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 Waldenström’s Macroglobulinemia/Lymphoplasmacytic Lymphoma
Indicated for the treatment of adult patients with Waldenström’s macroglobulinemia (WM)/Lymphoplasmacytic Lymphoma (LPL) [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
- Clinical justification provided explaining why Imbruvica tablet is preferred over the 140mg capsule despite having the same active ingredient (e.g., difficulty swallowing capsules, allergy or sensitivities to capsule inactive ingredients, digestive issues) (note: preference, convenience, or reluctance to take multiple 140mg capsules to achieve the required dosage are not considered valid reasons)
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
- Clinical justification provided explaining why Imbruvica tablet is preferred over the 140mg capsule despite having the same active ingredient (e.g., difficulty swallowing capsules, allergy or sensitivities to capsule inactive ingredients, digestive issues) (note: preference, convenience, or reluctance to take multiple 140mg capsules to achieve the required dosage are not considered valid reasons)
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
- Submission of medical records (e.g., chart notes) providing clinical justification explaining why Imbruvica tablet is preferred over the 140mg capsule despite having the same active ingredient (e.g., difficulty swallowing capsules, allergy or sensitivities to capsule inactive ingredients, digestive issues) (note: preference, convenience, or reluctance to take multiple 140mg capsules to achieve the required dosage are not considered valid reasons)
Imbruvica capsules, Imbruvica 420mg 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, 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
- Clinical justification provided explaining why Imbruvica tablet is preferred over the 140mg capsule despite having the same active ingredient (e.g., difficulty swallowing capsules, allergy or sensitivities to capsule inactive ingredients, digestive issues) (note: preference, convenience, or reluctance to take multiple 140mg capsules to achieve the required dosage are not considered valid reasons)
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
- Clinical justification provided explaining why Imbruvica tablet is preferred over the 140mg capsule despite having the same active ingredient (e.g., difficulty swallowing capsules, allergy or sensitivities to capsule inactive ingredients, digestive issues) (note: preference, convenience, or reluctance to take multiple 140mg capsules to achieve the required dosage are not considered valid reasons)
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
- Submission of medical records (e.g., chart notes) providing clinical justification explaining why Imbruvica tablet is preferred over the 140mg capsule despite having the same active ingredient (e.g., difficulty swallowing capsules, allergy or sensitivities to capsule inactive ingredients, digestive issues) (note: preference, convenience, or reluctance to take multiple 140mg capsules to achieve the required dosage are not considered valid reasons)
Imbruvica capsules, Imbruvica 420mg 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, 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
- Clinical justification provided explaining why Imbruvica tablet is preferred over the 140mg capsule despite having the same active ingredient (e.g., difficulty swallowing capsules, allergy or sensitivities to capsule inactive ingredients, digestive issues) (note: preference, convenience, or reluctance to take multiple 140mg capsules to achieve the required dosage are not considered valid reasons)
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
- Clinical justification provided explaining why Imbruvica tablet is preferred over the 140mg capsule despite having the same active ingredient (e.g., difficulty swallowing capsules, allergy or sensitivities to capsule inactive ingredients, digestive issues) (note: preference, convenience, or reluctance to take multiple 140mg capsules to achieve the required dosage are not considered valid reasons)
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
- Submission of medical records (e.g., chart notes) providing clinical justification explaining why Imbruvica tablet is preferred over the 140mg capsule despite having the same active ingredient (e.g., difficulty swallowing capsules, allergy or sensitivities to capsule inactive ingredients, digestive issues) (note: preference, convenience, or reluctance to take multiple 140mg capsules to achieve the required dosage are not considered valid reasons)
Imbruvica capsules, Imbruvica 420mg 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, 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
2025-04-18, 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 LLC. Sunnyvale, CA. December 2024.
- NCCN Drugs and Biologics Compendium (NCCN Compendium). Available at http://www.nccn.org/professionals/drug_compendium/content/contents.asp. Accessed February 13, 2025.
Revision History
- 2025-04-18: 2025 annual review: For 140mg and 280mg tablets, replaced trial/failure requirement through 140mg capsule with justification requirement. Removed 560mg tablet from guideline as it's obsolete May 2025. Background updates.
- 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
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