Imbruvica®

Drug - Imbruvica® (ibrutinib) [Pharmacyclics LLC]

December 2018

Therapeutic area - Oral Oncology

Initial approval criteria

Patient is 18 years of age or older AND
Patient has a diagnosis of Mantle Cell Lymphoma (MCL) AND
- Used as subsequent therapy as a single agent OR
- Used in combination with rituximab as pre-treatment to limit the number of induction therapy cycles OR
Patient has a diagnosis of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) OR
Patient has a diagnosis of Waldenström's Macroglobulinemia/ Lymphoplasmacytic Lymphoma (WM/LPL) AND
- Must be used as a single agent OR
Patient has a diagnosis of Marginal Zone Lymphoma (MZL) (including Nodal and Splenic) AND
- Used as single-agent, subsequent therapy for patients with refractory or progressive disease who have previously received anti-CD20 based therapy OR
Patient has a diagnosis of Chronic Graft versus Host Disease (cGVHD) AND
- Patient is post-allogeneic stem cell transplant (generally 3 or more months) AND
- Patient has failed 1 or more previous lines of systemic therapy for the treatment of cGVHD (e.g., corticosteroids or immunosuppressants such as cyclosporine) OR
Patient has a diagnosis of Gastric MALT Lymphoma AND
- Used as subsequent therapy for recurrent or progressive disease OR
Patient has a diagnosis of Nongastric MALT Lymphoma (NHL) AND
- Used as subsequent therapy for refractory or progressive disease OR
Patient has a diagnosis of Hairy Cell Leukemia AND
- Used as a single agent for progressive disease
Initial approval is for 6 months

Patient continues to meet the criteria above AND
Absence of unacceptable toxicity from the drug AND
If for oncology indications, tumor response with stabilization of disease or decrease in size of tumor or tumor spread OR
If for cGVHD, response to therapy with an improvement in 1 or more of the following:
- Clinician assessments (e.g., NIH Skin Score, Upper GI Response Score, NIH Lung Symptom Score, etc.) OR
- Patient-reported symptoms (e.g., Lee Symptom Scale, etc.)
Renewal is for 6 months

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