CurrentmhnPolicy CP.PHAR.273

Clinical Policy: Vismodegib (Erivedge)

Policy governing medical necessity criteria, approval durations, and usage requirements for vismodegib (Erivedge) for basal cell carcinoma and select off-label medulloblastoma in adult members across Commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyClinical Policy: Vismodegib (Erivedge)

Policy CodePolicy CP.PHAR.273

Change TypeAnnual review (revisions and reference updates)

Effective DateAug 1, 2016

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) supporting that member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

2Q 2025 annual review: no significant change; references reviewed and updated.

2Q 2024 annual review: for BCC, specified locally advanced BCC and added nodal BCC if surgery is not feasible per NCCN 2A recommendation.

2Q 2022 annual review: added diffuse BCC formation indication per NCCN category 2A and added generic redirection criteria; consolidated initial approval duration to 6 months for some lines.

2Q 2021 annual review: added BCC criteria for advanced/recurrent/metastatic BCC and single agent use for BCC and medulloblastoma; references updated.

2Covered Indications (listed)

150 mg/dayStandard maximum dose

18+Minimum covered age (years)

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Required prior exposure for continuation

Coverage Summary

Policy governing medical necessity, approval durations, and usage requirements for vismodegib (Erivedge) for basal cell carcinoma and select off-label medulloblastoma in adult members. Status: CURRENT; Effective date: 08.16 with last review 05.25. Coverage stance: covered_with_criteria. High-level coverage: aligned with the FDA label and NCCN guidance — Erivedge is covered for adults with metastatic BCC or locally advanced BCC not candidates for or recurrent after surgery/radiation when all specified criteria are met, and select off-label coverage is provided for recurrent, adult, SHH-positive medulloblastoma with prior chemotherapy and other criteria.

Initial Therapy Criteria

I. Initial Approval Criteria - Basal Cell Carcinoma

Covered when ALL of the following are met:

ALL of the following

Diagnosis (one of)
- Locally advanced, recurrent, or metastatic BCC and member meets one of: disease recurred following surgery
- Locally advanced, recurrent, or metastatic BCC and member meets one of: disease recurred following radiation
- Locally advanced, recurrent, or metastatic BCC and member meets one of: member is not a candidate for surgery or radiation
- Nodal disease if surgery is not feasible
- Diffuse BCC formation (e.g., Gorlin syndrome or other genetic forms of multiple BCC)
Prescribed by or in consultation with an oncologist
Age ≥ 18 years
Erivedge is prescribed as a single agent
Member must use generic vismodegib, if available, unless contraindicated or clinically significant adverse effects are experienced
Prescriber must document contraindication or adverse effects to use brand
Dose requirement (one of)
- Dose does not exceed 150 mg (one capsule) per day≤ 150 mg/day
- Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)
Prescribed regimen must be FDA-approved or recommended by NCCN
Policy requires regimen alignment with FDA or NCCN

I. Initial Approval Criteria - Medulloblastoma (off-label)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of recurrent medulloblastoma
Prescribed by or in consultation with an oncologist
Age ≥ 18 years
Member has received prior chemotherapy
Tumor is positive for a sonic hedgehog mutation
Erivedge is prescribed as a single agent

Continuation Therapy Criteria

II. Continued Therapy (All Indications in Section I)

Covered when ALL of the following are met:

ALL of the following

Member is currently receiving medication via Centene benefit, or documentation supports member has been receiving Erivedge for a covered indication for at least 30 days
Member has responded positively to therapy
Member must use generic vismodegib, if available, unless contraindicated or clinically significant adverse effects are experienced
Prescriber must document contraindication or adverse effects to use brand
Dose increase requirement (one of)

Diagnoses / Indications Not Authorized

III. Other Diagnoses/Indications

When covered:

ANY of the following

If drug label changed within last 6 months and policy not updated, follow formulary or non-formulary policies CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16 as applicable
If requested use is not listed in III (Diagnoses/Indications not authorized) and criterion re: recent label change does not apply, refer to off-label use policies CP.CPA.09, HIM.PA.154, CP.PMN.53

Applicable Codes

Product NDC / AvailabilityNDC

150 mg capsule

Erivedge product availability - capsule: 150 mg (product strength; exact NDC not specified)

Provider Actions & Operational Requirements

Documentation Required

Support clinical criteria with documentation

Provide documentation to support that the member meets all approval criteria. Required documents include recent office chart notes describing diagnosis, disease history and prior therapies (surgery, radiation, chemotherapy), pathology reports or molecular testing (e.g., SHH mutation for medulloblastoma), relevant imaging reports, and laboratory results. Include medication administration records or pharmacy fill history when applicable. For dose exceptions or off‑label uses, attach peer‑reviewed literature or guideline excerpts that justify the requested regimen.

Office/clinic progress notes detailing diagnosis and prior treatments
Pathology reports, molecular testing (e.g., SHH mutation) or diagnostic imaging
Laboratory results relevant to therapy safety monitoring
Pharmacy fill history or medication administration records
Supporting guidelines or peer‑reviewed literature for dose or off‑label requests

Prior Authorization

Clinical Evidence & References

Prescribing Information: Erivedge Prescribing Information. Genentech (March 2023). Accessed January 30, 2025.

Guideline: National Comprehensive Cancer Network, Basal Cell Skin Cancer Version 1.2025; NCCN Drugs and Biologics Compendium. Accessed January 30, 2025.

Background

Vismodegib (Erivedge) is a hedgehog pathway inhibitor indicated for adults with metastatic basal cell carcinoma (BCC) or locally advanced BCC that has recurred following surgery or who are not candidates for surgery and are not candidates for radiation.

The policy aligns coverage with the FDA label and NCCN recommendations for BCC and includes selected off-label medulloblastoma criteria: recurrent medulloblastoma in adults with prior chemotherapy and tumor positive for a sonic hedgehog (SHH) mutation, prescribed by or in consultation with an oncologist.

Dosage and administration: standard dosing is 150 mg PO once daily (capsule formulation available as 150 mg), and the policy requires that dose requests not exceed ≤ 150 mg/day unless supported by guidelines or peer-reviewed literature.

Other policy requirements include prescriber specialty (oncologist), use of generic vismodegib if available (unless contraindicated), single-agent use, and documentation to support that all approval criteria are met.

Product availability: capsule 150 mg.

This description and criteria reflect alignment with FDA-approved indications and incorporation of NCCN-based recommendations and selected off-label medulloblastoma use (SHH-positive, recurrent, adult).

Revision History

2021-05revised

2Q 2021 annual review: added BCC criteria for diagnosis of advanced, recurrent, or metastatic BCC; included prior surgery or radiation therapy criteria if eligible; added single-agent use for BCC and medulloblastoma; references updated. (P&T Approval Date = 05.21)

2022-05revised

2Q 2022 annual review: added diffuse BCC formation indication per NCCN category 2A; added generic redirection criteria; consolidated initial approval duration to 6 months for some lines; commercial approval durations revised to '12 months or duration of request, whichever is less'; references updated. (P&T Approval Date = 05.22)

2024-05

Policy Summary

Payermhn

PolicyClinical Policy: Vismodegib (Erivedge)

Policy CodePolicy CP.PHAR.273

Change TypeAnnual review (revisions and reference updates)

Effective DateAug 1, 2016

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) supporting that member meets all approval criteria.

SourceLink

On This Page

Member must use generic vismodegib, if available, unless contraindicated or clinically significant adverse effects are experienced

Prescriber must document contraindication or adverse effects to use brand

Dose requirement (one of)

Dose does not exceed 150 mg (one capsule) per day≤ 150 mg/day
Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)

Prescribed regimen must be FDA-approved or recommended by NCCN

New dose does not exceed 150 mg (one capsule) per day≤ 150 mg/day

New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)

Prescribed regimen must be FDA-approved or recommended by NCCN

Policy requires regimen alignment with FDA or NCCN

Prescriber specialty requirement

Erivedge must be prescribed by or in consultation with an oncologist. Prior authorization requests should document the prescribing clinician's specialty and, when applicable, include documentation of consultation with an oncologist (e.g., consultation note or shared care plan).

Prescriber specialty must be Oncology or documentation of oncologist consultation

Billing Rule

Generic redirection

Use generic vismodegib when available. If the brand Erivedge is requested, the prescriber must document a clinical rationale (e.g., intolerance to generic formulation, documented adverse reaction, or other contraindication) in the medical record.

Generic vismodegib should be used unless medically contraindicated
Prescriber must document reasons to use brand Erivedge in the chart

Prior Authorization

Dose limits and evidence for excess

Requests for doses above 150 mg/day require submission of supporting evidence. Prescribers must provide guideline recommendations or peer‑reviewed literature that justify the higher dose and explain the clinical rationale for the exceedance.

Dose > 150 mg/day: attach guideline or peer‑reviewed literature supporting the dose
Prescriber explanation of clinical rationale for dose escalation

Prior Authorization

Off-label use documentation

For off‑label uses not explicitly listed in this policy, providers must reference the applicable off‑label use policy for the patient’s line of business and submit sufficient documentation demonstrating efficacy and safety (e.g., clinical trial data, peer‑reviewed case series, guidelines). Include a clear statement of the requested indication, prior therapies tried, response to therapy, and rationale for why Erivedge is an appropriate choice.

Refer to off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (HIM), CP.PMN.53 (Medicaid)
Submit efficacy/safety evidence for the off‑label indication (clinical trials, case series, guidelines)
Document prior therapies, response, and clinical rationale for Erivedge use

2Q 2024 annual review: for BCC, specified locally advanced BCC and added nodal BCC if surgery is not feasible per NCCN 2A recommendation; references reviewed and updated. (P&T Approval Date = 05.24)

2025-05revisedLatest

2Q 2025 annual review: no significant change; references reviewed and updated. (P&T Approval Date = 05.25)