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The Pharmacoeconomic Evaluation Process in Ireland

Author

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  • Laura McCullagh

    (St James’s University Teaching Hospital
    St James’s University Teaching Hospital)

  • Michael Barry

    (St James’s University Teaching Hospital
    St James’s University Teaching Hospital)

Abstract

Background In Ireland, all new drugs are considered for a formal pharmacoeconomic evaluation (PE) prior to a reimbursement decision. All evaluations are conducted by the National Centre for Pharmacoeconomics (NCPE). The objectives of this study were to describe the evaluation process and to examine the movement of drugs through the process. Methods The movement of all drugs submitted to the NCPE (from January 2010 to December 2015 inclusive) was investigated. Results A total of 230 Rapid Review submissions (each pertaining to one drug for one indication) were made. The Rapid Review process determines the requirement for a full PE. A full PE was deemed unnecessary in 108 cases (47 %). A positive reimbursement recommendation was made in 100 of these (a price reductions was advised in 25 cases and a recommendation to restrict/monitor usage was made in 35). The requirement for a full PE was recognised in 122 cases (53 %). In 12, subsequent payer-led price negotiations negated the requirement for a full PE, and reimbursement was recommended. In 24 cases, a timely full submission was not made; cost effectiveness could not be established. Fifteen interventions are currently going through the submission process. To date, 71 full PEs have been completed by the NCPE. Reimbursement was recommended in 19 and was not recommended in eight. Reimbursement was not recommended ‘at the submitted price’ in 44. Of these, reimbursement was subsequently approved in 34 (77 %) following price negotiations. To date, negotiations are on-going in a further six cases. In all, negotiations have been informed by the NCPE. A negative recommendation was reached in the remaining four. Conclusions Over the study period, the NCPE evaluated 230 drugs for which reimbursement was sought. In total, a positive reimbursement recommendation has been made in 165 cases (72 % of all drugs submitted, or 79 % when drugs currently undergoing the process are excluded). A price reduction was deemed necessary in 71 (43 %) of the 165 cases, and a recommendation to restrict/monitor usage was made in 35 cases (21 %).

Suggested Citation

  • Laura McCullagh & Michael Barry, 2016. "The Pharmacoeconomic Evaluation Process in Ireland," PharmacoEconomics, Springer, vol. 34(12), pages 1267-1276, December.
  • Handle: RePEc:spr:pharme:v:34:y:2016:i:12:d:10.1007_s40273-016-0437-5
    DOI: 10.1007/s40273-016-0437-5
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    Cited by:

    1. Suaad Almajed & Nora Alotaibi & Sana Zulfiqar & Zahraa Dhuhaibawi & Niall O’Rourke & Richard Gaule & Caoimhe Byrne & Aaron M. Barry & Dylan Keeley & James F. O’Mahony, 2022. "Cost-effectiveness evidence on approved cancer drugs in Ireland: the limits of data availability and implications for public accountability," The European Journal of Health Economics, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 23(3), pages 375-431, April.
    2. Paul K. Gorecki, 2017. "Availability and Pricing New Medicines in Ireland: Reflections and Reform," PharmacoEconomics, Springer, vol. 35(10), pages 981-987, October.
    3. Laura McCullagh & Susanne Schmitz & Michael Barry & Cathal Walsh, 2017. "Examining the Feasibility and Utility of Estimating Partial Expected Value of Perfect Information (via a Nonparametric Approach) as Part of the Reimbursement Decision-Making Process in Ireland: Applic," PharmacoEconomics, Springer, vol. 35(11), pages 1177-1185, November.
    4. Felicity Lamrock & Laura McCullagh & Lesley Tilson & Michael Barry, 2020. "A retrospective analysis of budget impact models submitted to the National Centre for Pharmacoeconomics in Ireland," The European Journal of Health Economics, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 21(6), pages 895-901, August.

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