Osimertinib (Tagrisso)

Key Messages

• Reimbursement reviews are comprehensive assessments of the clinical effectiveness and cost-effectiveness, as well as patient and clinician perspectives, of a drug or drug class.
• The assessments inform nonbinding recommendations that help guide the reimbursement decisions of Canada’s federal, provincial, and territorial governments, with the exception of Quebec.
• This review assesses osimertinib (Tagrisso), 40 mg and 80 mg daily, oral tablets.
• Indication: For the treatment of patients with locally advanced, unresectable (stage III) NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations (either alone or in combination with other EGFR mutations) and whose disease has not progressed during or following platinum-based chemoradiation therapy.
• Osimertinib has been issued market authorization with conditions, pending the results of trials to verify its clinical benefit. The condition for authorization includes submission of the final Clinical Study Report of the LAURA trial.