ANALOGUE RESEARCH FOR AN ORPHAN DRUG INDICATED IN ADVANCED MELANOMA
This project was developed in the context of the execution of several P&R activities to support the EU launch of a new agent, indicated for the first-line treatment of patients with advanced or metastatic melanoma.
To understand which regulatory and market access pathways were followed by high cost, combination therapy analogues and which was their current market situation, in order to predict possible challenges and outcomes for the product in object.
- Systematic approach of analogue detection; analysis of attributes and level of fitting.
- Secondary and primary analysis of market access and price, by analogue (desk research + 1 interview per country).
- Analysis of price determinants.
- Estimated price potential for the product in object, based on analogue research.
The price level of analogue products, the commonly applied reimbursement processes and risk sharing/access restriction schemes, with a particular focus on high-cost drug combination cases, led to the elaboration of a pricing strategy for this product.