Skip to main content

Dosing Patterns and Economic Burden of Palbociclib Drug Wastage in HR+/HER2− Metastatic Breast Cancer

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.

This is a preview of subscription content, access via your institution.

References

  1. 1.

    BreastCancer.org. US Breast Cancer Statistics. 2017. http://www.breastcancer.org/symptoms/understand_bc/statistics. Accessed Aug 2017.

  2. 2.

    Keen JC, Davidson NE. The biology of breast carcinoma. Cancer. 2003;97(3 Suppl):825–33.

    Article  PubMed  Google Scholar 

  3. 3.

    Trivers KF, Lund MJ, Porter PL, et al. The epidemiology of triple-negative breast cancer, including race. Cancer Causes Control. 2009;20(7):1071–82.

    Article  PubMed  PubMed Central  Google Scholar 

  4. 4.

    Mayer M, Hunis A, Oratz R, et al. Living with metastatic breast cancer: a global patient survey. Community Oncol. 2010;7(9):406–12.

    Article  Google Scholar 

  5. 5.

    Siegel R, DeSantis C, Virgo K, et al. Cancer treatment and survivorship statistics, 2012. CA Cancer J Clin. 2012;62(4):220–41.

    Article  PubMed  Google Scholar 

  6. 6.

    Royce ME, Osman D. Everolimus in the treatment of metastatic breast cancer. Breast Cancer (Auckl). 2015;9:73–9.

    CAS  Google Scholar 

  7. 7.

    Burstein HJ, Prestrud AA, Seidenfeld J, et al. American Society of Clinical Oncology clinical practice guideline: update on adjuvant endocrine therapy for women with hormone receptor-positive breast cancer. J Clin Oncol. 2010;28(23):3784–96.

    Article  PubMed  PubMed Central  Google Scholar 

  8. 8.

    Lønning PE. The potency and clinical efficacy of aromatase inhibitors across the breast cancer continuum. Ann Oncol. 2010;22:503–14.

    Article  PubMed  PubMed Central  Google Scholar 

  9. 9.

    Ring A, Dowsett M. Mechanisms of tamoxifen resistance. Endocr Relat Cancer. 2004;11(4):643–58.

    Article  PubMed  CAS  Google Scholar 

  10. 10.

    Yamamoto-Ibusuki M, Arnedos M, André F. Targeted therapies for ER +/HER2− metastatic breast cancer. BMC Med. 2015;13(1):137.

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  11. 11.

    Schmidt M. Palbociclib - from bench to bedside and beyond. Breast Care. 2016;11(3):177–81.

    Article  PubMed  PubMed Central  Google Scholar 

  12. 12.

    FDA. IBRANCE® (palbociclib) highlights of prescribing information. 2015. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207103s000lbl.pdf. Accessed Aug 2017.

  13. 13.

    FDA. VERZENIO™ (abemaciclib) highlights of prescribing information. 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208716Orig1s000lbl.pdf. Accessed Oct 2017.

  14. 14.

    FDA. KISQALI® (ribociclib) highlights of prescribing information. 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209092s000lbl.pdf. Accessed Aug 2017.

  15. 15.

    Prasad V, Massey PR, Fojo T. Oral anticancer drugs: how limited dosing options and dose reductions may affect outcomes in comparative trials and efficacy in patients. J Clin Oncol. 2014;32(15):1620–9.

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  16. 16.

    Turner NC, Ro J, André F, et al. Palbociclib in hormone-receptor-positive advanced breast cancer. N Engl J Med. 2015;373(3):209–19.

    Article  PubMed  CAS  Google Scholar 

  17. 17.

    Hortobagyi GN, Stemmer SM, Burris HA, et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. N Engl J Med. 2016;375(18):1738–48.

    Article  PubMed  CAS  PubMed Central  Google Scholar 

  18. 18.

    Centers for Medicare and Medicaid Services. Prescription drug benefit manual. Chapter 9—part D program to control fraud, waste and abuse 2006. https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/downloads/pdbmanual_chapter9_fwa.pdf. Accessed Sept 2017.

  19. 19.

    Fasola G, Aita M, Marini L, et al. Drug waste minimisation and cost-containment in medical oncology: two-year results of a feasibility study. BMC Health Serv Res. 2008;8(1):70.

    Article  PubMed  PubMed Central  Google Scholar 

  20. 20.

    Daughton CG, Ruhoy IS. Lower-dose prescribing: minimizing “side effects” of pharmaceuticals on society and the environment. Sci Total Environ. 2013;443:324–37.

    Article  PubMed  CAS  Google Scholar 

  21. 21.

    Baird JA, Starner CI, Bowen K, Gleason PP. Palbociclib (Ibrance) utilization and costs among 18 million insured Americans: managed care pharmacy opportunities. Poster presented at the AMCP annual meeting 2015. 2015. https://www.primetherapeutics.com/content/dam/corporate/Documents/Newsroom/PrimeInsights/2015/posters/1015-fall-palbociclib.pdf. Accessed Aug 2017.

  22. 22.

    Li N, Du EX, Chu L, et al. Real-world palbociclib dosing patterns and implications for drug costs in the treatment of HR+/HER2− metastatic breast cancer. Expert Opin Pharmacother. 2017;18(12):1167–78.

    Article  PubMed  CAS  Google Scholar 

  23. 23.

    Hansen L. The Truven Health MarketScan Databases for life sciences researchers. 2017. https://truvenhealth.com/Portals/0/Assets/2017-MarketScan-Databases-Life-Sciences-Researchers-WP.pdf. Accessed Aug 2017.

  24. 24.

    Hurvitz S, Guerin A, Brammer M, et al. Investigation of adverse-event-related costs for patients with metastatic breast cancer in a real-world setting. Oncologist. 2014;19(9):901–8.

    Article  PubMed  PubMed Central  Google Scholar 

  25. 25.

    Ramsey SD, Martins RG, Blough DK, Tock LS, Lubeck D, Reyes CM. Second-line and third-line chemotherapy for lung cancer: use and cost. Am J Manag Care. 2008;14(5):297–306.

    PubMed  Google Scholar 

  26. 26.

    Seal BS, Sullivan SD, Ramsey S, et al. Medical costs associated with use of systemic therapy in adults with colorectal cancer. J Manag Care Pharm. 2013;19(6):461–7.

    PubMed  Google Scholar 

  27. 27.

    Zhu J, Sharma DB, Gray SW, Chen AB, Weeks JC, Schrag D. Carboplatin and paclitaxel with vs without bevacizumab in older patients with advanced non-small cell lung cancer. JAMA. 2012;307(15):1593–601.

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  28. 28.

    Cristofanilli M, Turner NC, Bondarenko I, et al. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2− negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial. Lancet Oncol. 2016;17(4):425–39.

    Article  PubMed  CAS  Google Scholar 

  29. 29.

    Finn RS, Crown JP, Lang I, et al. The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2− negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study. Lancet Oncol. 2015;16(1):25–35.

    Article  PubMed  CAS  PubMed Central  Google Scholar 

  30. 30.

    Finn RS, Martin M, Rugo H, et al. Palbociclib and letrozole in advanced breast cancer. NEJM. 2016;375(20):1925–36.

    Article  PubMed  CAS  Google Scholar 

  31. 31.

    Solutions, Micromedex. Red Book 2017: pirfenidone. Ann Arbor: Truven Health Analytics; 2017.

    Google Scholar 

  32. 32.

    Law AV, Sakharkar P, Zargarzadeh A, et al. Taking stock of medication wastage: unused medications in US households. Res Soc Adm Pharm. 2015;11(4):571–8.

    Article  Google Scholar 

Download references

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/).

Author information

Affiliations

Authors

Corresponding author

Correspondence to Geneviève Gauthier.

Additional information

Enhanced digital content

To view enhanced digital content for this article go to https://doi.org/10.6084/m9.figshare.6139178.

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

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

Download citation

Keywords

  • Dose modification
  • Drug wastage
  • Economic burden
  • HR+/HER2− metastatic breast cancer
  • Oncology
  • Palbociclib