Bringing a new drug to market involves more than just getting regulatory approval. Pharmaceutical companies must also secure favorable pricing and reimbursement decisions from payers and health technology assessment (HTA) groups. This process bridges the different goals of regulators evaluating safety/efficacy and payers focused on cost-effectiveness.
Key takeaways
- Regulatory approval does not guarantee payer acceptance and reimbursement.
- HTA requirements vary across countries despite harmonization efforts.
- Providing evidence of improved real-world benefits over current treatments.
- Dealing with uncertainties around using surrogate endpoints accepted by regulators.
- Timing of HTA submissions for fastest patient access after approval
Thorough preparation is important for navigating this complex landscape. Read this whitepaper to understand how to build a compelling value case, generate relevant data, and effectively negotiate pricing and reimbursement.
