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Metastatic Renal Cell Cancer: An Analysis of Reimbursement Decisions

Abstract

Introduction

Metastatic renal cell carcinoma is a complex cancer for which several drugs have been developed over the years. More recently, drugs that target the specific cancer cell mutations have been developed for metastatic cell carcinoma. However, even with the recent influx of targeted therapy options, significant unmet needs exist in around half of treated renal cell carcinoma patients following the failure of first-line therapy. The aim of this study was to review the health technology appraisals of renal cell carcinoma treatments in several countries to establish what factors might affect the reimbursement decisions.

Methods

The reimbursement data for 10 drugs in several countries were collated from the health technology assessment bodies for each country. The data included information on clinical trials used in the submission documents for the health technology assessment, the reimbursement decisions and the reasons for those decisions, as well as any specific restrictions for use of any of the included drugs.

Results

Of the 10 drugs reviewed, only everolimus received a positive reimbursement decision by all the health technology assessment bodies included in the study. The most common reason for a negative reimbursement decision was lack of demonstration of cost-effectiveness of the drugs. Another frequently cited reason was unproven clinical efficacy and poor impact on overall survival.

Conclusion

Despite the many treatment guidelines and current treatment options that are available for renal cell carcinoma, there remains an unmet need in patients with metastatic renal cell carcinoma. On the basis of this analysis, the key reason for a drug not obtaining a positive reimbursement decision is due to poor efficacy or uncertainty of the drug’s efficacy.

Funding

Eisai, Inc.

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Abbreviations

BSC:

Best supportive care

CADTH:

Canadian Agency for Drugs and Technologies in Health

ECOG:

Eastern Cooperative Oncology Group

ESMO:

European Society for Medical Oncology

G-BA:

Federal Joint Committee (Gemeinsamer Bundesausschuss)

HAS:

Haute Autorité de Santé

HTA:

Health Technology Assessment

IL-2:

Interleukin 2

IQWiG:

Institute for Quality and Efficiency in Healthcare

mRCC:

Metastatic renal cell carcinoma

MSKCC:

Memorial Sloan Kettering Cancer Center

mTOR:

Mammalian target of rapamycin

NCCN:

National Comprehensive Cancer Network

NICE:

National Institute for Health and Care Excellence

OS:

Overall survival

PAS:

Patient access scheme

PBAC:

Pharmaceutical Benefits Advisory Committee

PBS:

Pharmaceutical Benefits Scheme

pCODR:

pan-Canadian Oncology Drug Review

PD-1:

Programmed cell death-1

RCC:

Renal cell carcinoma

RECIST:

Response Evaluation Criteria In Solid Tumours

SMC:

Scottish Medicines Consortium

TGA:

Therapeutic Goods Administration

TKI:

Tyrosine kinase inhibitors

TLV:

Tandvårds-och läkemedelsförmånsverket

VEGF:

Vascular endothelial growth factor

WHO:

World Health Organisation

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Acknowledgements

Funding

This research and associated article processing charges were sponsored by Eisai, Inc. All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis.

Medical Writing Assistance

Medical writing services, provided by Carina Schey from Global Market Access Solutions, were funded by Eisai.

Authorship

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Authorship Contributions

Carina Schey was involved in the data extraction and analysis and drafted the manuscript. All authors approved the final manuscript.

Disclosures

Carina Schey was contracted and paid by Eisai to conduct the research. Genevieve Meier is an employee of Eisai. Janice Pan is an employee of Eisai. There are no other relevant competing or conflicts of interests from any of the authors.

Compliance with Ethics Guidelines

This article does not contain any studies with human participants or animals performed by any of the authors; therefore ethics approval was not required.

Data Availability

The datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request.

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Schey, C., Meier, G. & Pan, J. Metastatic Renal Cell Cancer: An Analysis of Reimbursement Decisions. Adv Ther 36, 1266–1278 (2019). https://doi.org/10.1007/s12325-019-00947-0

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Keywords

  • Health technology assessment
  • Metastatic renal cell carcinoma
  • Reimbursement