site.btaLack of Regulatory Provisions for Reimbursement of Biomarkers among Main Reasons for Increasing Cancer Mortality in Bulgaria

The lack of regulatory provisions for the reimbursement of biomarkers is one of the main reasons for the increasing mortality from oncological diseases in Bulgaria, experts concluded during a news conference, titled "Cancer patients cannot afford to wait. Reimbursement of biomarkers is a matter of life and dignity", held at BTA’s National Press Club in Sofia.

Addressing the event, the Chairperson of the Board of the Association for the Development of Bulgarian Healthcare, Boryana Boteva, said that the National Health Insurance Fund (NHIF) covers the treatment of oncological diseases with over 40 medications for more than 60 indications, primarily targeted therapies and immunotherapies. These therapies are effective for tumours with specific genetic mutations but require preliminary biomarker testing, she emphasized.

Boteva explained that without such tests, patients cannot receive the necessary medications because the tests determine the most appropriate therapy. She underscored that Bulgaria is the only EU country in which the state does not cover the costs of biomarker diagnostics.

Molecular geneticist Dr. Lyubomir Balabanski noted that patients often have to pay for the tests themselves. For some patients, the tests are covered through temporary donation programmes from pharmaceutical companies, as treatment cannot be prescribed by a doctor or reimbursed by the NHIF without these tests. Balabanski highlighted that, according to his personal statistics, one in three patients cannot afford these expenses, which, for certain indications, range from several hundred to several thousand leva.

Lawyer Silvia Velichkova, representative of the patient organizations in NHIF's Supervisory Board, said that a proposal for an outpatient procedure was submitted last year but the project was not reviewed. According to Velichkova, the state budget for 2025 will include funds for biomarker diagnostics, amounting to just over BGN 15 million annually, or 0.2% of the NHIF budget.

Lawyer Plamen Taushanov, Chairperson of Bulgarian Association for Patients’ Rights Defence, recalled that the issue was raised as early as 2021. Currently, Bulgaria remains the only EU country that does not cover the costs of tests. Taushanov noted that the current NHIF budget for oncological treatment exceeds BGN 1 billion, and explained that 29,396 people require biomarker diagnostics each year.

Assoc. Prof. Dimitar Kalev emphasized that without biomarker diagnostics, oncologists cannot make adequate therapeutic decisions, which increases mortality from oncological diseases in the country. Both patients and oncologists are disadvantaged, Kalev added.