CurrentAvMedPolicy N/A

Prior authorization for non-preferred bortezomib (Boruzu™ J9054)

Form and policy governing prior authorization and step-edit approval for Boruzu™ (bortezomib ready-to-use, J9054) when requested as a non-preferred medical/Part B oncology drug for AvMed members; affects prescribing oncologists and provider offices submitting PA requests.

Policy Summary

PayerAvMed

PolicyPrior authorization for non-preferred bortezomib (Boruzu™ J9054)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for J9054 Boruzu™ and submit documentation of diagnosis, prior therapies, and any required biomarker test results.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J9054Non-preferred code

J9041–J9051Preferred codes

6 moInitial auth

6 moReauth

Fax 1-877-535-1391Submission fax

Coverage Criteria

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Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial Authorization All Criteria: 1) The requesting provider is an oncologist; 2) Use of the requested oncology therapy is documented in FDA labeling for a specific indication OR accepted off‑label indication found in one of the listed compendia (American Hospital Formulary Service, NCCN Drugs & Biologics Compendium Category 1 or 2A, Elsevier Clinical Pharmacology, Thompson Micromedex DrugDex Class I/IIa/IIb, Wolters Kluwer Lexi‑Drugs Level A) OR medical necessity with supporting clinical rationale and documentation (experimental/investigational uses per the chemotherapy administration policy are excluded); 3) If a biomarker/genetic component is required for the drug's site of action, submit and attach results from an FDA‑approved test and identify the test used; 4) Member has tried and failed current treatment‑guideline and FDA label‑recommended first‑line agents OR has documented intolerance, an FDA‑labeled contraindication, or hypersensitivity to first‑line therapies; 5) Provider must submit documentation of contraindication, failure, or intolerance to any preferred agents prior to approval of a non‑preferred product (step therapy requirement applies to overlapping compendia‑supported indications/regimens); 6) Requesteddose/quantity must be in accordance with FDA‑approved labeling — if the quantity requested is higher than the FDA maximum, the prescriber must submit clinical literature and supporting medical documentation demonstrating safety and efficacy of the higher dose; 7) If requesting a brand formulation when generics exist, provider must submit documentation of failure, contraindication, or intolerance to the generic product.

All listed documentation (chart notes, prior regimen dates, labs, diagnostics, literature as applicable) must be submitted or the request may be denied.

Continuation/Reauthorization — Reauthorization covered when ALL of the following are met

Reauthorization covered when ALL of the following are met

Reauthorization Criteria: 1) Member is currently receiving the requested medication; 2) All initial authorization criteria continue to be met; 3) Provider submits documentation of contraindication, failure, or intolerance to any preferred agents if not already provided (step therapy applies to overlapping compendia‑supported indications/regimens); 4) Member requires continuation of therapy and is NOT experiencing disease progression; 5) Ongoing treatment is consistent with FDA labeling or compendia support; 6) Member is NOT experiencing an FDA‑labeled limitation of use or toxicity; 7) Quantity (dose) requested is in accordance with FDA‑approved labeling.

Chart documentation, including labs, diagnostics, and relevant chart notes, is required for review and may be requested to support continued approval.

Experimental or investigational use is excluded from medical necessity determinations in accordance with the chemotherapy administration policy. Requests for non‑preferred bortezomib (Boruzu™, J9054) that represent experimental or investigational use will not meet coverage criteria and should not be approved.

Provider Actions & Requirements

Prior Authorization

Authorization required for J9054 (Boruzu™)

Prior authorization is required for J9054 Boruzu™ (bortezomib ready-to-use). When all coverage criteria are met, initial approvals are granted for up to 6 months; reauthorization is available for 6 months with documentation of ongoing benefit and adherence to criteria.

Code requiring authorization: J9054

Step Therapy

Step therapy requirement — document failure/intolerance/contraindication

Providers must document failure, intolerance, or an FDA-labeled contraindication to preferred bortezomib agents (and generics if brand is requested) before a non-preferred product will be approved; step therapy applies to overlapping compendia-supported indications/regimens.

Submit documentation of contraindication, failure, or intolerance to any preferred agent prior to approval
Step therapy requirement applies to overlapping compendia-supported indications/regimens

Documentation Required

Required clinical documentation to support PA

Include supporting documentation with the prior authorization request: diagnosis, relevant labs and diagnostics, chart notes including prior chemotherapy regimens and dates, and biomarker/genetic test results (if required) using an FDA‑approved test with the test identified.

Documented diagnosis and indication consistent with FDA labeling or accepted compendia
Lab and diagnostic results and chart notes (including prior chemotherapy regimens and dates)
If biomarker/genetic requirement: submit FDA‑approved test results and identify the test used
If requesting higher-than‑label dose or brand when generics exist: submit supporting literature and documentation

Denial Risk

Incomplete or illegible submission may delay or deny authorization

Authorization requests can be delayed or denied if the information provided is incomplete, incorrect, or illegible; ensure the prescribing physician signature and all required fields are complete and legible before faxing.

Prescribing physician must sign and clearly print name (preprinted stamps not valid)
Fax completed request to 1-877-535-1391
Incomplete, incorrect, or illegible submissions may delay or result in denial of authorization

Background

Bortezomib is a proteasome inhibitor available in multiple manufacturer formulations. The ready‑to‑use preparation marketed as Boruzu™ (J9054) is designated non‑preferred by this payer and requires prior authorization; initial approvals are granted for up to 6 months with reauthorization available for an additional 6 months when ongoing benefit and criteria are documented.

When a biomarker or genetic component is required for the drug’s site of action, providers must submit results from an FDA‑approved test and identify which test was used. For non‑preferred Boruzu™, authorization also requires documentation that the member has tried and failed guideline‑ and FDA‑recommended first‑line agents or has a documented intolerance, contraindication, or hypersensitivity, and evidence of prior chemotherapy regimens (dates/cycles) as applicable.

Definitions & Compendia

Compendia-supported use

Acceptable compendia for off-label useAccepted off-label indications must be documented in one of the following: American Hospital Formulary Service Drug Information (AHFS), National Comprehensive Cancer Network Drugs & Biologics Compendium (Category 1 or 2A), Elsevier Gold Standard Clinical Pharmacology, Thompson Micromedex DrugDex (Class I, IIa, or IIb), or Wolters Kluwer Lexi-Drugs (Level A).

FDA labeling alternativeUse consistent with FDA labeling for a specific indication is acceptable in lieu of compendia support.

Medical necessity pathwayIf not supported by FDA labeling or listed compendia, provide clinical rationale and supporting chart notes/literature to substantiate medical necessity (experimental/investigational use is excluded).

Documentation requirementEnsure the diagnosis is documented on the request and cite the compendium or FDA labeling used to support the indication.

Biomarker / Genetic Test Requirements

Biomarker/genetic test requirements

Required test typeSubmit and attach genetic mutation, receptor, biomarker, or laboratory documentation using an FDA‑approved test, including both the results and identification of the test used.

When requiredThis requirement applies when a biomarker/genetic component is required for the drug's site of action.

Where to attachInclude the FDA‑approved test results and name of the test with the prior authorization submission (attach chart/lab reports).

Interaction with medical necessityFailure to provide required FDA‑approved test results may preclude approval if the biomarker is necessary to establish the drug's site‑of‑action for the requested indication.

J9041	Bortezomib Injection
J9046	Bortezomib Injection (Dr. Reddy's mfg.)
J9048	Bortezomib Injection (Fresenius mfg.)
J9049	Bortezomib Injection (Hospira mfg.)
J9051	Bortezomib Injection (Maia mfg.)

OpenPayer