OBJECTIVES: Innovative drug development takes years to complete all stages of drug development process and get market authorization & reimbursement approvals.

Innovative drugs need to have optimal price; be in affordable range to get faster access to drugs and also ensure that manufacturers are able to earn reasonable returns on investments and are encouraged enough for developing innovative drugs.

METHODS: Steps involved in Innovative Drug Development process which got due approvals from agencies were evaluated.

RESULTS: Key steps involved are:

(a) Thorough scientific knowledge & understanding about the product & disease area through target product profile, scientific literature and KOLs advisory boards.

(b) Evaluate correct target population & positioning of product vis-a-vis comparators including value advantage or differentiation against comparators.

(c) Evaluate analogues to get an insight into potential price points

(d) Based on product profile, clinical differentiation against comparators by conducting appropriately designed clinical trials evaluating correct end-points, primary research / workshops with physicians & payors and get an understanding about their willingness to pay.

(e) Econometric models to establish evidence based economically justifiable price.

(f) Pricing techniques: Gabor & Granger; Van Westendorp

CONCLUSIONS: There is no one method to set the optimal price of innovative drugs; it is a mix of various approaches & techniques. However, every technique to set the price has scientific basis and requires sound evidence to justify price recommendation of the product.