CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Gazyva (obinutuzumab) — coverage criteria for hematologic malignancies

Defines accepted indications, limits, coding, and evidentiary sources for Gazyva (obinutuzumab) for network providers; applies to medication authorization and reimbursement processing by Evolent for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyGazyva (obinutuzumab) — coverage criteria for hematologic malignancies

Policy CodePolicy N/A

Change TypeAdded clinical contenttemplate conversion

Effective DateN/A

Next Review DateN/A

Key ActionPrior authorization through Evolent is required; continuation requests allowed without re‑review if no disease progression and prior use within last year without >30 day lapse.

SourceLink

POLICY UPDATE CHANGES

Added venetoclax to initial and relapsed/refractory setting under CLL indication.

Converted to new Evolent guideline template and replaces UM ONC_1259 Gazyva (obinutuzumab).

J9301HCPCS

6 cyclesInitial therapy limit

2 yearsMaintenance limit

Mar 2025Last review

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CLL/SLL — Initial, Relapsed, Maintenance

Covered when ANY of the following are met for CD20-positive CLL/SLL:

CLL/SLL indications: Initial therapy as a single agent OR in combination with chemotherapy or venetoclax; treatment of relapsed or refractory disease in combination with chemotherapy or venetoclax; maintenance therapy as a single agent for up to 2 years.

Supports single agent or combination use including venetoclax; maintenance limited to 2 years.

Follicular Lymphoma — Initial, Relapsed, Maintenance

Covered when ANY of the following are met for CD20-positive Follicular Lymphoma:

FL indications: Initial therapy in combination with chemotherapy; treatment of relapsed or refractory disease in combination with chemotherapy; maintenance therapy as a single agent for up to 2 years.

Supports combination with chemotherapy for induction; maintenance limited to 2 years.

Coverage will be denied or excluded for members with a documented progression of disease while receiving Gazyva (obinutuzumab). Requests where the dosing exceeds the single‑dose limit of 1,000 mg will be denied. Treatment that would exceed policy duration limits is not covered: > 6 cycles for initial therapy and > 2 years for maintenance therapy. Known hypersensitivity or anaphylaxis to obinutuzumab or any excipient is a contraindication to coverage. Investigational or off‑label uses that lack sufficient evidence or are not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature are excluded.

The policy does not support the addition of obinutuzumab to single‑agent BTK inhibitor regimens such as acalabrutinib + obinutuzumab or ibrutinib + obinutuzumab. Randomized trials have not demonstrated an additional overall survival benefit when an anti‑CD20 antibody (for example, obinutuzumab) is added to acalabrutinib or ibrutinib compared to the BTK inhibitor alone; therefore these combinations are considered not supported by this policy.

Regimen	Indication / Notes	Coverage
Obinutuzumab as single agent
Initial therapy as single agent for CD20-positive CLL/SLL; maintenance single agent up to 2 years
Covered when criteria met (CD20-positive disease; maintenance limited to ≤ 2 years)
Obinutuzumab combined with chemotherapy
Initial or relapsed/refractory therapy for CD20-positive CLL/SLL in combination with chemotherapy
Covered when used for induction or relapsed disease per policy criteria
Obinutuzumab combined with venetoclax
Initial or relapsed/refractory therapy for CD20-positive CLL/SLL in combination with venetoclax
Covered when used for induction or relapsed disease per policy criteria
Maintenance obinutuzumab (single agent)
Maintenance therapy following induction or other therapy for up to 2 years
Covered up to 2 years as single-agent maintenance

Combination	Rationale	Coverage
Acalabrutinib + Obinutuzumab
Not supported because randomized trials do not show additional overall survival benefit when adding an anti-CD20 antibody to acalabrutinib.
Not supported by this policy
Ibrutinib + Obinutuzumab
Not supported because randomized trials do not show additional overall survival benefit when adding an anti-CD20 antibody to ibrutinib.
Not supported by this policy

Coding and Dosage Limits

HCPCS codesHCPCSCovered

J9301

Injection, obinutuzumab, 10 mg

inv-06: Single dose limit — ≤ 1,000 mg

Single dose limit≤ 1,000 mg per administration

Source noteRequests exceeding this single-dose limit will be excluded/denied

Related codingHCPCS J9301 (obinutuzumab, 10 mg) — dosing aggregated to mg limit

inv-07: Maintenance duration — ≤ 2 years

Maximum maintenance durationUp to 2 years as single‑agent maintenance following induction or other therapy

Applies toMaintenance for CLL/SLL and Follicular Lymphoma when given as single agent

Exclusion triggerTreatment exceeding 2 years will be excluded/denied

inv-08: Initial therapy total cycles — ≤ 6 cycles

Initial therapy total cycles limit≤ 6 cycles (total duration limit for initial therapy)

Exclusion triggerTreatment exceeding 6 cycles for initial therapy will be excluded/denied

Applies toInitial (induction) therapy regimens for CLL/SLL and FL when used with chemotherapy or venetoclax as indicated

Provider Requirements and Operational Rules

Prior Authorization

Prior Authorization Required

Prior authorization through Evolent is required for all requests for Gazyva (obinutuzumab). Continuation (renewal) requests may be approved without re‑review under this policy only when ALL of the following are met: the member has not experienced disease progression while on Gazyva; the medication was used within the last year without a lapse of more than 30 days from an active authorization; and no additional medications are being added to the continuation request.

All Gazyva requests must be submitted to Evolent for prior authorization
Continuation requests exempt from full re-review when all continuation conditions above are met

Documentation Required

Required Supporting Evidence

Use of Gazyva must be supported by one of the following sources of evidence: FDA‑approved product labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature that meets CMS standards (see CMS Medicare Benefit Policy Manual Chapter 15 for criteria). For off‑label uses, documentation must demonstrate that the patient and regimen are adequately represented in the published evidence and that study outcomes are clinically meaningful.

Acceptable supporting evidence: FDA labeling; CMS‑recognized compendia; NCCN or ASCO guidelines; peer‑reviewed literature meeting CMS criteria
Peer‑reviewed evidence must address population/regimen representation and clinically meaningful outcomes (e.g., ASCO‑recommended thresholds such as HR < 0.80 or ≥3 months survival benefit when applicable)
Case reports, meeting abstracts without a full peer‑reviewed publication, or insufficiently powered uncontrolled data are generally inadequate

Note

Regimen Preferences and Unsupported Combinations

Evolent identifies preferred regimens and explicitly does not support certain combinations where higher‑level evidence does not demonstrate added benefit. Providers should follow Evolent regimen preferences and avoid unsupported combinations unless strong supportive evidence is provided.

Preferred/acceptable uses include Gazyva as initial therapy, in combination with chemotherapy, in relapsed/refractory disease with chemotherapy, or as single‑agent maintenance for up to two years for appropriate indications (e.g., FL, CLL/SLL) when supported by evidence
Unsupported combinations include adding Gazyva (obinutuzumab) to BTK inhibitors such as acalabrutinib or ibrutinib for CLL/SLL — randomized trials have not shown additional overall survival benefit compared to single‑agent acalabrutinib or single‑agent ibrutinib
When requesting non‑preferred or unsupported combinations, submit robust supporting evidence from CMS‑recognized compendia or high‑quality peer‑reviewed studies meeting CMS standards

Denial Risk

Key Denial Triggers

Denial triggers include progression while receiving Gazyva, dosing above the single‑dose limit, exceeding duration limits, or investigational/off‑label uses lacking sufficient evidence.

Progression of disease while taking Gazyva is an exclusion and will trigger denial
Single dose limit: Gazyva 1,000 mg — requests exceeding this per‑dose limit may be denied
Duration limits: initial therapy limited to 6 cycles; maintenance limited to 2 years — exceeding these limits may result in denial
Investigational/off‑label uses without adequate CMS‑recognized compendia or acceptable peer‑reviewed evidence (per CMS criteria) are not supported

Regimens and Combinations

Regimen	Indication / Limits	Coverage
Obinutuzumab as single agent
Initial therapy or relapsed/refractory disease for CD20-positive CLL/SLL; maintenance single agent for up to 2 years
Covered when clinical criteria met; maintenance limited to ≤ 2 years
Obinutuzumab + chemotherapy
Initial or relapsed/refractory therapy for CD20-positive CLL/SLL in combination with chemotherapy
Covered when used for induction or relapsed disease per policy criteria (initial therapy total cycles ≤ 6)
Obinutuzumab + venetoclax
Initial or relapsed/refractory therapy for CD20-positive CLL/SLL in combination with venetoclax
Covered when used for induction or relapsed disease per policy criteria
Maintenance obinutuzumab (single agent)
Maintenance following induction or other therapy, limited to up to 2 years
Covered up to 2 years as single-agent maintenance

Combination	Evidence Summary	Coverage
Acalabrutinib + Obinutuzumab
Randomized trials do not demonstrate additional overall survival benefit of adding obinutuzumab to acalabrutinib compared to single-agent acalabrutinib.
Not supported by policy
Ibrutinib + Obinutuzumab
Randomized trials do not demonstrate additional overall survival benefit of adding obinutuzumab to ibrutinib compared to single-agent ibrutinib.
Not supported by policy

Line of Therapy Definitions

first-line | second-line | maintenance

Lines of therapy (CLL/SLL): First-line: Initial therapy as a single agent or in combination with chemotherapy or venetoclax; Second-line: Treatment of relapsed or refractory disease in combination with chemotherapy or venetoclax; Maintenance: Single-agent maintenance for up to 2 years.

Venetoclax explicitly included for initial and relapsed settings; maintenance duration limit 2 years.

first-line | second-line | maintenance

Lines of therapy (FL): First-line: Initial therapy in combination with chemotherapy; Second-line: Treatment of relapsed or refractory disease in combination with chemotherapy; Maintenance: Single-agent maintenance for up to 2 years.

Maintenance duration limited to 2 years.

OpenPayer

Gazyva (obinutuzumab) — coverage criteria for hematologic malignancies

Coverage Criteria for Gazyva (obinutuzumab)

Coding and Dosage Limits

Provider Requirements and Operational Rules

Regimens and Combinations

Line of Therapy Definitions

Biomarker Requirements

Definitions and Therapy Duration

Background

Policy Revision History