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HOLOCLAR (amplified autologous limbal stem cells), stem cells for autologous transplant
TRANSPARENCY COMMITTEE OPINION
Opinions on drugs -
Posted on
Jan 17 2017
Reason for request
Inclusion
Minor clinical added value in the treatment of moderate to severe bilateral limbal stem cell deficiencies, caused by chemical or physical eye burns
- HOLOCLAR has Marketing Authorisation in the treatment of adults with moderate to severe limbal stem cell deficiency (LSCD) (defined by the presence of a superficial corneal neovascularisation in at least two quadrants of the cornea, with involvement of the central cornea and severely altered visual acuity), either unilaterally or bilaterally, caused by chemical or physical eye burns. A minimum of 1 to 2 mm2 of undamaged limbus is required for biopsy.
- Its actual benefit is minor, only in bilateral forms that meet the following criteria: presence of a superficial corneal neovascularisation in at least two quadrants of the cornea in at least one of the eyes AND involvement of the central cornea AND severely altered visual acuity.
- In other forms, its actual benefit is insufficient to justify its reimbursement.
Clinical Benefit
| Substantial |
- |
| Insufficient |
Clinical Added Value
| minor |
- |
Therapeutic use
|
- |
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