Development and economic trends in anticancer drugs licensed in the UK from 2015 to 2019

Lythgoe, Mark P.; Krell, Jonathan; Mahmoud, Sarah; Liu, Christopher; Vasudevan, Aishwarya; Savage, Philip

doi:10.1016/j.drudis.2020.11.011

Cited by 9 publications

(12 citation statements)

References 19 publications

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“…2 The past decade has witnessed a record number of new oncology therapy approvals, including many first-in-class or breakthrough therapies, requiring timely review and authorization from regulatory agencies to provide prompt access to patients in need. [3][4][5] Over this same period, new review pathways have been developed by both the FDA (Breakthrough Designation) and EMA (Priority Medicines; PRIME) to enhance support for the development and review of medicines to treat serious conditions. Furthermore, expedited approval pathways (accelerated approval by the FDA and conditional marketing authorization by the EMA) have also been used to address many areas of unmet need within oncology.…”

Section: Introductionmentioning

confidence: 99%

Cancer Therapy Approval Timings, Review Speed, and Publication of Pivotal Registration Trials in the US and Europe, 2010-2019

et al. 2022

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Key Points Question When a new cancer therapy is approved by both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), are there notable differences in approval timings and review speed? Findings This cross-sectional study found that of 89 new oncology therapies approved by both the FDA and EMA from 2010 to 2019, the FDA approved 95% of therapies first, with a median delay to market authorization in Europe of 241 days. Meaning The findings of this study suggest that patients in the US have access to new oncology therapies earlier than in Europe.

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Section: Introductionmentioning

confidence: 99%

Cancer Therapy Approval Timings, Review Speed, and Publication of Pivotal Registration Trials in the US and Europe, 2010-2019

et al. 2022

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“…The increasing duration of new treatments in recent years has been reported by others, 1 , 8 which may be due to a transition from cytotoxic therapies administered in fixed durations, to monoclonal antibody strategies (including immunotherapy) and tyrosine kinase inhibitors which are administered continuously. For immunotherapy strategies, two examples in patients with unresectable or metastatic melanoma show that the duration of treatment in responders may be limited to 2 years (KEYNOTE-006 trial) 9 or unlimited per protocol (CheckMate 067 trial).…”

Section: Discussionmentioning

confidence: 99%

“…The shift away from cytotoxic therapies to targeted therapies, including monoclonal antibodies, has also led to an ∼75% increase in the duration of treatment for the patient, in part because of better tolerability of the drug. 1 With the better tolerability of newer drugs, the continuation of treatment beyond progression is being increasingly used in an effort to slow further progression. 2 , 3 However, regarding some classes of chronic treatment strategies, such as immune checkpoint inhibitors, long-term effects on the immune system are still unknown prompting others to caution against unnecessary lengthy durations of treatment.…”

Section: Introductionmentioning

confidence: 99%

Duration of treatment in oncology clinical trials: does the duration change when the same drug moves from the experimental arm to the control arm?

et al. 2022

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“…Over the past 2 decades, a range of new targeted medicines and immune therapies have been developed for different types of cancer. 1 These pharmaceutical innovations have the potential to improve the outcomes of patients with cancer. 2 However, this improvement can be realized only when all patients who may benefit have access to these new medicines at the right time.…”

Section: Introductionmentioning

confidence: 99%

Regulatory Approval, Reimbursement, and Clinical Use of Cyclin-Dependent Kinase 4/6 Inhibitors in Metastatic Breast Cancer in the Netherlands

et al. 2023

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ImportanceThe number of new cancer medicines that are being approved by regulatory agents is increasing exponentially. Yet little is known about the pace at which these medicines reach eligible patients in daily clinical practice during different phases of the postapproval access pathway.ObjectiveTo describe the entire postapproval access pathway of cyclin-dependent kinase 4/6 (CDK4/6) inhibitors in the Netherlands, from regulatory approval to reimbursement and to investigate the adoption of these medicines in clinical practice among patients with metastatic breast cancer.Design, Setting, and ParticipantsThis cohort study reviewed approval and reimbursement decisions of the CDK4/6 inhibitors palbociclib, ribociclib, and abemaciclib and estimated the number of patients with metastatic breast cancer who were eligible for these medicines compared with the actual use in clinical practice. The study used nationwide claims data that were obtained from the Dutch Hospital Data. Claims and early access data for patients with hormone receptor–positive and ERBB2 (formerly HER2)–negative metastatic breast cancer who were treated with CDK4/6 inhibitors from November 1, 2016, to December 31, 2021, were included.Main Outcomes and MeasuresDescription of the postapproval access pathway, monthly number of patients who were treated with CDK4/6 inhibitors in clinical practice, and estimated number of patients who were eligible for treatment. Aggregated claims data were used, and patient characteristics and outcomes data were not collected.ResultsThree CDK4/6 inhibitors have received European Union–wide regulatory approval for the treatment of HR-positive and ERBB2-negative metastatic breast cancer since November 2016. In the Netherlands, the number of patients who have been treated with these medicines increased to approximately 1847 (based on 1 624 665 claims over the entire study period) from approval to the end of 2021. Reimbursement for these medicines was granted between 9 and 11 months after approval. While awaiting reimbursement decisions, 492 patients received palbociclib, the first approved medicine of this class, via an expanded access program. By the end of the study period, 1616 patients (87%) were treated with palbociclib, whereas 157 patients (7%) received ribociclib, and 74 patients (4%) received abemaciclib. The CKD4/6 inhibitor was combined with an aromatase inhibitor in 708 patients (38%) and with fulvestrant in 1139 patients (62%). The pattern of use over time appeared to be somewhat lower compared with the estimated number of eligible patients (1847 vs 1915 in December 2021), especially in the first 2.5 years after approval.Conclusions and RelevanceThis study found that CDK4/6 inhibitors rapidly reached many eligible patients with metastatic breast cancer and were adopted gradually over time in the Netherlands. Adoption of innovative medicines may be further optimized, and better transparency of the availability of new medicines during different phases of the postapproval access pathway is needed.

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Development and economic trends in anticancer drugs licensed in the UK from 2015 to 2019

Cited by 9 publications

References 19 publications

Cancer Therapy Approval Timings, Review Speed, and Publication of Pivotal Registration Trials in the US and Europe, 2010-2019

Cancer Therapy Approval Timings, Review Speed, and Publication of Pivotal Registration Trials in the US and Europe, 2010-2019

Duration of treatment in oncology clinical trials: does the duration change when the same drug moves from the experimental arm to the control arm?

Regulatory Approval, Reimbursement, and Clinical Use of Cyclin-Dependent Kinase 4/6 Inhibitors in Metastatic Breast Cancer in the Netherlands

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