Bulgaria’s government has been referred to its anti-discrimination authority by patient organisations over the refusal of health institutions to introduce a reimbursement mechanism for biomarker diagnostics in oncology.

The complaint, filed with the Commission for Protection against Discrimination, centres on the continued lack of public procedures for funding the biomarker testing, now entering its third year. The absence of access to these diagnostics prevents many cancer patients from receiving precise diagnoses, which are essential for selecting the most appropriate, tumour-specific treatment.

The cost of these tests ranges from €500 to €2500 and is currently borne by patients who can afford them, despite Bulgaria’s solidarity-based healthcare system, funded through mandatory health insurance contributions.

Some testing is conducted through pharmaceutical research programmes, but this does not include broad or equitable patient access.

Two years ago, the government allocated €2.5 million to cover part of the biomarker testing costs. However, the funds remain unused, as authorities have yet to establish a procedure for reimbursing the tests.

Boryana Boteva, chair of the Bulgarian Healthcare Development Association, said, “Biomarker diagnostics are a prerequisite for effective and appropriate treatment. At present, the public health fund covers only one biomarker for breast cancer, while all others remain unfunded. At the same time, the state pays for more than 40 targeted therapies across over 56 indications, yet does not cover the tests needed to determine whether these treatments will be effective.”

Barriers to treatment

The national health fund requires biomarker testing as a condition for prescribing certain oncology therapies, leading to what patient advocates describe as a de facto denial of treatment for those unable to afford the tests. “This looks like an administrative mechanism to limit spending on treatment,” Boteva added.

Lawyer Silvia Velichkova, part of the legal team behind the complaint, argues that the authorities are engaging in direct discrimination against the majority of cancer patients in the country.

“They are depriving a large group of patients of access to necessary medical tests, while a small number of cases are covered,” she said.

Oncologist Dr Marcella Koleva backed the patient groups, stating that current policies not only discriminate but also create conditions for significant inefficiencies in healthcare spending. “Biomarker diagnostics ensure that costly medicines, ranging from €7,000 to €23,000 per month, are not used ineffectively,” she said.

The dispute between cancer patients and the state has been ongoing for nearly five years.

Bulgaria currently funds more than 40 targeted cancer therapies and immunotherapies for 56 oncological indications. These treatments are considerably more effective when matched to tumours with specific genetic mutations, but they cannot be prescribed or administered without prior biomarker testing.

[VA, BM]