Reform for more accessible and cheaper medicines in Bulgaria

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Summary and conclusions from the analysis of the sartan group:

The results of this study confirm the conclusions of previous analyses, such as the World Bank's 2015 study, as well as good practices from EU countries, and quantify the positive effects of implementing a progeneric policy within the sartan group. In the period 2006-2016, there was a growing demand for generic medicinal products from this group, which, with an unchanged reimbursement share of 25%, allows for lower costs for both households and the NHIF, against the background of growing consumption. This is due both to competition - in 2009, the NHIF reimbursed 11 medicinal products, and in 2016 they were 81 - and to consumer attitudes.

Depending on the assumptions in the analysis, the potential savings from implementing a progeneric policy vary widely between 2% and 35% of the annual cost of reimbursement of the NHIF for medicinal products from the sartan group. The analysis shows that, with an unchanged reimbursement budget, the progeneric policy could lead to an increase in the volume of reimbursed medicinal products from this group in the range of 2 to 106% of the annual cost of reimbursement of the NHIF. The additional fiscal space that such a policy opens up could also be used to increase the reimbursement rate, which is currently 25%, thus reducing the financial burden on household budgets.

Moreover, although the reimbursement by the NHIF is 25%, it is calculated on the reference price for the respective group, and not on the market price of the individual medications. For example, the amount reimbursed by the NHIF for medicinal products from the sartan group in 2016 amounted to about 3.4 million leva, and the consumer co-payments – about 19.6 million leva. Thus, the reimbursement amount actually represents about 15% of the total annual cost, while consumers pay the remaining 85%.

The costs of original medicines alone amounted to about 3.4 million BGN – 3 million BGN for consumers and 360 thousand BGN for the NHIF in 2016. Implementing a progeneric policy could reduce these costs to 957 thousand BGN for consumers and to about 318 thousand BGN for the NHIF. This is a reduction in total costs by over 62%, with costs for consumers decreasing by over 68% and those for the NHIF by about 12%. In short – a progeneric policy could help reduce consumer costs by over 60%.

Several conclusions can be drawn from the analysis:

• Generic entry contributes to significant savings for both consumers and the NHIF.
• 1 lev saved from NHIF reimbursement costs is accompanied by about 5.70 levs saved in consumer co-payments.
• Competition in the sartan drug group leads to:
  • increase in the choice of medications - in 2009, 11 medicinal products were reimbursed, and in 2016, there were 81;
  • annual decrease in their weighted average price;
  • Growth in access to medicinal products – annual consumption in 2016 was over 16 times higher compared to 2005.
• The saved costs of the NHIF can be used both to limit the growth of its drug budget and to increase the reimbursement rate in the relevant drug group.

However, implementing a progeneric policy depends on certain prerequisites such as:

• Conducting information campaigns among consumers, including creating online applications with information on prices, reimbursement levels, efficacy, safety, quality and interchangeability between all original and generic medicinal products according to their international non-proprietary name;
• Obligation for doctors and pharmacists to inform consumers about the cost of the prescribed treatment, as well as possible alternatives;
• Conducting training for doctors and pharmacists on the effects of implementing a progeneric policy.
• Introduction of electronic prescription and completion of efforts to introduce electronic healthcare;

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