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Search Results: 1 - 10 of 8072 matches for " Brian Godman "
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Policies to Enhance Prescribing Efficiency in Europe: Findings and Future Implications
Brian Godman
Frontiers in Pharmacology , 2011, DOI: 10.3389/fphar.2010.00141
Abstract: 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.
Prescribing restrictions – a necessary strategy among some European countries to enhance future prescribing efficiency?
Brian Godman,Rickard Malmstr?m,Marion Bennie,Solveig Sakshaug
Reviews in Health Care , 2012, DOI: 10.7175/rhc.v3i1.55
Abstract: The unsustainable growth in pharmaceutical expenditure has resulted in multiple initiatives across Europe to lower prices of generics and enhance their utilisation. These include prescribing restrictions. However, there have been concerns with their impact on subsequent quality of care as well as their influence in reality. OBJECTIVES: (a) Review the influence of prescribing restrictions and whether there are any differences depending on their nature and drug classes; (b) Ascertain whether prescribing restrictions can be added to existing demand-side measures to further enhance prescribing efficiency; (c) Whether they compromise subsequent quality of care. RESULTS: Prescribing restrictions have a variable impact on subsequent utilisation of patented protected products versus generics in a class, with their influence depending on the nature and follow-up of the restrictions rather than the class of drug. This is seen among the proton pump inhibitors, statins, and renin-angiotensin drugs. Prescribing restrictions can be successfully added to existing measures to further enhance prescribing efficiency, and do not appear to compromise subsequent quality of care. CONCLUSIONS: Prescribing restrictions can be a successful strategy as countries strive to maintain the European ideals for healthcare. However, care is needed when planning these programmes: else health authorities could be disappointed with their outcome.
Potential to Enhance the Prescribing of Generic Drugs in Patients with Mental Health Problems in Austria; Implications for the Future
Brian Godman,Anna Bucsics,Emanuel Raschi,Lars L. Gustafsson
Frontiers in Pharmacology , 2013, DOI: 10.3389/fphar.2012.00198
Abstract: Background:Scrutiny over pharmaceutical expenditure is increasing leading to multiple reforms. This includes Austria with measures to lower generic prices and enhance their utilization. However the situation for newer antidepressants and atypical antipsychotic medicines (AAPs) is different to PPIs, statins, and renin-angiotensin inhibitor drugs with greater tailoring of therapy and no wish to switch products in stable patients. Authorities welcome generics though given the high costs particularly of single-sourced AAPs. Objective: Assess (a) changes in utilization of venlafaxine versus other newer antidepressants before and after availability of generics, (b) utilization of generic versus originator venlafaxine, (c) price reductions of venlafaxine over time and their influence on total expenditure, (d) utilization of risperidone versus other AAPs, (e) suggest potential additional reforms that could be introduced if pertinent to further enhance the use of generics. Methodology: A quasi-experimental study design with a segmented time series and an observational study. Utilization measured in defined daily doses (DDDs) and total expenditure per DDD and over time. Results: No appreciable changes in the utilization of venlafaxine and risperidone after generics. The reduction in expenditure/DDD for venlafaxine decreased overall expenditure on newer antidepressants by 5% by the end of the study versus just before generics despite a 37% increase in utilization. Expenditure will further decrease if reduced prescribing of duloxetine. Conclusion: Depression, schizophrenia, and bipolar diseases are complex diseases. As a result, specific measures are needed to encourage the prescribing of generic risperidone and venlafaxine when multiple choices are appropriate. Authorities cannot rely on a “Hawthorne” effect between classes to enhance the use of generics. Measures may include prescribing restrictions for duloxetine. No specific measures planned for AAPs with more multiple-sourced AAPs becoming available.
Payers endorse generics to enhance prescribing efficiency: impact and future implications, a case history approach
Brian Godman, BSc, PhD,Mohammed Abuelkhair, PharmD,Agnes Vitry, PharmD, PhD,Shajahan Abdu, MD
Generics and Biosimilars Initiative Journal , 2012,
Abstract: Introduction: Pharmaceutical expenditure continues to rise driven by a number of factors including ageing populations and the continued launch of new premium-priced drugs. Increasing use of generics versus originators and patent-protected products of the same or related classes can help conserve valuable resources. However, concerns with their effectiveness and safety compared to originators as well as only limited introduction of measures to promote their demand in some countries have led to variable use among countries. Countries need to learn from each other to further enhance their prescribing efficiency.Study Objectives: Firstly to review successful case histories from different countries, and secondly, raise awareness about potential pitfalls that could undermine the success of future measures in order to provide future guidance on conserving resources in relation to generics. Methods: A narrative review of case histories selected by co-authors using a range of different approaches. Systematic reviews are published elsewhere.Results: Twelve case histories were selected depicting both supply- and demand-side measures. These include Croatia where the introduction of additional measures helped reduce drug expenditure as well as debt whilst improving access to new medicines, Lithuania where recent reforms decreased pharmaceutical expenditure in 2010 whilst the number of prescriptions increased by 9% versus 2009; Scotland where despite a 6.2 fold increase in statin utilisation, multiple measures limited the increase in reimbursed expenditure to just 7% in 2010 vs 2001; Sweden where the introduction of monthly auctions for generics has helped lower prices; and the US where managed care organisations actively encourage cross therapeutic opportunities for generics substitution where the safety and efficacy of a generic drug is similar to a patent-protected product in the class or related class to conserve resources.Conclusion: Payers across Australia, Europe, Middle East (United Arab Emirates), and US have introduced multiple measures to both enhance the prescribing of generics and obtain lower prices, with the result that they are increasingly able to take advantage of the availability of generics. However, due to growing pressures on healthcare resources, it is important that countries accelerate the sharing of lessons learned about which policies and new measures are most effective in controlling costs.
European payer initiatives to reduce prescribing costs through use of generics
Brian Godman, BSc, PhD,Bjorn Wettermark, MSc, PhD,Iain Bishop, BSc,Thomas Burkhardt, MSc
Generics and Biosimilars Initiative Journal , 2012,
Abstract: Introduction: Pharmaceutical expenditure is increasingly scrutinised by payers of health care in view of its rapid growth resulting in a variety of reforms to help moderate future growth. This includes measures across Europe to enhance the utilisation of generics at low prices.Methods: A narrative review of the extensive number of publications and associated references from the co-authors was conducted, supplemented with known internal health authority or web-based articles.Results: Each European country has instigated different approaches to generic pricing, which can be categorised into three groups, with market forces in Sweden and UK lowering the prices of generics to between 3–13% of pre-patent loss originator prices. Payers have also instigated measures to enhance the utilisation of generics versus originators and patent-protected products in a class or related class. These can be categorised under the 4Es: education, engineering, economics and enforcement, with the measures appearing additive. The combination of low prices for generics coupled with measures to enhance their utilisation has resulted in appreciable cost savings in some European countries with expenditure stable or decreasing alongside increased utilisation of products in a class.Conclusion: Reforms will increase as resource pressures continue to grow with the pace of implementation being likely to accelerate. Care though with the introduction of prescribing restrictions to maximise savings as outcomes may be different from expectations.
Different initiatives across Europe to enhance losartan utilisation post generics: impact and implications
Brian Godman,Samantha Alvarez-Madrazo,Anna Bucsics,Steven Simoens,Corinne Zara
Frontiers in Pharmacology , 2014, DOI: 10.3389/fphar.2014.00219
Abstract: Introduction: There is an urgent need for health authorities across Europe to fully realise potential savings from increased use of generics to sustain their healthcare systems. A variety of strategies were used across Europe following the availability of generic losartan, the first angiotensin receptor blocker [ARB] to be approved and marketed, to enhance its prescribing versus single-sourced drugs in the class. Demand-side strategies ranged from 100% co-payment for patented ARBs in Denmark to no specific measures. We hypothesised this heterogeneity of approaches would provide opportunities to explore prescribing in a class following patent expiry. Objective: Contrast the impact of the different approaches among European countries and regions to the availability of generic losartan to provide future guidance. Methodology: Retrospective segmented regression analyses applying linear random coefficient models with country specific intercepts and slopes were used to assess the impact of the various initiatives across Europe following the availability of generic losartan. Utilisation measured in defined daily doses (DDDs). Price reductions for generic losartan were also measured. Results: Utilisation of losartan was over 90% of all ARBs in Denmark by the study end. Multiple measures in Sweden and one English primary care group also appreciably enhanced losartan utilisation. Losartan utilisation actually fell in some countries with no specific demand-side measures. Considerable differences were seen in the prices of generic losartan. Conclusion: Delisting single-sourced ARBs produced the greatest increase in losartan utilisation. Overall, multiple demand-side measures are needed to change physician prescribing habits to fully realise savings from generics. There is no apparent ‘spill over’ effect from one class to another to influence future prescribing patterns even if these are closely related.
What lessons can be learned from the launch of generic clopidogrel?
Christoph Baumg?rtel, MD,Brian Godman, BSc, PhD,Rickard E Malmstrom, MD, PhD,Morten Andersen, MD, PhD
Generics and Biosimilars Initiative Journal , 2012,
Abstract: Introduction and study objectives: Resource pressures will continue to grow. Consequently, health authorities and health insurance agencies need to take full advantage of the availability of generics in order to continue funding comprehensive health care particularly in Europe. Generic clopidogrel provides such an opportunity in view of appreciable worldwide sales of the originator. However, early formulations contained different salts and only limited indications. Consequently, there is a need to assess responses by the authorities to the early availability of generic clopidogrel including potential reasons preventing them from taking full advantage of the situation. In addition, it is necessary to determine the extent of initial price reductions obtained in practice to guide future activities.Methods: Feedback from health authorities and health insurance personnel involved with the reforms surrounding generic clopidogrel was principally used to assess authority responses as there is limited information in the public domain. Abu Dhabi has been included as a representative of the Middle East since it has introduced compulsory international non-proprietary name (INN) prescribing except for limited situations. Generic clopidogrel is not one of these – providing direction to other health authorities alongside, e.g. Lithuania. Australia has also been included in view of the high court ruling in favour of generic clopidogrel.Results: Authorities from across Australia, Europe and the Middle East typically adopted a pragmatic approach to the availability of generic clopidogrel to enhance its prescribing and dispensing once approved by regulatory agencies such as EMA. This included guidance to enhance its utilisation such as academic publications, co-payment incentives and compulsory INN prescribing. However, this was not always possible with challenges to the availability of generics in some countries. Again, there was appreciable variation in the initial price reductions for generic clopidogrel versus the originator.Conclusion: Authorities can take full advantage of the early availability of generics despite different formulations and indications. Pharmaceutical companies need to accept this in order to help fund new premium price products as resource pressures grow.
Forecasting drug utilization and expenditure in a metropolitan health region
Bj?rn Wettermark, Marie E Persson, Nils Wilking, Mats Kalin, Seher Korkmaz, Paul Hjemdahl, Brian Godman, Max Petzold, Lars L Gustafsson, the Regional Drug Expert Consortium in Stockholm County Council
BMC Health Services Research , 2010, DOI: 10.1186/1472-6963-10-128
Abstract: Linear regression analysis was applied to aggregate sales data on hospital sales and dispensed drugs in ambulatory care, including both reimbursed expenditure and patient co-payment. The linear regression was applied on each pharmacological group based on four observations 2006-2009, and the crude predictions estimated for the coming two years 2010-2011. The crude predictions were then adjusted for factors likely to increase or decrease future utilization and expenditure, such as patent expiries, new drugs to be launched or new guidelines from national bodies or the regional Drug and Therapeutics Committee. The assessment included a close collaboration with clinical, clinical pharmacological and pharmaceutical experts from the regional Drug and Therapeutics Committee.The annual increase in total expenditure for prescription and hospital drugs was predicted to be 2.0% in 2010 and 4.0% in 2011. Expenditures will increase in most therapeutic areas, but most predominantly for antineoplastic and immune modulating agents as well as drugs for the nervous system, infectious diseases, and blood and blood-forming organs.The utilisation and expenditure of drugs is difficult to forecast due to uncertainties about the rate of adoption of new medicines and various ongoing healthcare reforms and activities to improve the quality and efficiency of prescribing. Nevertheless, we believe our model will be valuable as an early warning system to start developing guidance for new drugs including systems to monitor their effectiveness, safety and cost-effectiveness in clinical practice.During the last decades of the 20th century, several new and effective drugs have gained widespread use in the treatment of major diseases such as cardiovascular diseases, depression and diabetes mellitus [1]. These drugs markedly decreased mortality, shortened hospital stay and improved the quality of life for large groups of patients. In recent years, science has witnessed breakthroughs in molecular genet
Torsadogenic Risk of Antipsychotics: Combining Adverse Event Reports with Drug Utilization Data across Europe
Emanuel Raschi, Elisabetta Poluzzi, Brian Godman, Ariola Koci, Ugo Moretti, Marija Kalaba, Marion Bennie, Corrado Barbui, Bjorn Wettermark, Miriam Sturkenboom, Fabrizio De Ponti
PLOS ONE , 2013, DOI: 10.1371/journal.pone.0081208
Abstract: Background Antipsychotics (APs) have been associated with risk of torsade de Pointes (TdP). This has important public health implications. Therefore, (a) we exploited the public FDA Adverse Event Reporting System (FAERS) to characterize their torsadogenic profile; (b) we collected drug utilization data from 12 European Countries to assess the population exposure over the 2005-2010 period. Methods FAERS data (2004-2010) were analyzed based on the following criteria: (1) ≥4 cases of TdP/QT abnormalities; (2) Significant Reporting Odds Ratio, ROR [Lower Limit of the 95% confidence interval>1], for TdP/QT abnormalities, adjusted and stratified (Arizona CERT drugs as effect modifiers); (3) ≥4 cases of ventricular arrhythmia/sudden cardiac death (VA/SCD); (4) Significant ROR for VA/SCD; (5) Significant ROR, combined by aggregating TdP/QT abnormalities with VA and SCD. Torsadogenic signals were characterized in terms of signal strength: from Group A (very strong torsadogenic signal: all criteria fulfilled) to group E (unclear/uncertain signal: only 2/5 criteria). Consumption data were retrieved from 12 European Countries and expressed as defined daily doses per 1,000 inhabitants per day (DID). Results Thirty-five antipsychotics met at least one criterium: 9 agents were classified in Group A (amisulpride, chlorpromazine, clozapine, cyamemazine, haloperidol, olanzapine, quetiapine, risperidone, ziprasidone). In 2010, the overall exposure to antipsychotics varied from 5.94 DID (Estonia) to 13.99 (France, 2009). Considerable increment of Group A agents was found in several Countries (+3.47 in France): the exposure to olanzapine increased across all Countries (+1.84 in France) and peaked 2.96 in Norway; cyamemazine was typically used only in France (2.81 in 2009). Among Group B drugs, levomepromazine peaked 3.78 (Serbia); fluphenazine 1.61 (Slovenia). Conclusions This parallel approach through spontaneous reporting and drug utilization analyses highlighted drug- and Country-specific scenarios requiring potential regulatory consideration: levomepromazine (Serbia), fluphenazine (Slovenia), olanzapine (across Europe), cyamemazine (France). This synergy should be encouraged to support future pharmacovigilance activities.
Multiple policies to enhance prescribing efficiency for established medicines in Europe with a particular focus on demand-side measures: findings and future implications
Brian Godman,Menno van Woerkom,Samantha Alvarez-Madrazo,Anna Bucsics,Kristina Garuoliene,Catherine Sermet,Kamila Malinowska,Corinne Zara,Lars L. Gustafsson
Frontiers in Pharmacology , 2014, DOI: 10.3389/fphar.2014.00106
Abstract: Introduction: The appreciable growth in pharmaceutical expenditure has resulted in multiple initiatives across Europe to lower generic prices and enhance their utilization. However, considerable variation in their use and prices.
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