Re-assessment of actual benefit in accordance with article R163-12 of the Social Security code following submission of new clinical data (long-term patient follow-up).
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Clinical Benefit
Insufficient
The Committee notes the new data, which are not likely to change the actual benefit of STELARA as assessed by the Committee in its Opinion of 13 May 2009 : The actual benefit for other patients who do not meet these criteria for receiving this treatment is insufficient.
Substantial
The Committee notes the new data, which are not likely to change the actual benefit of STELARA as assessed by the Committee in its Opinion of 13 May 2009 : The opinion’s Committee is of the actual benefit provided by STELARA 45 mg solution for injection is substantial in adult patients suffering from serious chronic plaque psoriasis who have failed at least two systemic treatments, including phototherapy, methotrexate and ciclosporin (i.e. have not responded or cannot receive these treatments because of contraindication or intolerance).
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