- Second- and third-line treatment for adults with mycosis fungoides or Sézary syndrome reimbursed by Croatia’s National Health Insurance Fund (NHIF), effective as of 15th November 2024.
- Bulgaria’s Ministry of Health also confirms positive second-line reimbursement, effective 2nd January 2025.
Kyowa Kirin International (KKI), a wholly owned subsidiary of Kyowa Kirin Co. Ltd., and Swixx BioPharma AG today announced that the Croatian National Health Insurance Fund (NHIF) and the Bulgarian Ministry of Health have both approved the reimbursement of POTELIGEO® (mogamulizumab) for adult patients with mycosis fungoides (MF), and Sézary syndrome (SS).
MF and SS are two subtypes of cutaneous T-cell lymphoma (CTCL), a rare form of non-Hodgkin’s lymphoma that presents and persists in the skin and can cause debilitating physical, emotional and social challenges.1 MF—the most common CTCL subtype—accounts for approximately 60% of all CTCLs.2
With an average time to diagnosis of 3-4 years, MF is typically characterized by skin symptoms including patches or plaques, skin redness and tumours.3,4 SS is much rarer, accounting for around 5% of CTCLs,5 and is more aggressive, causing severe itching, erythroderma, intense scaling of the skin and frequent hair loss.6
Jeremy Morgan, President of Kyowa Kirin International, commented: “I am delighted that the Croatian and Bulgarian authorities have agreed to reimburse POTELIGEO for MF and SS patients. Both decisions are important milestones for people impacted by these rare and challenging forms of CTCL, and with mogamulizumab now reimbursed in more than 20 countries across the EMEA region we remain as committed as ever to delivering life changing value for people impacted by under-diagnosed and under-served diseases, and making more people smile.”
Poteligeo is distributed in Central and Eastern Europe by Swixx, on behalf of KKI. The two companies signed a Promotion and Distribution Agreement in October 2022. Under the terms of the agreement, Swixx will exclusively market, promote and distribute mogamulizumab in both Croatia and Bulgaria, among other countries.
“At Swixx, our mission is to unlock access to innovative medicines, and the recent reimbursement approvals in Croatia and Bulgaria mark significant progress in improving therapeutic options for patients with MF and SS in those markets,” said Dezso Martha, Chief Operating Officer of Swixx. “We will continue working closely with health authorities, the scientific community, and Kyowa Kirin to expand access to this important medicine, ensuring better outcomes for patients across our Central and Eastern European countries.”
With Croatian reimbursement effective as of 15th November 2024, and Bulgaria’s Ministry of Health confirming reimbursement as of 2nd January 2025, both decisions build on the inclusion of POTELIGEO® (mogamulizumab) in the Polish Ministry of Health’s Drug Programme announced in July 2024 and the ongoing expansion of access to patients across Central and Eastern Europe (CEE).
Discover the latest trends and insights—explore the Business Insights Journal for up-to-date strategies and industry breakthroughs!
