Cross-Comparison of Cancer Drug Approvals at Three International Regulatory Agencies

Samuel, Nardin; Verma, Subodh

doi:10.3747/co.23.2803

Cited by 18 publications

(18 citation statements)

References 10 publications

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“…The mean time from cancer medicine application at the FDA to submission at the European Medicines Agency or Health Canada was 12.9 months and 28.4 months, respectively . After regulatory approval by the European Medicines Agency or the FDA, it can take ≥1 year for a cancer medicine to be registered in low‐income and middle‐income countries .…”

Section: Optimizing Cancer Medicine Regulationmentioning

confidence: 99%

“…The approval was based on data from 149 patients with unresectable or metastatic, MSI-H or dMMR cancer (84% colorectal, 53% other tumors) across 5 trials; further trials are to be conducted to evaluate response and duration, and it is likely that these will select patients on the basis of MSI-H or dMMR biomarkers VOLUME 70 | NUMBER 2 | MARCH/APRIL 2020 Canada was 12.9 months and 28.4 months, respectively. 95 After regulatory approval by the European Medicines Agency or the FDA, it can take ≥1 year for a cancer medicine to be registered in low-income and middle-income countries. 96 The process for registering cancer medicines in low-income and middle-income countries is complex, inefficient, and costly.…”

Section: Nonrandomized Trials Using Historical Controlsmentioning

confidence: 99%

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Enhancing global access to cancer medicines

Cortés

Peréz-García

Llombart-Cussac

et al. 2020

CA A Cancer J Clinicians

153

108

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Globally, cancer is the second leading cause of death, with numbers greatly exceeding those for human immunodeficiency virus/acquired immunodeficiency syndrome, tuberculosis, and malaria combined. Limited access to timely diagnosis, to affordable, effective treatment, and to high‐quality care are just some of the factors that lead to disparities in cancer survival between countries and within countries. In this article, the authors consider various factors that prevent access to cancer medicines (particularly access to essential cancer medicines). Even if an essential cancer medicine is included on a national medicines list, cost might preclude its use, it might be prescribed or used inappropriately, weak infrastructure might prevent it being accessed by those who could benefit, or quality might not be guaranteed. Potential strategies to address the access problems are discussed, including universal health coverage for essential cancer medicines, fairer methods for pricing cancer medicines, reducing development costs, optimizing regulation, and improving reliability in the global supply chain. Optimizing schedules for cancer therapy could reduce not only costs, but also adverse events, and improve access. More and better biomarkers are required to target patients who are most likely to benefit from cancer medicines. The optimum use of cancer medicines depends on the effective delivery of several services allied to oncology (including laboratory, imaging, surgery, and radiotherapy). Investment is necessary in all aspects of cancer care, from these supportive services to technologies, and the training of health care workers and other staff.

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Section: Optimizing Cancer Medicine Regulationmentioning

confidence: 99%

Section: Nonrandomized Trials Using Historical Controlsmentioning

confidence: 99%

Enhancing global access to cancer medicines

Cortés

Peréz-García

Llombart-Cussac

et al. 2020

CA A Cancer J Clinicians

153

108

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“…Efforts to pursue harmonisation of drug regulation have been ongoing but differences in the approval characteristics of drugs by different agencies still persist 2. The speed of the regulatory review and approval processes between the major regulators, primarily the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have been analysed as a measure of the (dis)alignment of the agencies’ various approval models 3–10…”

Section: Introductionmentioning

confidence: 99%

To what degree are review outcomes aligned for new active substances (NASs) between the European Medicines Agency and the US Food and Drug Administration? A comparison based on publicly available information for NASs initially approved in the time period 2014 to 2016

et al. 2019

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ObjectiveTo compare review outcome alignment between European Medicines Agency (EMA) and US Food and Drug Administration (FDA) for medicines approved by both agencies in the time period 2014–2016.DesignUsing publicly available information from FDA and EMA websites, new active substances (NASs) approved by each agency from 2014 to 2016 were identified and their characteristics assessed. Divergences in regulatory outcomes for simultaneous (within 91 days) submissions to both agencies were identified and then examined for use of facilitated regulatory pathways and orphan designations; submitted versus approved indications; and approval times.ResultsIn 2014–2016, 115 NASs were approved by EMA or FDA or both; 74/115 were new chemical entities and 41 new biological/biotechnology entities; 82/115 were approved by both agencies, 24 only by FDA and nine only by EMA. Simultaneous submission occurred for 52/115; 13/52 received expedited review by both agencies and 18 only by FDA; 8/52 received conditional approval from both agencies, 2/52 only from FDA and 1/52 only from EMA; 17/52 were designated as orphans by both agencies and 10/52 by FDA only; 31/52 indications were approved as submitted and 21 changed by EMA and 29/46 were approved as submitted (six not assessed) and 17/46 changed by FDA. Median FDA review timelines were 319 days compared with 409 days for EMA.ConclusionsThere was general agreement in EMA / FDA conditional approvals. FDA used expedited pathways and orphan designation more often than EMA, suggesting stricter EMA criteria or definitions for these designations or less flexible processes. Despite consistency in submitted indications, there was lack of concordance in approved indications, which should be further investigated. FDA review times are faster because of a wider range of expedited pathways and the two-step EMA process; this may change with recent revisions to EMA accelerated assessment guidelines and the launch of Priority Medicines.

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“…When trials have shown the effectiveness or clinical benefit of a specific treatment, the treatment needs to be approved before it can be implemented and used in clinical practice. Several international regulatory agencies are responsible for these drug approval processes, such as the European Medicines Agency (EMA) and the Food and Drug Administration [ 3 ]. In addition, national bodies typically apply country specific regulations concerning drug approval.…”

Section: Introductionmentioning

confidence: 99%

Evidence on the cost of breast cancer drugs is required for rational decision making

Berghuis¹,

Koffijberg²,

Terstappen³

et al. 2018

ecancer

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BackgroundFor rational decision making, assessing the cost-effectiveness and budget impact of new drugs and comparing the costs of drugs already on the market is required. In addition to value frameworks, such as the American Society of Clinical Oncology Value Framework and the European Society of Medical Oncology–Magnitude of Clinical benefit Scale, this also requires a transparent overview of actual drug prices. While list prices are available, evidence on treatment cost is not. This paper aims to synthesise evidence on the reimbursement and costs of high-cost breast cancer drugs in The Netherlands (NL).MethodsA literature review was performed to identify currently reimbursed breast cancer drugs in the NL. Treatment costs were determined by multiplying list prices with the average length of treatment and dosing schedule.ResultsComparing list prices to the estimated treatment cost resulted in substantial differences in the ranking of costliness of the drugs. The average mean treatment length was unknown for 11/31 breast cancer drugs (26.2%). The differences in the 15 highest-cost drugs were largest for Bevacizumab, Lapatinib and everolimus, with list prices of €541, €158, €1,168 and estimated treatment cost of €174,400, €18,682 and €31,207, respectively. The lowest-cost (patented) targeted drug is €1,818 more expensive than the highest-cost (off-patent) generic drug according to the estimated drug treatment cost.ConclusionsA lack of evidence on the reimbursement and cost of high-cost breast cancer drugs complicates rapid and transparent evidence synthesis, necessary to focus strategies aiming to limit the increasing healthcare costs. Interestingly, the findings show that off-patent generics (such as paclitaxel or doxorubicin), although substantially cheaper than patented drugs, are still relatively costly. Extending standardisation and increasing European and national regulations on presenting information on costs per cancer drug is highly recommended.

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Cross-Comparison of Cancer Drug Approvals at Three International Regulatory Agencies

Abstract: BackgroundThe primary objective of the present study was to examine the drug approval process and the time to

Cited by 18 publications

References 10 publications

Enhancing global access to cancer medicines

Enhancing global access to cancer medicines

To what degree are review outcomes aligned for new active substances (NASs) between the European Medicines Agency and the US Food and Drug Administration? A comparison based on publicly available information for NASs initially approved in the time period 2014 to 2016

Evidence on the cost of breast cancer drugs is required for rational decision making

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