CurrentNeighborhood Health Plan of Rhode IslandPolicy 1997-A

Imbruvica

Defines coverage and authorization criteria for ibrutinib (Imbruvica) across FDA-approved indications and select compendial uses, authorization durations, continuation criteria, and exclusions (experimental/investigational for uses not listed).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyImbruvica

Policy CodePolicy 1997-A

Change TypeRevised references/compendia

Effective Date

Next Review Date

Key ActionRequest prior authorization for covered indications and document absence of unacceptable toxicity and disease progression for reauthorization.

SourceLink

POLICY UPDATE CHANGES

Document references and compendia citations updated; no other material clinical or coverage changes identified.

12 monthsTypical authorization duration

Multiple hematologic malignanciesCovered indications

Experimental/InvestigationalExcluded uses

Coverage Summary & Covered Indications

ANY of the following

Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL): treatment of adult patients with CLL/SLL, including those with 17p deletion.
Waldenström's Macroglobulinemia (WM): treatment of adult patients with WM.
Chronic Graft‑versus‑Host Disease (cGVHD): treatment of adult and pediatric patients age ≥1 year with cGVHD after failure of one or more lines of systemic therapy.
Mantle Cell Lymphoma (MCL): use consistent with authorization criteria (see policy), including use as single agent or in specified combinations/regimens.
Marginal Zone Lymphoma (MZL): including extranodal (gastric and nongastric MALT), nodal, and splenic marginal zone lymphoma (compendial use).
Hairy Cell Leukemia (compendial use).
Central Nervous System cancers (compendial use), including primary CNS lymphoma and brain metastases in lymphoma when criteria met.
Diffuse Large B‑cell Lymphoma (compendial use) — single‑agent subsequent treatment of non‑germinal center subtypes.
High‑Grade B‑cell Lymphoma (compendial use) — single‑agent subsequent treatment of non‑germinal center subtypes, including double/triple‑hit disease when applicable.
HIV‑related B‑cell lymphomas (compendial use) — single‑agent subsequent treatment of non‑germinal center subtypes.
Monomorphic Post‑Transplant Lymphoproliferative Disorders (PTLD), B‑cell type (compendial use) — see authorization criteria below.

Monomorphic Post‑Transplant Lymphoproliferative Disorders (PTLD)

Monomorphic Post‑Transplant Lymphoproliferative Disorders (PTLD) — Authorization criteria:

ALL of the following

Diagnosis of monomorphic post‑transplant lymphoproliferative disorder (PTLD), B‑cell type, confirmed by pathology/clinical documentation.
Member has undergone solid organ or hematopoietic stem cell transplantation and presents with PTLD consistent with monomorphic B‑cell histology.
Requested use is for single‑agent subsequent treatment of non‑germinal center PTLD (B‑cell type).
There is documentation of prior therapies and response: authorization of up to 12 months may be granted for single‑agent subsequent treatment; clinical rationale for use of ibrutinib as subsequent therapy is provided.
No evidence of contraindications or exclusions to ibrutinib therapy; prescriber attests to monitoring plan for toxicity and drug interactions.
For continuation/reauthorization: member demonstrates clinical benefit (no disease progression) and no unacceptable toxicity while on current regimen.

Initial Therapy / Indication-Specific Authorization Criteria

Mantle Cell Lymphoma (MCL) - Authorization criteria

Authorization of 12 months may be granted when ANY of the following are met:

ANY of the following

Member has received at least one prior therapy when ibrutinib is used as a single agent or in combination with rituximab or venetoclax
Ibrutinib will be used in combination with rituximab as pretreatment to induction therapy with RHyperCVAD regimen (rituximab, cyclophosphamide, vincristine, doxorubicin, dexamethasone)
Ibrutinib will be used as aggressive induction therapy as a component of TRIANGLE regimen: alternating RCHOP + covalent BTK inhibitor (ibrutinib)/RDHA + carboplatin
Ibrutinib will be used in combination with rituximab for members aged 65 years and older

CLL/SLL - Authorization criteria

Authorization of 12 months may be granted for treatment when ANY of the following apply:

ANY of the following

Treatment as a single agent
Treatment in combination with rituximab with or without bendamustine
Treatment in combination with obinutuzumab
First-line therapy in combination with venetoclax
Treatment for histologic (Richter) transformation to diffuse large B-cell lymphoma in combination with nivolumab or pembrolizumab

Waldenström's Macroglobulinemia / Lymphoplasmacytic Lymphoma / Bing-Neel syndrome - Authorization criteria

Authorization of 12 months may be granted when ANY of the following are met:

ANY of the following

Ibrutinib used as a single agent
Ibrutinib used in combination with rituximab

Marginal Zone Lymphoma (MZL) - Authorization criteria

Authorization of 12 months may be granted when ALL of the following are met:

ALL of the following

Diagnosis of MZL (extranodal/gastric or nongastric MALT, nodal, or splenic marginal zone lymphoma)
Member has received at least one prior therapy

Chronic Graft-Versus-Host Disease (cGVHD) - Authorization criteria

Authorization of 12 months may be granted when the following is met:

ALL of the following

Member has failed one or more lines of therapy

Hairy Cell Leukemia - Authorization criteria

Authorization of 12 months may be granted when the following is met:

ALL of the following

Relapsed/refractory hairy cell leukemia and ibrutinib is used as a single agent for disease progression

Central Nervous System (CNS) Cancers - Authorization criteria

Authorization of 12 months may be granted when ANY of the following are met:

ANY of the following

Ibrutinib used for relapsed or refractory disease as either a single agent
Ibrutinib used in combination with high-dose methotrexate and rituximab for primary CNS lymphoma
Ibrutinib used for induction therapy as a single agent for primary CNS lymphoma
Ibrutinib used as a single agent for brain metastases in lymphoma

Diffuse Large B-cell Lymphoma - Authorization criteria

Authorization of 12 months may be granted for:

ALL of the following

Single agent subsequent treatment of non-germinal diffuse large B-cell lymphoma

High-Grade B-cell Lymphoma - Authorization criteria

Authorization of 12 months may be granted for:

ALL of the following

Single agent subsequent treatment of non-germinal high-grade B-cell lymphoma (including double/triple hit and not otherwise specified)

HIV-Related B-cell Lymphomas - Authorization criteria

Authorization of 12 months may be granted for:

ALL of the following

Single agent subsequent treatment of non-germinal HIV-related B-cell lymphomas

Authorization & Documentation Requirements

Prior Authorization

Authorization requirement for listed indications

Authorization (prior authorization) of 12 months may be granted for covered indications meeting the policy criteria; provider must request authorization consistent with plan procedures.

Documentation Required

Clinical evidence for reauthorization

For continuation/reauthorization the provider must document absence of unacceptable toxicity and absence of disease progression on current regimen.

Key Operational Thresholds

Typical authorization duration12 months

Covered indications (summary)Multiple FDA‑approved hematologic malignancies and selected compendial uses including CLL/SLL (including 17p deletion), mantle cell lymphoma, Waldenström's macroglobulinemia, marginal zone lymphomas (MALT, nodal, splenic), hairy cell leukemia, CNS lymphomas, diffuse large B‑cell and high‑grade B‑cell lymphomas, HIV‑related B‑cell lymphomas, monomorphic PTLD, and cGVHD after prior therapy

Background

Imbruvica (ibrutinib) is a covalent Bruton's tyrosine kinase (BTK) inhibitor used in multiple hematologic disorders. The agent is indicated for adult patients with CLL/SLL (including those with 17p deletion), for Waldenström's macroglobulinemia, and for treatment of chronic graft-versus-host disease in patients age ≥1 year after failure of one or more systemic therapies. The policy aligns coverage with FDA approvals and selected compendial (NCCN) uses and specifies criteria for authorization and reauthorization.

Authorization provisions in the policy provide for typical initial and renewal approvals of 12 months when criteria are met (including absence of unacceptable toxicity and no disease progression for reauthorization) and enumerate covered indications and compendial uses. References include the Imbruvica package insert (Dec 2024) and the NCCN Drugs & Biologics Compendium (2025).

OpenPayer

Imbruvica

Coverage Summary & Covered Indications

Initial Therapy / Indication-Specific Authorization Criteria

Continuation of Therapy / Reauthorization Criteria

Exclusions / Not Medically Necessary

Authorization & Documentation Requirements

Applicable Codes

References & Clinical Sources

Background

Revision History