HTA and MA Support in Bulgaria

New Requirements for Health Technology Assessment in Bulgaria


Even as HTA had been on the agenda in Bulgaria for several years, written guidelines concerning HTA were only introduced as recently as 2015. As part of the passed amendments to the health insurance law, HTA became a mandatory element of the approval of new innovative medicines. Additionally, according to the amendments, medicinal products included in the Positive Drug List would require to undergo a reimbursement status maintenance procedure every 3 years from the date of inclusion in the list. This means that if a company wants to renew an application for the reimbursement, an assessment based on evidence considering health effects, costs and cost-effectiveness of a health technology needs to be performed.

Taking into account issues mentioned above and the fact that:

  • The new HTA requirements are very strict and similar to those introduced by NICE (UK),
  • HTA is relatively new in Bulgaria,

it is certain that both local and global pharmaceutical companies interested in introducing new drugs in Bulgaria would require collaboration with external, well experienced solution providers conducting a full HTA for their products.

Support at every stage of the reimbursement application process in Bulgaria

Arcana Institute, a company with vast experience in the entire European region, including CEE countries, is able to respond comprehensively to the growing Bulgarian market access requirements and expectations by providing its clients with a full HTA dossier meeting all local and legal requirements. 

We offer professional help and support in developing and implementing strategies of Market Access, reimbursement consulting and a full analytical service, including preparation of a complete reimbursement dossier in accordance with current standards of Health Technology Assessment (HTA) and Evidence Based Medicine (EBM).

 To find out more, contact us directly via phone +48 669 774 776/ 792 609 652 or e-mail: