Project Scope

Develop a GCC launch strategy and sequence, that will support quick regulatory approval and optimal pricing for a PKD drug. Explore measures to ensure sustained and broad access for the drug in the region, following indication expansion to include Thalassemia

Challenge

Our client is the manufacturer of an innovative PKD treatment, and intends to launch the product across all GCC markets. They sought to understand the market-specific activities that will support optimized pricing and expedited marketing approval for the PKD indication. Furthermore, the client also intended to explore how best to prepare for an indication expansion to accommodate thalassemia, and initiatives that will ensure sustained and broader access at the best possible price points, following such expansion

Solution

Implemented a comprehensive secondary research exercise covering all GCC markets to understand country-specific:

• P&R and MA pathways
• Decision-makers and stakeholders
• Submission & approval timelines
• Recent policy changes in GCC the region
• PKD disease and thalassemia prevalence, market size, treatment pathways, SoC, clinical guidelines, pricing of existing therapeutic alternatives
• Evidence needs pertaining to the approval of products within PKD & Thalassemia
• Nuances around early access, managed entry or named patient programmes

Delivered 4 virtual and interactive workshops with our client internal teams to ensure common understanding of the country-specific pathways and expectations as well as allow the subsequent fine-tuning of the draft GCC launch strategy & sequence

Results

• Successfully developed launch strategies and projected timelines for each indication in each GCC market
• Produced recommendations for gaps that should be addressed through further primary research
• Provided recommendations for MEA’s and NPS schemes that could potentially maximise the price and access potential of the product in the GCC