SIFI Announces Reimbursement Approval for AKANTIOR® in Spain
SIFI, a leading international company in the field of ophthalmology, has announced the approval of reimbursement for AKANTIOR® in Spain. The Spanish Interministerial Commission for Drug Prices (CIPM) has given a positive opinion on the cost reimbursement for AKANTIOR® under the national Spanish health system.
AKANTIOR® is expected to be available for Spanish patients starting from August 1, under full cost reimbursement. Spain becomes the first country in the world to approve the pricing and reimbursement of AKANTIOR® for the treatment of Acanthamoeba Keratitis in adults and children aged 12 and above.
Dr. Ana Hervás Ontiveros, an ophthalmologist specializing in cornea and refractive surgery at La Fe Hospital in Valencia, commented, „The approval of cost reimbursement for AKANTIOR is a significant step forward, bringing new hope for AK patients in Spain and more confidence for the eye doctors treating them. We now have the first approved, standardized, evidence-based treatment in Spain, which drastically improves patient outcomes and quality of life, and prevents blindness in the worst cases.“
AKANTIOR® received approval as an Orphan Drug for the treatment of Acanthamoeba Keratitis in August 2024 from the European Commission. The product has been available in Germany since October 2024.
With unparalleled clinical results, AKANTIOR® achieved cure rates of 85% in a pivotal Phase III study when used as a monotherapy following the innovative treatment protocol.
More than 70 patients in Spain have been treated through Early Access Programs before pricing and reimbursement were approved. The current availability through established processes in designated reference hospitals will be maintained until the product’s commercial launch.
Manuela Marrano, Executive Director of Market Access and Regulatory Affairs at SIFI, stated, „The positive opinion of the CIPM on reimbursement is a strategic milestone in our European access strategy for AKANTIOR, while reimbursement procedures in France, Italy, the United Kingdom, and Germany are still ongoing. The Spanish authorities are the first in the world to recognize the value of this therapy for AK patients and make it widely available immediately after diagnosis – a crucial advantage for achieving better clinical outcomes.“
About Acanthamoeba Keratitis
Acanthamoeba Keratitis is an extremely rare, severe, and progressive corneal infection that threatens vision, characterized by severe pain and light sensitivity. The infection caused by Acanthamoeba mainly affects contact lens wearers (usually young people) and can lead to permanent vision loss if left untreated or not appropriately and timely treated. With an estimated incidence of about 100 patients per year in Spain, there are currently no approved treatment options for AK, leaving patients and healthcare providers with limited empirical therapy approaches.
About SIFI
SIFI is a leading international ophthalmic company based in Italy, following an integrated business model that ranges from research and development to manufacturing and marketing in the pharmaceutical and biomedicine fields. Since its establishment in 1935, SIFI has been committed to improving people’s lives through meaningful innovations in ophthalmology. The company exports to more than 60 countries worldwide and is directly present on major European markets, Mexico, and through joint ventures in China and the United Arab Emirates.
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