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
Renewal criteria
- 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
Quantity limits
- MCL, MZL, MALT, & Hairy Cell Leukemia: 560 mg/day
- CLL/SLL, WM/LPL, & cGVHD: 420 mg/day
Questions?
MHCP Provider Call Center 651-431-2700 or 800-366-5411