CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Imbruvica (ibrutinib) coverage and authorization criteria

Defines covered indications, authorization durations, and clinical criteria for Imbruvica (ibrutinib) across FDA-approved and compendial uses, plus continuation/re-authorization rules. Applies to members when approval criteria are met and no exclusions to therapy exist.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyImbruvica (ibrutinib) coverage and authorization criteria

Policy CodePolicy N/A

Change Typeclarified

Effective Date

Next Review Date

Key ActionProviders must obtain authorization for Imbruvica; approvals are generally for 12 months and require meeting the indication-specific criteria (e.g., prior therapies, combination regimens, age for cGVHD).

POLICY UPDATE CHANGES

Policy lists FDA-approved and compendial indications and specifies 12-month authorization periods and indication-specific prerequisites (prior therapy, age, transplant candidacy).

12Listed covered indications (FDA + selected compendial)

1 yearTypical authorization duration

>=1Prior therapy required for some indications

Coverage Summary

Imbruvica (ibrutinib) is covered with clinical criteria and authorization rules that align to FDA-approved indications and selected compendial uses. Coverage is available for specified B-cell malignancies and chronic graft-versus-host disease when all indication-specific approval criteria are met and there are no exclusions to therapy. Approvals are generally granted for 12 months and are subject to reauthorization requirements (continued treatment requires no evidence of unacceptable toxicity or disease progression).

Thresholds & Quick Facts

Authorization duration12 months

Age for cGVHD>= 1 year

Prior therapy requirement (MCL)Member has received at least one prior therapy when used as single agent or in combination with rituximab or venetoclax

Prior anti‑CD20 therapy requirement (MZL)Received at least one prior anti‑CD20‑based therapy

Reauthorization requirementNo evidence of unacceptable toxicity or disease progression while on current regimen

Initial Therapy Criteria — FDA-Approved Indications

Covered Indications - FDA-Approved Indications

The following FDA-approved indications are considered covered when ALL applicable approval criteria are met and member has no exclusions to prescribed therapy:

ONE of the following FDA-approved indications

Mantle Cell Lymphoma (MCL)
- Authorization of 12 months may be granted when ANY of the following are met:
  - Prior therapy when used as single agent or with rituximab or venetoclax: Member has received at least one prior therapy when the requested medication is used as a single agent or in combination with rituximab or venetoclax.
  - Combination with rituximab as pretreatment to RHyperCVAD: Requested medication will be used in combination with rituximab as pretreatment to induction therapy with RHyperCVAD regimen (rituximab, cyclophosphamide, vincristine, doxorubicin, and dexamethasone).
  - Combination with rituximab for age >=65: Requested medication will be used in combination with rituximab for members aged 65 years and older.
Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL): Authorization of 12 months may be granted for treatment as a single agent or in combination with rituximab or obinutuzumab.12 months
Waldenström's Macroglobulinemia (WM): Authorization of 12 months may be granted for treatment when used as a single agent or in combination with rituximab.12 months
Marginal Zone Lymphoma (MZL): Authorization of 12 months may be granted for members who require systemic therapy and have received at least one prior anti-CD20-based therapy.12 months
Chronic Graft-Versus-Host Disease (cGVHD): Authorization of 12 months may be granted for treatment of adult and pediatric patients age >= 1 year after failure of one or more lines of systemic therapy.12 months
Age threshold: >= 1 year

Initial Therapy Criteria — Compendial Uses

Covered Indications - Compendial Uses

Compendial uses listed are considered covered when approval criteria are met (authorization duration and additional criteria described under specific indication sections):

ONE of the following compendial indications

Mantle cell lymphoma (compendial listing)
Marginal zone lymphomas: gastric MALT lymphoma
Marginal zone lymphomas: nongastric MALT lymphoma
Marginal zone lymphomas: nodal marginal zone lymphoma
Marginal zone lymphomas: splenic marginal zone lymphoma
Hairy cell leukemia
Waldenström's macroglobulinemia/lymphoplasmacytic lymphoma (WM/LPL)
Primary central nervous system lymphoma
Diffuse large B-cell lymphoma
High-grade B-cell lymphoma (including double/triple hit; NOS): High-grade B-cell lymphoma (including high-grade B-cell lymphoma with translocations of MYC and BCL2 and/or BCL6 [double/triple hit], and high-grade B-cell lymphoma, NOS)
AIDS-related B-cell lymphoma
Monomorphic post-transplant lymphoproliferative disorders (PTLD)
Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) (compendial listing)

Authorization Criteria for Specific Compendial / Other Indications

Authorization Criteria for Specific Compendial/Other Indications

Authorization of 12 months may be granted for the following compendial or other listed indications when the specified criteria are met:

ANY of the following

Hairy Cell Leukemia: Authorization of 12 months may be granted when the requested medication is used as a single agent for disease progression.12 months
Primary Central Nervous System Lymphoma
- PCNSL relapsed/refractory or induction: Requested medication is used for relapsed or refractory disease as either a single agent, or in combination with high-dose methotrexate and rituximab.
- PCNSL induction single agent: Requested medication is used for induction therapy as a single agent.
Diffuse Large B-Cell Lymphoma: Authorization of 12 months may be granted for single agent subsequent treatment in members who are non-candidates for transplant.12 months
High-grade B-cell lymphoma (including translocations of MYC and BCL2 and/or BCL6, double/triple hit, NOS): Authorization of 12 months may be granted for single agent subsequent treatment in members who are non-candidates for transplant.12 months
AIDS-related B-cell lymphomas: Authorization of 12 months may be granted for single agent subsequent treatment in members who are non-candidates for transplant.12 months
Monomorphic PTLD: Monomorphic post-transplant lymphoproliferative disorders: Authorization of 12 months may be granted for single agent subsequent treatment in members who are non-candidates for transplant.12 months

Continuation Therapy Criteria (Reauthorization)

Continuation of Therapy (Reauthorization)

Conditions for continued treatment reauthorization:

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in Section II when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.12 months

Provider Actions

Prior Authorization

Prior authorization required with indication-specific criteria

Providers must obtain prior authorization for Imbruvica. Approvals are generally granted for 12 months and require meeting the indication-specific criteria, such as required prior therapies (for example, prior anti-CD20 therapy for MZL or prior systemic therapy for cGVHD), use in specified combination regimens (e.g., with rituximab for certain MCL scenarios or RHyperCVAD pretreatment), and age requirements for cGVHD (age ≥ 1 year).

Documentation Required

Document prior therapy and response

Document prior lines of therapy and treatment response when requesting coverage. Examples include documenting prior anti-CD20–based therapy for MZL and prior systemic therapies for cGVHD. For reauthorization, document there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Background

Imbruvica is an FDA-approved oral Bruton's tyrosine kinase (BTK) inhibitor for multiple B-cell malignancies and for chronic graft-versus-host disease (cGVHD) in adults and pediatric patients age >= 1 year after failure of one or more lines of systemic therapy. Compendial uses (per NCCN and clinical literature) are also included for selected indications. The policy coverage aligns to FDA indications and select compendial recommendations and requires meeting indication-specific criteria (for example, prior therapies, combination regimens, and authorization duration of 12 months with reauthorization rules).

Definitions

DefinitionCoverage approvals for indicated uses are granted for a 12-month period, subject to reauthorization criteria.