Noncommunicable diseases, access to essential medicines and universal health coverage.

Universal Health Coverage is key to reach the overall health-related Sustainable Development Goal, and within this, access to safe, effective, quality, and affordable essential medicines is critical. Currently, medicines for noncommunicable diseases in many countries are not available when needed and if they are present, are unaffordable. Countries face the challenges of rising prevalence of noncommunicable diseases due to increasing risk factors and ageing populations, along with under-diagnosis and under-treatment. Providing noncommunicable disease medicines is only one piece of a complex picture of providing care within Universal Health Coverage that requires strengthening health-care systems, as well as financial resources, priority setting, and monitoring and evaluation systems. Financing for Universal Health Coverage needs to enable adequate resources to be allocated for medicines with a focus on equity as well as priority setting for noncommunicable diseases medicines for reimbursement in benefits packages, efficient procurement and distribution of these medicines, supported by price regulation. These processes need to be evidence-based, transparent and grounded on national values and priorities. Monitoring and evaluation of availability and affordability are key components of sustainable reimbursement systems. With the current Universal Health Coverage agenda, the World Health Organization and countries can no longer ignore the issue of access to medicines for noncommunicable disease and need to develop the appropriate responses in order to guarantee equitable access.

Financial Burden of Prescribed Medicines Included in Outpatient Benefits Package Schemes: Comparative Analysis of Co-Payments for Reimbursable Medicines in European Countries.

OBJECTIVE: The study aimed to analyse the financial burden that co-payments for prescribed and reimbursed medicines pose on patients in European countries. METHODS: Five medicines used in acute conditions (antibiotic, analgesic) and in chronic care (hypertension, asthma, diabetes) were selected. Co-payments (standard and five defined population groups, e.g. low-income people, patients with high consumption) were surveyed based on information retrieved from national price lists (September 2017) and co-payment regulation in nine countries (Albania, Austria, England, France, Germany, Greece, Hungary, Kyrgyzstan and Sweden). The financial burden of the selected medicines (originator and lowest-priced generic) was described as the percentage of patients' payments for 1 month's therapy or treatment of one episode in comparison to the national minimum monthly wage. RESULTS: The study showed large variation in co-payments between the countries. Financial burden resulting from co-payments for reimbursed medicines tended to be higher in lower-income countries (Kyrgyzstan: 9% of minimum monthly wage for generic amlodipine; 2-4% for generic and originator salbutamol; Albania: approximately 3% for originator amoxicillin/clavulanic acid and metformin). Most studied countries applied reduction or exemption mechanisms (children were exempt in five countries, no or lower co-payments for low-income people in five countries, exemptions from co-payments upon reaching a threshold of expenses in six countries). CONCLUSIONS: Co-payments for prescribed medicines can pose a substantial financial burden for outpatients, particularly in lower-income countries. The price of a medicine, availability of lower-priced medicines and the design of co-payments, including exemptions and reductions for specific groups, can considerably impact patients' expenses for medicines.

Cross-programmatic consultation on the role of primary care in the responsible use of medicines and the reduction of antimicrobial resistance.

This meeting was held from the 30 October to the 1 November 2018 in Almaty, Kazakhstan. The meeting brought together participants from 16 countries of central Asia, Caucasus, eastern Europe and expert speakers from western Europe and India. Participants discussed the analysis and use of data on antimicrobial medicines consumption, country experiences in enforcing legislation for prescription-only access to antibiotics, the role of primary health care (PHC) in tackling antimicrobial resistance (AMR), strategies to improving competencies of practitioners using evidence-based clinical protocols and public engagement in the responsible use of medicines. Moving toward prescription-only access to antibiotics requires that government involve, from the onset, different stakeholders, e.g. public, patients, practitioners, pharmacists and pharmaceutical industry in designing and applying policies that ensure access to antibiotics accompanied by measures that promote responsible use and limit excessive use.

Antimicrobial Medicines Consumption in Eastern Europeand Central Asia - An Updated Cross-National Study and Assessment of QuantitativeMetrics for Policy Action.

Introduction: Surveillance of antimicrobial medicines consumption is central to improving their use and reducing resistance rates. There are few published data on antibiotic consumption in Eastern Europe and Central Asia. To address this, 18 non-European Union (EU) countries and territories contribute to the WHO Regional Office for Europe (WHO Europe) Antimicrobial Medicines Consumption (AMC) Network. Objectives: (i) Analyze 2015 consumption of J01 class antibacterials for systemic use from 16 AMC Network members; (ii) compare results with 2011 data and 2015 ESAC-Net estimates; (iii) assess consumption against suggested indicators; (iv) evaluate the impact of planned changes to defined daily doses (DDDs) in 2019 for some commonly used antibiotics; and (v) consider the utility of quantitative metrics of consumption for policy action. Methods: Analysis methods are similar to ESAC-Net for EU countries. The Anatomical Therapeutic Chemical (ATC) classification and DDD methodology were used to calculate total consumption (DDD/1000 inhabitants/day [DID]), relative use measures (percentages), extent of use of WHO Watch and Reserve group antibiotics and impact of DDD changes. Findings: Total J01 consumption in 2015 ranged 8.0-41.5 DID (mean 21.2 DID), generally lower than in 2011 (6.4-42.3 DID, mean 23.6 DID). Beta-lactam penicillins, cephalosporins, and quinolones represented 16.2-56.6, 9.4-28.8, and 7.5-24.6% of total J01 consumption, respectively. Third-generation cephalosporins comprised up to 90% of total cephalosporin consumption in some countries. Consumption of WHO Reserve antibiotics was very low; Watch antibiotics comprised 17.3-49.5% of total consumption (mean 30.9%). Variability was similar to 2015 ESAC-Net data (11.7-38.3 DID; mean 22.6 DID). DDD changes in 2019 impact both total and relative consumption estimates: total DIDs reduced on average by 12.0% (7.3-35.5 DID), mostly due to reduced total DDDs for commonly used penicillins; impact on rankings and relative use estimates were modest. Discussion: Quantitative metrics of antibiotic consumption have value. Improvements over time reflect national activities, however, changes in total volumes may conceal shifts to less desirable choices. Relative use measures targeting antibiotics of concern may be more informative. Some, including WHO Watch and Reserve classifications, lend themselves to prescribing targets supported by guidelines and treatment protocols.

How Can Pricing and Reimbursement Policies Improve Affordable Access to Medicines? Lessons Learned from European Countries.

This article discusses pharmaceutical pricing and reimbursement policies in European countries with regard to their ability to ensure affordable access to medicines. A frequently applied pricing policy is external price referencing. While it provides some benchmark for policy-makers and has been shown to be able to generate savings, it may also contribute to delay in product launch in countries where medicine prices are low. Value-based pricing has been proposed as a policy that promotes access while rewarding useful innovation; however, implementing it has proven quite challenging. For high-priced medicines, managed-entry agreements are increasingly used. These agreements allow policy-makers to manage uncertainty and obtain lower prices. They can also facilitate earlier market access in case of limited evidence about added therapeutic value of the medicine. However, these agreements raise transparency concerns due to the confidentiality clause. Tendering as used in the hospital and offpatent outpatient sectors has been proven to reduce medicine prices but it requires a robust framework and appropriate design with clear strategic goals in order to prevent shortages. These pricing and reimbursement policies are supplemented by the widespread use of Health Technology Assessment to inform decision-making, and by strategies to improve the uptake of generics, and also biosimilars. While European countries have been implementing a set of policy options, there is a lack of thorough impact assessments of several pricing and reimbursement policies on affordable access. Increased cooperation between authorities, experience sharing and improving transparency on price information, including the disclosure of confidential discounts, are opportunities to address current challenges.

Pharmaceutical policies in a crisis? Challenges and solutions identified at the PPRI Conference.

In October 2015, the third international Pharmaceutical Pricing and Reimbursement Information (PPRI) Conference was held in Vienna to foster discussion on challenges in pricing and reimbursement policies for medicines. The research presented highlighted that commonly used pharmaceutical pricing and reimbursement policies are not sufficiently effective to address current challenges. Conference participants called for fundamental reforms to ensure access to medicines, particularly to new and potentially more effective and/or safe medicines, while safeguarding the financial sustainability of health systems and working towards universal health coverage.

Exploring the evidence base for national and regional policy interventions to combat resistance.

The effectiveness of existing policies to control antimicrobial resistance is not yet fully understood. A strengthened evidence base is needed to inform effective policy interventions across countries with different income levels and the human health and animal sectors. We examine three policy domains-responsible use, surveillance, and infection prevention and control-and consider which will be the most effective at national and regional levels. Many complexities exist in the implementation of such policies across sectors and in varying political and regulatory environments. Therefore, we make recommendations for policy action, calling for comprehensive policy assessments, using standardised frameworks, of cost-effectiveness and generalisability. Such assessments are especially important in low-income and middle-income countries, and in the animal and environmental sectors. We also advocate a One Health approach that will enable the development of sensitive policies, accommodating the needs of each sector involved, and addressing concerns of specific countries and regions.

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.

Antibiotic use in eastern Europe: a cross-national database study in coordination with the WHO Regional Office for Europe.

BACKGROUND: There are no reliable data on antibiotic use in non-European Union (EU) southern and eastern European countries and newly independent states. We aimed to collect valid, representative, comparable data on systemic antimicrobial use in these non-EU countries of the WHO European region. METHODS: Validated 2011 total national wholesale antibiotic-use data of six southern and eastern European countries and regions and seven newly independent states were analysed in accordance with the WHO anatomical therapeutic chemical (ATC)/defined daily doses (DDD) method and expressed in DDD/1000 inhabitants per day (DID). FINDINGS: Total (outpatients and hospital care) antibiotic use ranged from 15·3 DID for Armenia to 42·3 DID for Turkey. Co-amoxiclav was mainly used in Georgia (42·9% of total antibiotic use) and Turkey (30·7%). Newly independent states used substantial quantities of ampicillin and amoxicillin (up to 55·9% of total antibiotic use in Azerbaijan). Montenegro and Serbia were the highest consumers of macrolides (15·8% and 19·5% of total antibiotic use, respectively), mainly azithromycin. Parenteral antibiotic treatment is common practice: 46·4% of total antibiotic use in Azerbaijan (mainly ampicillin; 5·3 DID) and 31·1% of total antibiotic use in Tajikistan (mainly ceftriaxone; 4·7 DID). INTERPRETATION: This study provides publicly available total antibiotic-use data for 13 non-EU countries and areas of the WHO European region. These data will raise awareness of inappropriate antibiotic use and stimulate policy makers to develop action plans. The established surveillance system provides a method to develop quality indicators of antibiotic use and to assess the effect of policy and regulatory actions. FUNDING: Netherlands Ministry of Health, Welfare, and Sport, and EU.

Better noncommunicable disease outcomes: challenges and opportunities for health systems: Hungary country assessment: focus on diabetes

This report reviews health system challenges and opportunities in Hungary to scale up core services for the prevention, early diagnosis and management of diabetes. Diabetes is used in the report as a lens to assess the effectiveness of the health system in addressing the noncommunicable disease (NCD) burden. Although NCD mortality in general has been decreasing over the past 20 years, the prevalence of diabetes remains high and is growing. The report found good progress implementing innovative intersectorial nutrition policies including the Public Health Product Tax. At the same time, core individual services such as early detection and proactive management of diabetes and its complications require further efforts. The main barrier to better diabetes and NCD control in Hungary was found to be the lack of citizen empowerment; the population generally has a low level of health literacy and lacks the knowledge and skills to manage their own health. Other problems identified include a mismatch between the incentive system and the requirements for effective diabetes management, with current measures focusing on processes rather than outcomes. These challenges need to be addressed within a context of a shortage of human resources and a lack of standardized training in diabetes adapted to different cadres of health personnel. The report ends with six strategic recommendations to address these challenges.