Version: 05/11/18 TYPE-2 DIABETES CARE IN UKRAINE: BREAKPOINTS AND IMPLICATIONS FOR ACTION Ukraine faces a triple health challenge from non-communicable diseases (NCDs), infectious diseases, and the demographic situation with low fertility, out-migration, and excess adult male mortality.i It also has the challenge of re-focusing its health systems from a vertical hospital-based model with high hospitalization rates and length of stay to a community-based patient-centred model, emphasizing primary health care, out-patient care and health promotion. In short, it must move a system designed for injury and infectious diseases to one designed for better management of chronic care, prevention and promotion. KEY MESSAGES 1. Diabetes mellitus has become one of the most serious public health problems due to its increasing incidence, devastating complications if undiagnosed or untreated, and costs of patient care. 2. A cascade analysis was conducted to systematically identify the breakpoints along the type-2 diabetes care delivery chain in two regions of Ukraine. The continuum of diabetes care included the registration of diagnosed cases, linkage to care and treatment, glucose monitoring and the attainment of sustained glucose control while on treatment. The analysis found significant breakpoints across the diabetes cascade. 3. Screening and diagnosis: Diabetic cases are identified at health facilities and in some outreach activities, but up to 50% of cases are undiagnosed. People may avoid diagnosis due to recurrent costs of care and low risk perception of undiagnosed, untreated diabetes. Screening campaigns are poorly evaluated and not strategically targeted, and endocrinologists’ patient data are not flowing back to the PHC level. Also, the PHC level has insufficient capacity to confidently address the diabetes epidemic. 4. Linkage to appropriate care: Health care providers lacked fit-for-purpose data system to flag people who are diagnosed but not in care, or on treatment but failing targets. 5. Treatment monitoring: HbA1C testing is integrated in Poltava’s diabetes program but not Lviv’s where 42% of diabetics on medication have no record of HbA1C monitoring. Self-monitoring and treatment adherence are not sufficiently supported by the public sector providers and non-pharmacological interventions on weight loss and physical activity not well tracked and evaluated. 6. Disease control: Attainment of the glycated haemoglobin target was the largest breakpoint. In Lviv Region, 80% of HbA1C monitored cases didn’t achieve the target, according to the 2016 routine statistics, and in Poltava, 73% didn’t achieve the target in 2016. Patients experience economic (drug/monitoring costs), cognitive (knowledge, risk perception), psychological (fears, stigma), behavioural (nutrition habits) and medical barriers to sustained treatment adherence and long-term glucose control. 7. This analysis presents important lessons and policy implications for diabetes care in Ukraine: (i) Diabetes screening needs to be strengthened for better targeting, follow-up TYPE-2 DIABETES CARE IN UKRAINE: BREAKPOINTS AND IMPLICATIONS FOR ACTION and evaluation; (ii) The PHC level needs to have the confidence and capacity as well as Expenditure to resources to manage diabetes patients as tasks are shifted from specialists to family finance diabetes doctors; (iii) The new electronic medical record system can become the backbone for identifying patient-level gaps in prevention and care, and inform quality improvement; treatment is high (iv) There are opportunities for better diabetes patients’ education and empowerment and growing, a towards assisted self-monitoring; and (v) The cascade framework offers an analysis recent costing study approach to track change in the continuum of diabetes care as the PHC reform takes effect, and emphasizes the importance of evaluating the final outcome (glucose control of the Ukrainian among the entire diabetic population). pharmaceutical market reported for INTRODUCTION oral antidiabetic Type-2 diabetes mellitus (T2DM) is one of the leading causes of poor health and high medications alone health care expenditure in Ukraine. There are close to 3 million adults with diabetes and annual expenditure T2DM prevalence is at 8.4%.ii,iii This puts Ukraine into an average position across Eastern and of 22.6 million USD Central European countries for T2DM prevalence (Figure 1). in 2014 and 56.1 According to best estimates across countries by the International Diabetes Federation (IDF), million USD in 2016. Ukraine’s level of undiagnosed diabetes at about 40% of all diabetes is on a par with several countries in the region (Figure 2). However, due to the size of Ukraine’s population, this translates into over 1 million undiagnosed casesiv. Expenditure to finance diabetes treatment is high and growing, a recent costing study of the Ukrainian pharmaceutical market reported for oral antidiabetic medications alone annual expenditure of 22.6 million USD in 2014 and 56.1 million USD in 2016.v The annual expenditure for diabetes in Ukraine is about US$460 million.vi Figure 1 Diabetes prevalence in adults 18+ years, 2016 Figure2 Undiagnosed diabetes in adults 18+ years, 2016 Source: IDF 2017, estimates for year 2016 for Eastern and Central European countries, as per IDF 8th Diabetes Atlas Diabetes has become the 7th most important cause of Years Lived with Disability in Ukraine.vii The occurrence of T2DM is according to the WHO a result of rising overweight and obesity rates, lifestyle and dietary changes, and an aging population.viii The 2016 International Diabetes Management Practices Study reports very high hospital admission rates for diabetes cases in Ukraine.ix Seventy-seven percent of T2DM patients (and 85% of T1DM cases) reported at least one hospital stay over the last 12 month. The same study JULY 2018 2 TYPE-2 DIABETES CARE IN UKRAINE: BREAKPOINTS AND IMPLICATIONS FOR ACTION reports high levels of vascular complications with 38% of T2DM and 18% of T1DM patients suffering from macrovascular complications (and over 9 out of 10 from microvascular complications). While diabetes is a major driver of disability and impaired quality of life, it is also directly responsible for over 40,000 deaths annually.x Given patients’ challenges to afford Several reports have highlighted the charges Ukrainian diabetics face for diabetes diabetes care, the medication, self-monitoring equipment and routine laboratory tests.xi Given patients’ challenges to afford diabetes care, the Ukraine Government has embarked on Ukraine reimbursement schemes. An electronic register of diabetic patients was also introduced, Government has forming the backbone to better patient monitoring, data on health service performance, and embarked on medical statistics. Much of the ongoing difficulties in gathering reliable data comes from reimbursement how diabetes care has been organised, with patients managed by endocrinologists schemes. An employed by the government in a parallel system to the patient care provided by family doctors.xii Disparate data systems lead to poor information about burden, diagnosis rates, electronic register of treatment, as well as disease control in known diabetes cases. diabetic patients The World Bank, with support from the Swiss Development cooperation, implements the was also introduced, technical assistance program “Support to Reforms and Governance in the Health Sector in forming the Ukraine”. In 2017, an analysis was conducted on the continuum of care for T2DM in two backbone to better Ukrainian Regions, Lviv and Poltava. patient monitoring, The “cascade” framework was used for the analysis, asking four questions about a patient’s data on health pathway: service ► First, is a patient diagnosed if he/she has a health condition? performance, and ► Second, is the patient linked to appropriate care and treatment? medical statistics. ► Third, is the patient monitored on the care regimen? and ► Fourth, does the patient achieve disease control? Failure at each stage of the cascade precludes success at the next, which means the cascade of care may tumble rapidly. The diabetes cascades were developed for the Regions of Lviv (2,534,174 inhabitants) and Poltava (1,431,110 inhabitants) to appraise the breakpoints in the care cascade and consider priority setting for the diabetes program. The analysis also provided a 2016 baseline prior to the introduction of an affordable medicines, patient reimbursement and health sector strengthening program in these regions. FINDINGS Diabetes burden: The total burden was estimated by combining estimates of diagnosed and undiagnosed diabetes and data triangulation. The data sources were: ► For diagnosed diabetes: Health Index report 2016 providing prevalence of self-reported diabetes for regions and national in adults 18+ years,xiii Annual regional endocrinology The rates of reports 2016 (number of diabetics registered), and Ukraine data in the IDF database. registered diabetes ► For undiagnosed diabetes: Reports of 2016 screening campaigns in both regions, using per 10,000 adults the positive yield among people reporting no pre-existing diabetes,xiv expert opinion were 315 for Lviv and Ukraine data in the IDF database. and 398 for Poltava It was estimated that total diabetes prevalence in adults was 3.7%-6.3% in Lviv Region Regions. (74,000 – 129,000 diabetics) and 5.9%‒6.3% in Poltava Region (70,000-75,000 diabetics). JULY 2018 3 TYPE-2 DIABETES CARE IN UKRAINE: BREAKPOINTS AND IMPLICATIONS FOR ACTION The rates of registered diabetes per 10,000 adults were 315 for Lviv and 398 for Poltava Regions. CARE CASCADES: ALL AVAILABLE ROUTINE DATA DESCRIBING THE T2DM CONTINUUM OF CARE WERE BROUGHT TOGETHER: 1. Registered T2DM: Total number of registered cases based on the endocrinology reports 2. T2DM linked to care: Diabetics who are reported as under dispensary supervision, either for non-pharmacological treatment (lifestyle advice, diet, exercise), or for pharmacological treatment (medication), using annual form #12 data from regional medical statistics units 3. T2DM on medication: Total number of T2DM reported as on medication by the endocrinology reports 4. HbA1C monitored: Applying reported HbA1C test coverage from endocrinology reports 5. Two levels of reported HbA1C test data were interpreted: HbA1C≤8,0% as an indicator for reasonable disease control (Diabetes UK, 2017), and HbA1C≤7,0% as an indicator of sustained glucose control through effective management of the glucose metabolism. 6. Data on chronic morbidity and mortality were also consulted: Morbidity data came from endocrinology reports. Mortality in diabetes cases or deaths from diabetes-related causes came from diabetes register data and regional 2015 mortality statistics (the two regions reported diabetes mortality slightly differently) 7. In addition, there were patient-level data available from a specially implemented patient card survey in Poltava. The results of this survey are reported after the main cascades. Figure 3 Type 2 diabetes care cascades and breakpoints for adults in Lviv Region (2016) Sources: Lviv Region Endocrinology report 2016 and annual form #12 statistics, Lviv Endocrinology Centre 2016 campaign summary, and demographic statistics. In Lviv Region, there were several important breakpoints along the cascade (Figure 3). We estimated that 32-50% of T2DM were not detected and registered. Among those who had been registered at diagnosis, about 5,000 cases were not known to be under supervision and potentially lost to follow-up. Fifty-four percent of patients linked to care (and 42% of JULY 2018 4 TYPE-2 DIABETES CARE IN UKRAINE: BREAKPOINTS AND IMPLICATIONS FOR ACTION patients on diabetes medication) did not get HbA1C monitored based on public sector Among those who statistics. Four out of five patients with HbA1C monitoring data did not attain the glycated had been registered hemoglobin target level. Therefore, only 9% of T2DM cases recorded as linked to care (and at diagnosis, about 12% of cases on medication) had evidence of sustained glucose control (HbA1C<7%). About 8% of registered Lviv cases were reported to suffer from chronic morbidity. Deaths in people 5,000 cases were on the diabetes register made up 5.5% of all reported deaths (using 2015 mortality statistics not known to be reporting 32,869 deaths in total in the region). under supervision In Poltava Region, disease detection was also a major breakpoint in the cascade with and potentially lost about a third of estimated cases missing from the diabetes register due to lack of to follow-up. detection (Figure 4). About 8% were not linked to care. In contrast to Lviv, HbA1C monitoring was implemented at higher coverage in Poltava’s public sector once or twice annually for cases on both non-pharmacological and pharmacological treatment (a HbA1C test results is a condition for medicine prescription). Nevertheless, patients’ glucose control was again a large breakpoint with over seven out of ten HbA1C-monitored cases failing to achieve the glycated haemoglobin target level of ≤7,0%. Overall, only 25% of all T2DM cases linked to care (and about 63% of cases on medication) achieve the HbA1C target level. Of all diabetics registered in Poltava Region, 47% were reported to have complications. Known diabetes deaths among registered patients made up 0.2% of all deaths (using 2015 mortality statistics reporting 24,498 deaths). Figure 4 Type 2 diabetes care cascades and breakpoints for adults in Poltava Region (2016) Sources: Poltava Region Diabetes statistics 2016 and annual form #12 statistics, Poltava 2016 diabetes campaign summary, Demographic statistics DIABETES PATIENT CARD SURVEY POLTAVA: ANONYMISED PATIENT DATA WERE EVALUATED TO BETTER UNDERSTAND TREATMENT MONITORING AND GLUCOSE CONTROL. The following results were obtained from 398 of randomly selected ambulatory cards of Poltava diabetes cases: ► Demographics: 61% were female and 71% were 60 years old or younger ► Risk factors: 85% were overweight or obese, and 77% were also known hypertensives at diabetes diagnosis (“co-morbid patients”) JULY 2018 5 TYPE-2 DIABETES CARE IN UKRAINE: BREAKPOINTS AND IMPLICATIONS FOR ACTION ► Timing of treatment initiation: 93% of cases were initiated on the day of diagnosis, 96% within a month and 98% had evidence of treatment initiation within 12 months ► Current treatment: Most patients were on oral treatment (Figure 5), 29% were on insulin either alone or in combination, and 8% of patients were on non-pharmacological treatment (diet and exercise advice) ► Treatment monitoring: the penultimate and last monitoring visit was analysed for test data (Table 1). Coverage of fasting plasma glucose (FPG) monitoring was high at 97%, with a median interval between FPG checks of 83 days (79% of diabetic patients had FPG re-checked within 6 months, other random glucose checks not taken into account). Weight and blood pressure were recorded at all patients visits. Cholesterol test coverage was slightly higher among co-morbid patients. HbA1C results were not well reflected in the patient cards (and possibly not available at point of care), despite HbA1C monitoring being implemented according to the Endocrinology report (see Fig 4). However, is could be concluded that while male and female patients had similar HbA1C test coverage (one in 6), male patients had significantly better glycemic control (42%) compared to female patients (20%) using ≤7,0% cut-off. Figure 5 Treatments in Poltava diabetes patients Table 1 Treatment monitoring of Poltava diabetes patients (2017 data) Co-morbid (Diabetes/HTN) Diabetes only At At At last At last penultimate penultimate visit visit visit visit Weight 100% 100% 100% 100% Cholesterol 62% 51% 49% 32% Blood pressure 100% 100% 100% 100% HBA1c 17% 18% 18% 18% Fasting Glucose 97% 94% 97% 97% Random glucose test 13% 13% 29% 25% Source: Extracted from ambulatory care cards (form 025) Using each patient’s penultimate and last FPG test results, we evaluated patterns of elevated FPG while on anti-diabetic treatment. Young diabetes patients and those on treatment combinations for T2DM and HTN had poorest glucose control (Figure 6). Best FPG results were seen in patients provided with Patient cost for advice but no medication, but these patients were mainly pre-diabetics. The other group with relatively better success in glucose control were co-morbid patients on mono- medication and treatment for hypertension compared to receiving multiple hypertension drugs. monitoring tests In order to better understand the underlying reasons for the breakpoints in care, the study seemed to be team reviewed available information on barriers to diabetes care (Table 2). Patient cost for responsible for medication and monitoring tests seemed to be responsible for losses at each stage of the losses at each stage cascade. In Ukraine’s decentralised health system, the barriers on the health provider side of the cascade. may vary across regional health administrations, for instance, providers in Lviv Region were not able to offer free HbA1C monitoring whereas Poltava providers had budget allocations for offering the test. JULY 2018 6 TYPE-2 DIABETES CARE IN UKRAINE: BREAKPOINTS AND IMPLICATIONS FOR ACTION Figure 6 Prevalence of elevated fasting plasma glucose in Poltava patient groups (2017) Source: Poltava patient cards 025, combining FPG test results from penultimate and last visit. Table 2 Patient and provider barriers in diabetes cascades as of 2016 Barriers to… Patient side Provider side 1,3 Screening/ diagnosis ▪ Cost of diagnosis (e.g., test strips) ▪ Weak integration of diabetes in primary care, low ▪ Awareness of future treatment costs2 confidence to deal with diabetes at PHC3,6 ▪ Health seeking and disease prevention ▪ Lack of statistics at PHC levl e.g., glucose tolerance behaviours2 test6 ▪ Lack of risk perception2 ▪ Poor information flow endocrinologist—family ▪ Scepticism about treatment2 doctor5 ▪ Lack of health policies in companies2 ▪ Pre-diabetics not in register leading to initial losses2 ▪ Non-compliance with screening guidelines at PHC level Treatment initiation ▪ Cost of oral anti-diabetes drugs1,3,4 ▪ Poor patient support for linkage to treatment ▪ Cost of insulin analogs3,4 ▪ Consultations too short for proper patient ▪ Poor knowledge of disease4 engagement2 ▪ Non-adherence to lifestyle changes2 Treatment ▪ Need to pay private laboratory for ▪ Low availability of HbA1C test in public sector monitoring routine HbA1C testing (costing US$ 4‒ US$ 5)6 ▪ Need to purchase self-monitoring equipment3 Treatment ▪ Fear of hypoglycemia1 ▪ Insufficient insulin titration1 adherence/ disease ▪ Episodes of hypoglycemia1 ▪ Lack of routine system to track ABC control control ▪ Long-term cost of drugs (low inome)4 ▪ Lack of PHC test capacity to detect vascular flow ▪ Poor access to free insulin pumps3 problems6 Sources: 1 = International Diabetes Management Practices Study (Ukraine data from 53 physicians and 795 patients); 2 = Lviv endocrinologist interviews; 3 = Doničová et al. 2011; 4 = Матюха et al. 2016; 5 = Key informant ambulatory care level; 6 = Lviv programme costing and coverage assessment. JULY 2018 7 TYPE-2 DIABETES CARE IN UKRAINE: BREAKPOINTS AND IMPLICATIONS FOR ACTION IMPLICATIONS FOR ACTION The study, conducted in collaboration with the regional Endocrinology, Cardiology and Primary Care Teams, demonstrated the value of analyzing routine medical record data as well as triangulating data across multiple data sources. The analysis coincided with the early roll-out of the PHC reform which aims to bring a guaranteed service basket to patients and re-imbursement of diabetes medication costs, as well as an electronic medical record system (EMR). These changes have the potential to significantly improve diabetes prevention and care. The Ministry of Health, Ukrainian Public Health Centers, Regional Department of Health, care providers and technical agencies should collaborate to strengthen diabetes care and chronic care models in general, with focus on the following issues: ► Information should be disseminated on the diabetes cascade and the identified breakpoints in care, and on the performance of the services regarding diabetes screening, linkage to care, treatment and its monitoring, and patient outcomes, which can all guide quality improvements. ► Diabetes is a complex, prevalent and costly disease, providers at PHC level should therefore be equipped with knowledge, tools and aids to provide effective diabetes prevention and patient care to prevent diabetes-related vascular damage and clinical complications. ► The recently published National Guidance on Screeningxv needs to be translated into systems of regular screening of all eligible individuals and systematic follow up of identified cases. The Guidance recommends annual diabetes screening for persons aged 45 years and above and for younger persons with excessive body weight, abdominal obesity, gestational diabetes or a family history of diabetes. ► Screening campaigns to find the “missing cases” are important, but must be targeted to age and BMI/risk categories and tracked on the EMRs for efficiency (with implementation of ICPC-2 coding). Staff must be oriented on eligibility criteria and screening frequency, and automated electronic reminders should be generated by the system to facilitate patient follow-up. ► Treatment must continue to have a strong component of patient monitoring and targeted support to patient who struggle with adherence. Patient education and motivational counselling should be ensured to strengthen treatment adherence and improve overall outcomes given the link between patients’ risk factors and diabetes/CVDs complicationsxvi (48% of patients were obese at diabetes diagnosis with a BMI of 30 or above). ► The capacity of the PHC level to manage diabetes and hypertension needs to be a focus as the management of uncomplicated cases is transitioning from endocrinologists to family doctors. This requires continuous education on good prescription practices and the effective use of diagnostic equipment. Coordination of care between levels of care, and follow-up especially of severe hypertension and CVD cases need strengthening. ► There should be continued analysis of the diabetes care cascade to monitor the breakpoints and determine the impact on patient outcomes of drug reimbursement, PHC strengthening and EMR-facilitated patient monitoring. Measures of success should include screening coverage, patient monitoring as per norm, and test results (levels of JULY 2018 8 TYPE-2 DIABETES CARE IN UKRAINE: BREAKPOINTS AND IMPLICATIONS FOR ACTION glucose, BMI, cholesterol). Population-level data on undiagnosed, untreated and uncontrolled diabetes and hypertension should be collected regularly at both national and local levels, for evaluation and target-setting purposes. International evidence on the importance of patient education, assisted self-monitoring and incentive schemes should be consulted for the further development of the diabetes program. ACKNOWLEDGEMENTS Lviv Region: Iryna Mykychak, Marianna Sluzhynska, Orest. Tril, Mykhailo Shmidt, Svitlana Struk, Yuriy Venzylovych, Orest Petrychka, Stepan Pavlyk, Tetiana Tarasova, Liliya Yuhymiv, Khrystyna Pak, Iryna Shymanska Poltava Region: Viktor Lysak, Yuriy Kurylko, Alla Bredikhina, Olexandr Kuzmin, Hrihorij Oksak, Kostyantyn Vakulenko, Orest Vovk, Nina Durdykulyieva, Lubov Klymenko, Yurij Torianyk World Bank: Olena Doroshenko, Olga Khan, Nicole Fraser, David Wilson and Feng Zhao ENDNOTES i Twigg (2017). Ukraine’s Health Sector – Sustaining momentum for reform. CSIS Global Health Policy Center, August 2017. ii International Diabetes Foundation Atlas http://diabetesatlas.org/resources/2017-atlas.html iii International Diabetes Foundation, Ukraine country report 2017 https://reports.instantatlas.com/report/view/704ee0e6475b4af885051bcec15f0e2c/UKR iv Best IDF estimate was 1.153 million (0.785 - 1.923 million) for 2017, Ukraine country report 2017 v Demchuck M et al. (2018). Nationwide trends in antidiabetic drugs (type-2) utilization, Ukraine, 2014–2016. Int. J. Green Pharmacy • Jan-Mar 2018 (Suppl),12(1), S181 vi Based on International Diabetes Foundation mean expenditure/case=US$259 and 1.8 m diagnosed cases vii IHM global burden of disease estimations https://vizhub.healthdata.org/gbd-compare/ viii World Health Organization. Global Report on Diabetes 2016. ix IDMPS, 2017. International Diabetes Management Practices Study wave 7, 2016. Ukraine country report. x Best IDF estimate 41,500 (29,400 – 70,200) for 2017, Ukraine country report 2017 xi Doničová V, Broz J & Sorin I (2011), Health care provision for people with diabetes and postgraduate training of diabetes specialists in Eastern European countries, J. Diabetes Science and Technology: 5, 5, 1124-1136.; Khalangot M & Tronko M (2007) Primary care diabetes in Ukraine, Primary care diabetes 1, 203-205; Матюха Л et al. (2016), Ukrainian experience of health care for patients with diabetes, Wiad Lek 69 (3 pt 2), 465- 470. 2016. xii Doničová V, Broz J & Sorin I (2011). Health care provision for people with diabetes and postgraduate training of diabetes specialists in Eastern European countries. Journal of Diabetes Science and Technology: 5, 5, 1124- 1136. xiii IRF 2017. Health index Ukraine. 2016 report and 2016/2017 databases. International Renaissance Foundation. xiv Lviv 2016 diabetes screening campaign on 38,175 non-pregnant adults 18+ without pre-existing diabetes diagnosis, diagnostic yield=1.4% (confirmed cases), and Poltava 2016 diabetes screening campaign on 400 adults without pre-existing diabetes diagnosis, screening yield 7.5% and diagnostic yield=1.9% xv Ustinov O.V. (2018). Recommendations for disease screening and periodic examinations at the primary health care level developed by the Ministry of Health of Ukraine. Medychny Chasopys (Medical Bulletin) Online dated 2018-02-13. xvi International Diabetes Federation (2016). Diabetes and cardiovascular disease. Brussels, Belgium: IDF, 2016. JULY 2018 9 TYPE-2 DIABETES CARE IN UKRAINE: BREAKPOINTS AND IMPLICATIONS FOR ACTION © International Bank for Reconstruction and Development / The World Bank 1818 H Street NW, Washington DC 20433 Internet: www.worldbank.org; Telephone: 202 473 1000 This work is a product of the staff of The World Bank. The findings, interpretations, and conclusions expressed in this work do not necessarily reflect the views of the Executive Directors of The World Bank or other partner institutions or the governments they represent. The World Bank does not guarantee the accuracy of the data included in this work. 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