The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Adalimumab (Humira®) has been accepted for restricted use in the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. The restriction limits use individuals with severe disease as defined by a total Psoriasis Area Severity Index (PASI) score of ≥10 and a Dermatology Life Quality Index (DLQI) of >10.
Riociguat (Adempas®) has been accepted for restricted use in the treatment of pulmonary arterial hypertension (PAH) as monotherapy or in combination with endothelin receptor antagonists in adult patients with World Health Organisation Functional Class (WHO FC) II to III to improve exercise capacity. It is restricted to initiation and prescribing by specialists in the Scottish Pulmonary Vascular Unit or by similar specialists.
Rivaroxaban (Xarelto®) has been rejected for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers in combination with aspirin alone or with aspirin plus clopidogrel or ticlopidine. The submitting company did not present a sufficiently robust economic analysis to gain acceptance by SMC.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
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