3 March 2016 - The outcome for three medicines, ceritinib (Zykadia), osimertinib mesylate (Tagrisso) and alectinib hydrochloride (Alecensaro), demonstrate the advantages of robust clinical evidence.
The pERC has recommended the reimbursement of ceritinib for use as monotherapy by patients with anaplastic lymphoma kinase (ALK) positive locally advanced or metastatic non small-cell lung cancer (NSCLC) who have progressed on or who were intolerant to crizotinib so long its cost-effectiveness is reduced to an acceptable level.
The resubmission for ceritinib was supported by clinical evidence from a Phase III clinical trial (ASCEND-5); the initial submission was supported by clinical evidence from a Phase II clinical trial (ASCEND-4).
Osimertinib mesylate (Tagrisso) has been recommended for the treatment of patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC who have progressed on or after EGFR TKI therapy, so long its cost-effectiveness is reduced to an acceptable level. The submission was supported by one Phase II RCT (AURA-3).
The pERC has not recommended the reimbursement of alectinib hydrochloride (Alecensaro) for use as monotherapy for the treatment of patients with ALK positive, locally advanced or metastatic NSCLC who have progressed on or are intolerant to crizotinib and have CNS metastases. The Committee was not confident that alectinib is associated with a net clinical benefit because of limitations in the available clinical trials. The submission was supported by one Phase I and one Phase II clinical trial.
Read ERC initial recommendation for ceritinib