CurrentNeighborhood Health Plan of Rhode IslandPolicy 1785-A

Erivedge (vismodegib) coverage and authorization criteria

This policy governs coverage and authorization criteria for vismodegib (Erivedge) for adults with metastatic or locally advanced basal cell carcinoma and for select cases of recurrent adult medulloblastoma; it applies to members of Neighborhood Health Plan of Rhode Island under the payer's pharmacy/medical benefit as specified.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyErivedge (vismodegib) coverage and authorization criteria

Policy CodePolicy 1785-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization and document indication, prior therapies, and absence of unacceptable toxicity or progression to support approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

FDA-approved + compendialcovered indications scope

12 monthsauthorization duration

SHH mutationbiomarker requirement

single agentagent use

Coverage Criteria for Erivedge (vismodegib)

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Basal Cell Carcinoma (Initial therapy)

Covered when ALL of the following are met for Basal Cell Carcinoma:

BCC Coverage: 1) Diagnosis of metastatic basal cell carcinoma OR locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation; 2) Treatment with vismodegib (Erivedge) as a single agent; 3) Member has no exclusions to prescribed therapy.

Authorization of up to 12 months may be granted.

Adult Medulloblastoma (Compendial use)

Covered when ALL of the following are met for Adult Medulloblastoma:

Adult medulloblastoma coverage: 1) Diagnosis of recurrent adult medulloblastoma; 2) Prior systemic therapy has been received; 3) Tumor(s) have mutations in the sonic hedgehog (SHH) pathway; 4) Treatment with vismodegib (Erivedge) as a single agent.

Authorization of up to 12 months may be granted.

Continuation Therapy

Continuation of therapy:

Continuation/Reauthorization: For members requesting reauthorization for an indication listed above, authorization of up to 12 months may be granted when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Coverage is limited to the indications explicitly listed in this policy: FDA‑approved indications for basal cell carcinoma and the specified compendial use for recurrent adult medulloblastoma. All other diagnoses or uses not described in these criteria are outside the scope of coverage.

Use of Erivedge (vismodegib) for indications other than the FDA‑approved basal cell carcinoma indications and the listed compendial use for adult medulloblastoma is considered not medically necessary and may be denied as experimental/investigational.

Regimen	Indication / Setting	Single‑agent or combination	Prior therapy / requirement	Coverage status
Vismodegib (Erivedge)
Advanced, diffuse (e.g., Gorlin syndrome), recurrent, nodal, or metastatic basal cell carcinoma
Single agent
No prior systemic therapy requirement specified for BCC in policy
Covered

Provider Requirements, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial and continuation authorizations may be granted for up to 12 months; reauthorization requires documentation of clinical benefit and absence of unacceptable toxicity or disease progression.

Authorization duration: up to 12 months for initial therapy
Reauthorization: up to 12 months for continuation when no unacceptable toxicity or disease progression is documented

Documentation Required

Required Clinical Documentation

Provide documentation to support the requested indication and prior treatment history. Include tumor mutation status when applicable.

For Basal Cell Carcinoma: documentation of advanced, diffuse (e.g., Gorlin syndrome), recurrent, nodal, or metastatic disease and prior surgery/radiation status if applicable
For Adult Medulloblastoma: prior systemic therapy history and documentation of sonic hedgehog pathway mutation
Clinical notes showing treatment response or rationale for continued therapy for reauthorization
Medication start date, dosing, and any toxicity/management notes

Denial Risk

Non‑covered Indications / Denial Risk

Uses not listed as FDA-approved or compendial (see Section II) are considered experimental/investigational and will be denied.

Non‑covered indications include all indications other than: metastatic BCC, locally advanced BCC recurrent after surgery or not candidates for surgery/radiation, and compendial uses listed (basal cell carcinoma, adult medulloblastoma)
Requests for indications without supportive FDA approval or recognized compendia citations should be submitted with clinical justification but are likely to be denied

Regimen	Indication / Setting	Single‑agent or combination	Prior therapy / requirement	Coverage status
Vismodegib (Erivedge)
Recurrent adult medulloblastoma with tumor(s) harboring sonic hedgehog (SHH) pathway mutations
Single agent
Prior systemic therapy required
Covered

Biomarker Requirements for Compendial Use

Sonic hedgehog (SHH) pathway mutation — biomarker requirement

BiomarkerPresence of tumor mutations activating the Sonic hedgehog (SHH) pathway

Clinical contextRequired for compendial coverage of recurrent adult medulloblastoma treated with vismodegib (Erivedge)

Testing requirementMutation must be identified in the patient’s tumor tissue prior to coverage decision

Sonic hedgehog pathway mutation — required genomic alteration

DefinitionGenomic alterations in the tumor that result in activation of the Sonic hedgehog (SHH) signaling pathway

Indication linkageRequired for authorization of vismodegib for recurrent adult medulloblastoma after prior systemic therapy

Eligible populationAdults with recurrent medulloblastoma whose tumor(s) demonstrate SHH pathway mutations

Test sourceMutation must be demonstrated in tumor tissue (per clinical documentation)

Definitions and Clinical Terms

Locally advanced basal cell carcinoma not candidate for surgery — definition

DefinitionBasal cell carcinoma that has recurred following surgery or is not amenable to surgical intervention and for which radiation therapy is also not appropriate

Clinical implicationSupports use of vismodegib (Erivedge) as a single‑agent therapy for advanced or locally advanced disease

Coverage contextAuthorization of up to 12 months may be granted for treatment of locally advanced or recurrent BCC when surgery and radiation are not options