CurrentHealth NetPolicy N/A

Clinical Policy: Sonidegib (Odomzo)

Defines medical necessity criteria, prior authorization and approval durations for sonidegib (Odomzo) for treatment of basal cell carcinoma (BCC) across Commercial, HIM and Medicaid lines of business.

Policy Summary

PayerHealth Net

PolicyClinical Policy: Sonidegib (Odomzo)

Policy CodePolicy N/A

Change TypeAnnual review updates (2022, 2024, 2025)

Effective DateMay 1, 2012

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

2Q 2022 annual review expanded BCC indication to include local recurrence and diffuse BCC formation and added generic redirection criteria; Commercial approval duration revised.

2Q 2024 annual review added indication for nodal disease where surgery is not feasible per NCCN.

2Q 2025 annual review: no significant changes; references reviewed and updated.

1FDA-approved indication (BCC)

200 mg/dayStandard dose

>=18Minimum age

30 daysMin prior exposure for continuation

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Coverage Summary

Coverage stance: covered_with_criteria for Sonidegib (Odomzo). Scope: Defines medical necessity criteria, prior authorization and approval durations for sonidegib (Odomzo) for treatment of basal cell carcinoma (BCC) across Commercial, HIM and Medicaid lines of business. Effective date: 2012-05-01. Last review: 2025-05-25.

Initial Approval Criteria

Odomzo is medically necessary when ALL of the following are met:

a. Basal Cell Carcinoma (BCC) (must meet all):

Locally advanced/recurrent disease criteria
- i: Member has disease that recurred following surgery
- ii: Member has disease that recurred following radiation
- iii: Member is not a candidate for surgery or radiation
Diffuse BCC formation (e.g., Gorlin syndrome or other genetic forms of multiple BCC)
Listed as an indication
Nodal disease and surgery is not feasible
Added per 2Q 2024
Prescribed by or in consultation with an oncologist
Age ≥ 18 years>= 18 years
For Odomzo requests, member must use generic sonidegib, if available, unless contraindicated or clinically significant adverse effects are experienced
Odomzo is prescribed as a single agent
Dose requirements (must meet one)
- 200 mg per day200 mg/day
- Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)
Dose does not exceed both of the following: 1 tablet per day and 200 mg per daymax 1 tablet/day; max 200 mg/day
i. 1 tablet per day; ii. 200 mg per day
Prescribed regimen must be FDA-approved or recommended by NCCN

Continuation Therapy Criteria

Continued Therapy (Renewal) Criteria

Continuation is authorized when ALL of the following are met:

ALL of the following

Member is currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Odomzo for BCC and has received this medication for at least 30 days>= 30 days
Basal Cell Carcinoma (must meet all applicable BCC criteria as in initial approval)
Member is responding positively to therapy
For Odomzo requests, member must use generic sonidegib, if available, unless contraindicated or clinically significant adverse effects are experienced

Diagnoses / Indications NOT Authorized

Diagnoses/Indications NOT authorized

Coverage not authorized for:

Non-FDA approved indications which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off-label use policies (CP.CPA.09 commercial; HIM.PA.154 marketplace; CP.PMN.53 Medicaid) or evidence of coverage documents

Applicable Codes

Product availabilityNDC

200 mg capsule

Capsule strength/product availability

Provider Actions / Prior Authorization

Prior Authorization

Prior authorization required

Requests must meet the outlined initial or continuation criteria and be supported by the required documentation. Approval durations differ by line of business: Medicaid and HIM approvals are for 6 months at initiation; Commercial approvals are for 12 months or the duration requested, whichever is less.

Medicaid/HIM: 6 months (initial approval)
Commercial: 12 months or duration of request, whichever is less

Documentation Required

Clinical documentation required

Provider must submit clinical documentation (such as office chart notes, lab results, or other clinical information) that supports the member has met all approval criteria.

Documentation must support the diagnosis and that criteria for medical necessity are met.

Clinical Evidence & References

Evidence: Prescribing information last updated: August 2023 (Odomzo Prescribing Information). NCCN guideline referenced: NCCN Basal Cell Skin Cancer guideline (accessed January 30, 2025). Per the brief, an indication for nodal disease (where surgery is not feasible) was added in 2Q2024.

Background

Background: Sonidegib (Odomzo) is a hedgehog pathway inhibitor. The FDA-approved indication is for 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. Product availability: capsule formulation available as 200 mg.

Thresholds

Age>= 18 years

Dose200 mg per day (max 1 tablet per day)

Minimum prior exposure for continuation>= 30 days

Definitions

Definitions: BCC = basal cell carcinoma. NCCN = National Comprehensive Cancer Network.

Revision History

05.22annual_review

2Q 2022 annual review: expanded BCC indication to include local recurrence and diffuse BCC formation per NCCN; added generic redirection criteria; Commercial approval duration revised. (P&T Approval Date = 05.22)

05.24annual_review

2Q 2024 annual review: added indication for nodal disease where surgery is not feasible per NCCN; references reviewed and updated. (P&T Approval Date = 05.24)

05.25annual_reviewLatest