Centene Vismodegib (Erivedge) Prior Auth Policy

Coverage Criteria

Initial Approval - Basal Cell Carcinoma (BCC)

Covered when ALL of the following are met for BCC:

BCC Initial Therapy: 1) Diagnosis of locally advanced, recurrent, or metastatic basal cell carcinoma that meets one of: disease recurred following surgery; disease recurred following radiation; nodal disease if surgery is not feasible; or diffuse BCC formation (e.g., Gorlin syndrome or other genetic forms of multiple BCC); 2) Prescribed by or in consultation with an oncologist; 3) Age ≥ 18 years; 4) Erivedge (vismodegib) is prescribed as a single agent; 5) Dose does not exceed 150 mg (one capsule) per day; 6) For Erivedge requests, member must use generic vismodegib, if available, unless contraindicated or clinically significant adverse effects are experienced; 7) Prescribed regimen must be FDA-approved or recommended by NCCN, or dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

Structured from policy initial approval section

Initial Approval - Medulloblastoma (off-label)

Covered when ALL of the following are met for medulloblastoma (off-label):

Medulloblastoma Initial Therapy: 1) Diagnosis of recurrent medulloblastoma; 2) Prescribed by or in consultation with an oncologist; 3) Age ≥ 18 years; 4) Tumor positive for a sonic hedgehog mutation; 5) Member has received prior chemotherapy; 6) Erivedge (vismodegib) is prescribed as a single agent; 7) Dose does not exceed 150 mg (one capsule) per day; 8) For Erivedge requests, member must use generic vismodegib, if available, unless contraindicated or clinically significant adverse effects are experienced; 9) Prescribed regimen must be FDA-approved or recommended by NCCN, or dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

Structured from policy medulloblastoma initial approval section

Continuation Therapy

Continued therapy (all indications in section III must meet all):

Continued Therapy: 1) Member is currently receiving medication via the Centene benefit, or documentation shows member has been receiving Erivedge for at least 30 days; 2) Member has responded positively to therapy; 3) New dose does not exceed 150 mg (one capsule) per day; 4) For Erivedge requests, member must use generic vismodegib, if available, unless contraindicated or clinically significant adverse effects are experienced; 5) New prescribed regimen must be FDA-approved or recommended by NCCN, or the new dose/regimen is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

Structured from continued therapy section

Indications / Covered Uses

Coverage aligns with FDA label and NCCN; includes BCC and medulloblastoma indications added over time

Indications added: Policy includes advanced, recurrent, or metastatic basal cell carcinoma; locally advanced BCC; nodal BCC when surgery is not feasible; diffuse BCC per NCCN (including NCCN category 2A recommendations); and use as a single agent for medulloblastoma (off-label) when criteria are met.

Added across 2Q 2021-2024 reviews

Coverage is not authorized for non‑FDA approved indications that are not specifically addressed in this policy unless the provider submits sufficient documentation of efficacy and safety in accordance with the referenced off‑label use policies (CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or applicable evidence‑of‑coverage documents.

For members enrolled in Medicaid, state Medicaid coverage provisions take precedence when there is a conflict between those state provisions and the coverage provisions in this clinical policy. Providers should consult the applicable state Medicaid manual for specific coverage rules.

Initial Therapy Criteria

Initial Therapy

Initial authorization criteria by indication

Initial Therapy: See specific initial approval criteria for each indication (Basal Cell Carcinoma and Medulloblastoma) which require diagnosis-specific elements, prescriber specialty (oncologist or in consultation), age ≥ 18 years, single-agent use, dose limits (≤ 150 mg/day), generic redirection when available, and evidence support for off-label regimens.

Initial Therapy

Initial approval and indication additions documented in annual reviews

Initial approval duration and history: Annual reviews documented additions and clarifications to indications (2Q 2021, 2Q 2022, 2Q 2024) including consolidation of initial approval duration to 6 months and additions of diffuse and nodal BCC per NCCN guidance; subsequent reviews noted no significant change.6 months

See referenced annual review notes

Continuation / Renewal Criteria

Continued Therapy

Criteria for continued coverage

Continued Therapy Nodes: 1) Member currently receiving Erivedge via Centene benefit or has documentation of at least 30 days of therapy; 2) Member has demonstrated a positive clinical response to therapy; 3) Continued/new dose does not exceed 150 mg (one capsule) per day; 4) Continued therapy uses generic vismodegib if available unless contraindicated or clinically significant adverse effects are experienced; 5) Continued/new regimen must be FDA-approved or recommended by NCCN, or supported by practice guidelines/peer-reviewed literature for off-label use (prescriber must submit supporting evidence).

Continuation Therapy

Continuation/renewal durations and template notes referenced historically

Continuation notes: Approval duration references: Medicaid/HIM 12 months; Commercial 12 months or duration of request, whichever is less (historical consolidation to a 6-month initial approval was noted in 2Q 2022). Template verbiage was noted not to apply to the continued therapy section in later reviews.

See policy approval duration and annual review notes

Provider Actions and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must document the diagnosis, prescriber specialty (oncologist or in consultation with an oncologist), and that the request meets the policy's specified clinical criteria (e.g., advanced/recurrent/metastatic BCC, nodal disease when surgery is not feasible, diffuse BCC/Gorlin syndrome, or medulloblastoma criteria).

Prior authorization required before Erivedge (vismodegib) will be authorized
Prescriber must be an oncologist or documented consultation with an oncologist

Documentation Required

Documentation and Indication Mismatch May Lead to Denial

Requests lacking documentation that the member meets all applicable approval criteria — including objective evidence of prior surgery or radiation for recurrent BCC when required, molecular testing for SHH-mutant medulloblastoma, or peer-reviewed support for off-label dosing — may be denied.

Include office chart notes, pathology reports, operative notes, radiation records, imaging, and lab results as applicable

Step Therapy / Formulary Routing

Step	Requirement	Notes
1	Use generic vismodegib if available unless contraindicated or clinically significant adverse effects are experienced	Prescriber must justify use of brand (Erivedge) when generic is available; dose must not exceed 150 mg (one capsule) per day and regimen must be FDA‑approved or recommended by NCCN
	Prescribed by or in consultation with an oncologist when applicable	Applies to initial and continued therapy criteria where specified in policy

Step	Requirement	Notes
1	Generic redirection criteria added (2Q 2022)	Indicates possible step or formulary routing to generic vismodegib alternatives where applicable; operationalizes generic-first preference

Quantity Limits

Erivedge (vismodegib) — Dose and Product Strength

Maximum daily dose150 mg per day (one 150 mg capsule)

Dosing regimen (BCC)150 mg PO once daily

Product formulationCapsule: 150 mg

Definitions

BCC — Basal cell carcinoma

DefinitionBCC: basal cell carcinoma

Covered indication (policy)Advanced, recurrent, metastatic, or locally advanced basal cell carcinoma per criteria

Age / prescriber requirementPrescribed by or in consultation with an oncologist; age ≥ 18 years for covered indications

NCCN — National Comprehensive Cancer Network

AcronymNCCN: National Comprehensive Cancer Network

Role in policyReferenced as a source of guideline support for FDA-approved and off-label dosing/regimens

Reference note

Background

Vismodegib (Erivedge) is a hedgehog pathway inhibitor formulated as a 150 mg capsule and indicated for adults with metastatic basal cell carcinoma or locally advanced basal cell carcinoma that has recurred following surgery or for patients who are not candidates for surgery or radiation. The policy also addresses use in certain off‑label situations (for example, recurrent medulloblastoma with a sonic hedgehog mutation) when the documented criteria are met and supporting evidence from the FDA label, NCCN guidance, or peer‑reviewed literature is provided.

OpenPayer

Clinical Policy: Vismodegib (Erivedge)