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Reason for request
Inclusion on the list of medicines approved for hospital use in the extension of the indication "treatment of RA in patients with an inadequate response to one or more classic disease-modifying treatments, including MTX” and amendment to inclusion conditions (addition of paediatricians to the list of prescribers and inclusion of a new CIP code).
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Clinical Benefit
| Substantial |
The actual benefit of ORENCIA is substantial. |
Clinical Added Value
| no clinical added value |
In the indication: "treatment of moderate to severe active rheumatoid arthritis in adult patients who responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX) or a TNF-alpha inhibitor, ORENCIA does not provide an improvement in actual benefit (IAB V). |
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