Imbruvica

Ibrutinib

• Brand(s): Imbruvica
• Dosage Form/Strength: 140 mg capsule

For the treatment of patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who meet the following criteria:

1. Patient has received at least one prior therapy to treat CLL/SLL; AND

2. Patient’s prescriber has deemed that it would be inappropriate for the patient to receive treatment or retreatment with a fludarabine-based regimen.

Duration of Approval: 1 Year

Exclusion criteria:
Patients whose disease has progressed on idelalisib therapy in the relapsed setting are not eligible to receive iburitinib.

Renewals will be considered for patients who have not experienced disease progression while on ibrutinib (Imbruvica) therapy.

Duration of Approval: 1 Year

Initial criteria for Treatment naïve patients with high risk CLL/SLL (First-line therapy):

For patients with previously untreated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who present with one of the following cytogenic markers:

1. chromosome 17p deletion; OR

2. TP 53 mutation; OR

3. unmutated immunoglobulin heavy chain variable region (IgHV)

Renewal criteria: Patient has experienced no disease progression while on Imbruvica therapy.

Initial and renewal approval period: 1 year.

For treatment of patients with relapsed or refractory mantle cell lymphoma who have received at least one prior therapy.

Renewals will be considered if patient has experienced no disease progression while on Imbruvica therapy.

Initial and renewal approval period: 1 year.

EAP Drug Request Form:

Standard Form for EAP Drug Requests