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

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Accessibility

Affordability

Access to treatment • Physical access to diabetes care remains an issue, and difficulties arise mostly in rural areas.5,6,8,9 o In many regions, diabetologists and diabetes centres are found only in major cities, and the distribution of pharmacies remains unbalanced in favour of urban compared with rural areas.6,8,9 Stock and shortages • Of all the products surveyed, blood glucose test strips appear as the most likely to be affected by stock shortages. o Shortages often can be attributed to a breakdown in the supplier-pharmacy-health insurer chain. Delayed health insurance payments often mean pharmacies cannot afford to pay outstanding invoices; suppliers suspend future orders until previous invoices are settled. 5,6 o Survey respondents reported that during periods of low or no stock, they lived without diabetes supplies until stocks were restored.5

ROMANIA Looking ahead There is increasing debate over the reimbursement and the prescription criteria applied to new medicines and devices.6

• Most people with diabetes in Romania pay an out-of-pocket share of their treatment costs.5 These expenditure may aim to complement the coverage offered the national health insurance.5,6,7 They may also result from the internal reference price system – people choosing to pay the difference in price to get a more expensive brand (see below).7 • According to collected responses, median out-of-pocket payment for diabetes medicines and devices was RON 150 (USD 45) per month - RON 1,800 (USD 538) per year o It has been reported that affordability issues and financial difficulties are more common among respondents living further away from healthcare providers. Median annual out-of-pocket expenditure for diabetes supplies was also found higher among rural respondents than among people living in urban settings.5 • Despite a reimbursement system favouring non-branded products,3,4,8 their use seems to remain limited. Because of the internal reference pricing system for reimbursement, buying branded products can increase out-of-pocket expenditure.5,7 • Prices and mark-ups on these products are regulated and limited by the Ministry of Public Health. The price of prescription medicines is set through external reference pricing, based on the lowest price in 12 EU countries, together with a system of regressive mark-ups for wholesale and retail prices.4 Reduced VAT applies to medicines.3,4,5

Financial coverage Reimbursement for medicines is defined according to their clinical benefit and effectiveness, safety and cost, compared to current therapy. Insulin and anti-diabetes drugs are on a particular list that provides 100% coverage.4 * Reimbursement levels are based on the lowest-priced medicine in a therapeutic category (internal reference pricing).4,7 Private health insurers or income support (for people on a low income) can offer additional coverage for these products.6 Insulin and Anti-diabetes medication

Free(1,5,6,7) *

Medication for hypoglycaemia

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

Pens and related supplies

Free1,5,6,7,9 on a quota basis for supplies6,7

Syringes and needles

Free on a quotas basis6

Pumps and related supplies

Free1,5,6,7 for certain types of diabetes and under certain conditions (see Availability)

Blood glucose test strips and meters

Free for people on insulin with a limit of 100 test strips every three months Otherwise, not covered – 100% paid for by the person with diabetes 1,6,7

Ketone test strips

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

* Health insurance will only cover a drug up to the cost of the lowest priced brand. If a person chooses a more expensive brand, the price difference is paid out-of-pocket. Please note that the information below presents only 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 Vlădescu, C., Scîntee, G., Olsavszky, V., Allin, S., & Mladovsky, P. (2008) 4 PPRI & WHO (2011) 5 IDF-Europe Access survey (2013) 6 Romanian Society of Diabetes, Nutrition and Metabolic Diseases (personal communication) (2013) 7 Sanpetreanu, A. (personal communication) (2013) 8 Leopold, C., & Vogler, S. (2010). 9 Doničová, V., Brož, J., & Sorin, I. (2011)


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