Rare Disease Therapies in Georgia: Considerations on Market Entry Challenges

Our recent project on market entry for rare disease therapy in Georgia prompted us to share some sentiments about the decision-making of regulators in countries with restricted healthcare budgets regarding reimbursement of high-priced innovative medicines.

Even though Georgia is ranked as an upper-middle income (UMIC) country by the World Bank classification, the country's healthcare budget is mainly restricted due to funding ineffectiveness and overspending on secondary care.

Lots of endeavors are currently pending to enhance access to quality medical care and protect Georgians from financial hardships associated with receiving care. And while admitting that, nonetheless, the Ministry of Health is struggling to secure sufficient access to pricey on-patent medicines for both the most common non-communicable diseases (NCDs) and rare illnesses. Such dilemmas are prevalent for countries toiling to break the vicious cycle of ill prioritization—funding a bit of everything over funding less but more effectively.

Georgia, with the World Bank's support, has been conducting health reform designed to improve coverage, quality, and financial protection. So far, the country faces the challenge of providing greater financial protection to its citizens. For example, the same World Bank points out that Georgia’s out-of-pocket (OOP) health expenditure is high for a UMIC. (Source: World Bank Knowledge Brief, Georgia, 2022)

Therefore, when it comes to reimbursement of innovations in environments with highly restricted resources, the case of Georgia may depict decision-making approaches undertaken by countries in a similar context.

We elaborated on some key aspects advised to be considered by companies aiming to expand the presence of innovative therapy in such markets:

• Approvals granted by countries with strict regulatory agencies (SRAs);
  
• Availability of plausible real-world evidence in terms of safety and clinical effectiveness from the countries where the medicine has already been used;
  
• The ability of the regulator to monitor post-reimbursement clinical outcomes in patients receiving the treatment with the possibility for further re-evaluation of reimbursement decisions both in case of success and failure to deliver therapeutic results (performance-based approach);
  
• Price proposition statement of the manufacturer and potential for negotiations;
  
• Soft power originating from the local patient communities;
  
• Readiness of the medical community to communicate the value of treatment to regulator and support the development of clinical guidelines implementing the new therapy into existing clinical practice;
  
• Other treatment alternatives already available for patients;
  
• Favorable political context where reimbursement decisions may catalyze adjoining added value to change-makers.
  

Amidst an array of different health needs and mixed priorities, the voice of patients and their families is the most powerful leverage to clear the path for game-changing innovations in countries with limited resources for funding expensive therapies.

Hence, strategizing all other mentioned factors reinforced by patient engagement from the very beginning will contribute to the successful launch of the product in this context and bring hope to communities where it is needed the most. That is where we, the Eirhub team, may come in handy with market access consulting.