikats. Eine bedürfnisorientierte Analyse, Diskussionspapier im Auftrag der Direktion der Justiz und des Innern des Kantons Zürich
Differenzierungen nach Immunitätsstatus und der Einsatz des Covid-Zertifikats. Eine bedürfnisorientierte Analyse, Diskussionspapier im Auftrag der Direktion der Justiz und des Innern des Kantons Zürich Open