Slovenia has regulatory mechanisms in place that enable essential unlicensed prescription medicines to be treated almost as if they were licensed. Lenis is the pioneer and now leading supplier of such medicines with over 30 unlicensed medicines reimbursed and dispensed through pharmacies.
Lenis has managed for years to preserve this product’s value in Slovenia and, consequently, through the IRP system, in the region. This resulted in additional revenue for the principal.
Despite a less-than-perfect dossier, Lenis successfully completed product registrations in Serbia and Albania, leading to market exclusivity and a significant sales increase.
Due to well-executed cross-functional efforts of our medical and marketing teams, this drug has become the leading HIV medicine in the region. Soon after the launch, following an early reimbursement, Slovenia has risen to the top 3 countries in the world in market share.
After the Slovenian Health Insurance Fund expressed interest, Lenis started supplying and obtained reimbursement for this unlicensed medicine more than 10 years ago.
The market potential then was estimated by a leading specialist to be 10.000 packs per year. Since then, this product became the leading UTI medicine in Slovenia with over 60.000 packs sold in 2022. Over the years, Lenis managed to mitigate supply chain issues with a variety of regulatory and commercial tools.
As a local regulatory agent, Lenis helped the principal obtain marketing authorization through a shortened procedure (Cyprus clause). This is still the only Rx product in the country with an MA based on the Cyprus clause.