Abstract
Introduction
Targeted therapies have revolutionized the treatment of hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2−) metastatic breast cancer (mBC). However, as for many oncology drugs, the dose of targeted therapies may need to be adjusted over time, leading to drug wastage when a dose modification is needed but the dose cannot be split or saved. This has been shown to be the case for palbociclib and has led to concerns among payers. This study described palbociclib dosing patterns and estimated the economic burden of the drug wastage associated with palbociclib dose modifications in postmenopausal women with HR+/HER2− mBC.
Methods
A large US claims database was used to identify postmenopausal women with HR+/HER2− mBC who received a palbociclib-based therapy during one of their first three lines of therapy for mBC between February 2015 (palbociclib approval) and December 2015. Dosing patterns (dosing modifications and sequences) were reported; a dose modification was defined as an increase/decrease of at least 25 mg daily compared to the preceding dose. Estimates of drug wastage costs were based on days with overlap in prescription fills for different palbociclib doses.
Results
A total of 473 postmenopausal palbociclib-treated women with HR+/HER2− mBC were included (first line 214; second line 157; third line 120). Over an average duration of line of therapy of approximately 4 months, dose modification was observed in 17.8%, 31.2%, and 35.0% of patients in first, second, and third line. Average overlap in prescription fills was 9.2, 9.9, and 5.4 days in first, second, and third line. This potential drug wastage resulted in an average cost of $4376, $4740, and $2592 per patient in first, second, and third line.
Conclusions
This study showed that drug wastage due to palbociclib dose modification results in substantial costs. Treatment options with more flexible dosing may help reduce the costs of drug wastage.
Funding
Novartis Pharmaceuticals Corporation.
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Acknowledgements
Funding
Sponsorship for this study (including article processing charges) was funded by Novartis Pharmaceuticals Corporation.
Medical Writing, Editorial, and Other Assistance
Medical writing assistance was provided by Dr. Cinzia Metallo, an employee of Analysis Group, Inc. Analysis Group, Inc. received consulting fees from Novartis for the conduct of this study.
Authorship
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. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article and have given their approval for this version to be published.
Disclosures
Anand A. Dalal is an employee of Novartis Pharmaceuticals Corporation and may own stock/stock options. Tania Small is an employee of Novartis Pharmaceuticals Corporation and may own stock/stock options. Patrick Gagnon-Sanschagrin is an employee of Analysis Group Inc., which has received consultancy fees from Novartis. Rebecca Burne is an employee of Analysis Group Inc., which has received consultancy fees from Novartis. Annie Guérin is an employee of Analysis Group Inc., which has received consultancy fees from Novartis. Geneviève Gauthier is an employee of Analysis Group Inc., which has received consultancy fees from Novartis. Polly Niravath received honoraria from Novartis as a consultant.
Compliance with Ethics Guidelines
Data are de-identified and comply with the confidentiality requirements of the Health Insurance Portability and Accountability Act and the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. No institutional review was required for this study.
Data Availability
The claims database (Truven MarketScan Commercial Database) is proprietary, provided by a third-party vendor, and the authors do not have permission to disseminate the data without the vendor’s approval. The study sponsor has purchased access to the database (the authors have been granted access to the data on a contract per project use). Access to this data set is available to any other interested parties for a fee set by Truven Health Analytics (https://marketscan.truvenhealth.com/marketscanportal/).
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Dalal, A.A., Gagnon-Sanschagrin, P., Burne, R. et al. Dosing Patterns and Economic Burden of Palbociclib Drug Wastage in HR+/HER2− Metastatic Breast Cancer. Adv Ther 35, 768–778 (2018). https://doi.org/10.1007/s12325-018-0701-5
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DOI: https://doi.org/10.1007/s12325-018-0701-5