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Innovative therapies are usually defined as newly introduced or modified health technologies with unproven effect or side effect undertaken in the best interest of the patient. These therapies could be situated at any point of the continuum: from genuine innovation with no precedent, to relative innovation representing a small variation from standard therapy, or using a conventional treatment in a different context (1). While the conception of innovative health technologies is not limited by therapeutic form (drugs, devices, procedures) or disease indication, innovative therapies are generally associated with expensive original drugs (2). Inclusion and provision of these therapies tend to be one of the most resource-consuming tasks for national health systems and payers. The above mentioned perceptions are well illustrated by the National Health Insurance Fund (NHIF) in Bulgaria and its funding activities. NHIF is an independent public entity that was established to carry out the mandatory health insurance in the country. Progress in medical science and introduction of innovative therapies, together with aging population and increased prevalence of chronic non-communicable diseases have put NIHF into a permanent situation of budget deficit. Overspending has led to concerns about the overall sustainability of NHIF and the present health insurance model in Bulgaria. Moreover, NHIF is currently lacking effective mechanisms to address this growing financial risk. National Health Insurance Fund budget is annually set and approved through a legal act by the National Assembly of Bulgaria. Its funds that are intended to cover drug therapies are distributed between two cost items as defined by the relevant legislation – costs for outpatient drugs and costs for inpatient cancer drugs. The first category mainly includes outpatient medicinal therapies, although a limited part of these funds are earmarked to medical devices and medical foods. NHIF total drug expenditure steadily rose between 2011 and 2014 (Figure 1). These total costs were 268 million EUR in 2011 and were expected to reach up to 488 million EUR in 2014 (3–7). At first sight, the expansion of NHIF coverage during that period explains the significant increase of drug spending. The provision of several categories of innovative medicinal therapies (such as rare disease and some cancer drugs) was transferred from the Ministry of Health to NHIF in 2011 and 2012, respectively. Those were all included in the outpatient drug budget category, thus increasing its spending share in absolute and relative terms. Inpatient cancer drugs were also established as a separate cost item to be funded by NHIF in 2012. This budget category alone was expected to stand at up to 100 million EUR in 2014. While nominally not all outpatient drugs paid by NHIF are innovative, Bulgarian stakeholders have generally attributed deficit spending to outpatient medicinal therapies for rare disease

Prospects of Risk-Sharing Agreements for Innovative Therapies in a Context of Deficit Spending in Bulgaria