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Figure.
Trends in All Filgrastim Administrations
Trends in All Filgrastim Administrations

The figure summarizes the number (A) and percentage (B) of administration of all filgrastim products (filgrastim [originator], filgrastim-sndz, and tbo-filgrastim) for each month during the study period from the study start to study end dates (January 1, 2014, to December 31, 2016). Given that the use of filgrastim and alternative filgrastim products cannot be observed in the Medicare data until the approval of a Healthcare Common Procedure Coding System (HCPCS) code, the study start date was restricted to the tbo-filgrastim HCPCS approval date (January 2014) rather than the drug approval date (August 2012). Therefore, tbo-filgrastim use between the drug approval date and the HCPCS approval date is not included in this study. To capture all filgrastim administrations through late 2016, the Medicare data were evaluated in September 2017. The red and blue broken lines indicate the US FDA and HCPCS code approval dates for tbo-filgrastim and filgrastim-sndz, respectively.

Table.  
Demographic Characteristics of Filgrastim Usersa
Demographic Characteristics of Filgrastim Usersa
1.
Megerlin  F, Lopert  R, Taymor  K, Trouvin  JH.  Biosimilars and the European experience: implications for the United States.  Health Aff (Millwood). 2013;32(10):1803-1810. doi:10.1377/hlthaff.2009.0196PubMedGoogle ScholarCrossref
2.
US Food and Drug Administration. Center for Drug Evaluation and Research list of licensed biological products. https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM560162.pdf. Accessed June 4, 2018.
3.
Royzman  I. United States: the value of being highly similar: first US biosimilar. http://www.mondaq.com/unitedstates/x/391742/food+drugs+law/The+Value+of+Being+Highly+Similar+First+US+Biosimilar. Accessed February 18, 2018.
4.
FDANews. Sandoz launches Zarxio at 15 percent lower price than Neupogen. https://www.fdanews.com/articles/173036-sandoz-launches-zarxio-at-15-percent-lower-price-than-neupogen. Accessed February 18, 2018.
5.
Grabowski  H, Guha  R, Salgado  M.  Biosimilar competition: lessons from Europe.  Nat Rev Drug Discov. 2014;13(2):99-100. doi:10.1038/nrd4210PubMedGoogle ScholarCrossref
6.
IMS Institute for Healthcare Informatics. Delivering on the Potential of Biosimilar Medicines: The Role of Functioning Competitive Markets. March 2016. https://www.medicinesforeurope.com/wp-content/uploads/2016/03/IMS-Institute-Biosimilar-Report-March-2016-FINAL.pdf. Accessed February 18, 2018.
Research Letter
September 4, 2018

Uptake of the Biologic Filgrastim and Its Biosimilar Product Among the Medicare Population

Author Affiliations
  • 1Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland
  • 2Acumen LLC, Burlingame, California
  • 3Centers for Medicare & Medicaid Services, Washington, DC
JAMA. 2018;320(9):929-931. doi:10.1001/jama.2018.9014

Biologic pharmaceuticals are complex, high-cost therapeutics used to treat severe and chronic conditions.1 Biosimilar biological products can increase access to therapy and lower health care costs. The development and approval of biosimilar biologics in the United States was made possible by the Biologics Price Competition and Innovation Act passed in 2010. As of June 1, 2018, 10 biosimilars had been approved by the US Food and Drug Administration (FDA).2 This study evaluated uptake of the first approved biosimilar biologic, filgrastim-sndz (Zarxio), relative to its originator filgrastim product (Neupogen). These products share multiple indications for neutropenia and malignancy. Tbo-filgrastim (Granix), a stand-alone alternative biologic with a single indication, was also evaluated.

Methods

All filgrastim administrations of any dose between January 1, 2014, and December 31, 2016, in Medicare Part B claims were identified using Healthcare Common Procedure Coding System billing codes. Beneficiaries were enrolled in Medicare fee for service from at least 6 months before to at least 10 days after administration. Cohorts were defined by the filgrastim product administered; beneficiaries were included in multiple cohorts if they received multiple products during the study period. Beneficiary demographics and prevalence of indicated conditions were evaluated. This descriptive study was approved as an FDA surveillance activity by the FDA Center for Drug Evaluation and Research institutional review board liaison. Least squares regression was used to depict the utilization trend. A standardized mean difference threshold of 0.1 was used to highlight larger differences between cohort characteristics. Analyses were performed using SAS, version 9.4 (SAS Institute Inc).

Results

Monthly administrations of any filgrastim product decreased by 13%, from 28 520 in January 2014 to 24 898 in December 2016 (Figure, A). Monthly administrations of filgrastim-sndz increased to 32% of all filgrastim use and tbo-filgrastim increased to 16%, while the originator filgrastim product declined from 97% to 52% (Figure, B). Initial uptake of filgrastim-sndz was rapid, with monthly use surpassing tbo-filgrastim in March 2016.

Beneficiaries who received filgrastim-sndz were on average slightly older. Product choice also differed by geographic region and original Medicare enrollment status (Table). Among beneficiaries who received filgrastim-sndz, 22% had previously received the originator filgrastim and 73% were new users.

The prevalence of indications was similar across all products despite tbo-filgrastim’s single indication for patients with nonmyeloid malignancies receiving myelosuppressive chemotherapy. This indication was associated with 70% to 73% of claims across all products.

Discussion

Substantial uptake of alternative filgrastim products occurred in 2014-2016, including among beneficiaries previously receiving the originator product. The more rapid uptake of filgrastim-sndz over the stand-alone biologic does not appear to be driven by the products’ list prices, as the tbo-filgrastim discount from the originator product was similar to or higher than3 the initial discount of 15% for filgrastim-sndz.4 The use of tbo-filgrastim beyond its labeled indication may result from clinicians’ familiarity with product use outside the US approval system, accepted practices, product availability, or other factors. Although biosimilar uptake rates in the United States mirror the experience of some European Union countries,5 the decline in filgrastim use differs from the increase in the United Kingdom.6 Although this study looked at filgrastim administrations billed only through Medicare Part B, a small percentage of overall filgrastim claims are billed through Part D instead. Additionally, presence of indications was identified with claims data definitions; no medical record confirmation was available. Data on filgrastim utilization can inform future research and policy as the number of approved biosimilar products increases.

Section Editor: Jody W. Zylke, MD, Deputy Editor.
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Article Information

Accepted for Publication: June 7, 2018.

Corresponding Author: Steven Kozlowski, MD, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave, White Oak Building 71, Room 2230, Silver Spring, MD 20993 (steven.kozlowski@fda.hhs.gov).

Author Contributions: Drs Kozlowski and Kelman had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: All authors.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Kozlowski, Birger, Brereton, Christl, Kelman.

Critical revision of the manuscript for important intellectual content: Kozlowski, Birger, McKean, Wernecke, Christl, Kelman.

Statistical analysis: Birger, McKean, Wernecke.

Obtained funding: Kozlowski, Kelman.

Administrative, technical, or material support: Kozlowski, Birger, Brereton, Wernecke, Christl, Kelman.

Supervision: Birger, Brereton, McKean, Wernecke, Kelman.

Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.

Disclaimer: This manuscript reflects the views of the authors and should not be construed to represent the FDA’s or Centers for Medicare & Medicaid Services’ views or policies.

Additional Contributions: We thank David Graham, MD, MPH, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, for analysis and interpretation of data and critical revision of manuscript for important content. We thank Robert Ball, MD, MPH, ScM, and Michael Blum, MD, MPH, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, for critical review of this manuscript. We thank Ms Natasha Flowers, BA, Acumen LLC, for analysis and critical review of this manuscript. They received no compensation beyond institutional salaries.

References
1.
Megerlin  F, Lopert  R, Taymor  K, Trouvin  JH.  Biosimilars and the European experience: implications for the United States.  Health Aff (Millwood). 2013;32(10):1803-1810. doi:10.1377/hlthaff.2009.0196PubMedGoogle ScholarCrossref
2.
US Food and Drug Administration. Center for Drug Evaluation and Research list of licensed biological products. https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM560162.pdf. Accessed June 4, 2018.
3.
Royzman  I. United States: the value of being highly similar: first US biosimilar. http://www.mondaq.com/unitedstates/x/391742/food+drugs+law/The+Value+of+Being+Highly+Similar+First+US+Biosimilar. Accessed February 18, 2018.
4.
FDANews. Sandoz launches Zarxio at 15 percent lower price than Neupogen. https://www.fdanews.com/articles/173036-sandoz-launches-zarxio-at-15-percent-lower-price-than-neupogen. Accessed February 18, 2018.
5.
Grabowski  H, Guha  R, Salgado  M.  Biosimilar competition: lessons from Europe.  Nat Rev Drug Discov. 2014;13(2):99-100. doi:10.1038/nrd4210PubMedGoogle ScholarCrossref
6.
IMS Institute for Healthcare Informatics. Delivering on the Potential of Biosimilar Medicines: The Role of Functioning Competitive Markets. March 2016. https://www.medicinesforeurope.com/wp-content/uploads/2016/03/IMS-Institute-Biosimilar-Report-March-2016-FINAL.pdf. Accessed February 18, 2018.
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