Access to Quality Medicines and Medical Devices for Diabetes Care in Europe

Page 94

BULGARIA

From the survey • The very low number of respondents who were not being treated with insulin makes it difficult to evaluate access for these people. • Many respondents reported encountering some kind of difficulty obtaining the medicines and medical devices they need – a pattern confirmed by healthcare professionals. • Occasional stock issues (mainly for insulin analogues) and recurring affordability issues were the main causes of these difficulties, which left people without new supply for approximately one week in many cases. • Although most of the people with diabetes reported having received education or information about treatment, the training is not yet universal and was far less common among their relatives. • Monthly out-of-pocket expenditure for diabetes medicines and medical devices was higher among rural respondents than those who live in urban areas.

Healthcare expenditure profile (2011)2

Key background information: country health system

45%

Total health expenditure per capita: USD 521.5 Proportion of government expenditure on health: 11.3%

55%

 Public expenditure  Private expenditure Out-of-pocket expenditure represents 97% of private spending on health

Health system overview

- Bulgaria’s Health Insurance System, administered by the National Health Insurance Fund (NHIF), covers most of the population.3 - The Ministry of Health defines the care package3 - Medicines and medical devices are mainly supplied by private actors, according to the Ministry of Health’s regulations – in line with EU regulations.3,9 Specialised agencies ensure that these regulations are applied.3,4,9 - A quality-control system prior to distribution is in place but the existence of an issue-reporting system could not be confirmed.5

Diabetes prevalence (2011)1

Key diabetes data

IDF Atlas

National Data

9.3% of 20-79 year-olds

Official records: 8.3% of the adult population Healthcare professionals estimates: 7% of the adult population

Diabetes care procedure

- Prescription provided by GPs, based on a regimen defined by an endocrinologist (an additional procedure is required for people with type 1 diabetes and some people with type 2 diabetes – see below).6,9 - GPs and/or endocrinologists are also the main points of diabetes information and advice.6 - Diabetes products are dispensed mostly at pharmacies.5,6 Insulin can only be dispensed in specialised pharmacies.6

Presence of products at national level

• At least one product from each of the categories surveyed was reported authorised for sale1,10 and effectively present in the country.5,6,7

Availability

Guidelines and specific prescription criteria

• Bulgaria has national guidelines for diabetes care.1 o People with type 1 diabetes and people with type 2 diabetes on new-medicines-based regimen (insulin analogues and incretin-based therapy) have to have their treatment regimen defined by an endocrinologist and then, approved by the NHIF.6,9 • This approval procedure is about to be lightened - especially regarding approval from NHIF. Further responsibilities will be transferred to GPs.6 o Specific prescription criteria seem to apply mainly to medicines – the prescription of medical devices left mainly to the prescriber’s assessment.5 • Newer medications (like insulin analogues, DPP4 inhibitors and GLP-1 receptor agonists), depend on a person’s ability to follow treatment, and their not achieving good control with other therapies.5,6,7 • The consumption and prescription of diabetes medicines and medical devices is closely related to reimbursement (see Affordability).6

Use 94

• Pens remain the main insulin injection device5 – pump therapy requiring 100% out-of-pocket payment by the user.6 • The use of the different types of medications reflects the criteria mentioned above.5 • The use blood glucose-monitoring devices appear to be quite widespread (at least among people using insulin).5


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