Personalizing health care: feasibility and future implications.

Considerable variety in how patients respond to treatments, driven by differences in their geno- and/ or phenotypes, calls for a more tailored approach. This is already happening, and will accelerate with developments in personalized medicine. However, its promise has not always translated into improvements in patient care due to the complexities involved. There are also concerns that advice for tests has been reversed, current tests can be costly, there is fragmentation of funding of care, and companies may seek high prices for new targeted drugs. There is a need to integrate current knowledge from a payer's perspective to provide future guidance. Multiple findings including general considerations; influence of pharmacogenomics on response and toxicity of drug therapies; value of biomarker tests; limitations and costs of tests; and potentially high acquisition costs of new targeted therapies help to give guidance on potential ways forward for all stakeholder groups. Overall, personalized medicine has the potential to revolutionize care. However, current challenges and concerns need to be addressed to enhance its uptake and funding to benefit patients.

Review and Assessment of Policy Options for Improving Access to Combination Therapies in Oncology in Europe.

OBJECTIVES: Combinations of on-patent therapies (CTs) are increasingly common in oncology. They cause challenges for funding and affordability, and hence patient access, especially when constituent therapies are owned by different manufacturers. The aim of our study was to develop policy proposals for the assessment, pricing, and funding of CTs and identify which might be relevant in different European countries. METHODS: Following a review of available literature, seven hypothetical policy proposals were developed and subsequently assessed through 19 semi-structured interviews with health policy, pricing, technology assessment and legal experts in seven European countries to identify those most likely to gain traction. RESULTS: Experts saw a need for agreed approaches within a country to manage affordability and funding challenges for CTs. Changes to health technology assessment (HTA) and funding models were considered unlikely, but other policy proposals were seen as mostly useful, with country-specific adaptations. Bilateral discussions between manufacturers and payers were deemed important, and less challenging and protracted than arbitrated dialogue between manufacturers. Usage-specific pricing, possibly using weighted average prices, was considered a prerequisite for the financial management of CTs. CONCLUSIONS: There is a growing need to ensure that CTs are affordable to health systems. It would appear that there is no one set of policies that is appropriate for all countries in Europe, so countries wishing to ensure that patients have (or continue to have) access to CTs of value to them must explore and implement the policies that are best suited to their general approach to funding health care and to the assessment and reimbursement of medicines.

The challenge of ensuring elderly people can access their health insurance entitlements: a mixed methods study on the Republic of Srpska's Protector of Patients' Health Insurance Entitlements.

INTRODUCTION: Healthcare utilisation requires knowing one's entitlements and how to access them (navigation) and having access to grievance redressal when entitlements are denied. To ensure citizen access to and use of health insurance entitlements, the Health Insurance Fund established an initiative called the Protector of Patients' Health Insurance Entitlements (PPHIE). PPHIEs are supposed to provide patient navigation and grievance redressal services. This paper explores to what extent this initiative meets its objectives and is used by the elderly in rural areas. METHODS: This study employed a mixed methods approach. We conducted in-depth interviews with elderly patients in rural areas, PPHIEs, health providers and health insurance managers (N=39), as well as focus groups (N=5) and a household survey (N=715) with elderly rural patients. Qualitative data were analysed using content analysis, and the household survey results were analysed using descriptive statistics. RESULTS: The majority of elderly patients were not aware of the PPHIE initiative and instead received patient navigation support from their healthcare providers. The PPHIE programme was poorly publicised among the population. Although PPHIEs had a mandate to pursue grievance redressal they rarely did so, and their role in the system was more symbolic than functional. CONCLUSION: While healthcare providers have (by default) filled the navigation role left by inactive PPHIEs, the grievance redressal role remains unfilled. Information about health insurance entitlements and access to grievance redressal must be provided through visible, accessible and efficient mechanisms that should be continuously monitored and improved.

Comparing pharmaceutical pricing and reimbursement policies in Croatia to the European Union Member States.

AIM: To perform a comparative analysis of the pharmaceutical pricing and reimbursement systems in Croatia and the 27 European Union (EU) Member States. METHODS: Knowledge about the pharmaceutical systems in Croatia and the 27 EU Member States was acquired by literature review and primary research with stakeholders. RESULTS: Pharmaceutical prices are controlled at all levels in Croatia, which is also the case in 21 EU Member States. Like many EU countries, Croatia also applies external price referencing, i.e., compares prices with other countries. While the wholesale remuneration by a statutorily regulated linear mark-up is applied in Croatia and in several EU countries, the pharmacy compensation for dispensing reimbursable medicines in the form of a flat rate service fee in Croatia is rare among EU countries, which usually apply a linear or regressive pharmacy mark-up scheme. Like in most EU countries, the Croatian Social Insurance reimburses specific medicines at 100%, whereas patients are charged co-payments for other reimbursable medicines. Criteria for reimbursement include the medicine's importance from the public health perspective, its therapeutic value, and relative effectiveness. In Croatia and in many EU Member States, reimbursement is based on a reference price system. CONCLUSION: The Croatian pharmaceutical system is similar to those in the EU Member States. Key policies, like external price referencing and reference price systems, which have increasingly been introduced in EU countries are also applied in Croatia and serve the same purpose: to ensure access to medicines while containing public pharmaceutical expenditure.

Is it too expensive to fight cancer? Analysis of incremental costs and benefits of the Croatian National Plan Against Cancer.

This cost-effectiveness study analyses the expected impacts of activities proposed by the Croatian National Plan Against Cancer (NPAC) on cancer incidence and survival rates, as related to their respective costs. We evaluated the impact of the NPAC on two main outcomes, namely, reduced incidence and the improved survival of cancer patients, expressed as life years gained (LYGs), which enabled the calculation of incremental cost-effectiveness ratios (ICERs) in the form of cost per LYG. In the analysis of costs, we considered both the direct costs of NPAC activities as well as the wider indirect societal costs of cancer, thus permitting the calculation of the ICER both from the narrower national health insurer's perspective (accounting only for the direct costs) and the wider societal perspective (accounting both for the direct and indirect costs). We estimated that on average, for all patients benefiting from the implementation of the NPAC in Croatia, an additional LYG would be yielded at the additional cost of €1.021 (societal perspective). The NPAC can, for some sites, even be considered a dominant intervention due to the negative cost/LYG ratio, meaning that it generates additional LYGs while at the same time, reducing total societal costs. Taking a narrower health insurer's perspective (i.e., accounting only for the direct costs), the NPAC produces an additional LYG at an additional cost of €1.408. Both cost per LYG estimates can be considered cost-effective investment options.

Pricing and Reimbursement of Patent-Protected Medicines: Challenges and Lessons from South-Eastern Europe.

BACKGROUND: Efficiency and transparency of pricing and reimbursement (P&R) rules and procedures as well as their implementation in South-eastern Europe (SEE) lag substantially behind Western European practice. Nevertheless, P&R systems in SEE are rarely critically assessed, warranting a detailed and wider-encompassing exploration. OBJECTIVE: Our study provides a comparative assessment of P&R processes for patent-protected medicines in ten SEE countries-EU member states: Croatia, Slovenia, Hungary, Romania and Bulgaria; and non-EU countries: Albania, Montenegro, Serbia, North Maceodina, Bosnia and Herzegovina. P&R systems are compared and evaluated through a research framework that focuses on: (1) public financing of patent-protected medicines, (2) definition of benefit packages, (3) requirements for the submission of reimbursement dossiers, (4) assessment and appraisal processes, (5) reimbursement decision making, (6) processes that occur post reimbursement, and (7) pricing. The study aims to contribute to the discussion on improving the efficiency and quality of P&R of patent-protected medicines in the region. METHODS: We conducted a non-systematic literature review of published literature, as well as policy briefs and reports on healthcare systems in the SEE region along with legal documents framing the P&R procedures in local languages. The information gathered from these various sources was then discussed and clarified through structured telephone interviews with relevant national experts from each SEE country, mainly current and former senior officials and/or executives of the funding and assessment/ appraisal bodies (total of 20 interviews conducted in late 2019). RESULTS: Capacity building through sharing knowledge and information on successful reforms across borders is an opportunity for SEE countries to further develop their P&R policies and increase (equitable) access to patent-protected medicines (especially expensive medicines), increasing affordability and containing costs. Simple yet robust and systematic decision-making frameworks that rely on international health technology assessment (HTA) procedures and are based on the pursuit of transparency seem to be the most cost-effective approach to strengthening P&R systems in SEE. CONCLUSIONS: Further reforms aiming to develop transparent and robust national decision-making frameworks (including oversight) and build institutional HTA-related and decision-making capacity are awaited in most of SEE countries, especially the non-EU members. In non-EU SEE countries, these efforts could increase access to patent-protected medicines, which is-at the moment-very limited. The EU-member SEE countries operate more developed P&R systems but could further benefit from developing their procedures, oversight and value-for-money assessment toolbox and capacity, hence further improving the transparency and efficiency of procedures that regulate access to patent-protected medicines.

Potential approaches for the pricing of cancer medicines across Europe to enhance the sustainability of healthcare systems and the implications.

Introduction: There are growing concerns among European health authorities regarding increasing prices for new cancer medicines, prices not necessarily linked to health gain and the implications for the sustainability of their healthcare systems.Areas covered: Narrative discussion principally among payers and their advisers regarding potential approaches to the pricing of new cancer medicines.Expert opinion: A number of potential pricing approaches are discussed including minimum effectiveness levels for new cancer medicines, managed entry agreements, multicriteria decision analyses (MCDAs), differential/tiered pricing, fair pricing models, amortization models as well as de-linkage models. We are likely to see a growth in alternative pricing deliberations in view of ongoing challenges. These include the considerable number of new oncology medicines in development including new gene therapies, new oncology medicines being launched with uncertainty regarding their value, and continued high prices coupled with the extent of confidential discounts for reimbursement. However, balanced against the need for new cancer medicines. This will lead to greater scrutiny over the prices of patent oncology medicines as more standard medicines lose their patent, calls for greater transparency as well as new models including amortization models. We will be monitoring these developments.

Integrative Review of Managed Entry Agreements: Chances and Limitations.

BACKGROUND AND OBJECTIVE: Managed entry agreements (MEAs) consist of a set of instruments to reduce the uncertainty and the budget impact of new high-priced medicines; however, there are concerns. There is a need to critically appraise MEAs with their planned introduction in Brazil. Accordingly, the objective of this article is to identify and appraise key attributes and concerns with MEAs among payers and their advisers, with the findings providing critical considerations for Brazil and other high- and middle-income countries. METHODS: An integrative review approach was adopted. This involved a review of MEAs across countries. The review question was 'What are the health technology MEAs that have been applied around the world?' This review was supplemented with studies not retrieved in the search known to the senior-level co-authors including key South American markets. It also involved senior-level decision makers and advisers providing guidance on the potential advantages and disadvantages of MEAs and ways forward. RESULTS: Twenty-five studies were included in the review. Most MEAs included medicines (96.8%), focused on financial arrangements (43%) and included mostly antineoplastic medicines. Most countries kept key information confidential including discounts or had not published such data. Few details were found in the literature regarding South America. Our findings and inputs resulted in both advantages including reimbursement and disadvantages including concerns with data collection for outcome-based schemes. CONCLUSIONS: We are likely to see a growth in MEAs with the continual launch of new high-priced and often complex treatments, coupled with increasing demands on resources. Whilst outcome-based MEAs could be an important tool to improve access to new innovative medicines, there are critical issues to address. Comparing knowledge, experiences, and practices across countries is crucial to guide high- and middle-income countries when designing their future MEAs.

The Expiry of Humira® Market Exclusivity and the Entry of Adalimumab Biosimilars in Europe: An Overview of Pricing and National Policy Measures.

Background: From October 2018, adalimumab biosimilars could enter the European market. However, in some countries, such as Netherlands, high discounts reported for the originator product may have influenced biosimilar entry. Objectives: The aim of this paper is to provide a European overview of (list) prices of originator adalimumab, before and after loss of exclusivity; to report changes in the reimbursement status of adalimumab products; and discuss relevant policy measures. Methods: Experts in European countries received a survey consisting of three parts: 1) general financing/co-payment of medicines, 2) reimbursement status and prices of originator adalimumab, and availability of biosimilars, and 3) policy measures related to the use of adalimumab. Results: In May 2019, adalimumab biosimilars were available in 24 of the 30 countries surveyed. Following introduction of adalimumab biosimilars, a number of countries have made changes in relation to the reimbursement status of adalimumab products. Originator adalimumab list prices varied between countries by a factor of 2.8 before and 4.1 after loss of exclusivity. Overall, list prices of originator adalimumab decreased after loss of exclusivity, although for 13 countries list prices were unchanged. When reported, discounts/rebates on originator adalimumab after loss of exclusivity ranged from 0% to approximately 26% (Romania), 60% (Poland), 80% (Denmark, Italy, Norway), and 80-90% (Netherlands), leading to actual prices per pen or syringe between €412 (Finland) and €50 - €99 (Netherlands). To leverage competition following entry of biosimilar adalimumab, only a few countries adopted measures specifically for adalimumab in addition to general policies regarding biosimilars. In some countries, a strategy was implemented even before loss of exclusivity (Denmark, Scotland), while others did not report specific measures. Conclusion: Even though originator adalimumab is the highest selling product in the world, few countries have implemented specific policies and practices for (biosimilar) adalimumab. Countries with biosimilars on the market seem to have competition lowering list or actual prices. Reported discounts varied widely between countries.

Health care needs, utilization and barriers in croatia--regional and urban-rural differences.

Even the most socially aware countries in the World have noticed the gap increase between the poorest and the richest population groups. The purpose of this study was to investigate the presence of inequity and to identify main barriers for equitable health care utilization by economic status, region and area of living, controlled for health needs in the Croatian adult population. The data from the Croatian Adult Health Survey 2003 were used in this study. The results show that among the respondents with higher health needs, those with economic status above average had higher proportion of regular annual general practitioner and medical specialist visits. In contrast, highly frequent visits to physician were more common in respondents who were below average economic status. Economically worse-off women, regardless on their health care needs reported gynecologist visits less regularly than the better-off women. Long waiting and the large distance from the health care facilities were the most commonly reported barriers in health care utilization. High expenses were present as the main barrier at dentist and inpatient health services utilization. Suburban and rural settlements were more burdened with long distance from the health care facilities and high expenses for all health services, aggravated by the long waiting time for visits to GP. Respondents from the urban settings reported long waiting time and unkindness of the health personnel as the main barriers. The results of this study clearly show the main barriers in the equitable health care delivery to Croatia population from the health care users perspective.

Translation of evidence-based tobacco use prevention programming in Croatia.

Croatia faces a major threat of smoking-related health burdens given the monumental changes this newly formed country has undergone in the past 15 years because of its postcommunist democratic and economic transitions and the destructive 1991-1995 war with Serbia. This article provides information on Croatia's general background, current smoking prevalence and attitudes, and current evidence-based smoking prevention efforts. Furthermore, various cultural and contextual conditions within Croatia that facilitate or impede smoking prevention research utilization are discussed. Finally, it is concluded that new research is needed that continues to build on comprehensive research-tested multicomponent prevention initiatives utilizing school-, family-, community-, and mass media-based delivery modalities, which specifically focus on the social influences of smoking.

Health care funding reforms in Croatia: a case of mistaken priorities.

This study provides an overview of funding mechanisms in Croatian health care and analyses them in terms of sustainability, efficiency and equity. The study presents an in depth investigation of problems facing funding health care in Croatia: high expenditure, inadequate financial resources, continuous deficits of the state insurance fund, lack of transparency in funding, an aging population, etc. Furthermore, the study provides a critical overview of reforms that have been implemented to counter those issues from 1990 to 2002. The study argues that the implemented reforms over relied on shifting health expenditure from public to private sources in addressing financial deficits in the system. The study argues that, instead, the reforms should have focused more on curbing rising expenditure in health care providers. Emphasis has been put on the extent to which the reforms affected the conceptual-social foundations of the system. Finally, the paper provides recommendations for policy makers in Croatia and presents an overview of Croatian experiences that might be of interest to researchers and policy makers internationally.

Use of preventive health care services among the unemployed in Croatia.

AIM: To analyze the association between unemployment and the use of preventive health care services in Croatia. METHODS: Data on the use of preventive health care services and employment status were taken from the 2003 Croatia Adult Health Survey. A multistage stratified sample design was used to define a representative sample (n=9070 individuals) of the Croatian general adult population. Binary logistic regression was used for analysis. Odds ratios were estimated for the association between employment status and preventive health care services, controlling for age, sex, region, marital status, level of education, occupation, and distance from general practitioner (GP) facilities. RESULTS: Our sample comprised 1356 men and 1932 women. Out of them, 382 men (28.2%) and 472 women (24.4%) were unemployed. Unemployment was negatively associated with the use of some preventive health care services in the year before the study among healthy individuals (regular blood pressure control odds ratio [OR], 0.738, 95% CI, 0.576-0.945; blood glucose control OR, 0.751, 95% CI, 0.565-0.999; attending general preventive examinations OR, 0.563, 95% CI, 0.410-0.772) as well as among individuals who reported cardiovascular and/or metabolic diseases (attending general preventive examinations OR, 0.661, 95% CI, 0.456-0.959; receiving doctor's advice for food habit change and influenza immunizations OR, 0.627, 95% CI, 0.424-0.928). CONCLUSION: Both the unemployed who had cardiovascular and metabolic diseases and those who did not, used less preventive health services than respective subgroups of the employed. In order to achieve a more equitable distribution of preventive health care services, the Croatian health care system should provide additional attention to the unemployed; for instance by developing a program of preventive health examinations targeting this vulnerable population.

Association of social roles, health, and health behavior of elderly women in Croatia.

AIM: To explore the association between the social role and objective and subjective health measures and use of health care services in the population of women older than 65 years in Croatia. METHODS: We used the data from the 2003 Croatian Adult Health Survey (Short Form 36 Health Survey). Two sub-populations, retired women and housewives aged over 65 years, were analyzed and compared according to anthropometric measures, health self-assessment, utilization of health care services, and socioeconomic status. RESULTS: The final sample consisted of 791 housewives and 1151 retired women. Housewives had larger waist circumference (98.44+/-13.9 vs 96.49+/-13.5, P=0.002, t test) and higher systolic blood pressure (152.88+/-25.2 vs 147.79+/-22.8, P<0.001, t test). On self health assessment, housewives had lower index on Mental Component Summary (MCS) (40.28+/-12.5 vs 42.96+/-12.4, P<0.001, t test). They also had lower self-assessed quality of life (40.28+/-12.5 vs 42.96+/-12.4, P<0.001, t test). Housewives performed regular breast check-ups significantly less often in the 12 months before the survey (7.5% vs 13.6%, chi2=18.0350, P<0.001), but they performed other forms of medical examinations, including general physical check-ups as often as retired women. CONCLUSION: Housewives differed from retired women of the same age in objective and subjective measures of health status, use of health care services, self perceived health, and self-assessed quality of life. These differences should be taken into account when planning public health measures for these age groups of women.

The Implementation of Managed Entry Agreements in Central and Eastern Europe: Findings and Implications.

BACKGROUND: Managed entry agreements (MEAs) are a set of instruments to facilitate access to new medicines. This study surveyed the implementation of MEAs in Central and Eastern Europe (CEE) where limited comparative information is currently available. METHOD: We conducted a survey on the implementation of MEAs in CEE between January and March 2017. RESULTS: Sixteen countries participated in this study. Across five countries with available data on the number of different MEA instruments implemented, the most common MEAs implemented were confidential discounts (n = 495, 73%), followed by paybacks (n = 92, 14%), price-volume agreements (n = 37, 5%), free doses (n = 25, 4%), bundle and other agreements (n = 19, 3%), and payment by result (n = 10, >1%). Across seven countries with data on MEAs by therapeutic group, the highest number of brand names associated with one or more MEA instruments belonged to the Anatomical Therapeutic Chemical (ATC)-L group, antineoplastic and immunomodulating agents (n = 201, 31%). The second most frequent therapeutic group for MEA implementation was ATC-A, alimentary tract and metabolism (n = 87, 13%), followed by medicines for neurological conditions (n = 83, 13%). CONCLUSIONS: Experience in implementing MEAs varied substantially across the region and there is considerable scope for greater transparency, sharing experiences and mutual learning. European citizens, authorities and industry should ask themselves whether, within publicly funded health systems, confidential discounts can still be tolerated, particularly when it is not clear which country and party they are really benefiting. Furthermore, if MEAs are to improve access, countries should establish clear objectives for their implementation and a monitoring framework to measure their performance, as well as the burden of implementation.

Importance of health care issues in 2005 presidential elections in Croatia.

Health and health care provision are among the most important and politically sensitive public service areas. Politicians carefully incorporate health care program changes in their political agendas to gain votes. However, knowing health care priorities of the electoral body is not useful only to politicians, but also to health policy makers, as it enables them to target the most problematic areas in health care. We conducted a telephone survey of representative sample of voters (n=643) immediately before the presidential elections in Croatia in 2005, to determine the possible differences in health care priorities between left-wing and right-wing voters, and found a high level of homogeneity in their opinions. Health care organization, corruption, and financing issues were identified as the top priorities by both left- and right-wing voters. This agreement in voters' expectations, probably caused by a similar frame of mind of Croatian citizens inherited from pre-democratic times of self-government, could be used by health policy makers to rationally invest the means and efforts in dealing with the most problematic health care issues.

Multiple policies to enhance prescribing efficiency for established medicines in Europe with a particular focus on demand-side measures: findings and future implications.

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. OBJECTIVE: Assess the influence of multiple supply and demand-side initiatives across Europe for established medicines to enhance prescribing efficiency before a decision to prescribe a particular medicine. Subsequently utilize the findings to suggest potential future initiatives that countries could consider. METHOD: An analysis of different methodologies involving cross national and single country retrospective observational studies on reimbursed use and expenditure of PPIs, statins, and renin-angiotensin inhibitor drugs among European countries. RESULTS: Nature and intensity of the various initiatives appreciably influenced prescribing behavior and expenditure, e.g., multiple measures resulted in reimbursed expenditure for PPIs in Scotland in 2010 56% below 2001 levels despite a 3-fold increase in utilization and in the Netherlands, PPI expenditure fell by 58% in 2010 vs. 2000 despite a 3-fold increase in utilization. A similar picture was seen with prescribing restrictions, i.e., (i) more aggressive follow-up of prescribing restrictions for patented statins and ARBs resulted in a greater reduction in the utilization of patented statins in Austria vs. Norway and lower utilization of patented ARBs vs. generic ACEIs in Croatia than Austria. However, limited impact of restrictions on esomeprazole in Norway with the first prescription or recommendation in hospital where restrictions do not apply. Similar findings when generic losartan became available in Western Europe. CONCLUSIONS: Multiple demand-side measures are needed to influence prescribing patterns. When combined with supply-side measures, activities can realize appreciable savings. Health authorities cannot rely on a "spill over" effect between classes to affect changes in prescribing.

Dabigatran - a continuing exemplar case history demonstrating the need for comprehensive models to optimize the utilization of new drugs.

BACKGROUND: There are potential conflicts between authorities and companies to fund new premium priced drugs especially where there are effectiveness, 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 showed dabigatran to be cost-effective but there are budget concerns given the prevalence of AF. These concerns resulted in extensive activities pre- to post-launch to manage its introduction. OBJECTIVE: To (i) review authority activities across countries, (ii) use the findings to develop new models to better manage the entry of new drugs, and (iii) review the implications based on post-launch activities. METHODOLOGY: (i) Descriptive review and appraisal of activities regarding dabigatran, (ii) development of guidance for key stakeholder groups through an iterative process, (iii) refining guidance following post launch studies. RESULTS: 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, centering on three pillars of pre-, peri-, and post-launch activities. Post-launch activities include increasing use of patient registries to monitor the safety and effectiveness of new drugs in clinical practice. CONCLUSION: Models for introducing new drugs are essential to optimize their prescribing especially where concerns. Without such models, new drugs may be withdrawn prematurely and/or struggle for funding.

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.