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

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 Without such models, new drugs may be withdrawn prematurely and/or struggle for funding.

Initiatives to enhance the quality and efficiency of statin and PPI prescribing in the UK: impact and implications.

AIM: To assess the impact of a range of national and regional initiatives introduced in the North Lancashire Teaching Primary Care Trust (NLTPCT) since 2004 to enhance the quality and efficiency of prescribing proton pump inhibitors (PPIs), statins and ezetimibe. In addition, to suggest additional measures that could be introduced in NLTPCT to further enhance the quality and efficiency of prescribing based on initiatives in other European countries. METHOD: A before-and-after observational study was undertaken on the utilization and expenditure of prescriptions dispensed in ambulatory care in NLTPCT from 2004 to 2007. Utilization was assessed using 'defined daily doses' (DDDs) and 'DDDs/1000 inhabitants per day' and compared over the study period. Reimbursed expenditure was assessed in terms of overall expenditure, expenditure/DDD, as well as expenditure/1000 inhabitants per year. RESULTS: The combination of measures and initiatives enhanced the utilization of generic PPIs. International Nonproprietary Name (INN) prescribing of omeprazole reached 98% of all omeprazole by 2007. The measures also resulted in limited utilization of esomeprazole and lowered reimbursed expenditure/DDD of generic omeprazole to GB pound0.13 by 2007. This was 87% below 2004 originator prices, leading to a 41% fall in PPI expenditure during the study period despite increased utilization. Utilization of statins grew by over 130% during the study period enhanced by increased utilization of high doses of simvastatin and atorvastatin following the introduction of the quality and outcomes framework. Simvastatin dominated statin utilization by 2007, with generic simvastatin accounting for over 99.5% of total simvastatin. Reimbursed expenditure/DDD for generic simvastatin was pound0.03 in 2007, 95% below 2004 originator prices, leading to a fall in overall expenditure on statins. It proved difficult to undertake an impact analysis as, typically, a range of measures were introduced sequentially and simultaneously during the study period. CONCLUSION: The findings are in line with expectations and do provide examples to other European countries. This includes a high rate of INN prescribing, low reimbursed prices for generic simvastatin and omeprazole and growing utilization of higher strength statins. The high rate of INN prescribing reduces the need for additional measures that have been instigated in other European countries to further enhance the prescribing and dispensing of generics to fully realize the resource benefits. Additional demand side measures are feasible and have already been instigated to conserve resources.

Policies to enhance prescribing efficiency in europe: findings and future implications.

INTRODUCTION: European countries need to learn from each other to address unsustainable increases in pharmaceutical expenditures. OBJECTIVE: To assess the influence of the many supply and demand-side initiatives introduced across Europe to enhance prescribing efficiency in ambulatory care. As a result provide future guidance to countries. METHODS: Cross national retrospective observational study of utilization (DDDs - defined daily doses) and expenditure (Euros and local currency) of proton pump inhibitors (PPIs) and statins among 19 European countries and regions principally from 2001 to 2007. Demand-side measures categorized under the "4Es" - education engineering, economics, and enforcement. RESULTS: Instigating supply side initiatives to lower the price of generics combined with demand-side measures to enhance their prescribing is important to maximize prescribing efficiency. Just addressing one component will limit potential efficiency gains. The influence of demand-side reforms appears additive, with multiple initiatives typically having a greater influence on increasing prescribing efficiency than single measures apart from potentially "enforcement." There are also appreciable differences in expenditure (€/1000 inhabitants/year) between countries. Countries that have not introduced multiple demand side measures to counteract commercial pressures to enhance the prescribing of generics have seen considerably higher expenditures than those that have instigated a range of measures. CONCLUSIONS: There are considerable opportunities for European countries to enhance their prescribing efficiency, with countries already learning from each other. The 4E methodology allows European countries to concisely capture the range of current demand-side measures and plan for the future knowing that initiatives can be additive to further enhance their prescribing efficiency.