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New HTA Decisions in France
December 2019
Drug name
SKYRIZI™ (risankizumab)
Company
AbbVie
Decision date
06/11/2019
Therapeutic area
Skin conditions
Therapeutic sub area
Psoriasis
Official notice date
12/11/2019
Reimbursement %
65
Decision (SMR)
Important
Decision (ASMR)
No improvement (V)
Indication
SKYRIZI™ is indicated for the treatment of severe chronic plaque psoriasis in adults who require systemic therapy. Severe chronic plaque psoriasis is defined by: - failure (insufficient response, contraindication or intolerance) of at least two treatments among non-biological systemic treatments and phototherapy, and - extensive form and/or psychosocial impact.
Decision (SMR)
Insufficient to justify reimbursement
Decision (ASMR)
Indication
SKYRIZI™ is indicated for the treatment of other forms of moderate to severe plaque psoriasis in adults who require systemic therapy.
Decision Type
New technology assessment
Summary
The committee considered the actual benefit of SKYRIZI™ to be 'important' in the treatment of severe chronic plaque psoriasis in adults who require systemic therapy, and insufficient to justify reimbursement in other forms of moderate to severe plaque psoriasis in adults who require systemic therapy. Considering: - the superiority of risankizumab over adalimumab (HUMIRA®) and ustekinumab (STELARA®) with clinically relevant differences in percentage of complete or near-complete disappearance of lesions (sPGA = 0 or 1) and percentage of PASI 90 responses after 16 weeks (co-primary endpoints), maintaining this superiority until week 52; - non-inferiority of risankizumab compared to secukinumab (COSENTYX®) on the percentage of PASI 90 responses at week 16; - a safety profile comparable to that of other anti-interleukins; - lack of efficacy and long-term tolerance data (beyond 104 weeks); it was concluded that SKYRIZI™ does not provide any improvement in the medical service rendered (ASMR V) compared to COSENTYX® in in adults with severe chronic plaque psoriasis. The committee proposed 65% reimbursement.