CurrentCignaPolicy N/A

Erivedge (vismodegib) prior authorization for hedgehog pathway inhibitor therapy

Defines prior authorization requirements and medical necessity criteria for coverage of Erivedge (vismodegib capsules) for adults, including FDA‑approved indications and certain supportive-evidence uses, for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyErivedge (vismodegib) prior authorization for hedgehog pathway inhibitor therapy

Policy CodePolicy N/A

Change TypeMaterial updates: added neoadjuvant approval optionremoved previous applicability note

Effective DateJan 21, 2026

Next Review DateJan 21, 2026

Key ActionSubmit prior authorization documentation supporting age, diagnosis, prior therapies and SHH mutation as applicable; approvals issued for 1 year when criteria met.

SourceLink

POLICY UPDATE CHANGES

Erivedge will be used as neoadjuvant therapy before surgery was added as an option for approval for locally advanced basal cell carcinoma.

The note excluding applicability to patients already started on Erivedge for prior progression on Odomzo was removed.

2FDA-approved indications

2Supportive-evidence uses

1 yearApproval duration

≥18Minimum age

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Coverage and Medical Necessity Criteria

inv-01: FDA-Approved Indications

Covered when ALL of the following are met for FDA‑approved indications:

Locally Advanced BCC Approval

One of the following for Locally Advanced: i. Erivedge will be used as neoadjuvant therapy before surgery; OR ii. Erivedge will be used in combination with radiation therapy; OR iii. Patient has recurrent basal cell carcinoma following surgery or radiation therapy; OR iv. According to the prescriber, the patient is not a candidate for radiation therapy or surgery.
options i-iv

Metastatic BCC Approval: Approve for 1 year if ALL: Patient is >= 18 years of age (includes primary or recurrent nodal metastases and distant metastatic disease).

inv-02: Other Uses with Supportive Evidence

Covered when ALL of the following are met for Other Uses with Supportive Evidence:

Diffuse Basal Cell Carcinoma Formation: Approve for 1 year if patient is >= 18 years of age (includes basal cell nevus [Gorlin] syndrome or other genetic forms of multiple basal cell carcinoma).

Central Nervous System Cancer (medulloblastoma): Approve for 1 year if ALL: A) Patient is >= 18 years of age; AND B) Patient has medulloblastoma; AND C) Patient has tried at least one chemotherapy regimen (examples: cyclophosphamide, etoposide, carboplatin, cisplatin, vincristine); AND D) Patient has a mutation of the sonic hedgehog (SHH) pathway.

Includes brain and spinal cord tumors. NCCN lists this as an option for recurrent medulloblastoma with prior systemic therapy and SHH mutation (useful in certain circumstances, category 2A).

Use of Erivedge (vismodegib) is limited to the indications and situations described in this policy. Treatments not meeting the specific medical necessity criteria listed for FDA‑approved indications or for the other uses with supportive evidence are considered not medically necessary and are not covered. Prior authorization is required and approvals are issued for 1 year when criteria are met; documentation must support the patient’s age (≥ 18 years), the qualifying diagnosis, and any required prior therapies or biomarker status as specified in the policy.

Erivedge is explicitly considered not medically necessary for basal cell carcinoma (locally advanced or metastatic) in a patient with disease progression while on Odomzo (sonidegib). The policy cites lack of data supporting benefit after progression on another hedgehog pathway inhibitor and notes that patients who develop resistance to one hedgehog inhibitor are not expected to respond to another; an open‑label study reported patients resistant to Odomzo also progressed on Erivedge.

Coding and Age Requirements

Covered CPT/HCPCS/ICD Coding Expectationsmixed

No codes listed

Minimum patient age

Minimum patient agePatient must be ≥ 18 years of age for all approvals noted in this policy.

ApplicationApplies to FDA‑approved indications (locally advanced and metastatic basal cell carcinoma) as well as supportive‑evidence uses (diffuse BCC formation, CNS medulloblastoma).

Documentation requirementProvider should document date of birth or other evidence of age in the prior authorization request.

Prior Authorization, Documentation, and Billing Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for coverage of Erivedge (vismodegib). When criteria are met, approvals are issued for 1 year.

Approval duration: 1 year when required criteria are met

Step Therapy

Step and Failure Therapy

For certain indications, members must have tried and failed prior therapy before Erivedge will be approved. Specifically, for central nervous system cancers (including medulloblastoma), the patient must have tried at least one chemotherapy regimen (examples: cyclophosphamide, etoposide, carboplatin, cisplatin, vincristine) prior to approval.

Required prior therapy for CNS medulloblastoma: ≥1 chemotherapy regimen (e.g., cyclophosphamide, etoposide, carboplatin, cisplatin, vincristine)

Definitions and Clinical Terms

Locally Advanced BCC

DefinitionLocally advanced basal cell carcinoma: disease for which Erivedge is approved as neoadjuvant therapy before surgery, in combination with radiation, for recurrent disease after surgery or radiation, or when the prescriber states the patient is not a candidate for surgery or radiation.

Approval durationAuthorize for 1 year when criteria are met.

Guideline contextNCCN lists Erivedge for locally advanced (extensive) disease including situations where surgery/radiation may not be curative or would cause significant functional limitation (category 2A/2B).

Diffuse BCC Formation

DefinitionDiffuse basal cell carcinoma formation: multiple BCCs including basal cell nevus (Gorlin) syndrome or other genetic forms of multiple BCCs.

Approval criteria

Line-of-Therapy and Salvage Use

inv-15: salvage

salvage: Patient has received prior systemic therapy (at least one chemotherapy regimen) before Erivedge is considered for CNS medulloblastoma.

Examples of chemotherapy agents include cyclophosphamide, etoposide, carboplatin, cisplatin, vincristine.

Biomarker and Mutation Requirements

SHH (sonic hedgehog) pathway mutation

Required biomarkerPresence of a mutation in the sonic hedgehog (SHH) pathway is required for approval in CNS medulloblastoma cases.

Indication-specific useSHH mutation requirement applies to adult medulloblastoma (brain or spinal cord) approved after prior systemic therapy.

Supporting examplesNCCN lists Erivedge as an option for recurrent medulloblastoma with SHH mutations after prior systemic therapy (useful in certain circumstances, category 2A).

Approved Regimens and Guideline-Based Uses

Regimen	Indication	Coverage Status	Support/Citation
Vismodegib (Erivedge)
Medulloblastoma with SHH (sonic hedgehog) pathway mutation after prior systemic therapy
Covered with criteria
NCCN lists Erivedge as a treatment option for recurrent medulloblastoma after prior systemic therapy in patients with SHH pathway mutations (category 2A). Coverage requires prior systemic therapy and documentation of SHH mutation.

Background

Erivedge (vismodegib) is a hedgehog pathway inhibitor indicated for adults with metastatic basal cell carcinoma or locally advanced basal cell carcinoma that has recurred after surgery or for patients who are not candidates for surgery or radiation. Clinical guidance (NCCN) supports use of vismodegib for locally advanced and metastatic basal cell carcinoma and recognizes its role as an option in SHH‑mutated medulloblastoma after prior systemic therapy.

Per the policy, approvals for covered indications are contingent on meeting the age and clinical criteria described elsewhere in this document, including minimum age ≥ 18 years, documentation of diagnosis, prior therapy history where required, and SHH pathway mutation status for central nervous system medulloblastoma cases.