#SFHS2604662VNotice on Prices of Pharmaceutical Specialties Published Pursuant to Article L. 162-16-6 of the Social Security Code
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
This official French notice sets the reimbursement tariff and maximum selling prices for two intravenous formulations of VYLOY (zolbetuximab) manufactured by Astellas Pharma SAS. Under a negotiated agreement with the Economic Committee for Health Products, the responsibility tariff (tarif de responsabilité) and the hospital sales price limit are both fixed at €523.75 per unit for the 100mg perfusion vial and €1,571.25 per unit for the 300mg perfusion vial, both exclusive of VAT. These prices apply specifically to sales to healthcare establishments. The publication fulfills the transparency obligation under Article L. 162-16-6 of the Social Security Code and enables hospitals to purchase the medicine at or below the capped price while allowing full reimbursement at the listed tariff.
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Key Changes
- Sets tariff de responsabilité HT at €523.75 per UCD for VYLOY 100mg perfusion flask (UCD 3400890043106)
- Sets tariff de responsabilité HT at €1,571.25 per UCD for VYLOY 300mg perfusion flask (UCD 3400890049719)
- Maximum hospital selling price (prix limite de vente HT) fixed at exactly the same levels: €523.75 and €1,571.25 respectively
+ 3 more changes with Pro
Obligations
What this law requires
Set and maintain the responsibility tariff (tarif de responsabilité) for VYLOY 100mg perfusion vial at €523.75 per unit (excluding VAT)
Set and maintain the responsibility tariff (tarif de responsabilité) for VYLOY 300mg perfusion vial at €1,571.25 per unit (excluding VAT)
Enforce maximum selling price limit of €523.75 per unit (excluding VAT) for VYLOY 100mg perfusion vial in all sales to healthcare establishments
Enforce maximum selling price limit of €1,571.25 per unit (excluding VAT) for VYLOY 300mg perfusion vial in all sales to healthcare establishments
Publish and maintain public notice of the established responsibility tariffs and maximum selling prices in accordance with Article L. 162-16-6 of the Social Security Code