Cariprazine (Reagila) has been accepted for the treatment of schizophrenia in adults. The use of cariprazine as a second-line therapy is restricted to patients with schizophrenia in whom predominantly negative symptoms have been identified as a primary feature. Evidence showed a greater improvement in negative symptoms with cariprazine vs another second-generation antipsychotic.
Pembrolizumab (Keytruda) has been accepted as monotherapy for the adjuvant treatment of adults with melanoma (Stage III) with lymph node involvement who have undergone complete resection. Evidence from a phase 3 study showed a significantly longer recurrence-free survival with pembrolizumab vs placebo. The acceptance came after its evaluation through the Patient and Clinician Engagement process. The SMC advice considers the benefits of a 'Patient Access Scheme' that improves the cost-effectiveness of pembrolizumab.
However, doxylamine succinate and pyridoxine hydrochloride (Xonvea) has not been accepted for the treatment of nausea and vomiting of pregnancy in women unresponsive to conservative management. Although the drug combination improved symptoms of nausea and vomiting compared with placebo, the SMC rejected it as the manufacturer failed to provide a strong clinical or economic analysis.