CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Um Onc_1480 Columvi Glofitamab Gxbm_08302024

Defines accepted indications, inclusion and exclusion criteria, continuation rules, and authorization workflow for Columvi (glofitamab-gxbm) for applicable lines of business (Commercial, Exchange, Medicaid). Policy references FDA label, CMS compendia, NCCN/ASCO guidelines and peer-reviewed literature.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyUm Onc_1480 Columvi Glofitamab Gxbm_08302024

Policy CodePolicy N/A

Change TypeClarified (metadata/ dates)

Effective DateAug 30, 2024

Next Review Date

Key ActionSubmit medication authorization requests to Evolent with documentation supporting FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature per CMS Medicare Benefit Policy Manual Chapter 15.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes; policy metadata documents committee review dates (08/09/23, 08/14/24), approval date (08/14/24) and effective date (08/30/24).

1Covered Indications

4Exclusion Criteria

3Continuation Exemption Conditions

Coverage Summary

Defines accepted indications for Columvi (glofitamab-gxbm), including use as monotherapy for relapsed or refractory DLBCL or LBCL arising from follicular lymphoma after failure of at least two systemic therapies including an anti-CD20 monoclonal antibody. Continuation requests are exempt when the member has not progressed on the medication, the medication was used within the last year with a lapse of <= 30 days from active authorization, and no additional medications are being added. Exclusions include disease progression while on Columvi, concurrent use with other anticancer therapies, dosing that exceeds a 30 mg single dose, or investigational/off-label uses lacking sufficient evidence. Applicable lines of business: Commercial, Exchange, Medicaid.

Initial Therapy Criteria (Indication: DLBCL / LBCL)

Indication: Diffuse Large B-Cell Lymphoma (DLBCL) / Large B-cell lymphoma (LBCL) arising from follicular lymphoma

Covered when ALL of the following are met:

ALL of the following

Columvi (glofitamab-gxbm) is requested as monotherapy
Diagnosis: relapsed or refractory DLBCL or LBCL arising from follicular lymphoma
Member has failed at least two systemic therapies>= 2 systemic therapies including an anti-CD20 monoclonal antibody (examples: R-CHOP, R-ICE, R-DHAP, R-ESHAP, R-EPOCH, R-GDP)
Failed therapies must include an anti-CD20 monoclonal antibody (examples listed: R-CHOP, R-ICE, R-DHAP, R-ESHAP, R-EPOCH, R-GDP)
Includes
- Patients with disease progression after transplant
- Patients with disease progression after CAR T-cell therapy

Continuation Therapy Criteria

Continuation request exemption

Continuation requests for a not-approvable medication shall be exempt from this Evolent policy provided:

ALL of the following

The member has not experienced disease progression on the requested medication
The requested medication was used within the last year without a lapse of more than 30 days of having an active authorization<= 30 days lapse
Additional medication(s) are not being added to the continuation request

Exclusions / Not Covered (Investigational)

Exclusion criteria (Not covered / Deny)

Therapy is not approved when ANY of the following exclusion criteria are present:

ANY of the following

Disease progression while taking Columvi (glofitamab-gxbm)
Concurrent use with other anticancer therapies
Dosing exceeds single dose limit of Columvi (glofitamab-gxbm) 30 mg> 30 mg single dose
ALL of the following
- Insufficient evidence defined as any of the following:
  - Clinical characteristics of patient and cancer not adequately represented in published evidence
  - Administered regimen not adequately represented in published evidence
  - Reported study outcomes do not represent clinically meaningful outcomes (ASCO definitions: e.g., HR >= 0.80 or survival benefit < 3 months)
  - Experimental design inappropriate to address investigative question
  - Non-randomized trials without significant subject numbers are insufficient alone
  - Case reports and anecdotal information are insufficient
  - Abstracts without full peer-reviewed articles lack sufficient evidence

Denial Risk

Denial for excluded scenarios

Claims may be denied when any exclusion criterion is met. Examples include: disease progression while taking Columvi; concurrent use with other anticancer therapies; dosing that exceeds the single‑dose limit of 30 mg; and investigational or off‑label uses that lack sufficient supporting evidence as defined by the policy (e.g., patient or regimen not represented in published evidence, outcomes not clinically meaningful by ASCO standards, reliance on case reports or abstracts without full peer‑reviewed articles).

Disease progression while taking Columvi
Concurrent use with other anticancer therapies
Single dose > 30 mg
Off‑label use without sufficient evidence per policy criteria (investigational)

Provider Actions

Prior Authorization

Authorization required

Evolent processes all medication requests for Columvi and determines authorization. Medications not authorized by Evolent may be deemed not approvable and not reimbursable. Requests must be supported by FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature per CMS Medicare Benefit Policy Manual Chapter 15.

Documentation Required

Document prior therapies and response

Document the patient’s prior systemic therapy history and responses. At minimum, include documentation of at least two prior systemic therapies and confirmation that one prior regimen included an anti‑CD20 monoclonal antibody. Also document any prior transplant or CAR T‑cell therapy and whether the patient had disease progression after those therapies, as applicable.

At least two prior systemic therapies
One prior regimen must include an anti‑CD20 monoclonal antibody
Record prior transplant or CAR T‑cell therapy and response/progression

Clinical Evidence & References

Policy states accepted uses include FDA-approved indications and off-label uses supported by CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature; Evolent processes medication requests and determines authorization in accordance with these sources and the CMS Medicare Benefit Policy Manual Chapter 15.

Evidence sources

Key clinical referenceDickinson et al., NEJM 2022; Glofitamab for relapsed or refractory DLBCL

Product labelingColumvi prescribing information, Genentech 2023

Guideline compendiaNCCN Cancer Guidelines and Drugs and Biologics Compendium 2024

Revision History

08/09/23committee_review

Utilization Management Committee review on 08/09/23.

08/14/24committee_reviewLatest

Utilization Management Committee review and committee approval dated 08/14/24.

2024-08-30effective_dateLatest

Policy effective date set to August 30, 2024.