CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tecentriq and Tecentriq Hybreza (atezolizumab IV/SC)

Defines approved and non-approved indications, continuation rules, dosing limits, substitution of subcutaneous formulation, exclusion criteria, and documentation/evidence requirements for coverage of atezolizumab (IV and SC) for members. Applies to UM processing of medication requests and references FDA labeling, CMS compendia, NCCN/ASCO guidance and peer-reviewed literature.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTecentriq and Tecentriq Hybreza (atezolizumab IV/SC)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateNov 29, 2024

Next Review Date

Key ActionAll medication requests for Tecentriq/Tecentriq Hybreza must be processed by Evolent; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

POLICY UPDATE CHANGES

No material clinical or coverage changes

MultipleCovered Indications

Melanoma comboNot Supported Regimens

Dose limitsOperational Restrictions

Coverage Summary & Accepted Indications

This policy addresses coverage for atezolizumab administered intravenously (Tecentriq) and subcutaneously (Tecentriq Hybreza), including substitution of the subcutaneous formulation for IV for indications listed in the policy. Coverage determinations align with FDA labeling, CMS-recognized compendia, NCCN/ASCO guidance and peer-reviewed literature, and utilization management determinations are processed by Evolent with final approvals by the UM Committee.

Continuation Therapy & Exemptions

Note

Continuation exemption criteria

For continuation requests, document that the medication was used within the last year, the member has not experienced disease progression or intolerance to the medication, and no additional medications are being added to the continuation request.

Requested medication was used within the last year
No disease progression and/or no intolerance to the requested medication
No additional medication(s) are being added to the continuation request

Evidence Requirements & Key Sources

Key trials / sources cited: IMbrave150, IMbrave050, IMscin001, IMpower150, IMvigor130, IMspire150, IMpower010; Tecentriq and Tecentriq Hybreza prescribing information (2024); clinical compendia including NCCN, Clinical Pharmacology, and Micromedex.

Investigational / off‑label uses are evaluated for sufficiency of evidence based on whether the patient and tumor characteristics and the administered regimen are adequately represented in published evidence; whether study outcomes meet clinically meaningful thresholds (ASCO examples such as HR < 0.80 and a survival benefit of at least 3 months for OS/PFS); whether the experimental design is appropriate to the question; and acknowledgement that non‑randomized trials with substantial subjects may be supportive while case reports and abstracts without full peer‑reviewed articles generally do not provide adequate evidence.

Exclusion Criteria (Not Covered)

Denial Risk

Denial for excluded combinations or prior PD-(L)1 progression

Claims will be excluded or denied when atezolizumab is used after disease progression with the same regimen or after progression on prior anti-PD-1/PD-L1 therapy. Claims will also be denied for use in combination with cobimetinib + vemurafenib for metastatic/recurrent/unresectable BRAF V600 malignant melanoma.

Applicable Codes & Dose Limits

Dose limits (operational)mixed

Dose	Tecentriq IV single dose limits: 840 mg every 2 weeks; 1,200 mg every 3 weeks; 1,680 mg every 4 weeks. Tecentriq Hybreza SC single dose limit: 1875 mg every 3 weeks.

Billing Rule

Dose limit enforcement

Claims exceeding the policy single-dose limits for either formulation may be denied. Ensure single-dose dosing does not exceed the following limits for each route:

IV single-dose limits: 840 mg every 2 weeks; 1,200 mg every 3 weeks; 1,680 mg every 4 weeks
SC single-dose limit: 1,875 mg every 3 weeks

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required by Evolent

All medication requests for Tecentriq/Tecentriq Hybreza must be processed by Evolent. Medications not authorized by Evolent may be deemed not approvable and therefore not reimbursable.

Documentation Required

Supportive evidence/documentation required

Use must be supported by one of the following: FDA approved product labeling, CMS-approved compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 requirements. Documentation should address clinical characteristics of the patient and cancer, whether the administered regimen is represented in published evidence, and whether reported study outcomes represent clinically meaningful outcomes.

FDA approved product labeling
CMS-approved compendia
NCCN or ASCO clinical guidelines
Peer-reviewed literature meeting CMS Medicare Benefit Manual Chapter 15
Documentation should address clinical characteristics, regimen representation, and clinically meaningful outcomes

Background & Definitions

Background: This policy describes accepted indications for atezolizumab IV (Tecentriq) and SC (Tecentriq Hybreza), and allows substitution of the SC formulation for IV for the indications listed. Evolent (Utilization Management) processes all medication requests and the Utilization Management Committee provides final approval authority.

Definitions: - High risk of recurrence (HCC): any of the following: tumor size > 5 cm; > 3 tumors; macrovascular invasion or microvessel invasion on histology; or grade 3/4 histology.