What is an HTA submission?
An HTA submission presents the full value proposition of a therapy to national or regional health authorities responsible for assessing new technologies. It typically includes clinical trial data, real-world evidence, cost-effectiveness models, epidemiological information, and budget impact analyses. The format and requirements vary by country or agency.
Why is an HTA submission important in market access?
Approval from HTA bodies is often a prerequisite for reimbursement and formulary inclusion. A well-prepared submission can accelerate access, justify price, and strengthen payer relationships. It also supports long-term planning for updates as new data become available.
