ModifiedNeighborhood Health Plan of Rhode IslandPolicy N/A

Um Onc_1262 Imbruvica Ibrutinib_05312024

Defines accepted indications, exclusions, continuation criteria, dosing limits, and utilization management requirements for Imbruvica (ibrutinib) for Evolent/Neighborhood Health Plan of Rhode Island members, including FDA-approved and selected off-label uses supported by compendia/guidelines.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyUm Onc_1262 Imbruvica Ibrutinib_05312024

Policy CodePolicy N/A

Change TypeCoverage position updates

Effective DateMay 31, 2024

Next Review Date

Key ActionProcess medication requests through Evolent and ensure use is supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature per CMS manual.

SourceLink

POLICY UPDATE CHANGES

Approval date May 08, 2024 and effective date May 31, 2024 recorded reflecting committee approval.

Policy position: Imbruvica is not supported for relapsed/refractory mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL) following manufacturer voluntary withdrawal and FDA guidance.

Combination use with anti-CD20 antibodies for CLL/SLL is not supported.

3Supported Primary Indications (CLL/SLL, Waldenstrom's, cGVHD)

2Not Supported Indications (MCL, MZL)

420Single Dose Limit (mg)

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Coverage Summary

Scope: This policy defines accepted uses of Imbruvica (ibrutinib) for Evolent/Neighborhood Health Plan of Rhode Island members, including FDA-approved and selected off‑label indications supported by CMS‑recognized compendia and professional guidelines. Primary accepted indications include Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) as single‑agent initial or subsequent therapy, Waldenstrom's macroglobulinemia/lymphoplasmacytic lymphoma (single agent or with rituximab), and chronic graft‑versus‑host disease (cGVHD) in patients aged ≥1 year after failure of one or more systemic therapies. Exclusions: Imbruvica is not supported for relapsed/refractory mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL). Concomitant use with anti‑CD20 antibodies for CLL is not supported. Dosing/quantity limits include a single dose limit of 420 mg (CLL/SLL and Waldenstrom's) and monthly maximums by strength/form: 120 (140 mg) or 240 (70 mg) capsules per month; 120 (140 mg), 60 (280 mg), 30 (420 mg), 30 (560 mg) tablets per month. Overall coverage stance: mixed. Required supporting sources for utilization decisions include FDA prescribing information, CMS‑recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature per CMS policy.

Quick Facts / Quantity Limits

Single dose limit420 mg

Monthly capsule limits120 (140 mg) or 240 (70 mg) capsules per month

Monthly tablet limits120 (140 mg), 60 (280 mg), 30 (420 mg), 30 (560 mg) tablets per month

Supported primary indications (count)3 (CLL/SLL, Waldenstrom’s, cGVHD)

Not supported indications (count)2 (relapsed/refractory MCL, MZL)

Initial Therapy Criteria (Approved Indications)

Approved Indications / Inclusion Criteria

Imbruvica may be used when criteria below are met for each disease state:

Indication: CLL/SLL

Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL): Imbruvica may be used as a single agent for initial or subsequent therapy for all prognostic categories of CLL/SLL
NOTE: Use in combination with an anti-CD20 antibody (e.g., rituximab or obinutuzumab) is not supported by Evolent Policy
Based on Level 1 evidence (Burger et al.) showing no added benefit of adding rituximab/obinutuzumab to single-agent ibrutinib in first-line CLL

Indication: Waldenstrom's macroglobulinemia

Member has a diagnosis of Waldenstrom's macroglobulinemia/Lymphoplasmacytic Lymphoma

Continuation Therapy Criteria

Continuation Requests Exemption

Continuation requests for a not-approvable medication shall be exempt provided ALL of the following are met:

ALL of the following

The requested medication was used within the last year
The member has not experienced disease progression and/or no intolerance to the requested medication
Additional medication(s) are not being added to the continuation request

Not Supported Indications / Exclusions

Not Supported Indications (Exclusions)

Use is not supported when ANY of the following exclusion criteria apply:

ANY of the following

Disease progression while receiving Imbruvica (ibrutinib) containing regimen or another BTK inhibitor-containing regimen (e.g., acalabrutinib, zanubrutinib)
For treatment of CLL: concurrent use with an anti-CD20 antibody including any rituximab products or obinutuzumab
Dosing exceeds single dose limit of Imbruvica 420 mg (for CLL/SLL and Waldenstrom's)420 mg
Treatment exceeds the maximum monthly quantity limits: 120 (140 mg) or 240 (70 mg) capsules a month; 120 (140 mg), 60 (280 mg), 30 (420 mg), 30 (560 mg) tablets a month

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization / medical necessity review

Medication requests must be processed by Evolent. Use must be supported by FDA approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets the requirements of the CMS Medicare Benefit Policy Manual Chapter 15. Medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Documentation Required

Support diagnosis and prior therapies

For chronic graft-versus-host disease (cGVHD), document that the member is age 1 year or older and that the condition persisted after failure of one or more lines of systemic therapy. For Waldenstrom's macroglobulinemia, document the diagnosis when Imbruvica is used in combination with rituximab or a rituximab biosimilar.

Applicable Codes

Drug NDCs / CodesNDC

No codes listed

Clinical Evidence & Rationale

Background guidance: Evolent processes medication requests and requires that use of Imbruvica be supported by one of the following: FDA approved product labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer‑reviewed literature in accordance with the CMS Medicare Benefit Policy Manual Chapter 15. For medication management details, reviewers are directed to the FDA label/package insert (prescribing information).

Burger et al. 2019Level 1 RCT: no added benefit of rituximab/obinutuzumab + ibrutinib vs ibrutinib alone in first-line CLL (supports single-agent use)

Janssen Apr 6, 2023Manufacturer voluntary withdrawal and FDA update: Imbruvica accelerated approvals for MCL/MZL not supported after confirmatory trials (policy excludes relapsed/refractory MCL & MZL)

Evidence items to populate:

Prescribing information: Imbruvica prescribing information, Pharmacyclics, 2024.

Primary evidence: Burger JA et al., Blood. 2019 (randomized trial showing no added benefit of adding rituximab/obinutuzumab to single‑agent ibrutinib in first‑line CLL).

Regulatory action: Manufacturer voluntary withdrawal and FDA guidance (Janssen update April 6, 2023) regarding U.S. accelerated approvals for MCL and MZL.

Definitions

Continuation request: A request to continue a medication previously used within the last year provided there is no disease progression or intolerance and no additional medications are being added to the continuation request.

Not‑approvable medication: A medication that is not authorized by Evolent and therefore may not be reimbursable.

Revision History

May 08, 2024approvalLatest

Committee approval recorded (Approval date May 08, 2024).

May 31, 2024effective

Policy effective date set to May 31, 2024.

April 06, 2023coverage_exclusion

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyUm Onc_1262 Imbruvica Ibrutinib_05312024

Policy CodePolicy N/A

Change TypeCoverage position updates

Effective DateMay 31, 2024

Next Review Date

SourceLink

On This Page

Imbruvica will be used as a single agent or in combination with rituximab/rituximab biosimilar as initial therapy or therapy for relapsed disease

Indication: chronic Graft-versus-Host Disease (cGVHD)

Imbruvica may be used in adult and pediatric members age 1 year and older with chronic graft-versus-host disease after failure of one or more lines of systemic therapy

120 (140 mg) or 240 (70 mg) capsules; 120 (140 mg), 60 (280 mg), 30 (420 mg), 30 (560 mg) tablets

Investigational use for off-label indication not supported by CMS-recognized compendia or acceptable peer-reviewed literature as defined by policy

Material policy revision: The policy was updated to reflect a substantive coverage exclusion—Imbruvica is not supported for relapsed/refractory MCL and MZL—based on the manufacturer's voluntary withdrawal and subsequent FDA guidance following confirmatory study results. Committee approval and effective dates were recorded (approval May 08, 2024; effective May 31, 2024).

Denial Risk

Concomitant anti-CD20 with CLL is disallowed

Requests for Imbruvica used concurrently with anti-CD20 antibodies (e.g., rituximab or obinutuzumab) for the treatment of CLL/SLL are not supported by policy and may be denied.

Billing Rule

Quantity limits enforcement

Claims exceeding the policy's single-dose or monthly quantity limits are excluded and may be denied. Single-dose limit: 420 mg. Monthly quantity limits by formulation/strength: capsules — 120 (140 mg) or 240 (70 mg) per month; tablets — 120 (140 mg), 60 (280 mg), 30 (420 mg), or 30 (560 mg) per month.

Substantive exclusion: Imbruvica (ibrutinib) is not supported for relapsed/refractory mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL) based on manufacturer voluntary withdrawal and FDA guidance following confirmatory study results showing no overall survival or progression-free survival advantage.

2019coverage_clarification

Clarification: Combination use of ibrutinib with anti-CD20 antibodies (e.g., rituximab or obinutuzumab) for CLL/SLL is not supported, based on level 1 evidence (Burger et al.) showing no added benefit of adding rituximab/obinutuzumab to single-agent ibrutinib in first-line CLL.