CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Erivedge 1785 A Sgm P2024

Defines coverage criteria for Erivedge (vismodegib) for FDA-approved metastatic or locally advanced basal cell carcinoma and compendial use for adult medulloblastoma, including authorization duration and continuation criteria. All other indications are considered experimental/investigational and not medically necessary.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyErivedge 1785 A Sgm P2024

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrior authorization required for Erivedge; authorizations are granted for up to 12 months for covered indications (FDA-approved metastatic or locally advanced BCC, specified compendial BCC uses, and compendial adult medulloblastoma meeting criteria).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes noted in this update.

2Covered Indications (distinct)

1Compendial Uses Listed

12Auth Duration (months)

Coverage Summary & Indications

Erivedge (vismodegib) is indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation. Coverage also includes specified compendial uses such as advanced or recurrent basal cell carcinoma subtypes and recurrent adult medulloblastoma with sonic hedgehog pathway mutations. Coverage is contingent on meeting the listed approval criteria and absence of exclusions; authorizations of 12 months may be granted where specified.

Covered Indications and Authorization

Erivedge is covered for the following indications when all approval criteria are met and the member has no exclusions to the prescribed therapy:

FDA-Approved Indication: Treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation.
Authorization of 12 months may be granted; single-agent use.
Compendial Use: Basal cell carcinoma: Basal cell carcinoma — treatment of advanced, diffuse (e.g., Gorlin syndrome), recurrent, nodal, or metastatic basal cell carcinoma.
Authorization of 12 months may be granted; single-agent use.
Compendial Use: Adult medulloblastoma: Adult medulloblastoma — treatment of recurrent adult medulloblastoma in patients who have received prior systemic therapy and whose tumor(s) have mutations in the sonic hedgehog pathway.
Authorization of 12 months may be granted; single-agent use.

Continuation / Reauthorization Criteria

Criteria for continued therapy:

Member requests reauthorization for an indication listed in Covered Indications.
Tolerability: No evidence of unacceptable toxicity while on the current regimen.
Efficacy: No evidence of disease progression while on the current regimen.

Prior Authorization, Documentation, and Denial Risk

Prior Authorization

Authorization required

Prior authorization required for Erivedge; authorizations are granted for up to 12 months for covered indications (FDA-approved metastatic or locally advanced BCC, compendial BCC uses, and compendial adult medulloblastoma meeting criteria).

Documentation Required

Documentation of prior therapies and mutation status

For adult medulloblastoma, documentation must show prior systemic therapy and tumor mutation in the sonic hedgehog pathway.

Denial Risk

Not covered for other indications

Claims for Erivedge for indications other than those listed (FDA-approved BCC or specified compendial uses) may be denied as experimental/investigational and not medically necessary.

Evidence & References

Evidence sources for this policy include the Erivedge package insert (Genentech, March 2023) and the NCCN Drugs & Biologics Compendium (2023). Compendial support exists for certain indications (see compendial uses below).

Evidence type	Citation
Package insert
Erivedge [package insert], Genentech, March 2023
Compendium reference
NCCN Drugs & Biologics Compendium, 2023

Definitions & Background

Indications and compendial uses: FDA-approved indication is for adults with metastatic basal cell carcinoma or locally advanced basal cell carcinoma recurrent after surgery or who are not surgical candidates and are not candidates for radiation. Compendial uses include treatment of advanced, diffuse (e.g., Gorlin syndrome), recurrent, nodal, or metastatic basal cell carcinoma as a single agent, and treatment of recurrent adult medulloblastoma in patients who have received prior systemic therapy and whose tumor(s) have mutations in the sonic hedgehog pathway, as a single agent. All other indications are considered experimental/investigational and not medically necessary. Authorization of 12 months may be granted for initial or continued therapy when criteria are met and there is no evidence of unacceptable toxicity or disease progression.