Prior authorization required for non-preferred brand/reference products

Non-preferred brand/reference products (for example: Avastin, Alymsys, Jobevne, Vegzelma; Herceptin, Herceptin Hylecta, Hercessi, Herzuma, Ogivri, Ontruzant; Rituxan, Rituxan Hycela, Riabni) require prior authorization for all lines of business; preferred biosimilars do not require prior authorization.

• Adequate medical justification must be provided for BOTH preferred formulations before coverage of a non-preferred product (e.g., if the patient has tried Mvasi, the patient must also have a trial of Zirabev or medical justification why Zirabev cannot be used).
• Requests inconsistent with FDA labeling will be reviewed per the Off-Label Use of FDA Approved Drugs policy and, if criteria are met, preferred biosimilars will be required unless adequate justification exists.

Prior authorization governed by Pharmacy Management Drug Policy

Authorization decisions and any specific prior authorization processes for oncology biosimilar drugs are governed by the health plan’s Pharmacy Management Drug Policy.

• Preferred product rules apply to all lines of business and new starts only; the Pharmacy Management Drug Policy defines operational details and may impose step therapy in addition to LCD/NCD requirements.
• Refer to contract/benefit plan language for coverage limitations and to the Pharmacy Management Drug Policy for authorization procedures.

Preferred product requirement for new starts — trial preferred biosimilars first

New starts must use preferred biosimilars first; preferred product requirements apply to all lines of business and to new starts only. A trial of preferred biosimilars is required unless an accepted exception applies.

• If one preferred biosimilar has been tried, the member may be required to trial the other preferred biosimilar or provide medical justification why the second cannot be used before coverage of a non-preferred product.
• Legal/state contract exceptions (e.g., contraindication, intolerance, prior stability, prior use under previous plan) are recognized per the policy guidelines.

Step therapy requirements managed under Pharmacy Management Drug Policy

Any step therapy requirements or specifics beyond the general preferred-product rule are managed under the Pharmacy Management Drug Policy; this excerpt does not provide explicit step therapy algorithms.

• Policy notes that step therapy may be imposed in addition to LCD/NCD requirements and that specifics are defined in the broader Pharmacy Management Drug Policy.
• Providers should consult the Pharmacy Management Drug Policy for operational step therapy rules for a given member or product.

Submit supporting clinical documentation for initial requests and recertification

Clinical documentation must be submitted for each request (initial and recertification) to support medical necessity and continued benefit.

• Include progress notes, prior treatment history, diagnostic testing, laboratory/biomarker results, imaging, and other objective or subjective measures.
• Recertification requires documentation that the drug provides ongoing benefit (improvement or stability) and that dosing remains consistent with FDA label or guideline-supported recommendations.

Policy references: DrugDex, NCCN compendium, prescribing information

The policy was developed using DrugDex, the NCCN compendium, and each drug’s full prescribing information; these references inform indication rationale and criteria.

• Documentation of indication and rationale may be expected during review in accordance with these references.
• When evaluating off-label uses, reviewers may refer to compendia and prescribing information cited in the policy.

Prior authorization required for specific non‑preferred formulations (listed)

Prior authorization is required for the listed non-preferred formulations when requested: Avastin, Alymsys, Jobevne, Vegzelma; Herceptin, Herceptin Hylecta, Hercessi, Herzuma, Ogivri, Ontruzant; Rituxan, Rituxan Hycela, Riabni. Preferred biosimilars (e.g., Mvasi, Zirabev, Trazimera, Kanjinti, Ruxience, Truxima) do not require prior authorization.

• Coverage of a non-preferred formulation requires adequate medical justification for inability to use BOTH preferred biosimilars.
• Treatment requests inconsistent with FDA labeling are reviewed per the Off-Label Use policy; if clinical criteria are met, preferred biosimilars will be required unless adequate justification is provided.

No additional provider actions specified in this segment

None specified in this document segment.

Administer under medical benefit at applicable sites of care

These drugs are administered by a healthcare professional and are covered under the medical benefit; sites of care include infusion center, office, hospital outpatient department, or home when applicable.

• Requested site of care may impact approval timeframe and is subject to review.

Infusion center site-of-care note

The policy does not specify site-of-care restrictions or special requirements for infusion centers in this excerpt.

Use preferred bevacizumab formulations (Mvasi, Zirabev) first

Mvasi and Zirabev are the preferred bevacizumab formulations and do not require prior authorization; they must be used for FDA‑approved and compendia‑supported indications unless adequate medical justification for not using them is provided.

• If a patient tries one preferred agent, documentation of trial of the other preferred agent or medical justification for inability to use it is required before covering non-preferred Avastin-family products.

Preferred bevacizumab formulations do not require prior authorization

Preferred bevacizumab formulations (Mvasi and Zirabev) do not require prior authorization and must be used for FDA‑approved and compendia‑supported indications unless both are medically contraindicated or cannot be used.

Use preferred trastuzumab formulations (Trazimera, Kanjinti) first

Trazimera and Kanjinti are the preferred trastuzumab formulations and do not require prior authorization; they must be used for FDA‑approved and compendia‑supported indications unless adequate medical justification for not using them is provided.

• If patient has tried one preferred trastuzumab biosimilar, trial of the other or justification for inability to use it is required before coverage of non-preferred trastuzumab products.

Preferred trastuzumab formulations do not require prior authorization

Preferred trastuzumab formulations (Trazimera and Kanjinti) do not require prior authorization and must be used for FDA‑approved and compendia‑supported indications unless adequate medical justification is documented.

Use preferred rituximab formulations (Ruxience, Truxima) first

Ruxience and Truxima are the preferred rituximab formulations and do not require prior authorization; they must be used for FDA‑approved and compendia‑supported indications unless adequate medical justification for not using them is provided.

• Rituxan, Rituxan Hycela, and Riabni require prior authorization for all lines of business if preferred options cannot be used.

Preferred rituximab formulations do not require prior authorization

Preferred rituximab formulations (Ruxience and Truxima) do not require prior authorization and should be used for FDA‑approved and compendia‑supported indications unless both preferred agents cannot be used.

HCPCS Q5107 (Mvasi) listed; no explicit code-level preference in excerpt

The HCPCS codes Q5107 (Mvasi) is listed corresponding to reference bevacizumab J9035; the excerpt lists the code but does not state an explicit preference rule beyond the preferred-product statements.

HCPCS Q5118 (Zirabev) listed; no explicit code-level preference in excerpt

The HCPCS code Q5118 (Zirabev) is listed corresponding to reference bevacizumab; no explicit additional preference guidance at the HCPCS-code level is provided in this excerpt.