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

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Accessibility

Affordability

Access to treatment • People collect their diabetes products monthly on a given date.6 • Physical access to endocrinologists (who must define the person’s treatment regimen) and specialised pharmacies dispensing insulin remains difficult for some people5 as these facilities are only located in major cities.6 o Some specialised healthcare facilities located in more remote settings have been closed over the last years.6 • Some gaps have been identified regarding the information and education received by people with diabetes about their treatment.5 Stock and shortages • Occasional stock issues were reported, mainly affecting insulin analogues.5 o According to the Bulgarian Diabetes Association, supply delays at the national level5 affected specific types of insulin analogues during 2012-2013, but this was an isolated incident and ad hoc solutions were found with healthcare professionals while negotiations were on-going with the manufacturers of the analogues. • Other shortages could not be confirmed by the Bulgarian Diabetes Association.5,6

• Affordability of medicines and medical devices appears to be a major difficulty for people with diabetes.5 o A 2006 study carried out among the whole population also showed that the affordability of prescribed medicines was problematic for people.3 o If few medicines appear to be free for all people with diabetes, the financial coverage of medical devices strongly differs according to the treatment regimen (see Table). Thus, the majority of people seem to pay a share of their treatment out-of-pocket.5,6 o Additionally, as the mandatory health system has yet to cover the whole population,3 some people may receive no financial coverage at all.1 o According to respondents to our survey,5 the median monthly out-of-pocket expense for diabetes medicines and medical devices was BGN 200 (USD 132) – BGN 2,400 (USD 1,590) per year. The latter was higher among rural respondents than among their urban peers, although the reason for this difference is not clear. • Although few non-branded products appear to be available on the market, most respondents reported using branded products.5 o The brand appears to be determined by the prescriber.5 • It appears that some medical devices5 and all medicines4,7 have their price regulated by the same committees in charge of reimbursements (see Table). However, the methodology used to do so varies according to the type of products.4,8 For prescribed medicines, external reference pricing is applied. The mark-ups applied by wholesalers and pharmacists are regulated through a regressive scheme.4 A standard 20% VAT is applied to all medicines.3,4 The methodology for setting the price of medical devices could not be confirmed. o Prices reported by people with diabetes in the survey5 were usually higher than those reported by healthcare professionals – even for the same brand of product. However, the reason for such discrepancies could not be assessed and would require further research.

BULGARIA Looking ahead Achieving changes has been difficult over the last year because of the overall political situation. Leadership and personnel at the Ministry of Health have been changing regularly, making advocacy work and developing cooperation complicated.6 However, some progress were made recently regarding the cooperation between associations and the Ministry of Health. A working group including experts from associations should be established soon by the Ministry of Health to develop the national health strategy on diabetes care .

Financial coverage Special committees under the Council of Ministers and the Ministry of Health decide on reimbursement. For medicines, the decision is based on therapeutic, pharmacological, pharmaco-economic and socio-economic criteria.3,4,8 Levels of reimbursement depend on the person’s condition(s) and on NHIF annual budget.3,4,8 Type 1 diabetes is on the list of conditions that exempt people of co-payments on certain medicines.8 Insulin

Free (see Availability for criteria on insulin analogues)1,5,6,7

Anti-diabetes medication

Depending on the medicines, fully, partially or not covered at all1,5,6,7

Medication for hypoglycaemia

Only people treated with insulin receive these free of charge. Otherwise, not covered – 100% paid for by the person with diabetes5,6

Pens and related supplies

Pens are free5,6 but associated supplies are not covered – 100% paid for by the person with diabetes5,6

Syringes and needles

Only syringes are free5,6 but associated supplies are not covered – 100% paid for by the person with diabetes5,6

Pumps and related supplies

Not covered – 100% paid for by the person with diabetes5,6,7

Blood glucose test strips

Only people treated with insulin get them for free but limited to 1,100 strips per year for people under 18; 150 strips per year for others. Otherwise, not covered- 100% paid for by the person with diabetes6,7

Glucometers

Only people treated with insulin get one for free. Otherwise, not covered – 100% paid for by the person with diabetes,6,7,9

Ketone test strips

Not covered – 100% paid for by the person with diabetes5,6

Please note that the information provided above only present a summary of the reimbursement system and may not apply to individual cases.

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References 1 EURADIA, FEND, IDF, & PCDE. (2011) 2 Global health observatory data repository. (2013) 3 Dimova, A., et al. (2012) 4 PPRI & WHO (2011) 5 IDF-Europe Access survey (2013) 6 Bulgarian Diabetes Association (personal comunication) (2013) 7 Doničová, V., Brož, J., & Sorin, I. (2011) 8 Andre, G., & Semerdjiev, E. (2010) 9 Bulgarian Society of Endocrinology (personal comunication) (2013)


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