CurrentHighmark DelawarePolicy N/A

Outpatient chemotherapy trastuzumab (Herceptin) request form

Form and requirements for requesting outpatient administration of trastuzumab and specified biosimilars under the medical benefit for Highmark Delaware members; applies to providers submitting authorization/fax requests for covered trastuzumab products.

Policy Summary

PayerHighmark Delaware

PolicyOutpatient chemotherapy trastuzumab (Herceptin) request form

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionFax the completed request form with member/provider details, J-code(s), diagnosis code(s), clinical answers and attachments to 1-833-619-5745.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2Preferred biosimilar options listed

4Non-preferred products listed

1Fax number for submission

MedicalBenefit type shown on form

Coverage Criteria

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Authorization criteria

Coverage consideration consistent with form answers and product preference

Form submission and clinical documentation: Completed request form submitted via fax to 1-833-619-5745 with member and provider details, J-code(s) and diagnosis code(s), answers to clinical questions (cancer type/histology and stage, chemotherapy regimen, line of therapy, prior therapies with progression/relapse status, ECOG score, resectability) and attached pertinent clinical records.

Required for any consideration

Product selection rules: If a preferred biosimilar (Kanjinti Q5117 or Trazimera Q5116) is selected, proceed with review. If a non-preferred trastuzumab product (Herceptin J9355, Ontruzant Q5112, Ogivri Q5114, or Herzuma Q5113) is selected, document prior adequate therapeutic trial and failure of a preferred product, or documentation of intolerance/contraindication; Medicare members already established on non-preferred therapy are exempt from the trial requirement.

Non-preferred rationale must be provided on form

Before submitting a request for outpatient administration of trastuzumab or an FDA-designated biosimilar, verify the member's eligibility and benefits through the health plan. The completed request form must be faxed to Highmark at 1-833-619-5745 and include member identifiers, physician and facility details, the J- or Q-code(s) requested, diagnosis code(s), and the clinical answers requested on the form (cancer type/histology and stage, regimen, line of therapy, prior therapies with progression/relapse status, ECOG, resectability). Attach pertinent clinical records such as progress notes and genetic testing to support medical necessity.

If a non-preferred product (for example Herceptin J9355, Ontruzant Q5112, Ogivri Q5114, or Herzuma Q5113) is selected on the form, provide a clear clinical rationale. A non-preferred product will only be considered when there is documentation of therapy failure after an adequate trial of a preferred product, or when the preferred product is not tolerated or is contraindicated. Note that Medicare members already established on a non-preferred trastuzumab product are exempt from the trial requirement.

Provider Actions and Requirements

Prior Authorization

Prior Authorization via Fax

Prior authorization is required for outpatient trastuzumab (Herceptin and biosimilars). Submit the completed Outpatient Chemotherapy Herceptin (Trastuzumab) Request Form via fax to 1-833-619-5745. Include all required identifiers, physician and facility details, J-code(s), diagnosis code(s), date of service, and attached clinical documentation to avoid delays.

Fax number: 1-833-619-5745
Required identifiers: Member name, date of birth, UMI, insurance type (Medicare or Commercial)
Provider details: Requesting physician name, NPI, address, office contact phone and fax
Facility details: Facility name, NPI, address
Service details: Date of service, J-code(s), diagnosis code(s)

Step Therapy

Preferred-First Requirement and Non-Preferred Products

Preferred-first requirement: Preferred trastuzumab products must be tried first. A non-preferred product (listed below) will only be approved when there is documentation of an adequate therapeutic trial and failure of a preferred product, intolerance to the preferred product, or a contraindication to the preferred product. For Medicare members already established on a non-preferred therapy, a trial of a preferred agent is not required.

Non-preferred products: Herceptin (J9355), Ontruzant (Q5112), Ogivri (Q5114), Herzuma (Q5113)
Medicare exception: Established Medicare members on a non-preferred therapy are exempt from preferred-first requirement
Verification: Please verify member eligibility and benefits through the health plan prior to submission

Documentation Required

Required Form Fields and Attachments

Complete and attach all required form fields and supporting documentation. Incomplete forms or missing attachments may result in denial or delays.

Required form fields: Member name, DOB, UMI, insurance type, requesting physician name, NPI, physician address, office contact phone and fax, facility name, facility NPI, facility address, date of service, J-code(s), diagnosis code(s)
Clinical questions to complete: cancer type and histology, disease stage, complete chemotherapy regimen, line of therapy (first/second/subsequent), prior therapies and response (progression/relapse), ECOG performance status, resectable vs unresectable disease
Attachments: Pertinent clinical information such as progress notes, pathology/genetic testing, prior therapy records
Submission reminder: Fax the completed form and attachments to 1-833-619-5745

Denial Risk

Non-Preferred Product Rationale

When a non-preferred product is requested, provide a clear rationale documenting an adequate trial and failure of a preferred product, intolerance, or a contraindication. Include dates, duration, and clinical response to prior preferred therapy; if intolerance or contraindication is cited, provide supporting clinical details.

If non-preferred selected, include rationale on the form: specific prior preferred agent(s) tried, start/stop dates, reason for discontinuation (progression, toxicity, allergic reaction, contraindication), and objective evidence of failure when available
For intolerance, include description of adverse events and relevant clinical documentation
For contraindication, specify the contraindicating condition and supporting clinical notes or test results

Initial Therapy Criteria

Preferred product expectation

Preference and trial expectations for initial/continuing therapy

Preferred product use: Use of preferred biosimilars (Kanjinti [Q5117] or Trazimera [Q5116]) is expected for all indications unless contraindicated or not tolerated.

Preferred for all indications

Non-preferred product requirements: Non-preferred trastuzumab products (Herceptin [J9355], Ontruzant [Q5112], Ogivri [Q5114], Herzuma [Q5113]) require documentation of prior adequate therapeutic trial and failure of a preferred product, or documentation of intolerance/contraindication before approval; Medicare members already established on non-preferred therapy are not required to trial a preferred agent.

Provide rationale on the form when selecting non-preferred product

Step	Requirement	Medicare exception
1	Documented therapy failure after an adequate therapeutic trial of a preferred trastuzumab biosimilar (Kanjinti Q5117 or Trazimera Q5116), or documentation that the preferred product was not tolerated or is contraindicated. Providers must submit the completed request form with member and provider details, J-code(s) and diagnosis code(s), answers to clinical questions, and attach pertinent clinical records.	Medicare members currently established on a non-preferred trastuzumab product are exempt from the preferred-product trial requirement.

Definitions

Non-preferred product — approval requirements

DefinitionA trastuzumab product listed as non-preferred that requires documented failure, intolerance, or contraindication to a preferred product for consideration.

Approval requirementA non-preferred product will be considered only when the member has documented therapy failure after an adequate therapeutic trial of a preferred product, or the preferred product was not tolerated or is contraindicated.

Medicare exceptionMedicare members currently established on a non-preferred therapy are not required to try a preferred option and are exempt from the trial requirement.

Documentation neededIf selecting a non-preferred product, the provider must provide the rationale on the form and attach pertinent clinical information (progress notes, genetic testing, prior therapies with progression/relapse status).

Submission instructionFax the completed form with rationale and attachments to Highmark at 1-833-619-5745 for consideration.

Background

Trastuzumab and its FDA-designated biosimilars are HER2-directed monoclonal antibodies used in the treatment of HER2-positive cancers as part of outpatient chemotherapy regimens. The Highmark Delaware outpatient chemotherapy request form covers trastuzumab and listed biosimilars and is intended to collect the clinical details necessary to determine medical necessity, including cancer histology and stage, complete chemotherapy regimen, line of therapy, prior therapies, ECOG performance status, and resectability. The form also identifies preferred biosimilars (Kanjinti Q5117, Trazimera Q5116) and lists other trastuzumab products for consideration when appropriate clinical justification is provided.

OpenPayer

Outpatient chemotherapy trastuzumab (Herceptin) request form

Coverage Criteria

Coding and Billing Codes

Provider Actions and Requirements

Initial Therapy Criteria

Step Therapy Requirements

Site of Care

Biosimilar Preference

Definitions

Background

Q5117	Kanjinti
Q5116	Trazimera
J9355	Herceptin
Q5112	Ontruzant
Q5114	Ogivri
Q5113	Herzuma