CurrentNeighborhood Health Plan of Rhode IslandPolicy 1785-A

Erivedge (vismodegib) coverage

Defines coverage criteria for Erivedge (vismodegib) for FDA-approved indications and select compendial uses (adult medulloblastoma), including authorization durations and continuation/reauthorization rules for Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyErivedge (vismodegib) coverage

Policy CodePolicy 1785-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionProviders must obtain authorization for Erivedge; authorization may be granted for 12 months for covered indications (advanced/recurrent/metastatic BCC and eligible adult medulloblastoma).

POLICY UPDATE CHANGES

No material clinical or coverage changes were reported in this update.

2Covered Indications Included

1Compendial Use Specified

All othersNot Covered (Experimental/Investigational)

Coverage Summary & Indications

Covered Indications and Authorization Criteria

Erivedge is covered for the indications below provided all approval criteria are met and the member has no exclusions to the prescribed therapy.

Covered Indications

FDA-Approved Indication: Basal cell carcinoma
- FDA 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.
Compendial Use: Recurrent adult medulloblastoma
- Medulloblastoma: patient criteria: Patient is an adult with recurrent medulloblastoma.
- Medulloblastoma: prior therapy: Patient has received prior systemic therapy.
- Medulloblastoma: tumor genetics: Patient's tumor(s) have mutations in the sonic hedgehog (SHH) pathway.
- Medulloblastoma: single agent use: Use as a single agent.

Not Medically Necessary / Experimental

All other indications are considered experimental/investigational and not medically necessary.

Not Medically Necessary / Experimental: Any indication for vismodegib not listed as an FDA-approved indication or the specified compendial use (adult medulloblastoma) is considered experimental/investigational and not medically necessary.

Continuation / Reauthorization Criteria

Authorization of 12 months may be granted for continued treatment when reauthorization is requested.

Reauthorization criteria

Indication is one listed in the Covered Indications section (FDA-approved BCC or compendial adult medulloblastoma).
Toxicity: No evidence of unacceptable toxicity while on current regimen.
Disease status: No evidence of disease progression while on current regimen.

Applicable Codes

Drug reference / identifierNDC

No codes listed

FDA-approved indication: Basal cell carcinoma (metastatic or locally advanced recurrent or not candidates for surgery/radiation)mixedCovered

Erivedge (vismodegib)	Indicated for 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 duration	Authorization of 12 months may be granted for advanced, diffuse, recurrent, nodal, or metastatic basal cell carcinoma as a single agent.

Compendial use: Adult medulloblastoma (SHH-mutant)mixedCovered

Erivedge (vismodegib)	Recurrent adult medulloblastoma in patients who have received prior systemic therapy and whose tumors have mutations in the sonic hedgehog (SHH) pathway; single agent use.
Authorization duration	Authorization of 12 months may be granted for treatment of recurrent adult medulloblastoma meeting criteria.

Not Medically Necessary / ExperimentalmixedNot Covered

All other indications

Any indication not listed as FDA-approved BCC or the specified compendial use (adult medulloblastoma) is considered experimental/investigational and not medically necessary.

Continuation / Reauthorization criteriamixedCovered

Reauthorization conditions

Authorization of 12 months may be granted for continued treatment when indication is listed in Covered Indications and there is no evidence of unacceptable toxicity or disease progression while on current regimen.

Provider Requirements & Authorization

Prior Authorization

Authorization required for covered indications

Providers must obtain prior authorization for Erivedge when used for covered indications. Authorization may be granted for up to 12 months for treatment of advanced, diffuse, recurrent, nodal, or metastatic basal cell carcinoma and for eligible compendial uses.

Documentation Required

Document tumor genetics for medulloblastoma

For compendial use in recurrent adult medulloblastoma, document that the patient is an adult with recurrent disease, has received prior systemic therapy, and that the tumor has a mutation in the sonic hedgehog (SHH) pathway.

Denial Risk

Use for unlisted indications

Requests for Erivedge for any indication other than the FDA‑approved basal cell carcinoma indication or the specified compendial adult medulloblastoma use are considered experimental/investigational and will be denied as not medically necessary.

Background

Background: Erivedge (vismodegib) is indicated for 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 (FDA labeling). Compendial support is provided for use in recurrent adult medulloblastoma with sonic hedgehog (SHH) pathway mutations.