Regulatory Affairs

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 implemented the Early Patient Access program in 2022, obtained a higher than IRP approved price, performed local labelling, and arranged individual patient reimbursement as one of the first EU countries. The product owner recently asked Lenis to extend the EPA program to three additional countries.

Based on the request of a KOL, Lenis started distributing this medicine 10 years ago as a reimbursed unlicensed Rx medicine in Slovenia even before it had marketing authorization in any country (“Special” status in UK). Due to successful market penetration the product owner decided to register the drug in Slovenia. Over the years, this product has become the standard of care with over 17.000 doses sold in 2022.

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.

Gastro-resistant capsules were launched as reimbursed unlicensed prescription medicine and soon completely replaced an immediate release medicine with the same active ingredient. It is now the standard of care for patients before and on dialysis, because it contributes to better disease management for patients, and saves the health insurance fund money. After reaching the agreed sales threshold, Lenis helped the principal to obtain marketing authorization and a favorable reimbursement price.

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.