Alecensaro

Alectinib

• Brand(s): Alecensaro
• Dosage Form/Strength: 150 mg capsule

Initial Criteria:

For the treatment of anaplastic lymphoma kinase (“ALK”) – positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) in patients meeting ALL the following criteria:

1. Alectinib is used as first line treatment OR after experiencing disease progression or intolerance on crizotinib^{1, 2, 3}; AND

2. Alectinib is used as monotherapy; AND

3. Patient has good performance status (ECOG ≤ 2).

¹Patients who have progressed during or following first-line therapy with alectinib are not eligible to receive alectinib as a subsequent-line therapy.

²Time-limited funding will be considered case-by-case in patients with ALK-positive NSCLC who have progressed on chemotherapy and crizotinib OR crizotinib and an immune checkpoint inhibitor commenced prior to the public funding of alectinib.

³Include details of the intolerance including the grade of toxicity and reasons why crizotinib was not able to be used.

Exclusion criteria:

• Alectinib will not be funded if the patient has experienced disease progression while on an ALK inhibitor other than crizotinib.
• Alectinib will not be funded beyond third line.

Public funding will be considered for only one of Alectinib (Alecensaro) OR Ceritinib (Zykadia) and vice versa.

Recommended dose: 600 mg twice daily

Renewal Criteria:

Ongoing funding will be considered in patients who have not experienced disease progression or unacceptable toxicities to treatment with Alectinib.

Approval duration of initial and renewal requests: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests