CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Imbruvica (ibrutinib) — Coverage Criteria

Defines coverage criteria, exclusions, and authorization requirements for Imbruvica (ibrutinib) for Neighborhood Health Plan of Rhode Island members across FDA-approved and selected off-label oncology indications.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyImbruvica (ibrutinib) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMay 31, 2024

Next Review DateMay 8, 2024

Key ActionSubmit prior authorization with documentation showing FDA labeling or accepted compendia/guideline support; continuation requests must document prior use within the last year and absence of progression or intolerance.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

May 31, 2024Effective date

cGVHD ≥1 yrPediatric allowance

420 mgSingle-dose limit

Monthly limitsMonthly caps

Coverage Criteria for Imbruvica (ibrutinib)

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Indications Covered

Covered when ALL of the following are met per indication-specific rules

CLL/SLL: Ibrutinib may be used as a single agent for initial or subsequent therapy for all prognostic categories of chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL).single-agent only (no concurrent anti-CD20)

Combination with anti-CD20 antibodies (e.g., rituximab, obinutuzumab) is not supported by policy.

Waldenstrom's macroglobulinemia / lymphoplasmacytic lymphoma: Member has a diagnosis of Waldenstrom's macroglobulinemia/lymphoplasmacytic lymphoma AND ibrutinib will be used as a single agent or in combination with rituximab/rituximab biosimilar for initial or relapsed therapy.diagnosis required

Chronic graft-versus-host disease (cGVHD): Ibrutinib 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.age >= 1 year and prior therapy failure

This policy defines coverage limitations for Imbruvica (ibrutinib). Imbruvica is covered for specific indications when the indication-specific rules are met (see coverage criteria): CLL/SLL as single-agent therapy across prognostic categories; Waldenstrom's macroglobulinemia/lymphoplasmacytic lymphoma as single agent or in combination with rituximab/rituximab biosimilar; and chronic graft-versus-host disease (cGVHD) for members age ≥ 1 year after failure of one or more lines of systemic therapy. Exclusions include treatment for relapsed/refractory mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL), disease progression while receiving ibrutinib or another BTK inhibitor, concurrent use of ibrutinib with anti-CD20 antibodies for CLL, and requests with dosing or quantity that exceed specified limits.

Off-label or investigational uses of Imbruvica that are not supported by sufficient evidence are considered not medically necessary. Sufficient evidence is defined by conformity with accepted standards — including representation of the patient and cancer in published evidence, adequate description of the administered regimen, clinically meaningful outcomes (e.g., recommended survival benefit thresholds), appropriate study design, and preference for randomized or otherwise robust trials over anecdotal case reports or abstracts without full peer‑reviewed publication. Requests for indications lacking support in CMS‑recognized compendia or acceptable peer‑reviewed literature will not be approved.

Provider Actions and Utilization Management

Prior Authorization

Prior Authorization Requirement

Prior authorization is required. All requests will be reviewed by the Utilization Management Department with final approval determined by the Utilization Management Committee.

All medication requests processed by Evolent; medications not authorized may be deemed not approvable and not reimbursable.

Denial Risk

Combination with anti‑CD20 Not Supported

Ibrutinib (Imbruvica) should be used as a single agent for CLL/SLL. The use of ibrutinib in combination with an anti‑CD20 antibody (for example, rituximab or obinutuzumab) is not supported by policy and will be excluded.

Examples: Rituxan (rituximab), Gazyva (obinutuzumab)

Denial Risk

MCL and MZL Exclusion

Requests for relapsed/refractory mantle cell lymphoma (MCL) or marginal zone lymphoma (MZL) are not supported by policy and will be excluded.

Manufacturer voluntary withdrawal and FDA guidance following confirmatory study results cited in source

Denial Risk

Insufficient Supporting Evidence — Denial Risk

Requests lacking adequate supporting evidence may be denied. Use only one or more of the following sources to support use: FDA approved labeling, CMS‑recognized compendia, NCCN/ASCO clinical guidelines, or peer‑reviewed literature that meets CMS manual standards. Documentation should demonstrate that the patient and regimen are represented in the evidence and that outcomes are clinically meaningful.

Insufficient evidence examples: clinical characteristics not represented, regimen not represented, outcomes not clinically meaningful

Documentation Required

Continuation Request Documentation

For continuation (renewal) requests, provide documentation of prior benefit from ibrutinib and absence of disease progression or intolerance while on therapy. Continuation requests must include prior authorization history, clinical status demonstrating no progression while on ibrutinib, and relevant laboratory/imaging results as applicable.

Document prior use of ibrutinib without progression or intolerance
Include recent clinical assessments, labs, and imaging supporting continued benefit

Billing Rule

Dose/Quantity Limits

Dose and quantity limits apply. Dosing that exceeds a single dose limit of 420 mg (for CLL/SLL and WM) will be excluded. Monthly maximums are enforced: 120 capsules (140 mg), 240 capsules (70 mg) per month or equivalent tablet/package limits (for example, 30 tablets of 420 mg). Requests exceeding these single‑dose or monthly maxima may be denied.

Single‑dose maximum: 420 mg
Monthly limits examples: 120 (140 mg) or 240 (70 mg) capsules per month; 30 (420 mg) tablets per month — see policy for full mapping

Initial Therapy Coverage Rules

Initial therapy

Initial therapy coverage rules by indication

CLL/SLL initial: Ibrutinib may be used as single-agent initial therapy for chronic lymphocytic leukemia / small lymphocytic lymphoma across prognostic categories.single-agent only

Combination with anti-CD20 antibodies is not supported by policy.

Waldenstrom's initial: Ibrutinib may be used as a single agent or in combination with rituximab/rituximab biosimilar for initial therapy of Waldenstrom's macroglobulinemia/lymphoplasmacytic lymphoma.diagnosis required

Continuation Therapy and Renewal Criteria

Continuation requests

Continuation requests for previously used non-approvable medications may be exempt if ALL of the following are met

Continuation exemption: Requested medication was used within the last year AND member has not experienced disease progression and/or intolerance to the requested medication AND additional medication(s) are not being added to the continuation request.all conditions required

Applies to continuation of non-approvable medications per policy.

Step	Requirement	Coverage stance
1	Ibrutinib must be used as a single agent for initial or subsequent therapy of CLL/SLL; concurrent addition of an anti‑CD20 antibody (e.g., rituximab, obinutuzumab) is not supported by policy.	Single‑agent ibrutinib supported; ibrutinib + anti‑CD20 not supported

Background

Ibrutinib is a Bruton tyrosine kinase (BTK) inhibitor used to treat several B‑cell malignancies and chronic graft‑versus‑host disease. The policy recognizes its approved roles in CLL/SLL (as single‑agent initial or subsequent therapy across prognostic categories), in Waldenstrom's macroglobulinemia (as single agent or combined with rituximab/rituximab biosimilar), and in cGVHD for patients age 1 year and older after failure of prior systemic therapy. The policy also notes manufacturer and FDA actions relevant to MCL and MZL that informed the decision not to support Imbruvica for relapsed/refractory disease in those indications.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyImbruvica (ibrutinib) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMay 31, 2024

Next Review DateMay 8, 2024

SourceLink

On This Page

OpenPayer

Imbruvica (ibrutinib) — Coverage Criteria

Coverage Criteria for Imbruvica (ibrutinib)

Coding and Dose Limits

Provider Actions and Utilization Management

Initial Therapy Coverage Rules

Continuation Therapy and Renewal Criteria

Step Therapy and Treatment Sequencing

Quantity and Dispensing Limits

Site of Care Restrictions

Definitions

Background