CurrentBlue Cross Blue Shield - IowaPolicy 05.04.23

Trastuzumab product coverage and exception process

Defines preferred trastuzumab products, lists non-preferred/targeted trastuzumab products, and describes criteria and prior authorization process for coverage of non-preferred trastuzumab for Wellmark members.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyTrastuzumab product coverage and exception process

Policy CodePolicy 05.04.23

Change TypeNo material change

Effective DateJan 1, 2025

Next Review DateAug 1, 2025

Key ActionObtain prior authorization and submit documentation of an intolerable adverse event to preferred trastuzumab products when requesting a non-preferred product.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2Preferred trastuzumab products listed

5Targeted/non-preferred trastuzumab products listed

1Primary exception criterion

8Billing & HCPCS/CPT codes

Coverage Criteria for Non-Preferred Trastuzumab

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Exception Criteria for Non-Preferred Products

Coverage for a non-preferred trastuzumab product is provided when ALL of the following are met:

Exception criteria for non-preferred trastuzumab: 1) Member requests a non-preferred trastuzumab product.

2) The member has had a documented intolerable adverse event to the preferred products, and the adverse event was not an expected adverse event attributed to the active ingredient as described in the prescribing information (i.e., not a known adverse reaction for both the reference product and biosimilar products).

3) Clinical documentation supports that the member cannot use the preferred biosimilar products (clinical circumstances excluding use of preferred product).

Documentation should include clinical rationale and supporting records as described in the prior authorization process.

Benefit determinations are based on the applicable contract language in effect at the time services were rendered. This policy may not apply to Federal Employee Program (FEP) members; benefits, exclusions, and any limits for FEP members are determined by the member's contract and the Federal Employee Program.

Use of a non-preferred trastuzumab product without meeting the policy's exception criteria is not supported by this policy and may be denied. Coverage for non-preferred products is considered only when clinical circumstances meet the documented exception requirements and prior authorization is obtained.

Procedure and Billing Codes

Procedure/HCPCS and unclassified codesHCPCS

J9355	Injection; trastuzumab (Herceptin), excludes biosimilar; 10 mg
J9356	Injection; trastuzumab, 10 mg and hyaluronidase-oysk
Q5112	Injection, trastuzumab-dttb, (Ontruzant); 10 mg
Q5113	Injection, trastuzumab-pkrb, (Herzuma); 10 mg
Q5114	Q5114 (listed without description in source)
Q5116	Injection, trastuzumab-qyyp, (Trazimera), 10 mg
Q5117	Injection, trastuzumab-anns, (Kanjinti), 10 mg
Q5146	Injection, trastuzumab-strf (Hercessi), biosimilar, 10 mg (effective 1/1/25)
J3490	Unclassified drugs
J3590	Unclassified biologics

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Provider Requirements and Authorization Process

Prior Authorization

Non-preferred trastuzumab prior authorization — Prior Authorization Required

Prior Authorization Required: Prior authorization is required for all non-preferred trastuzumab products. Coverage for a non-preferred product will be considered only when an exception is granted demonstrating appropriate clinical circumstances.

Applies to all members requesting treatment with a non-preferred trastuzumab product.

Note

Preference program — Preferred products designated; non-preferred require exception

Preference Program: A preference program is in place designating preferred trastuzumab biosimilars/products. Non-preferred products require an exception through the prior authorization process and will be reviewed against the exception criteria.

Preferred biosimilars are designated; non-preferred products require an exception process.

Documentation Required

Required documentation — Document intolerable adverse event; dosing considerations

Required Documentation: Provide documented clinical evidence that the member experienced an intolerable adverse event to the preferred trastuzumab product(s). The adverse event must be beyond expected adverse reactions attributed to the active ingredient as described in the prescribing information (i.e., not a known adverse reaction common to both the reference product and biosimilars). Approvals may also be subject to dosing limits consistent with FDA-approved labeling, accepted compendia, and evidence-based practice guidelines.

Documented intolerable adverse event to preferred product(s) — include clinical notes, dates, and nature of reaction.
Documentation that the adverse event is not an expected/known reaction to the active ingredient per prescribing information.
Relevant prior treatment history showing use of preferred product(s) when applicable.
Prescribed dosing and intent; approvals may include dosing limits per FDA labeling or evidence-based guidelines.

Denial Risk

Denial risk for non-preferred product without exception — Requests may be denied without exception

Denial Risk: Requests for non-preferred trastuzumab products may be denied if an exception is not granted. Lack of required documentation demonstrating an intolerable adverse event to preferred products or documentation showing the event is an expected reaction to the active ingredient may result in denial.

Requests without documentation meeting the exception criteria may be denied.
Approvals that are granted may still be subject to dosing limits per FDA labeling and evidence-based guidelines.

Background and Clinical Context

Trastuzumab is a HER2-targeted monoclonal antibody used for HER2-positive cancers; multiple reference and biosimilar formulations are addressed by this policy. The policy designates certain trastuzumab products as preferred and establishes an exception pathway and prior authorization process for requests for non-preferred products when clinical circumstances preclude use of the preferred options.

Preferred and Non-Preferred Product Listing

Preferred vs Targeted/Non-Preferred trastuzumab products

Preferred productKanjinti (trastuzumab-anns)

Preferred productTrazimera (trastuzumab-qyyp)

Targeted / Non-preferred productHerceptin (trastuzumab)

Targeted / Non-preferred productHerceptin Hylecta (trastuzumab and hyaluronidase-oysk)

Targeted / Non-preferred productHercessi (trastuzumab-strf)

Targeted / Non-preferred productHerzuma (trastuzumab-pkrb)

Targeted / Non-preferred productOgivri (trastuzumab-dkst)

Preferred Biosimilars

Billing Rule

Kanjinti — preferred product

Kanjinti (trastuzumab-anns) is listed as a preferred trastuzumab product.