#SFHS2614038AOpuviz Added to France’s Approved Hospital Medicines List
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This order adds two presentations of OPUVIZ 40 mg/ml, an aflibercept injectable medicine, to the list of medicines approved for use by public hospitals, local authorities, and other public services in France. Health insurance coverage is limited to specified adult eye conditions, including wet age-related macular degeneration, retinal vein occlusion-related macular edema, diabetic macular edema under defined conditions, and myopic choroidal neovascularization. The medicine must be given by intravitreal injection by ophthalmologists experienced in this procedure.
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Key Changes
- Adds OPUVIZ 40 mg/ml vial presentation to the approved public-sector medicines list
- Adds OPUVIZ 40 mg/ml pre-filled syringe presentation to the approved public-sector medicines list
- Limits health insurance coverage to specified adult retinal and macular eye conditions
Obligations
What this law requires
Public hospitals, local authorities, and other public services may use only the listed presentations of OPUVIZ 40 mg/ml that have been added to the approved medicines list: the 0.1 ml glass vial with filter needle and the 0.1 ml pre-filled syringe presentations identified by their CIP codes.
Health insurance coverage for OPUVIZ 40 mg/ml must be limited to the therapeutic indications expressly listed in the annex, including wet age-related macular degeneration, retinal vein occlusion-related macular edema, diabetic macular edema under the specified clinical conditions, branch retinal vein occlusion-related macular edema, and myopic choroidal neovascularization in adults.
For diabetic macular edema, OPUVIZ 40 mg/ml may be covered only for adult patients with diffuse edema or leakage close to the macular center, visual acuity less than or equal to 5/10, and optimized diabetes management.
OPUVIZ treatment must be administered only by intravitreal injection.
OPUVIZ treatment must be administered only by ophthalmologists experienced in intravitreal injections.