The Role of Real-World Evidence in the Price and Reimbursement Decisions for Rare Diseases in Spain

While Spain is a highly attractive market for pharmaceutical and biotech companies, 50% of new orphan drugs approved by the European Medicines Agency are not approved by the payers in Spain; lack of mature evidence a key factor.

Real-world evidence (RWE) is a promising source of data that could help to accelerate drug access in rare diseases. In Spain, however, RWE applicability in price and reimbursement (P&R) decisions is currently limited to a supporting tool for outcome-based agreements.

The RWE can be fully leveraged in P&R decisions in Spain under the following conditions:

• a commitment from the public administration to set a framework for the use and applicability of RWE
• commitment from pharmaceutical companies to publish generated evidence
• transparency of the decision-making process
• he use of AI technologies to extract the RWD from primary sources
• define Data governance
• early dialogue between developers and payers
• greed RWE studies included within drug evidence generation plans

RWE can potentially help companies to provide Spanish payers with the additional data they need to approve new medicines and to implement innovative pricing strategies as “uncertainty-based” or “dynamic” price strategies

If you would like to explore this topic further, read the article “Support of Real-World Evidence in the Price and Reimbursement Decision-Making Process for Rare Diseases in Spain”.