Trend of Antihypertensive Medicine Use in the Baltic States between 2008 and 2018: A Retrospective Cross-National Comparison

High blood pressure is a major risk factor contributing to death and disability rates in the Baltic states. The aim of this study was to compare the utilization of antihypertensive medicines in Estonia, Latvia and Lithuania from 2008 to 2018. In this retrospective cross-national comparison, nationally representative wholesale data from the IQVIA National Retail Audit were analyzed. The utilization of inhibitors of the renin–angiotensin system, beta blockers, calcium channel blockers, diuretics and centrally acting antihypertensives by Defined Daily Doses per 1000 inhabitants and day (DDD/TID) was used to calculate utilization. Time series analysis was used to analyze trends. The utilization increased annually by 10.88, 8.04 and 6.42 DDD/TID in Estonia, Latvia and Lithuania, respectively, from 2008. The utilization of antihypertensive drugs in 2018 was 372, 267 and 379.5 DDD/TID, respectively. Inhibitors of the renin–angiotensin system were the most commonly used class in 2008 and 2018. From 2008, the utilization of beta blockers and fixed-dose combinations including renin–angiotensin system inhibitors increased substantially, while that of calcium channel blockers decreased. Country-specific utilization trends were noted; e.g., the utilization of centrally acting antihypertensives was 30.9 DDD/TID in Lithuania compared to 3.01 DDD/TID in Estonia and 16.17 DDD/TID in Latvia. The use of antihypertensive medicines increased over the study period, but the trends for the different drug classes differed between countries

Differences in utilisation rates between commercial and administrative databases : implications for future health economic and cross national studies

Comparative cross national (CNC) drug utilization studies are challenging. However, there can be concerns with the accuracy and robustness of the data collected with previous studies showing differences in utilisation rates between different databases. In addition, if utilisation rates vary appreciably between countries with no logical explanation. These studies have been carried out for the same class across countries. This has now been extended to compare utilisation rates between different databases among four high volume classes among administrative and commercial databases in one country (Lithuania) between 2004 and 2012 alongside health policies. There were appreciable differences in the utilisation of PPIs (5 to 7 fold) and statins (2 to 6 fold) between the different databases with limited differences for the other two classes. This could be explained by restricted reimbursement for the PPIs and statins, with similar utilisation of renin-angiotensin inhibitors in Lithuania between the databases and with Western European countries in the absence of prescribing restrictions. Low utilisation of anti-depressants in Lithuania versus Western European countries also explained by ongoing policies. Essential to always record the database content in CNC studies alongside health policies otherwise the findings could be misinterpreted. Joint reporting should become standard for future CNC studies

Improving the managed introduction of new medicines : sharing experiences to aid authorities across Europe

The 3-day course on the managed introduction of new drugs was organised by the Piperska group together with the Agency for Health Technology Assessment and Tariff System (AOTMiT) and WHO Europe to share experiences and case histories among health authority and health insurance company personnel, academics and those from commercial organisations from across Europe on potential ways to optimise the managed entry of new medicines. This starts pre-launch with horizon scanning and budgeting, then peri-launch including critical drug evaluation, and finally post launch including monitoring prescribing of new medicines against agreed guidance and indicators. There were also discussions on issues regarding managed entry schemes and procurement strategies including biosimilars

Systemic Measures and Legislative and Organizational Frameworks Aimed at Preventing or Mitigating Drug Shortages in 28 European and Western Asian Countries

Drug shortages have been identified as a public health problem in an increasing number of countries. This can negatively impact on the quality and efficiency of patient care, as well as contribute to increases in the cost of treatment and the workload of health care providers. Shortages also raise ethical and political issues. The scientific evidence on drug shortages is still scarce, but many lessons can be drawn from cross-country analyses. The objective of this study was to characterize, compare, and evaluate the current systemic measures and legislative and organizational frameworks aimed at preventing or mitigating drug shortages within health care systems across a range of European and Western Asian countries. The study design was retrospective, cross-sectional, descriptive, and observational. Information was gathered through a survey distributed among senior personnel from ministries of health, state medicines agencies, local health authorities, other health or pharmaceutical pricing and reimbursement authorities, health insurance companies and academic institutions, with knowledge of the pharmaceutical markets in the 28 countries studied. Our study found that formal definitions of drug shortages currently exist in only a few countries. The characteristics of drug shortages, including their assortment, duration, frequency, and dynamics, were found to be variable and sometimes difficult to assess. Numerous information hubs were identified. Providing public access to information on drug shortages to the maximum possible extent is a prerequisite for performing more advanced studies on the problem and identifying solutions. Imposing public service obligations, providing the formal possibility to prescribe unlicensed medicines, and temporary bans on parallel exports are widespread measures. A positive finding of our study was the identification of numerous bottom-up initiatives and organizational frameworks aimed at preventing or mitigating drug shortages. The experiences and lessons drawn from these initiatives should be carefully evaluated, monitored, and presented to a wider international audience for careful appraisal. To be able to find solutions to the problem of drug shortages, there is an urgent need to develop a set of agreed definitions for drug shortages, as well as methodologies for their evaluation and monitoring. This is being progressed

Are new models needed to optimize the utilization of new medicines to sustain healthcare systems?

Medicines have made an appreciable contribution to improving health. However, even high-income countries are struggling to fund new premium-priced medicines. This will grow necessitating the development of new models to optimize their use. The objective is to review case histories among health authorities to improve the utilization and expenditure on new medicines. Subsequently, use these to develop exemplar models and outline their implications. A number of issues and challenges were identified from the case histories. These included the low number of new medicines seen as innovative alongside increasing requested prices for their reimbursement, especially for oncology, orphan diseases, diabetes and HCV. Proposed models center on the three pillars of pre-, peri- and post-launch including critical drug evaluation, as well as multi-criteria models for valuing medicines for orphan diseases alongside potentially capping pharmaceutical expenditure. In conclusion, the proposed models involving all key stakeholder groups are critical for the sustainability of healthcare systems or enhancing universal access. The models should help stimulate debate as well as restore trust between key stakeholder groups

Corrigendum to "Utilisation trend of long-acting insulin analogues including biosimilars across Europe: findings and implications"

In the article titled "Utilisation Trend of Long-Acting Insulin Analogues including Biosimilars across Europe: Findings and Implications" [1], the captions of Figures 3 and 4 were incorrect. The corrected captions for Figures 3 and 4 appear below

Barriers for Access to New Medicines: Searching for the Balance Between Rising Costs and Limited Budgets

Introduction: There is continued unmet medical need for new medicines across countries especially for cancer, immunological diseases and orphan diseases. However, there are growing challenges with funding new medicines at ever increasing prices along with funding increased medicine volumes with the growing prevalence of both infectious diseases and non-communicable diseases across countries. This has resulted in the development of new models to better manage the entry of new medicines, new financial models being postulated as well as strategies to improve prescribing efficiency. However, more needs to be done. Consequently, the primary aim of this paper is to consider potential ways to optimise the use of new medicines balancing rising costs with increasing budgetary pressures to stimulate debate especially from a payer perspective. Methods: A narrative review of pharmaceutical policies and implications, as well as possible developments, based on key publications and initiatives known to the co-authors principally from a health authority perspective. Results: A number of initiatives and approaches have been identified including new models to better manage the entry of new medicines based on three pillars (pre-, peri-, and post-launch activities). Within this, we see the growing role of horizon scanning activities starting up to 36 months before launch, managed entry agreements and post launch follow-up. It is also likely there will be greater scrutiny over the effectiveness and value of new cancer medicines given ever increasing prices. This could include establishing minimum effectiveness targets for premium pricing along with re-evaluating prices as more medicines for cancer lose their patent. There will also be a greater involvement of patients especially with orphan diseases. New initiatives could include a greater role of multicriteria decision analysis, as well as looking at the potential for de-linking research and development from commercial activities to enhance affordability. Conclusion: There are a number of ongoing activities across countries to try and fund new valued medicines whilst attaining or maintaining universal healthcare. Such activities will grow with increasing resource pressures and continued unmet need

Utilization of cardiovascular medicines and cardiovascular mortality in Lithuania, Sweden and Norway in 2003–2012

Objective: The aim of this ecological study was to evaluate whether any changes in cardio-vascular (CV) medicine utilization, population, socioeconomic and health system factors were associated with CV mortality in Lithuania, Sweden and Norway in 2003–2012.Materials and methods: CV drug utilization was calculated using the Anatomical Therapeutic Chemical/Defined Daily Dose (DDD) methodology and expressed as a number of DDD per 1000 inhabitants per day (DDD/TID). The CV age-standardized death rate (CV-SDR) and risk factors data were obtained from the WHO, EUROSTAT, and FAOSTAT databases. The multiple linear regression model was used for modeling outcome measures - the relationship between the CV-SDR and CV medicine utilization including socioeconomic (GDP, unemployment and divorce rate), population (alcohol consumption, smoking and amount of kcal per day, consumption of fruit and vegetables, health status self-evaluation) and health system factors (number of hospital beds, practicing physicians and health care expenditure).Results: The higher CV medicine utilization in Sweden (307–455 DDD/TID, P < 0.001) and Norway (306–394 DDD/TID, P < 0.001) was associated with a definite decline in CV-SDR (in Norway from 215 to 146 and in Sweden from 233 to 174). In Lithuania, the increasing but lower consumption of CV medicines (135–360 DDD/TID, P < 0.001) and twice higher CV-SDR (from 541 to 447) was registered. A significant inverse correlation was observed between CVSDR and DDD/TID. We found a strong association between the DDD/TID and the CV-SDR (R2 = 0.67, P < 0.001). There was a strong correlation between CV-SDR and nine factors (P < 0.05), except the number of practicing physicians, amount of kcal per day. There was a strong correlation between DDD/TID and nine factors (P < 0.05), except the unemployment rate and amount of kcal per day. Association between an increase in the use of medicines and a decrease in CV-SDR was stronger in the case of higher alcohol consumption, higher number of available beds in hospitals and the lower unemployment rate.Conclusions: We confirmed the strong negative correlation between CV medicine utilization and CV mortality in all countries. The strong correlation was found between CV-SDR and nine factors, also between the use of CV medicines and nine factors. The impact of factors on the medicines induced decrease in CV-SDR showed the stronger influence in case of lower unemployment, higher alcohol consumption and higher number of beds for hospitalization

Healthcare professional-led interventions on lifestyle modifications for hypertensive patients – a systematic review and metaanalysis

Abstract Background: About 0.9 billion people in the world have hypertension. The mortality due to hypertension increased dramatically over the last decades. Healthcare professionals should support patients with hypertension to modify their lifestyle to decrease blood pressure, but an overview of effective lifestyle interventions is lacking. The aim of this study was to determine whether healthcare professional-led interventions on lifestyle modifications are effective in lowering blood pressure in patients with hypertension. Methods: A systematic literature review following the PRISMA guidelines was conducted. PubMed, EMBASE and CINAHL databases were searched for randomized control trials (RCTs) of interventions on lifestyle modifications of hypertensive patients which were performed by healthcare professionals (physician, nurse, pharmacist) and which reported blood pressure measurements. Papers were reviewed by two reviewers and analysed using Cochrane software Revman 5.4. In a meta-analysis difference in systolic blood pressure (SBP), diastolic blood pressure (DBP) and the percentage of patients with controlled blood pressure (BP) was analysed. Results: In total, 34 clinical trials reporting on 22,419 patients (mean age 58.4 years, 49.14% female, 69.9% used antihypertensive medications) were included. The mean difference SBP was − 4.41 mmHg (95% CI, − 5.52to − 3.30) and the mean difference DBP was − 1.66 mmHg (95% CI − 2.44 to − 0.88) in favor of the intervention group vs usual care. Fifty-six percent of patients achieved BP control in the intervention group vs 44% in usual care, OR = 1.87 (95% CI, 1.51 to 2.31). Conclusion: Healthcare professional-led interventions were effective. Patients achieved almost 5 mmHg decrease of SBP and more patients achieved BP control. The results suggest that efforts are needed for widespread implementation

Pharmaceutical Regulation in Central and Eastern European Countries: A Current Review

Objectives: The aim of this study was to review reimbursement environment as well as pricing and reimbursement requirements for drugs in selected Central and Eastern Europe (CEE) countries.Methods: A questionnaire-based survey was performed in the period from November 2016 to March 2017 among experts involved in reimbursement matters from CEE countries: Bulgaria, Croatia, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Slovakia, and Romania. A review of requirements for reimbursement and implications of Health Technology Assessment (HTA) was performed to compare the issues in above-mentioned countries. For each specified country, data for reimbursement costs, total pharmaceutical budget, and total public health care budget in the years 2014 and 2015 were also collected. Questionnaires were distributed via emails and feedback data were obtained in the same way. Additional questions, if any, were also submitted to respondents by email. Pricing and reimbursement data were valid for March 2017.Results: The survey revealed that the relation of drug reimbursement costs to total public healthcare spending ranged from 0.12 to 0.21 in the year 2014 and 2015 (median value). It also revealed that pricing criteria for drugs, employed in the CEE countries, were quite similar. External reference pricing as well as internal reference pricing were common in mentioned countries. Positive reimbursement lists were valid in all countries of the CEE region, negative ones were rarely used; reimbursement decisions were regularly revised and updated in the majority of countries. Copayment was common and available levels of reimbursement differed within and between the countries and ranged from 20 to 100%. Risk-sharing schemes were often in use, especially in the case of innovative, expensive drugs. Generic substitution was also possible in all analyzed CEE countries, while some made it mandatory. HTA was carried out in almost all of the considered CEE countries and HTA dossier was obligatory for submitting a pricing and reimbursement application.Conclusions: Pricing and reimbursement requirements are quite similar in the CEE region although some differences were identified. HTA evaluations are commonly used in considered countries