Modelling the Financial Framework of the Pharmacotherapy Cost of Rare Diseases with Orphan Medicines—Part II

The objective of this analysis is to build a regression cost model towards the data for budget expenditures for rare diseases in Bulgaria and to evaluate the future impact on the health care budget. Four regression cost models were built based on previously published results of the macro costing top down financial analysis of the expenditures for medicines spent by the 3rd party payer. In Bulgaria that is the national health insurance fund (NHIF). The previous analysis covers the period 2010-2013 year and the regression models are forecasting the future expenditures till 2016 year. Four models follow linear regression among the researched variables and expected future changes. The cost of all reimbursed medicines, dietary food and medical devices is expected to reach 703 million of BGN, medicines expenditures are expected to reach 680 million, number of reimbursed medicines is expected to be 2315, and expenditures for rare diseases will reach 96 million of BGN. The number of patients, as well as the budget allocated for orphan drugs is increasing in time, with the addition of the critical fact that the oncology drugs were transferred to the NHIF. This is a positive result based on a number of factors, but also reveals the importance of carefully predicting and allocating the funds needed for orphan drugs. The model analyzing costs for pharmacotherapy shows that these expenses will increase linearly in the next three years, which in turn will put the financial capabilities of the NHIF to the test, as well as limit the access of patients to orphan drugs.