Imbruvica (ibrutinib) - PA, NF
Indications for Prior Authorization
Imbruvica (ibrutinib)
-
For diagnosis of Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) -
For diagnosis of Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) with 17p deletion
Indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) with 17p deletion -
For diagnosis of Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma
Indicated for the treatment of adult patients with Waldenström’s macroglobulinemia (WM)/Lymphoplasmacytic Lymphoma [2] -
For diagnosis of Chronic graft versus host disease (cGVHD)
Indicated for the treatment of adult and pediatric patients age 1 year and older with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy.
Criteria
Imbruvica 140mg tablet, Imbruvica 280mg tablet
Prior Authorization (Initial Authorization)
Length of Approval: 6 Month(s)
For diagnosis of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- Diagnosis of one of the following:
- chronic lymphocytic leukemia
- small lymphocytic lymphoma
- Trial and failure, or intolerance to Imbruvica 140mg capsule
Imbruvica 140mg tablet, Imbruvica 280mg tablet
Prior Authorization (Reauthorization)
Length of Approval: 6 Month(s)
For diagnosis of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- Patient does not show evidence of progressive disease while on therapy AND
- Trial and failure, or intolerance to Imbruvica 140mg capsule
Imbruvica 140mg tablet, Imbruvica 280mg tablet
Non Formulary
Length of Approval: 12 Month(s)
For diagnosis of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- Diagnosis of one of the following:
- chronic lymphocytic leukemia
- small lymphocytic lymphoma
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, or intolerance to Imbruvica 140mg capsule
Imbruvica capsules, Imbruvica 420mg tablet, Imbruvica 560mg tablet, Imbuvica oral suspension
If patient meets criteria above, please approve with GPI List: IMBRUVICPA
Prior Authorization (Initial Authorization)
Length of Approval: 6 Month(s)
For diagnosis of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- Diagnosis of one of the following:
- chronic lymphocytic leukemia
- small lymphocytic lymphoma
Imbruvica capsules, Imbruvica 420mg tablet, Imbruvica 560mg tablet, Imbuvica oral suspension
If patient meets criteria above, please approve with GPI List: IMBRUVICPA
Prior Authorization (Reauthorization)
Length of Approval: 6 Month(s)
For diagnosis of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- Patient does not show evidence of progressive disease while on therapy
Imbruvica 140mg tablet, Imbruvica 280mg tablet
Prior Authorization (Initial Authorization)
Length of Approval: 6 Month(s)
For diagnosis of Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma
- Diagnosis of Waldenstrom's Macroglobulinemia AND
- Trial and failure, or intolerance to Imbruvica 140mg capsule
Imbruvica 140mg tablet, Imbruvica 280mg tablet
Prior Authorization (Reauthorization)
Length of Approval: 6 Month(s)
For diagnosis of Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma
- Patient does not show evidence of progressive disease while on therapy AND
- Trial and failure, or intolerance to Imbruvica 140mg capsule
Imbruvica 140mg tablet, Imbruvica 280mg tablet
Non Formulary
Length of Approval: 12 Month(s)
For diagnosis of Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma
- Diagnosis of Waldenstrom's Macroglobulinemia AND
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, or intolerance to Imbruvica 140mg capsule
Imbruvica capsules, Imbruvica 420mg tablet, Imbruvica 560mg tablet, Imbuvica oral suspension
If patient meets criteria above, please approve with GPI List: IMBRUVICPA
Prior Authorization (Initial Authorization)
Length of Approval: 6 Month(s)
For diagnosis of Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma
- Diagnosis of Waldenstrom's Macroglobulinemia
Imbruvica capsules, Imbruvica 420mg tablet, Imbruvica 560mg tablet, Imbuvica oral suspension
If patient meets criteria above, please approve with GPI List: IMBRUVICPA
Prior Authorization (Reauthorization)
Length of Approval: 6 Month(s)
For diagnosis of Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma
- Patient does not show evidence of progressive disease while on therapy
Imbruvica 140mg tablet, Imbruvica 280mg tablet
Prior Authorization (Initial Authorization)
Length of Approval: 6 Month(s)
For diagnosis of Chronic graft versus host disease (cGVHD)
- Diagnosis of chronic graft versus host disease (cGVHD) AND
- Patient is 1 year of age or older AND
- Trial and failure of at least one or more lines of systemic therapy (e.g., corticosteroids like prednisone or methylprednisolone, mycophenolate) AND
- Trial and failure, or intolerance to Imbruvica 140mg capsule
Imbruvica 140mg tablet, Imbruvica 280mg tablet
Prior Authorization (Reauthorization)
Length of Approval: 6 Month(s)
For diagnosis of Chronic graft versus host disease (cGVHD)
- Patient does not show evidence of progressive disease while on therapy AND
- Trial and failure, or intolerance to Imbruvica 140mg capsule
Imbruvica 140mg tablet, Imbruvica 280mg tablet
Non Formulary
Length of Approval: 12 Month(s)
For diagnosis of Chronic graft versus host disease (cGVHD)
- Diagnosis of chronic graft versus host disease (cGVHD) AND
- Patient is 1 year of age or older AND
- Trial and failure of at least one or more lines of systemic therapy (e.g., corticosteroids like prednisone or methylprednisolone, mycophenolate) AND
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, or intolerance to Imbruvica 140mg capsule
Imbruvica capsules, Imbruvica 420mg tablet, Imbruvica 560mg tablet, Imbuvica oral suspension
If patient meets criteria above, please approve with GPI List: IMBRUVICPA
Prior Authorization (Initial Authorization)
Length of Approval: 6 Month(s)
For diagnosis of Chronic graft versus host disease (cGVHD)
- Diagnosis of chronic graft versus host disease (cGVHD) AND
- Patient is 1 year of age or older AND
- Trial and failure of at least one or more lines of systemic therapy (e.g., corticosteroids like prednisone or methylprednisolone, mycophenolate)
Imbruvica capsules, Imbruvica 420mg tablet, Imbruvica 560mg tablet, Imbuvica oral suspension
If patient meets criteria above, please approve with GPI List: IMBRUVICPA
Prior Authorization (Reauthorization)
Length of Approval: 6 Month(s)
For diagnosis of Chronic graft versus host disease (cGVHD)
- Patient does not show evidence of progressive disease while on therapy
P & T Revisions
2024-10-23, 2024-09-12, 2024-05-15, 2024-04-10, 2023-11-02, 2023-11-01, 2023-06-05, 2023-04-10, 2022-10-07, 2022-03-29, 2021-09-27, 2021-05-19, 2021-05-03
References
- Imbruvica Prescribing Information. Pharmacyclics, Inc. Sunnyvale, CA. August 2022.
Revision History
- 2024-10-23: No changes to criteria, Update to operational notes.
- 2024-09-12: No changes to criteria. Updated operational note.
- 2024-05-15: Added PA, NF to guideline name
- 2024-04-10: Annual Review
- 2023-11-02: Drug Specific NF criteria applied.
- 2023-11-01: Drug Specific NF criteria applied. New criteria created for Imbruvica 140mg tablet and 280mg tablet, addition of operational note and modified reauthorization PA to new standardized language.
- 2023-06-05: Removed prescriber requirement.
- 2023-04-10: Annual Review - criteria for MCL and MZL removed
- 2022-10-07: Background update and addition of new suspension formulation
- 2022-03-29: Annual Review - no changes to criteria
- 2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
- 2021-05-19: Addition of EHB formulary to guideline, no changes to criteria
- 2021-05-03: Updated GPIs
HEALTHY LIVING