The Challenge
The challenge was to provide end-to-end HTA support including strategic advice, submission development, and negotiations for an orphan drug.
Solution
NHTA delivered a full-spectrum solution including strategic landscape and comparator assessments, development of request for assessments, country-specific adaptations of cost-effectiveness and budget impact models, dossier development, payer engagement, post-submission support, pricing and negotiation guidance, and in-depth interviews with local KOLs.
Our deep local expertise and early engagement with payers and KOLs ensured that all adaptations were tailored to national requirements and aligned with the specific treatment landscapes – maximizing the impact and relevance of the submission.
Impact
The result were positive reimbursement decisions by HTA agencies, despite initial data gaps, including the absence of relevant EU/Nordic/UK comparators. The submission led to successful reimbursement outcomes, with the base case effectively defended.
