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Assessment of FDA-Approved Drugs Not Recommended for Use or Reimbursement in Other Countries, 2017-2020

https://doi.org/10.1001/jamainternmed.2022.6787
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What this work says

Outgoing claims: the papers this work cites, builds on, or argues with.

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The High Cost of Prescription Drugs in the United States
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Trends in Prescription Drug Launch Prices, 2008-2021
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Potential Cost Implications for All US Food and Drug Administration Oncology Drug Approvals in 2018
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Analysis of Supportive Evidence for US Food and Drug Administration Approvals of Novel Drugs in 2020
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Analysis of Launch and Postapproval Cancer Drug Pricing, Clinical Benefit, and Policy Implications in the US and Europe
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A Comparison of EMA and FDA Decisions for New Drug Marketing Applications 2014–2016: Concordance, Discordance, and Why
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A comparison of new drugs approved by the FDA, the EMA, and Swissmedic: an assessment of the international harmonization of drugs
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Medicare Spending on Drugs and Biologics Not Recommended for Coverage by International Health Technology Assessment Agencies
inferredcites →https://doi.org/10.1016/j.healthpol.2014.11.012openalex-snapshot
Medicare's use of cost-effectiveness analysis for prevention (but not for treatment)
inferredcites →https://doi.org/10.1016/j.healthpol.2016.08.001openalex-snapshot
Health benefit assessment of pharmaceuticals: An international comparison of decisions from Germany, England, Scotland and Australia
inferredcites →https://doi.org/10.1016/j.healthpol.2016.08.006openalex-snapshot
A comparative study of drug listing recommendations and the decision-making process in Australia, the Netherlands, Sweden, and the UK
inferredcites →https://doi.org/10.1016/j.jval.2020.11.009openalex-snapshot
International Reference Pricing for Prescription Drugs in the United States: Administrative Limitations and Collateral Effects
inferredcites →https://doi.org/10.1016/j.jval.2022.01.010openalex-snapshot
The History and Future of the “ISPOR Value Flower”: Addressing Limitations of Conventional Cost-Effectiveness Analysis
inferredcites →https://doi.org/10.1016/j.yrtph.2018.05.002openalex-snapshot
Canadian, European and United States new drug approval times now relatively similar
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Prices and clinical benefit of cancer drugs in the USA and Europe: a cost–benefit analysis
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Value‐based drug pricing in the Biden era: Opportunities and prospects
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Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study
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Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study
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Cost-Effectiveness of Tafamidis Therapy for Transthyretin Amyloid Cardiomyopathy
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Health technology assessment of drugs for rare diseases: insights, trends, and reasons for negative recommendations from the CADTH common drug review
inferredcites →https://doi.org/10.1200/jco.2021.39.15_suppl.1575openalex-snapshot
Time intervals between U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) new cancer therapy approvals.
inferredcites →https://doi.org/10.1200/jop.17.00058openalex-snapshot
Examining Trends in Cost and Clinical Benefit of Novel Anticancer Drugs Over Time
inferredcites →https://doi.org/10.1200/op.21.00909openalex-snapshot
Clinical Benefit and Expedited Approval of Cancer Drugs in the United States, European Union, Switzerland, Japan, Canada, and Australia
inferredcites →https://doi.org/10.1377/hlthaff.2020.00094openalex-snapshot
National Health Expenditure Projections, 2019–28: Expected Rebound In Prices Drives Rising Spending Growth
inferredcites →https://doi.org/10.1377/hpb20180216.92303openalex-snapshot
Policy Strategies For Aligning Price And Value For Brand-Name Pharmaceuticals
inferredcites →https://doi.org/10.18553/jmcp.2018.24.12.1230openalex-snapshot
Coverage of Novel Therapeutic Agents by Medicare Prescription Drug Plans Following FDA Approval
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Do different clinical evidence bases lead to discordant health-technology assessment decisions? An in-depth case series across three jurisdictions

What points at this work

Incoming claims: where this work appears in other papers’ reference lists and arguments.

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Pharmaceutical Pricing and R&D as a Global Public Good
inferred← citeshttps://doi.org/10.1002/hec.70105openalex-snapshot
Pharmaceutical Pricing and R&D as a Global Public Good
inferred← citeshttps://doi.org/10.1007/s40140-024-00631-2openalex-snapshot
Direct Oral Anticoagulants: An Update on Monitoring and Antidotes for the Perioperative Physician
inferred← citeshttps://doi.org/10.1007/s40258-025-00968-7openalex-snapshot
Cost-Effectiveness and Value of Information Analyses of Caplacizumab for the Treatment of Thrombotic Thrombocytopenic Purpura in Brazil
inferred← citeshttps://doi.org/10.1007/s43441-025-00771-5openalex-snapshot
Cross-sectional Study and Comparison between Japan and the United States on Special Regulatory Pathways for Expedited Drug Development and Approval
inferred← citeshttps://doi.org/10.1056/nejmc2406975openalex-snapshot
Recombinant ADAMTS13 for Immune Thrombotic Thrombocytopenic Purpura
inferred← citeshttps://doi.org/10.1080/20523211.2024.2389120openalex-snapshot
Australian access to FDA-approved breakthrough therapy designation medicines: a 10-year review
inferred← citeshttps://doi.org/10.1093/crocol/otag087openalex-snapshot
Evaluating the access process for patients transitioning from intravenous to subcutaneous biologic administration for inflammatory bowel disease
inferred← citeshttps://doi.org/10.1093/haschl/qxad028openalex-snapshot
Food and Drug Administration novel drug decisions in 2017: transparency and disclosure prior to and 5 years following approval
inferred← citeshttps://doi.org/10.1136/bmjph-2024-001995openalex-snapshot
Disparities in the access to immune checkpoint inhibitors approved in the United States, the European Union and mainland China: a serial cross-sectional study
inferred← citeshttps://doi.org/10.1136/dtb.2023.000011openalex-snapshot
International variation in approval of medicines
inferred← citeshttps://doi.org/10.1182/blood.2025030872openalex-snapshot
Global access to commercial CAR T-cell therapies: a cross-sectional study of health technology assessment across the G20 countries
inferred← citeshttps://doi.org/10.12788/jfp.0559openalex-snapshot
5 non-COVID vaccine recommendations from ACIP
inferred← citeshttps://doi.org/10.12788/jfp.0562openalex-snapshot
Meaningful improvement for patients like Tante Ilse
inferred← citeshttps://doi.org/10.1371/journal.pone.0286802openalex-snapshot
New drug submissions in Canada and a comparison with the Food and Drug Administration and the European Medicines Agency: Cross-sectional analysis
inferred← citeshttps://doi.org/10.1377/hlthaff.2024.01072openalex-snapshot
First-In-Class Drugs Experienced Different Regulatory Treatment In The US And Europe
inferred← citeshttps://doi.org/10.1377/hlthaff.2025.00595openalex-snapshot
Review Times For New Drugs And Submission Delays Among The FDA And 4 International Regulators, 2014–22
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