Biosimilar drugs significantly influence the reimbursement systems of 10 Central and Eastern European countries (CEE), and the expenditure on the reimbursement of biosimilars (percentage of drug price covered by public payers) in those countries is increasing as biosimilars become more accessible to patients, according to the results of a questionnaire-based survey by Pawel Kawalec and colleagues, published in the June 2017 issue of Frontiers in Pharmacology.
The countries studied were Bulgaria, Czech Republic, Croatia, Estonia, Hungary, Latvia, Lithuania, Poland, Slovakia, and Romania, and covered all 25 biosimilars approved by the European Medicines Agency (EMA) between November 2016 and January 2017.
The survey also collected data on the extent of reimbursement of biologic drugs (separately for original products and biosimilars) for the years 2014 and 2015. Data were collected for each country, along with data on the total pharmaceutical and total public health care budgets.
The study found that no specific criteria were applied for the pricing and reimbursement of biosimilars in the selected CEE countries. The price of biosimilars was usually reduced compared with original drugs, and specific price discounts were common. Substitution and interchangeability were generally allowed, but in most countries these actions were at the discretion of the physician after a clinical assessment.
Originator biologic drugs and the corresponding biosimilars were usually grouped in the same homogeneous group in the 10 nations studied, and internal reference pricing was usually employed. The reimbursement rate of biosimilars in the majority of the CEE countries that were surveyed was the same, and amounted to 100%. Generally, the higher shares of expenditures were shown for the reimbursement of original drugs than for biosimilars, except for filgrastim, somatropin, and epoetin (alfa and zeta).
The shares of expenditures on the reimbursement of biosimilar products ranged from 8.0% in Estonia in 2014 to 32.4% in Lithuania in 2015, and generally increased in 2015. The share of expenditures on reimbursement of biosimilars in the total pharmaceutical budget differed between countries, with the highest observed value for Slovakia and Hungary and the lowest for Croatia.
Biologic drugs were reimbursed in the majority of cases in all countries: filgrastim for neutropenia or febrile neutropenia; etanercept for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and ankylosing spondylitis; infliximab for all approved indications (except for plaque psoriasis in Latvia); insulin glargine for diabetes mellitus; and somatropin for growth disturbance or growth hormone deficiency.
“Our study revealed that biosimilars significantly influenced the reimbursement systems in the selected CEE countries,” the study authors note. Expenditures on the reimbursement of biosimilars are increasing, and patient access to this type of treatment is improving. The share of expenditures on the reimbursement of biosimilars in the CEE countries studied increased during the study period, along with an increase in expenditures on the reimbursement of biosimilars as percentage of the total pharmaceutical budget. The authors said their study was novel, explaining that they had also performed a systematic review of medical databases to identify relevant studies referring to biosimilar drug policy in CEE countries, but found no publications in line with the scope of their study.