IDEAS home Printed from https://ideas.repec.org/a/spr/pharme/v38y2020i10d10.1007_s40273-020-00934-2.html
   My bibliography  Save this article

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
    as

    Download full text from publisher

    File URL: http://link.springer.com/10.1007/s40273-020-00934-2
    File Function: Abstract
    Download Restriction: Access to the full text of the articles in this series is restricted.
    File URL: https://libkey.io/10.1007/s40273-020-00934-2?utm_source=ideas
    LibKey link: if access is restricted and if your library uses this service, LibKey will redirect you to where you can use your library subscription to access this item
    ---><---

    As the access to this document is restricted, you may want to search for a different version of it.

    References listed on IDEAS

    as
    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.
    Full references (including those not matched with items on IDEAS)

    Citations

    Blog mentions

    As found by EconAcademics.org, the blog aggregator for Economics research:
    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

    Most related items

    These are the items that most often cite the same works as this one and are cited by the same works as this one.
    1. Bence Kovács & Miklós Darida & Judit Simon, 2021. "Drugs Becoming Generics—The Impact of Genericization on the Market Performance of Antihypertensive Active Pharmaceutical Ingredients," IJERPH, MDPI, vol. 18(18), pages 1-20, September.
    2. Landsem, Mari Magnussen & Magnussen, Jon, 2018. "The effect of copayments on the utilization of the GP service in Norway," Social Science & Medicine, Elsevier, vol. 205(C), pages 99-106.
    3. Wang, Chao & Li, Qing & Sweetman, Arthur & Hurley, Jeremiah, 2015. "Mandatory universal drug plan, access to health care and health: Evidence from Canada," Journal of Health Economics, Elsevier, vol. 44(C), pages 80-96.
    4. Berlanda, Andrea & Cervellati, Matteo & Esposito, Elena & Rohner, Dominic & Sunde, Uwe, 2024. "Medication against conflict," Journal of Development Economics, Elsevier, vol. 170(C).
    5. Costa Font, Joan & Gemmill Toyama, Marin, 2011. "Does cost sharing really reduce inappropriate prescriptions among the elderly?," Health Policy, Elsevier, vol. 101(2), pages 195-208, July.
    6. Wenqiang Qian & Xiangyu Cheng & Guoying Lu & Lijun Zhu & Fei Li, 2019. "Fiscal Decentralization, Local Competitions and Sustainability of Medical Insurance Funds: Evidence from China," Sustainability, MDPI, vol. 11(8), pages 1-21, April.
    7. Devlin, Rose Anne & Sarma, Sisira & Zhang, Qi, 2011. "The role of supplemental coverage in a universal health insurance system: Some Canadian evidence," Health Policy, Elsevier, vol. 100(1), pages 81-90, April.
    8. Mario Martínez-Jiménez & Pilar García-Gómez & Jaume Puig-Junoy, 2021. "The Effect of Changes in Cost Sharing on the Consumption of Prescription and Over-the-Counter Medicines in Catalonia," IJERPH, MDPI, vol. 18(5), pages 1-21, March.
    9. Cristina Hernández-Izquierdo & Beatriz González López-Valcárcel & Stephen Morris & Mariya Melnychuk & Ignacio Abásolo Alessón, 2019. "The effect of a change in co-payment on prescription drug demand in a National Health System: The case of 15 drug families by price elasticity of demand," PLOS ONE, Public Library of Science, vol. 14(3), pages 1-39, March.
    10. Gemmill-Toyama M & Costa-Font J, "undated". "Does Cost Sharing Affect the Quality of Pharmaceutical Care for the Elderly?," Health, Econometrics and Data Group (HEDG) Working Papers 09/04, HEDG, c/o Department of Economics, University of York.
    11. Ernst R. Berndt & Rena M. Conti & Stephen J. Murphy, 2017. "The Landscape of US Generic Prescription Drug Markets, 2004-2016," NBER Working Papers 23640, National Bureau of Economic Research, Inc.
    12. Skipper, Niels, 2012. "On reimbursement reforms and stockpiling of prescription drugs: The case of insulin," Health Policy, Elsevier, vol. 106(3), pages 233-240.
    13. Jennie McKenney & Anders Chen & Karen W Hoover & Jane Kelly & David Dowdy & Parastu Sharifi & Patrick S Sullivan & Eli S Rosenberg, 2017. "Optimal costs of HIV pre-exposure prophylaxis for men who have sex with men," PLOS ONE, Public Library of Science, vol. 12(6), pages 1-13, June.
    14. Shou-Lin Yang & Chiung-Ying Lee, 2015. "Analysis of the medical demands of elderly dementia patients considering the caregiver cost of medical accompaniment: an application of the travel cost method and altruistic utility function," Quality & Quantity: International Journal of Methodology, Springer, vol. 49(1), pages 423-439, January.
    15. Guo, Elaine Xiaoyu & Sweetman, Arthur & Guindon, G. Emmanuel, 2020. "Socioeconomic differences in prescription drug supplemental coverage in Canada: A repeated cross-sectional study," Health Policy, Elsevier, vol. 124(3), pages 252-260.
    16. Eunja Park & Sookja Choi, 2020. "Who Benefits from the Fixed Copayment of Medical and Pharmaceutical Expenditure among the Korean Elderly?," IJERPH, MDPI, vol. 17(21), pages 1-11, November.
    17. Michael D. Frakes & Melissa F. Wasserman, 2020. "Investing in Ex Ante Regulation: Evidence from Pharmaceutical Patent Examination," NBER Working Papers 27579, National Bureau of Economic Research, Inc.
    18. Astrid Kiil & Kurt Houlberg, 2014. "How does copayment for health care services affect demand, health and redistribution? A systematic review of the empirical evidence from 1990 to 2011," The European Journal of Health Economics, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 15(8), pages 813-828, November.

    More about this item

    Statistics

    Access and download statistics

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:spr:pharme:v:38:y:2020:i:10:d:10.1007_s40273-020-00934-2. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    If CitEc recognized a bibliographic reference but did not link an item in RePEc to it, you can help with this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Sonal Shukla or Springer Nature Abstracting and Indexing (email available below). General contact details of provider: http://www.springer.com .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.