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Market Exclusivity for Drugs with Multiple Orphan Approvals (1983–2017) and Associated Budget Impact in the US

Author

Listed:
  • William V. Padula

    (University of Southern California
    University of Southern California)

  • Sonal Parasrampuria

    (Johns Hopkins Bloomberg School of Public Health)

  • Mariana P. Socal

    (Johns Hopkins Bloomberg School of Public Health)

  • Rena M. Conti

    (Boston University Questrom School of Business)

  • Gerard F. Anderson

    (Johns Hopkins Bloomberg School of Public Health)

Abstract

Objectives The Orphan Drug Act extends exclusivity of branded drugs by 7 years for each rare disease approval. By extending market exclusivity, manufacturers can forestall generic competition. We determined the prevalence of drugs with multiple orphan approvals, the duration for which manufacturers are able to maintain exclusivity using this mechanism, and the budget impact of these additional exclusivity periods on US spending on orphan drugs. Methods We analyzed a retrospective cohort of US orphan drug approvals filed between 1983 and 2017. Drug costs throughout this time period were measured using IQVIA claims data. We estimated additional years of exclusivity per drug per orphan approval using mixed-effects negative binomial regression. The budget impact analyzed potential cost-savings for exclusivity periods greater than 7 years after the initial orphan approval based on potential price reductions from the introduction of biosimilar/generic competition. Results A total of 432 branded drugs were approved for 615 orphan indications, of which 108 had multiple indications. Market exclusivity, beyond the initial 7 years, increased by 4.7 years with two orphan approvals, and there were 3.1-, 2.7-, and 2.9-year extensions for three, four, and five approvals, respectively (p 10 years through the Orphan Drug Act, thereby delaying rare disease cohorts’ access to generic/biosimilar equivalents.

Suggested Citation

  • William V. Padula & Sonal Parasrampuria & Mariana P. Socal & Rena M. Conti & Gerard F. Anderson, 2020. "Market Exclusivity for Drugs with Multiple Orphan Approvals (1983–2017) and Associated Budget Impact in the US," PharmacoEconomics, Springer, vol. 38(10), pages 1115-1121, October.
    • Handle: RePEc:spr:pharme:v:38:y:2020:i:10:d:10.1007_s40273-020-00934-2
    DOI: 10.1007/s40273-020-00934-2
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    References listed on IDEAS

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    1. Li, Xin & Guh, Daphne & Lacaille, Diane & Esdaile, John & Anis, Aslam H., 2007. "The impact of cost sharing of prescription drug expenditures on health care utilization by the elderly: Own- and cross-price elasticities," Health Policy, Elsevier, vol. 82(3), pages 340-347, August.
    2. Rena M. Conti & Ernst R. Berndt, 2014. "Specialty drug prices and utilization after loss of U.S. patent exclusivity, 2001-2007," NBER Working Papers 20016, National Bureau of Economic Research, Inc.
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    1. Chris Sampson’s journal round-up for 12th October 2020
      by Chris Sampson in The Academic Health Economists' Blog on 2020-10-12 11:00:03

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