CurrentNeighborhood Health Plan of Rhode IslandPolicy 1786-A

Odomzo (sonidegib) for basal cell carcinoma

Defines coverage for Odomzo (sonidegib) for adult patients with locally advanced basal cell carcinoma (BCC) per FDA-approved and compendial indications, including authorization duration and continuation criteria. Excludes all other indications as experimental/investigational.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOdomzo (sonidegib) for basal cell carcinoma

Policy CodePolicy 1786-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionAuthorization may be requested for up to 12 months for initial therapy and reauthorization when criteria are met; providers must request authorization and document indication and absence of unacceptable toxicity or disease progression for continuation.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes

1Covered Indications (FDA-approved)

1Compendial Covered Indications

All othersExperimental/Not Medically Necessary

Coverage Summary

Scope: Defines coverage for Odomzo (sonidegib) for adult patients with locally advanced basal cell carcinoma (BCC) per FDA-approved and compendial indications, including authorization duration and continuation criteria. Odomzo is indicated for adults with locally advanced BCC that has recurred following surgery or radiation therapy, or for patients who are not candidates for surgery or radiation therapy. Compendial (NCCN) use for basal cell carcinoma is also covered. All other indications are excluded and considered experimental/investigational.

FDA-Approved Indication - Initial Authorization

Covered when ALL of the following are met:

Adult patient: Patient is an adult
Odomzo indicated for adult patients
Diagnosis of locally advanced basal cell carcinoma (BCC)
Includes locally advanced or diffuse BCC (e.g., Gorlin syndrome)
Recurrence or not candidate: Disease has recurred following surgery or radiation therapy, OR patient is not a candidate for surgery or radiation therapy
Either recurrence after surgery/radiation OR inoperable / not candidate

Not Medically Necessary / Experimental

Not covered:

Other indications excluded: Any indication other than FDA-approved indications or compendial uses
All other indications are considered experimental/investigational and not medically necessary

Authorization, Continuation & Provider Requirements

Authorization Duration / Continuation

Authorization rules:

Initial authorization: up to 12 months as a single agent for treatment of locally advanced or diffuse BCC (e.g., Gorlin syndrome)up to 12 months
Authorization of 12 months may be granted
Continuation authorization: up to 12 months when requesting reauthorization for a listed indication and there is no evidence of unacceptable toxicity or disease progression while on the current regimenup to 12 months
Requires absence of unacceptable toxicity or disease progression

Prior Authorization

Prior authorization required for Odomzo

Prior authorization is required for Odomzo (sonidegib). The provider must request authorization and demonstrate that the patient's indication meets FDA-approved labeling or compendial criteria for basal cell carcinoma.

Initial authorization: up to 12 months
Reauthorization: document no unacceptable toxicity or disease progression

Documentation Required

Documentation for reauthorization

For reauthorization/continuation of therapy, the provider must document there is no evidence of unacceptable toxicity and no disease progression while on the current regimen. Include clinical assessment notes that address toxicity and disease status to support the continuation request.

Document clinical assessment of toxicity (no unacceptable toxicity)
Document evidence of no disease progression on current regimen

Background & Evidence

Odomzo (sonidegib) is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or for patients who are not candidates for surgery or radiation therapy, following FDA labeling. Compendial guidance from the NCCN Drugs & Biologics Compendium also lists basal cell carcinoma as a covered compendial use. Definition: Locally advanced basal cell carcinoma (BCC) is basal cell carcinoma that is advanced and not amenable to curative surgery or radiation, including diffuse disease such as Gorlin syndrome.

Evidence: Odomzo [package insert], Sun Pharmaceutical Industries, Inc.; August 2023. NCCN Drugs & Biologics Compendium, 2023.