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Key Announcement:
AKANTIOR® will be available for Spanish patients on August 1st.
Spain is the first country globally to approve the price and reimbursement for AKANTIOR® for the treatment of Acanthamoeba keratitis (AK) in adults and children aged 12 and older.
Details of the Reimbursement:
The Spanish inter-ministerial commission for drug prices (CIPM) issued a positive reimbursement notice.
Full reimbursement is expected from august 1st, following standard procedures by the Spanish Ministry of Health.
Meaning of the Approval:
Dr. Ana Hervás Ontiveros (ophthalmologist) states this is a “big step forward,” offering “new hope” and “greater confidence” for patients and ophthalmologists in Spain.
It provides the first approved, standardized, and evidence-based treatment for AK in Spain, which is expected to improve outcomes and quality of life, and prevent blindness.
AKANTIOR® Background:
Received European Commission approval as an orphan medication in August 2024. Demonstrated “unprecedented clinical results” with an 85% medical healing rate in a Phase III trial when used as monotherapy.
Over 70 patients in Spain received the drug through early access programs prior to this approval.
Sifi‘s Perspective:
manuela Marrano (Sifi’s Executive Director of Market Access and Regulatory Affairs) calls the Spanish reimbursement a “strategic step” in their European access strategy. Reimbursement procedures are also underway in France, Italy, the United Kingdom, and Germany. She emphasizes the advantage of Spain’s early recognition of the therapy’s value, ensuring broad and swift availability after diagnosis.
About Acanthamoeba Keratitis (AK):
An extremely rare,serious,and sight-threatening corneal infection.
Characterized by intense pain and photophobia.
Caused by Acanthamoeba, primarily affecting contact lens wearers (ofen young people).
Can lead to permanent vision loss if not treated promptly and correctly.
Estimated to affect around 100 patients per year in Spain.
Previously lacked approved therapeutic options, leaving limited treatment choices.
About Sifi:
A leading international ophthalmic company based in Italy.
Has an integrated business model covering R&D, manufacturing, and marketing in pharmaceuticals and biomedical sectors.
* Its mission since 1935 is to improve lives through eye care innovations.
