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Early commercial strategy during drug development is a critical element of market access planning. If your payer deems the drug ‘benefit not proven’ you could be forced to run more studies or abandon the trial altogether.
The top reasons drugs fail to be recommended for market access are:
1. Non-robust economics
2. Uncertain clinical benefit
3. Inappropriate trial design, comparator, or patient population
4. Increased drug costs
5. Safety concerns
All of these reasons signify the importance of evidenced-based strategy early in the development process and a development partner that keeps market access and reimbursement requirements front of mind.
A successful product launch demands intense early engagement with an array of stakeholders beyond regulators and payers.…
Early Planning & Modelling
Regulatory & Payer Submissions