Advertisement

Springer Nature is making Coronavirus research free. View research | View latest news | Sign up for updates

The relationship between the number of available therapeutic options and government payer (medicare part D) spending on topical drug products

  • 2 Accesses

Abstract

The cost of prescription drugs has increased at rates far exceeding general inflation in recent history, with topical drugs increasing at a disproportionate rate compared to other routes of administration. We assessed the relationship between net changes in the number of therapeutic options, defined as any approved drug or therapeutic equivalent on the market, and prescription topical drug spending. Drugs were divided based on the category of use through pairing of Medicare Part D Prescriber Public Use and Food and Drug Administration (FDA) approved drug products databases. Across drug classes, we modeled the log of the ratio of total spending per unit in 2015 to total spending per unit in 2011 as a linear function of net number of topical therapeutic options over this time period. Primary outcomes include total Medicaid Part D spending on topical drugs and net change in the number of available therapeutic options within each category of use. Total spending on topical drugs increased by 61%, while the number of units dispensed increased by only 18% from 2011–2015. The greatest total spending increases were in categories with few new therapeutic options, such as topical corticosteroid and antifungal medications. Each net additional therapeutic option during 2011–2015 was associated with an reduction in how much relative spending per unit increased (95% CI 2.5%–14.4%, p = 0.013). Stimulating greater competition through increasing the net number of therapeutic options within each major topical category of use may place downward pressure on topical prescription drug spending under medicare Part D.

This is a preview of subscription content, log in to check access.

Fig. 1
Fig. 2
Fig. 3
Fig. 4
Fig. 5

References

  1. 1.

    National Health Expenditure Data Historical (2018) Centers for Medicare & Medicaid Services. https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/NationalHealthAccountsHistorical.html. Accessed 3 Mar 2019

  2. 2.

    Generic Drugs Under Medicare: Part D Generic Drug Prices Declined Overall, but Some Had Extraordinary Price Increases (2016) U.S. Government Accountability Office. https://www.gao.gov/products/GAO-16-706. Accessed 3 Mar 2019

  3. 3.

    Walter JR, Xu S (2015) Topical drug innovation from 2000 through 2014. JAMA Dermatol 151:792–794

  4. 4.

    Kinch MS, Haynesworth A, Kinch SL, Hoyer D (2014) An overview of FDA-approved new molecular entities: 1827–2013. Drug Discovery Today 19:1033–1039

  5. 5.

    Welty LJ, Rasmussen LV, Baldridge AS, Whitley E (2016) StatTag. Galter Health Sciences Library, Chicago. doi: https://doi.org/10.18131/G3K76

  6. 6.

    McKesey J, Pandya AG (2019) A pilot study of 2% tofacitinib cream with narrow-band UVB for the treatment of facial vitiligo. J Am Acad Dermatol. https://doi.org/10.1016/j.jaad.2019.04.032

  7. 7.

    Generic Competition and Drug Prices (2017) U.S. Food & Drug Administration. https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm129385.htm. Accessed 3 Mar 2019

  8. 8.

    Li DG, Joyce C, Mostaghimi A (2018) Association between market competition and prices of generic topical dermatology drugs. JAMA Dermatol

  9. 9.

    Abbreviated New Drug Application (ANDA) (2019) U.S. Food & Drug Administration. https://www.fda.gov/drugs/types-applications/abbreviated-new-drug-application-anda. Accessed 26 May 2019

  10. 10.

    Luke MC (2017) Overcoming barriers and improving patient access to topical dermatological drugs. Paper presented at the FDA Public Workshop Topical Dermatological Generic Drug Products: Overcoming Barriers to Development and Improving Patient Access, Silver Spring (MD), 2017 Oct 20

  11. 11.

    Raney SG, Franz TJ, Lehman PA, Lionberger R, Chen M-L (2015) Pharmacokinetics-based approaches for bioequivalence evaluation of topical dermatological drug products. Clin Pharmacokinet 54:1095–1106

  12. 12.

    Eaglstein WH, Corcoran G (2011) New drugs and new molecular entities in dermatology. Arch Dermatol 147:568–572

  13. 13.

    Gottlieb S (2017) FDA Working to Lift Barriers to Generic Drug Competition. U.S. Food & Drug Administration. https://www.fda.gov/NewsEvents/Newsroom/FDAVoices/ucm612018.htm. Accessed 31 Jan 2019

  14. 14.

    Simamora P (2017) In vitro bioequivalence data for a topical product: chemistry review perspective. Paper presented at the FDA Public Workshop Topical Dermatological Generic Drug Products: Overcoming Barriers to Development and Improving Patient Access, Silver Spring (MD), 20 Oct 2017

  15. 15.

    Impact Story: Developing New Ways to Evaluate Bioequivalence for Topical Drugs (2019) U.S. Food & Drug Administration. https://www.fda.gov/Drugs/ScienceResearch/ucm573849.htm. Accessed 5 Mar 2019

  16. 16.

    FTC Puts Conditions on Novartis AG's Acquisition of Fougera Holdings, Inc: Settlement Order Protects Competition in Markets for Skin Care Gels and Cream. (2012) Federal Trade Comission. https://www.ftc.gov/news-events/press-releases/2012/07/ftc-puts-conditions-novartis-ags-acquisition-fougera-holdings-inc. Accessed 3 Mar 2019

Download references

Funding

None.

Author information

Correspondence to Shuai Xu or Betty Kong.

Ethics declarations

Conflict of interest

The authors declare that they have no conflict of interest.

IRB

The study is exempt from IRB review.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Kwa, M.C., Tegtmeyer, K., Welty, L.J. et al. The relationship between the number of available therapeutic options and government payer (medicare part D) spending on topical drug products. Arch Dermatol Res (2020). https://doi.org/10.1007/s00403-020-02042-9

Download citation

Keywords

  • Topical drugs
  • Market competition
  • Generics
  • Medicare
  • FDA