CurrentUnitedHealthcarePolicy N/A

Erivedge (vismodegib) prior authorization

Prior authorization and notification rules for coverage of Erivedge (vismodegib) for UnitedHealthcare members, including criteria for metastatic or locally advanced basal cell carcinoma and medulloblastoma; affects prescribers and pharmacies submitting coverage requests.

Policy Summary

PayerUnitedHealthcare

PolicyErivedge (vismodegib) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateDec 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation that meets the specified diagnostic and clinical criteria for the requested indication.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsstandard authorization period

metastatic BCC; locally advanced BCC; medulloblastomaindications addressed

auto processmembers under age 19

NCCN recognizedNCCN recognition

Coverage and Authorization Criteria

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inv-01: Initial Authorization — Basal Cell Carcinoma

Covered when ONE of the following for adult patients:

Adult BCC indications: (1) Diagnosis of metastatic basal cell carcinoma; OR (2) Diagnosis of locally advanced basal cell carcinoma AND one of: cancer has recurred following surgery; patient is not a candidate for surgery; patient is not a candidate for radiation.

Authorization issued for 12 months.

inv-02: Reauthorization — Basal Cell Carcinoma

Reauthorization criteria for patients already on therapy:

Reauthorization BCC: Patient does not show evidence of progressive disease while on Erivedge therapy.

Authorization issued for 12 months.

inv-03: Initial Authorization — Medulloblastoma

Covered when ALL of the following are met:

Medulloblastoma initial: (1) Diagnosis of medulloblastoma; (2) Patient has mutations in the sonic hedgehog pathway; (3) Patient has failed prior chemotherapy.

Authorization issued for 12 months.

inv-04: Reauthorization — Medulloblastoma

Reauthorization criteria for medulloblastoma:

Reauthorization medulloblastoma: Patient does not show evidence of progressive disease while on Erivedge therapy.

Authorization issued for 12 months.

State-specific mandates and compendium requirements may affect coverage determinations. Some states mandate benefit coverage for off-label use of medications or require use of particular compendium references; when such state mandates apply, they supersede the language in this policy or the notification/coverage criteria.

For members under the age of 19 years, the prescription will automatically process without a coverage review per the policy rules unless a state mandate specifies otherwise.

Initial Therapy

inv-14: Initial Therapy — Initial approval rules by indication:

Initial approval rules by indication:

Adult BCC initial: Diagnosis of metastatic BCC OR diagnosis of locally advanced BCC plus one of: recurrence after surgery; not a candidate for surgery; not a candidate for radiation.

12-month authorization.

Medulloblastoma initial: Diagnosis of medulloblastoma AND mutations in the sonic hedgehog pathway AND failed prior chemotherapy.

12-month authorization.

Continuation / Reauthorization

inv-15: Continuation Therapy — Reauthorization/continuation rules:

Reauthorization/continuation rules:

Continuation therapy: Approval for continued therapy requires no evidence of progressive disease while on Erivedge.

Authorization issued for 12 months.

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required and will be approved only when the submitted documentation meets the specified diagnostic and clinical criteria.

Note

Provider Highlight

Provider highlight: Confirm diagnosis coding and ensure prior authorization is submitted before initiating therapy to avoid claim denials or delays.

Documentation Required

Supporting Documentation

Coverage may be approved based on previous claim or medication history, submitted diagnosis codes (ICD-10), and/or claim logic. Automated approval processes may be used depending on the program.

ICD-10 diagnosis coding should reflect metastatic BCC, locally advanced BCC, or medulloblastoma as applicable
Previous medication or claim history may support approval when clinical documentation is limited
Automated approval/reauthorization may vary by program

Denial Risk

Criteria-based Coverage Required

Requests that do not meet the documented diagnostic and clinical criteria (e.g., metastatic basal cell carcinoma, or locally advanced basal cell carcinoma with recurrence or when the patient is not a candidate for surgery or radiation; medulloblastoma with SHH-pathway mutation and prior chemotherapy failure) are at risk for denial.

Initial authorization criteria include metastatic BCC OR locally advanced BCC with recurrence or ineligibility for surgery/radiation (authorization issued for 12 months)
For medulloblastoma: diagnosis plus SHH-pathway mutation and failed prior chemotherapy (authorization issued for 12 months)

Key Definitions

Locally advanced basal cell carcinoma (policy definition)

DefinitionLocally advanced basal cell carcinoma: disease that has recurred following surgery or when the patient is not a candidate for surgery or radiation (as used in this policy).

PopulationAdults with locally advanced basal cell carcinoma who have recurrence after surgery or who are not candidates for surgery or radiation.

Authorization periodAuthorization issued for 12 months when approved per policy criteria.

Medulloblastoma with SHH mutation (policy definition)

DefinitionMedulloblastoma with SHH mutation: recurrent medulloblastoma in patients with mutations in the sonic hedgehog (SHH) pathway who have failed prior chemotherapy.

Required diagnostic elementsDiagnosis of medulloblastoma plus documented mutation in the sonic hedgehog pathway and prior failure of chemotherapy.

Authorization periodAuthorization will be issued for 12 months when initial criteria are met.

Background

Vismodegib (Erivedge) 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. Authorization for these indications is based on documentation of the qualifying diagnosis and clinical circumstances.

NCCN guidance also recognizes vismodegib for certain recurrent medulloblastoma cases. Coverage for medulloblastoma is limited to patients with documented sonic hedgehog (SHH) pathway mutations who have failed prior chemotherapy.

Prior authorization is required for Erivedge and approvals are issued for 12 months when the submitted documentation meets the specified diagnostic and clinical criteria; reauthorization requires evidence that the patient does not show progressive disease while on therapy.

Step	Requirement
1	No step therapy requirements specified in this document.

Policy Revision History

2025-12-01effective_dateLatest

Policy effective date updated to 2025-12-01 (per header Effective Date).

2025-10-25last_review

Annual review completed in October 2025 with no changes to coverage criteria; references updated.

2024-10-01annual_review

Annual review with no changes to coverage criteria; references updated.

2023-10-01annual_review

Annual review with no changes to coverage criteria; references updated.

2022-10-01annual_review

Annual review with no changes to coverage criteria and a state mandate was added; references updated.

2020-09-01annual_review

Annual review that added coverage for medulloblastoma and incorporated NCCN recommended review criteria; references updated.

2016-09-01annual_review

Annual review increased authorization period from 10 months to 12 months and updated background and references.

2014-11-01change_control

Change control entry documenting prior authorization/notification for Erivedge (vismodegib).

Policy Summary

PayerUnitedHealthcare

PolicyErivedge (vismodegib) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateDec 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation that meets the specified diagnostic and clinical criteria for the requested indication.

SourceLink

On This Page

OpenPayer

Erivedge (vismodegib) prior authorization

Coverage and Authorization Criteria

Initial Therapy

Continuation / Reauthorization

Provider Actions and Documentation Requirements

Key Definitions

Background

Step Therapy Requirements

Quantity Limits and Supply Constraints

Site-of-Care Restrictions

Policy Revision History