Global value dossier localised for MENA markets: SGLT2 inhibitor in heart failure — HTA-ready adaptation
A globally calibrated value dossier does not travel to MENA without adaptation
The brand had a strong global value dossier for their SGLT2 inhibitor in heart failure — built primarily on the DAPA-HF and EMPEROR-Reduced data, with cost-effectiveness modelling calibrated to European payer thresholds and comparator landscapes.
Several MENA markets had been prioritised for reimbursement submissions. Each had distinct characteristics — comparators, cost-effectiveness thresholds, and the way economic evidence was weighted all varied significantly across markets, as did submission format requirements.
In MENA, the economics of heart failure management look different — different hospital cost structures, different comparator acquisition costs, different threshold sensitivities. A dossier that does not reflect local economics does not work.
The global Market Access team had neither the regional expertise nor the in-house capacity to manage five concurrent local adaptations while maintaining global dossier development for other markets.
What we did
Measurable impact
All MENA adaptations were completed and submitted within the agreed timeline. The majority of target markets issued positive reimbursement decisions. Markets requesting additional local economic data were supported with supplementary analysis. The adapted dossier framework was used as the basis for a subsequent MENA submission for a second product in the same portfolio.
HTA submissions
decisions achieved
submissions prepared
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From the field:
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