Driving BioPharma value, evidence, and access in Bulgaria

Planning for biopharma access in smaller EU markets, such as Bulgaria, is often overlooked until after an asset is reimbursed in the major European markets. Understanding the key considerations and evidentiary requirements ahead of time will support the development of a robust evidence package, aid launch sequence planning, and help secure optimum market access.

This update focuses on value, evidence, and access in Bulgaria and explores:  

• Reimbursement pathways for medicinal products 
• National access options 
• Reimbursement entry requirements and discount negotiation process 
• Stakeholder mapping and deadlines for medical devices 

The full report is available to download now and includes insight on Bulgaria, the Czech Republic, Finland, the Netherlands, and Romania. 

 
Bulgaria: reimbursement pathways for medicinal products 

The market in Bulgaria is not large but has had consistent double-digit growth for over 10 years, which makes it an attractive market according to HTA Ltd (www.hta.bg), a specialist consulting company in Bulgaria. 

The reimbursement pathway in Bulgaria is identical for all medicinal products – there are no special reimbursement pathways for oncology products, breakthrough therapies, or products for unmet medical needs – and involves several steps. 

Source: “Value, Evidence, and Access: insights for markets outside of the EU5” 

• European Medicines Agency (EMA) approval of the indication for a product with a summary of product characteristics in Bulgarian.
  
  
• Registration of a price according to the regulatory requirements in Bulgaria (equal to the lowest from a basket of 17 referent countries).
  
  
• HTA: Once a medicinal product has received marketing authorization, it must undergo HTA. The assessment is conducted by the National Council on Prices and Reimbursement of Medicinal Products (NCPRMP) and takes 180 days for new proprietary products, from submission until receiving positive or negative statement. 
   

There is a 30 day “stop-clock” for answering questions by the HTA committee; therefore, it is very important for the marketing authorization holder (MAH) to have a local partner in the HTA submission process.

• Pricing and Negotiation with the National Health Insurance Fund (NHIF): After the HTA, the dossier is sent to the NHIF for negotiation of a mutually agreed price that reflects the product’s value and cost-effectiveness.

Risk-sharing agreements are not provided for officially in Bulgarian legislation, but financial-based agreements are used regularly and our team is experienced with the preparation of different scenarios for the negotiation process.  
 
Early negotiations are not a formal process in Bulgaria, but we advise our clients to have preliminary discussion with the NCPRMP and NHIF before submission.

• Reimbursement decision: After the price negotiations, the NCPRMP makes a decision on whether to include the medicinal product in the reimbursement list. This decision takes into account various factors, including the HTA results, therapeutic benefit, cost-effectiveness, and available budget, as well as the decision by the NHIF. The product may be fully reimbursed, partially reimbursed, or not reimbursed at all. 
   
• Reimbursement list and reimbursement levels: Approved medicinal products are included in the Positive Drug List (PDL), which specifies which drugs are eligible for reimbursement in Bulgaria. Each product on the list is assigned a reimbursement level, indicating the percentage of the product’s cost that will be covered by the NHIF. The PDL is open for new entries once per year, on 1 January. 

Bulgaria: national access options 

Products that are not on the PDL may be financed through hospital treatment programs, compassionate use, donations, direct hospital purchase, or out-of-pocket payments. 

These are not frequently used paths for procurement and are not very well accepted by the local authorities, as in these cases there are no price regulations. There are cases of ‘extreme pricing’, and these will soon be updated. 

Source: “Value, Evidence, and Access: insights for markets outside of the EU5” 

Bulgaria: reimbursement has strict entry requirements and a challenging discount negotiation process 

For a product to be reimbursed and included in the PDL, it must have: 

• at least one positive HTA decision from France, Germany, Sweden, or the UK 
  
  
• reimbursement in five out of 17 EU reference countries (and five out of all EU member states for orphan drugs) 
  
  
• for products prescribed for home treatment – inclusion of the disease in the NHIF disease list. 

These requirements, together with the once-yearly update of the PDL, are key factors that slow down patient access in Bulgaria. 

Source: “Value, Evidence, and Access: insights for markets outside of the EU5”  

Bulgaria: stakeholder mapping and deadlines for medical devices 

For both pharmaceuticals and medical devices, there are numerous stakeholders in the market access process. For advanced therapy medicinal products such as gene therapies, thorough planning is an important part of this process. 

Source: “Value, Evidence, and Access: insights for markets outside of the EU5”  

The formal HTA process is clear and well documented, but the informal negotiations should not be underestimated, as the patient access of some of the products requires changes in regulations for healthcare delivery, ways of payment for medical services, and changes in laws and/or regulations, where the agreement of various stakeholders is needed. Early negotiations are highly recommended, in particular with medical societies, the NCPRMP, and the NHIF. 
 

This update was taken from the free report “Value, Evidence, and Access: insights for markets outside of the EU5″, [link to eBook landing page] which is available to download now.  

The report summarizes: 

• health technology assessment and market access processes in several smaller EU markets: Bulgaria, the Czech Republic, Finland, the Netherlands, and Romania 
  
  
• key considerations for manufacturers ahead of launch in these markets to drive operational excellence and secure timely, quality access 
  
  
• how operational excellence and the PRMA Navigator® digital application can help maximize the likelihood of success in these markets. 
  
  

About the author: HTA Ltd  

HTA Ltd is a consulting company based in Bulgaria, with a subsidiary in North Macedonia and outreach across the region. We specialize in HTA analysis for pharmaceuticals and medical devices, and have conducted over 850 for more than 80 multinational companies over the last 8 years. Our team is also active in value-based healthcare projects and health policy advice. www.hta.bg