CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Odomzo (sonidegib) — Coverage Criteria for Basal Cell Carcinoma

Defines coverage criteria for Odomzo (sonidegib) for adult patients with locally advanced basal cell carcinoma (BCC), including FDA-approved and compendial uses, and specifies authorization durations and continuation criteria.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOdomzo (sonidegib) — Coverage Criteria for Basal Cell Carcinoma

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document that the member meets all approval criteria and has no exclusions to therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 moinitial auth

12 mocontinuation auth

1FDA indication listed

>=1Compendial use

Coverage Criteria for Odomzo (sonidegib)

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FDA or compendial indication: Member has a diagnosis of locally advanced basal cell carcinoma that has recurred after surgery or radiation, or is not a candidate for surgery or radiation (FDA-approved); or basal cell carcinoma as a compendial use.

Based on FDA labeling and NCCN compendium

Authorization duration: Initial authorization may be granted for 12 months for treatment of locally advanced or diffuse basal cell carcinoma (e.g., Gorlin syndrome).12 months

Single-agent use

Continuation therapy

Continuation therapy covered when ALL of the following are met:

Continued benefit: Member is requesting reauthorization for an indication listed in Section II and there is no evidence of unacceptable toxicity or disease progression while on the current regimen.12 months per authorization

Reauthorization duration up to 12 months

Provider Actions, Authorization, and Documentation

Documentation Required

Provider Actions, Authorization, and Documentation

Authorization may be granted for 12 months for initial treatment and for 12 months for continuation/re-authorization. Provider must document that all approval criteria are met and that the member has no exclusions to the prescribed therapy. Use of the medication for indications other than basal cell carcinoma (including non-FDA and non-compendial uses) is considered experimental/investigational and not medically necessary and may be denied. No step therapy requirements are specified in this policy.

Background on Odomzo (sonidegib)

Odomzo (sonidegib) is addressed in this policy as a systemic therapy for basal cell carcinoma. The policy specifies coverage for locally advanced basal cell carcinoma and compendial use for basal cell carcinoma and restricts use outside of that context as experimental or not medically necessary.

Definitions

Locally advanced basal cell carcinoma (BCC) — Definition and qualifying clinical context

DefinitionLocally advanced basal cell carcinoma (BCC): BCC that has recurred following surgery or radiation therapy, or disease in patients who are not candidates for surgery or radiation therapy.

Covered indicationOdomzo (sonidegib) is indicated for treatment of adult patients with locally advanced BCC that has recurred after surgery or radiation or who are not candidates for surgery or radiation.

Authorization durationInitial authorization may be granted for up to 12 months as a single agent for treatment of locally advanced BCC.

Documentation requirementProvider must document that the member meets the definition of locally advanced BCC (recurrent after surgery/radiation or not a candidate for those therapies).

Diffuse BCC (e.g., Gorlin syndrome) — Definition and note that authorization may be granted

DefinitionDiffuse BCC (e.g., Gorlin syndrome): Widespread or multiple basal cell carcinoma lesions (such as seen in Gorlin syndrome) for which systemic therapy may be appropriate.

Authorization noteAuthorization may be granted for up to 12 months as a single agent for diffuse BCC (e.g., Gorlin syndrome).

Coverage stanceDiffuse BCC is included within covered basal cell carcinoma indications when clinical criteria for systemic therapy are met; other non-BCC indications are considered experimental/investigational and not medically necessary.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOdomzo (sonidegib) — Coverage Criteria for Basal Cell Carcinoma

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document that the member meets all approval criteria and has no exclusions to therapy.

SourceLink

On This Page

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Odomzo (sonidegib) — Coverage Criteria for Basal Cell Carcinoma

Coverage Criteria for Odomzo (sonidegib)

Coding and Reference Numbers

Provider Actions, Authorization, and Documentation

Background on Odomzo (sonidegib)

Definitions