Planning for biopharma access in smaller EU markets, such as Romania, 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:
- The “Scorecard” of key reimbursement criteria
- How outcomes in other markets contribute to successful reimbursement
- How product attributes and disease characteristics impact reimbursement
The full report is available to download now and includes insight on Bulgaria, the Czech Republic, Finland, the Netherlands, and Romania.
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Romania: reimbursement is determined by a ‘scorecard’ based on key criteria
The decision as to whether to reimburse a product in Romania is determined by a “scorecard” system, where the success of reimbursement is based on the number of points gained.
In total, 60 points are required to qualify for conditional reimbursement (where inclusion in the reimbursed list is via a mandatory price-volume agreement), and at least 80 points are needed for unconditional inclusion in the list.
Points are awarded based on several factors, including:
- HTA outcomes: The outcome of HTA evaluations in France, Germany, and the UK
- Reimbursement status: The reimbursement status of the product for the target indication in other EU markets
- Budget impact: The budget impact of the product in Romania
- European prevalence: Whether the target indication meets the EU definition for a rare disease
- Unmet need: The level of unmet need in the target indication, specifically whether the target indication is considered a life-threatening disease for which there are no therapeutic alternatives
- Orphan drug designation: Whether the product has an EMA orphan drug designation
- Evidence for Romanian patients: Whether the manufacturer can provide evidence of efficacy in Romanian patients (through real-world evidence or local patients within the clinical trial)
Romania: outcomes in other European markets contribute to the likelihood of successful reimbursement
One of the major factors of success in Romania is the status in other European markets.
Existing HTA outcomes for the product in the target indication
Up to 45 points are available based on the outcomes of HTA evaluations in France, Germany, and the UK. In total, 15 points per market can be given for optimal decisions, and seven points per market for suboptimal decisions. Optimal and suboptimal decisions are defined as follows:
- France: following the evaluation by HAS, an optimal decision is based on the level of therapeutic benefit, or SMR rating. An optimal decision would be an SMR rating of 1 or 2; a suboptimal decision would be an SMR rating of 3 or 4.
- Germany: points are awarded based on the level of additional benefit determined by the G-BA. An optimal decision would be any level of additional benefit granted to the full licensed population. A suboptimal decision would be any level of additional benefit granted to a subpopulation.
- UK: the outcome of the NICE evaluation determines the number of points given. An optimal decision is considered as a positive recommendation to the entire licensed population. A suboptimal decision is considered as a recommendation for a restricted population.
Reimbursement status of the product
The reimbursement status of the product for the target indication in EU markets is also a consideration. If a product has full national reimbursement in 14 or more EU markets, 25 points will be given. Ten or 20 points can also be given if a product is reimbursed in at least three or eight markets, respectively.
Romania: product attributes and disease characteristics also factor into the reimbursement score
In addition to the reimbursement status in other markets, other attributes of the product or the target indication also determine the number of points awarded.
Source: “Value, Evidence, and Access: insights for markets outside of the EU5”
- Up to 30 points can be awarded based on the budget impact of the product; 30 points are given if the product provides at least 5% cost savings compared with the current standard of care.
- Fifteen points are given if the product offers cost parity to the current standard of care (plus or minus 5%).
- A more recently added category is the level of unmet need and added therapeutic value. If there are no therapeutic alternatives, 10 points each are available if:
- The current average survival is below 12 months (or the only option for pediatric patients aged below 12 months), and/or
- The product increases survival by at least 3 months
- Products with an EMA orphan drug designation are automatically granted 70 points; however, up to 10 points are also available for non-orphan drugs, based on the European prevalence of the target indication.
- Ten points are given if the indication meets the EMA definition of a rare disease, ie, affecting no more than 5 in 10,000 people in the EU.
The manufacturer submits the recommended score, along with a supporting rationale, which is critiqued by the authorities, who then have the final say on the score and reimbursement decision.
The report summarizes:
- HTA 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.