Frontiers in Pharmacology (May 2013)

Dabigatran - a case history demonstrating the need for comprehensive approaches to optimise the use of new drugs

  • Rickard eMalmstrom,
  • Brian eGodman,
  • Brian eGodman,
  • Brian eGodman,
  • Eduardo eDiogene,
  • Christoph eBaumgaertel,
  • Marion eBennie,
  • Marion eBennie,
  • Iain eBishop,
  • Anna eBrzezinska,
  • Anna eBucsics,
  • Stephen eCampbell,
  • Alessandra eFerrario,
  • Alexander eFinlayson,
  • Jurij eFurst,
  • Kristina eGaruoliene,
  • Miguel eGomes,
  • Iñaki eGutiérrez-Ibarluzea,
  • Alan eHaycox,
  • Krystyna eHviding,
  • Harald eHerholz,
  • Mikael eHoffmann,
  • Saira eJan,
  • Jan eJones,
  • Roberta eJoppi,
  • Marija eKalaba,
  • Christina eKvalheim,
  • Ott eLaius,
  • Irene eLangner,
  • Julie eLonsdale,
  • Sven-Ake eLoov,
  • Kamila eMalinowska,
  • Kamila eMalinowska,
  • Laura eMcCullagh,
  • Ken ePaterson,
  • Vanda eMarkovic-Pekovic,
  • Vanda eMarkovic-Pekovic,
  • Andrew eMartin,
  • Jutta ePiessnegger,
  • Gisbert eSelke,
  • Catherine eSermet,
  • Steven eSimoens,
  • Faik Cankat Tulunay,
  • Dominik eTomek,
  • Luka eVoncina,
  • Vera eVlahovic-Palcevski,
  • Janet eWale,
  • Michael eWilcock,
  • Magda eWladysiuk,
  • Menno van Woerkom,
  • Corrine eZara,
  • Lars L Gustafsson

DOI
https://doi.org/10.3389/fphar.2013.00039
Journal volume & issue
Vol. 4

Abstract

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Background: There are potential conflicts between authorities and companies to fund new premium priced drugs especially where there are safety and/ or budget concerns. Dabigatran, a new oral anticoagulant for the prevention of stroke in patients with non-valvular AF, exemplifies this issue. Whilst new effective treatments are needed, there are issues in the elderly with dabigatran due to variable drug concentrations, no known antidote and dependence on renal elimination. Published studies have shown dabigatran to be cost-effective but there are budget concerns given the prevalence of atrial fibrillation. There are also issues with potentially re-designing anticoagulant services. This has resulted in activities across countries to better manage its use. Objective: To (i) review authority activities in over 30 countries and regions, (ii) use the findings to develop new models to better manage the entry of new drugs , and (iii) review the implications for all major stakeholder groups. Methodology: Descriptive review and appraisal of activities regarding dabigatran and the development of guidance for groups through an iterative process. Results: There has been a plethora of activities to manage dabigatran including extensive pre-launch activities, risk sharing arrangements, prescribing restrictions and monitoring of prescribing post launch. Reimbursement has been denied in some countries due to concerns with its budget impact and/or excessive bleeding. Development of a new model and future guidance is proposed to better manage the entry of new drugs, centring on three pillars of pre-, peri- and post-launch activities. Conclusion: Models for introducing new drugs are essential to optimise their prescribing especially where there are concerns. Without such models, new drugs may be withdrawn prematurely and/ or struggle for funding.

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