CurrentHawaii Medical Service Association (HMSA)Policy N/A

Bevacizumab and Biosimilars Prior Authorization Coverage Criteria

Prior authorization request form and clinical criteria for bevacizumab (Avastin) and its biosimilars (Alymsys, Mvasi, Vegzelma, Zirabev) for HMSA Medicare Advantage members; directs providers how to request authorization and what clinical information is required.

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyBevacizumab and Biosimilars Prior Authorization Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionRequest prior authorization from CVS Caremark Specialty Programs (fax 1-866-237-5512) before coverage is determined.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5+bevacizumab & biosimilars listed

PA requiredPrior auth required

Trials listedClinical trial pathway

Chart notesDocumentation required

Coverage Criteria for Bevacizumab and Biosimilars

Authorized indications and evidence

Coverage assessment is based on submitted clinical information and meeting one of the following pathways:

Coverage pathways: (1) Requested medication/regimen is for an FDA-approved indication, an NCCN-supported indication with a I or IIA recommendation, or supported by the manufacturer's prescribing information; OR (2) Member is enrolled in specified NCI-sponsored clinical trials (examples: C80405, E4203); OR (3) Member has prior authorization history for the regimen and there is evidence the patient is benefitting from treatment (e.g., positive clinical response or lack of disease progression).

Providers must attach supporting documentation as indicated on the form.

Biosimilar preference and exceptions

Biosimilar preference and exception logic:

Biosimilar preference: Preferred products for the patient's health plan are Mvasi and Zirabev. If requesting a non-preferred product, indicate whether the patient can be switched to a preferred product; if the patient has documented intolerable adverse events to both preferred products, attach supporting chart notes.

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyBevacizumab and Biosimilars Prior Authorization Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionRequest prior authorization from CVS Caremark Specialty Programs (fax 1-866-237-5512) before coverage is determined.

SourceLink

On This Page

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Regimen and benefit documentation

Regimen and benefit assessment:

Regimen documentation: List or describe all agents in the oncology regimen (single agent or multiple agents); provide the patient's diagnosis and ICD-10 code and attach relevant supporting data; indicate whether the medication/regimen is for an FDA-approved indication, an NCCN I or IIA supported indication, or supported by the manufacturer's prescribing information; document contraindications per the medication's prescribing information; report prior authorization history for the regimen and evidence of clinical benefit (e.g., positive response or lack of disease progression).

If the indication is not FDA/NCCN/manufacturer supported, the form directs skipping to later questions; clinical trial enrollment may qualify under a separate pathway.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization must be requested from CVS Caremark Specialty Programs for bevacizumab (Avastin) and its biosimilars. Fax completed prior authorization requests to 1-866-237-5512. If you have questions regarding the prior authorization, contact CVS Caremark at 1-808-254-4414. For Specialty Customer Care (copay or medication delivery) contact CaremarkConnect at 1-800-237-2767.

Send completed form and supporting documentation to CVS Caremark Specialty Programs via fax: 1-866-237-5512
Prior authorization requests must include the most accurate diagnosis and supporting clinical information
Failure to submit a prior authorization request to CVS Caremark may result in noncoverage

Note

Preferred Biosimilar Products

The preferred biosimilar products for the patient's health plan are Mvasi and Zirabev. If either preferred product is clinically appropriate, prescribers are asked whether the patient can be switched to Mvasi or Zirabev. Selection of a non-preferred product (Alymsys, Avastin, Vegzelma) requires justification in the prior authorization submission.

If Mvasi is acceptable: indicate 'Yes; Mvasi' on the form and skip to criteria questions
If Zirabev is acceptable: indicate 'Yes; Zirabev' on the form and skip to criteria questions
If not acceptable, provide clinical justification for use of the requested product

Documentation Required

Required Documentation

Attach relevant and supportive documentation to the prior authorization request. If the patient has documented intolerable adverse events to both preferred products (Mvasi and Zirabev), include chart notes detailing the adverse events. If the intolerable adverse event was not an expected adverse event attributed to the active ingredient per prescribing information, attach supporting chart notes explaining why the reaction is not an expected adverse event.

Provide documentation of the patient's diagnosis and ICD-10 code
List or describe all agents in the oncology regimen (single agent or multiple agents)
If asserting intolerance to Mvasi and Zirabev, include chart notes documenting the intolerable adverse events and whether they are expected adverse reactions per prescribing information

Denial Risk

Submission Requirement

Failure to submit the prior authorization request and required supporting documentation to CVS Caremark Specialty Programs may result in denial of coverage.

Fax: 1-866-237-5512 — send completed form and all supporting documents
Questions: CVS Caremark 1-808-254-4414; Specialty Customer Care/CaremarkConnect 1-800-237-2767

Background

Bevacizumab (Avastin) and multiple biosimilars (including Alymsys, Mvasi, Vegzelma, and Zirabev) are used in oncology regimens across a range of cancers. The prior authorization form collects key regimen and patient information to determine coverage: list all agents in the oncology regimen, indicate whether the therapy is single‑agent or multi‑agent, provide the patient’s diagnosis and ICD‑10 code, and document prior response, contraindications, and clinical trial enrollment when relevant.

The form also implements a biosimilar preference workflow: providers are asked whether the patient can be switched to preferred biosimilars (Mvasi or Zirabev), whether the patient received the requested product in the past 365 days, and whether there is a documented intolerable adverse event to both preferred products — with instructions to attach supporting chart notes when intolerance is claimed.

Definitions and Coverage Standards

Preferred product

Preferred productsMvasi and Zirabev are the preferred biosimilar products for the patient’s health plan.

Switching questionForm asks whether the patient’s treatment can be switched to a preferred product (Mvasi or Zirabev); if yes, instructions direct skipping to the Criteria Questions.

Documentation if cannot switchIf the patient cannot be switched and a non-preferred product is requested, the form requires documentation of intolerable adverse events to both Mvasi and Zirabev with supporting chart notes.

Contact for submissionSend completed form to CVS Caremark Specialty Programs (phone/fax provided on form).

Covered indication standard

Covered indication standardRequested medication/regimen must be prescribed for an FDA-approved indication, an NCCN-supported indication with a I or IIA recommendation, or an indication supported by the manufacturer’s prescribing information.

If not meeting standardIf the indication is not FDA/NCCN/manufacturer supported, the form directs the provider to skip to later questions (see #7 on form).

Required supporting dataProviders must attach relevant and supportive data of the patient’s diagnosis (including ICD-10 code) when submitting the form.

Clinical trial pathwayEnrollment in specified NCI-sponsored clinical trials is an alternate pathway for coverage (listed on the form).

Initial Therapy Criteria

Initial therapy criteria

Covered when ALL of the following are met:

Initial therapy: Indication for therapy is FDA‑approved, supported by NCCN with a I or IIA recommendation, or supported by the manufacturer's prescribing information; all agents in the oncology regimen are listed; the patient's diagnosis and ICD‑10 code are provided with supporting documentation; any contraindications listed in the medication prescribing information are addressed; if not meeting the covered‑indication standard, follow alternate questions or clinical trial pathways.

Clinical trial enrollment is an alternate initial pathway per the form.

Step	Requirement	Provider action / Documentation
1
Provider must indicate whether the patient can be switched to a preferred product (preferred products: Mvasi or Zirabev).
If yes (patient can be switched to Mvasi or Zirabev), skip to criteria questions; if no, answer whether the patient has documented intolerable adverse events to both preferred products and attach supporting chart notes.

Biosimilar Preferences and Notes

Billing Rule

Avastin — ask about switch to Mvasi and require documentation if unable

When Avastin is requested, the form asks whether the patient can be switched to the preferred biosimilar Mvasi; if the patient cannot be switched, documentation (chart notes) of intolerance to the preferred product must be attached.

If Yes (can be switched to Mvasi), skip to Criteria Questions for Mvasi.
If No, attach documentation of intolerable adverse events to Mvasi to support a non-preferred request.

Billing Rule

Avastin — ask about switch to Zirabev and require documentation if unable

When Avastin is requested, the form asks whether the patient can be switched to the preferred biosimilar Zirabev; if the patient cannot be switched, documentation (chart notes) of intolerance to the preferred product must be attached.

If Yes (can be switched to Zirabev), skip to Criteria Questions for Zirabev.
If No, attach documentation of intolerable adverse events to Zirabev to support a non-preferred request.

OpenPayer

Bevacizumab and Biosimilars Prior Authorization Coverage Criteria

Coverage Criteria for Bevacizumab and Biosimilars

Diagnosis and Billing Codes

Provider Actions and Authorization Requirements

Background

Definitions and Coverage Standards

Initial Therapy Criteria

Continuation / Renewal Criteria

Step Therapy / Product Switching

Site of Care

Biosimilar Preferences and Notes