Dabigatran – a case history demonstrating the need for comprehensive approaches to optimize the use of new drugs

Abstract

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 atrial fibrillation (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 AF. 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 among authorities to manage the prescribing of 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, centering on three pillars of pre-, peri-, and post-launch activities.Conclusion: Models for introducing new drugs are essential to optimize their prescribing especially where there are concerns. Without such models, new drugs may be withdrawn prematurely and/or struggle for funding.

Ongoing initiatives to improve prescribing efficiency in China; statins as a case history

“…This growth has been driven by well-known factors including ageing populations and new premium priced drugs (1,2,(4)(5)(6). Initiatives for new medicines include models to better manage the entry of new medicines to optimise the use of available resources (6)(7)(8). Initiatives for established medicines include measures to enhance the utilisation of low cost generics rather than originators and single sourced (patented) products in a single or related class where all products are seen as essentially similar (2,6,(9)(10)(11).…”

Evidence-based decision making in healthcare in Central Eastern Europe

“…Using the example of dabigratran [13], Brian Godman (Senior Researcher at the Karolinska Institute, Sweden and Professor Strathclyde Institute of Pharmacy and Biomedicial Sciences, Scotland) presented the model of pre-, peri-and postlaunch activities [14] to optimize use of new drugs. The model starts from horizon scanning and goes all the way to evaluating adherence to guidelines.…”

The Potential Effect of Using the Cockcroft-Gault Method on Tenofovir-Associated Renal Impairment Reports and on Clinical Decisions Regarding Tenofovir Use in Individual Patients: Implications for the Future

“…Sub-Saharan Africa, being the most affected region of the world with the HIV pandemic, has gained tangible benefits from the use of combination antiretroviral therapy (cART) [3][4][5]. Despite these tangible benefits, ARV medicines are associated with adverse drug reactions, the impact, incidence, and prevalence of which is not completely measured at the time these medicines are approved for clinical use especially if patients have greater co-morbidities than those enrolled into Phase III trials [6]. Nevertheless, the establishment of pharmacovigilance centres like the Therapeutics Information and Pharmacovigilance Centre (TIPC) in Namibia exposes the safety concerns pertaining to these ARV medicines.…”