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ORENCIA (abatacept) (EPI ASCORE & ORA)

Opinions on drugs - Posted on Nov 17 2021

Reason for request

Reevaluation

Key points

Favourable opinion for maintenance of reimbursement, in combination with methotrexate, in the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX) or a tumour necrosis factor (TNF)-alpha inhibitor.

Special recommendations

The Committee reiterates that subcutaneous treatment must be initiated by specialists. ORENCIA subcutaneous (SC) may be initiated with or without an intravenous (IV) loading dose. Given the rare but serious identified risk of systemic reactions following injection, including anaphylactic reactions observed with subcutaneous abatacept but also with other biologic disease-modifying drugs, the Transparency Committee considers that the first subcutaneous injection of this drug should be given in an appropriate care structure.


Clinical Benefit

Substantial

The Committee deems that the clinical benefit of ORENCIA (abatacept) remains substantial, in combination with methotrexate, in the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX) or a tumour necrosis factor (TNF)-alpha inhibitor. 


Clinical Added Value

Comments without ASMR value

The Committee considers that the new data available is not of a nature to modify the assessment of the clinical added value formulated in its previous opinions of 18/07/2007, 14/03/2012, 04/12/2013 and 22/06/2016.


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