In order to secure regulatory approval, manufacturers need to clearly demonstrate TA products are safe and efficacious. However, demonstration of safety and efficacy to regulators is not the key challenge facing manufacturers wishing to achieve market access. The key challenge is how to demonstrate therapeutic value to payers relative to standard of care therapies across multiple histologies, as acceptance by regulatory authorities does not automatically translate into acceptance by national payers. Manufacturers need to demonstrate value to both.
Earlier this year we spoke to over 20 payers across Europe to discuss the challenges of assessing therapeutic value. Download our latest Free Thinking whitepaper to find out what they had to say