HTA Feasibility Study

The client was preparing the European rollout of a first-in-class targeted oncology therapy for a rare CNS tumour indication. Before committing resources to a full HTA dossier in Ukraine, the team needed a fast, structured read on whether reimbursement was realistic at all — and, if so, which route stood the best chance.

Two strategic questions were on the table:

1. would the cost-effectiveness profile support inclusion on the National Essential Medicines List,
2. or would a managed entry agreement remain the only commercially defensible option?

A pre-submission feasibility view was required inside one month so that the Ukrainian launch sequencing decision could be made in the same global planning cycle.

4 weeks

Delivered a decision-support package that gave the client an evidence-based go/no-go view on a Ukrainian HTA submission. The deliverable mapped the eligible patient population, the most defensible comparator set, the transferability of existing pharmacoeconomic evidence, and the gaps the client would need to close before a State Expert Centre dossier could be submitted. Eirhub's recommendation framed both reimbursement routes — National Essential Medicines List and managed entry agreement — against the client's clinical and commercial objectives, and sequenced the work that would be required to pursue either.

• Built the PICO framework against the licensed indication and the Ukrainian standard-of-care setting.
• Sized the eligible patient population in Ukraine using prevalence data, diagnostic registries and demographic projections.
• Conducted structured interviews with leading Ukrainian clinical experts to capture current treatment practice, prescribing patterns and likely positioning.
• Identified and stress-tested the comparator set most relevant for the State Expert Centre's review framework.
• Reviewed published pharmacoeconomic studies and economic models from other HTA markets, and assessed their transferability to Ukrainian payer assumptions.
• Drafted strategic recommendations for the development of HTA dossier materials, including the evidence gaps to close, the sequencing of country-specific adaptation work, and the negotiation room available under each reimbursement route.