CurrentBlue Cross Blue Shield - IowaPolicy 05.05.28

Ogsiveo (nirogacestat) — Coverage Criteria for Desmoid Tumors

Criteria for coverage of Ogsiveo (nirogacestat) for members with desmoid tumors, including FDA‑approved and compendial uses, dosing and quantity limits, and authorization durations affecting Wellmark Blue Cross and Blue Shield members.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyOgsiveo (nirogacestat) — Coverage Criteria for Desmoid Tumors

Policy CodePolicy 05.05.28

Change TypeNo material changes

Effective DateAug 19, 2024

Next Review Date

Key ActionRequest prior authorization for up to 12 months for initial or continued treatment when the member meets criteria and shows no unacceptable toxicity or disease progression.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period

50/100/150 mgtablet strengths

180 (50 mg)example quantity limit

adult DTsFDA indication

41%DeFi trial ORR

Ogsiveo (nirogacestat) Coverage Criteria

Coverage criteria for Ogsiveo (nirogacestat)

Covered when ALL of the following are met

FDA-approved indication: Member is an adult with progressing desmoid tumors who require systemic treatment (FDA-approved indication).

Reference: FDA-approved indication

Compendial use for desmoid tumors may be covered as described in the policy when applicable and when the approval criteria are met.

Compendial uses are considered per policy guidance

Authorization duration and continuation: Authorization may be granted for 12 months for initial treatment and for continued treatment upon reauthorization if there is no evidence of unacceptable toxicity or disease progression while on the current regimen.12 months

Continuation requires no unacceptable toxicity or disease progression

Dosing and quantity limits: Approvals may be subject to dosing limits per FDA labeling and quantity limits listed in the policy (see Quantity Limits).

Quantity limits provided in policy

Coverage for Ogsiveo (nirogacestat) is available only when the policy's specified criteria are met. If the member does not meet the approval criteria described in this policy (for example, adult patients with progressing desmoid tumors who require systemic treatment and other listed requirements), Ogsiveo is considered not medically necessary and will not be authorized.

Use of Ogsiveo is not medically necessary when the member fails to meet the policy’s approval criteria — for example, when the indication, disease progression, authorization requirements, or dosing/quantity limits set forth in this policy are not satisfied.

Initial Authorization Criteria

Initial therapy

Initial authorization

Initial authorization: Authorization of 12 months may be granted for treatment of progressive, morbid, or symptomatic desmoid tumors as a single agent.12 months

Criteria for Continued Authorization

Continuation therapy

Criteria for continued authorization

Reauthorization: Authorization of 12 months may be granted for continued treatment when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.12 months

Revenue and Diagnostic Codes

Revenue and ICD diagnostic codesmixed

No codes listed

Provider Actions and Authorization Details

Prior Authorization

Prior Authorization Required

Prior authorization is required for Ogsiveo (nirogacestat). Authorization may be granted for up to 12 months for initial treatment of progressive, morbid, or symptomatic desmoid tumors as a single agent, and for continued treatment when reauthorization is requested if there is no evidence of unacceptable toxicity or disease progression.

Authorization length: up to 12 months
Reauthorization allowed if no unacceptable toxicity or disease progression

Note

Place in Therapy

Place Ogsiveo in the context of treatment for desmoid tumors: it is indicated for adult patients with progressing desmoid tumors who require systemic treatment. Surgery and local ablative therapies remain options depending on tumor site and prior management; Ogsiveo is part of the medical therapy options when systemic treatment is required.

Ogsiveo Tablet Quantity Limits

Ogsiveo 50 mg — quantity limit

Drug and strengthOgsiveo (nirogacestat) 50 mg tablets

Quantity limit180 tablets per 30 days

Unittablets

Source noteQuantity Limits section of policy

Ogsiveo 100 mg — quantity limit

Drug and strengthOgsiveo (nirogacestat) 100 mg tablets

Quantity limit60 tablets per 30 days

Background

Desmoid tumors are locally aggressive connective tissue neoplasms that do not metastasize but can cause significant morbidity from local invasion. For members with progressive, morbid, or symptomatic desmoid tumors, authorization of Ogsiveo may be granted for up to 12 months for initial treatment. Continued authorization for subsequent 12‑month periods may be approved when there is no evidence of unacceptable toxicity or disease progression on the current regimen.

Definitions

Desmoid tumor (DT) definition

DefinitionA locally aggressive, non‑metastatic tumor of connective tissue with potential for recurrence and morbidity due to local invasion (desmoid tumor, DT).

Clinical behaviorDoes not metastasize but can be locally invasive and cause pain, disfigurement, bleeding, and impaired range of motion.

IncidenceApproximately 900 to 1500 new cases diagnosed annually in the United States.

Treatment contextManagement has shifted from routine surgery to observation and selective use of medical therapies; medical therapies are second‑line for many sites failing observation.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyOgsiveo (nirogacestat) — Coverage Criteria for Desmoid Tumors

Policy CodePolicy 05.05.28

Change TypeNo material changes

Effective DateAug 19, 2024

Next Review Date

Key ActionRequest prior authorization for up to 12 months for initial or continued treatment when the member meets criteria and shows no unacceptable toxicity or disease progression.

SourceLink

On This Page

Indication context: progressing desmoid tumors requiring systemic therapy

Consider prior/concurrent therapies: observation, surgery, local ablative treatments, and other systemic agents

Documentation Required

Benefit Verification and Medical Necessity

Verify member benefits and confirm medical necessity prior to initiating therapy. Benefit determinations are based on the member's contract in effect on the date of service; exclusions, limitations, or exceptions may apply. Wellmark (Blue Cross Blue Shield - Iowa) reviews medical necessity only if the benefit exists and no contract exclusions apply.

Confirm member-specific benefits and any applicable exclusions
Medical necessity review contingent on benefit eligibility

Denial Risk

Not Medically Necessary if Criteria Not Met

Ogsiveo is considered not medically necessary for members who do not meet the clinical criteria outlined in this policy. Requests that fail to meet specified indications, demonstrate disease progression on therapy, or show unacceptable toxicity should be denied.

Not medically necessary when policy criteria are not met
Deny or discontinue when there is disease progression or unacceptable toxicity

Source noteQuantity Limits section of policy

Ogsiveo 150 mg — quantity limit

Drug and strengthOgsiveo (nirogacestat) 150 mg tablets

Quantity limit60 tablets per 30 days

Unittablets

Source noteQuantity Limits section of policy