CurrentCentenePolicy CP PHAR.671

Nirogacestat (Ogsiveo) coverage

Defines Centene medical necessity and prior authorization criteria for nirogacestat (Ogsiveo) for adult patients with progressive desmoid tumors and related coverage rules across lines of business.

Policy Summary

PayerCentene

PolicyNirogacestat (Ogsiveo) coverage

Policy CodePolicy CP PHAR.671

Change TypeUpdated product dosing strengths

Effective Date03.01.24

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, progressive desmoid tumor, age >18, oncologist consultation, dosing ≤300 mg/day, and evidence of use of nirogacestat if available.

SourceLink

POLICY UPDATE CHANGES

Added new dosage strengths (100 mg and 150 mg tablets) and removed specification of 6 tablets for 300 mg daily dose per product labeling.

1Q 2025 annual review: no significant changes; references reviewed and updated.

150 mg PO BIDrecommended dosing for desmoid tumors

300 mg/daymaximum daily dose

6 moinitial approval length

12 mocontinued therapy approval length

50/100/150 mg

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria

Initial Therapy — Initial Approval

Initial Approval — Ogsiveo is medically necessary when ALL of the following are met:

Initial Approval Criteria: 1) Diagnosis of a desmoid tumor (aggressive fibromatosis); 2) Prescribed in consultation with an oncologist; 3) Documentation of a progressing desmoid tumor; 4) Age > 18 years; 5) Member must use nirogacestat (Ogsiveo) if available unless contraindicated or clinically significant adverse effects are experienced; 6) Dose does not exceed 300 mg per day; 7) Prescribed regimen must be FDA‑approved or recommended by NCCN; relevant off‑label uses must be supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence).

Approval duration: 6 months

Continuation Therapy — Renewal

Continued Therapy — coverage criteria for renewal:

Continued Therapy Criteria: 1) Member is currently receiving Ogsiveo via Centene benefit or documentation shows the member has received Ogsiveo for at least 30 days; 2) Member is responding positively to therapy; 3) For requests that include a dose increase, the new dose must meet one of the following: (a) be FDA‑approved or NCCN‑recommended, or (b) be supported by relevant peer‑reviewed literature (prescriber must submit supporting evidence); 4) For Ogsiveo requests, member must use nirogacestat if available unless contraindicated or clinically significant adverse effects are experienced; 5) New dose does not exceed 300 mg per day;

Approval duration: 12 months

Requests for uses of nirogacestat (Ogsiveo) that are not FDA‑approved and are not specifically addressed by this policy are excluded unless the provider submits sufficient clinical evidence demonstrating efficacy and safety. Evidence must follow applicable off‑label use policies: CP.CPA.09 (commercial), HIM.PA.154 (health insurance marketplace), or CP.PMN.53 (Medicaid), or be supported by the member's evidence of coverage documents.

Initial Therapy

Initial Therapy — Coverage Conditions and Dosing

Initial coverage conditions and dosing

Initial Therapy: 1) Diagnosis of a desmoid tumor (aggressive fibromatosis); 2) Prescribed in consultation with an oncologist; 3) Documentation of a progressing desmoid tumor; 4) Age > 18 years; 5) Member must use nirogacestat (Ogsiveo) if available unless contraindicated or clinically significant adverse effects are experienced; 6) Dosing: 150 mg orally twice daily until disease progression or unacceptable toxicity (maximum 300 mg per day); 7) Prescribed regimen must be FDA‑approved or recommended by NCCN; relevant off‑label uses require supporting evidence (prescriber must submit supporting literature).

Continuation Therapy

Continuation Therapy — Renewal Criteria

Renewal criteria for members already on therapy

Continued Therapy: 1) Member is currently receiving Ogsiveo via Centene benefit or has documentation of at least 30 days of therapy; 2) Member is responding positively to therapy (clinical benefit); 3) Any requested dose change must adhere to dosing rules: recommended dosing is 150 mg PO twice daily and must not exceed 300 mg per day; dose increases must be FDA‑approved or NCCN‑recommended or supported by peer‑reviewed literature (prescriber must submit supporting evidence); 4) Member must use nirogacestat if available unless contraindicated or clinically significant adverse effects are experienced.

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Ogsiveo (vimseltinib) is approved only when all initial criteria are met: diagnosis of desmoid tumor (aggressive fibromatosis); age > 18 years; prescribing clinician has consulted with an oncologist; documentation of a progressing desmoid tumor; member must use nirogacestat if available unless contraindicated or causes clinically significant adverse effects; dose does not exceed 300 mg per day; and the prescribed regimen is FDA‑approved or recommended by NCCN. Approval duration: 6 months.

Diagnosis: desmoid tumor (aggressive fibromatosis)
Age: > 18 years
Prescriber: in consultation with an oncologist
Progression: documentation of a progressing desmoid tumor required
Nirogacestat: member must use nirogacestat if available unless contraindicated or unacceptable adverse effects occur
Dose limit: ≤ 300 mg per day
Regimen: must be FDA‑approved or recommended by NCCN
Initial approval duration: 6 months

Coding & Dosing Limits

Maximum daily dose

Maximum daily dose300 mg/day

Recommended dosing for desmoid tumors150 mg PO BID (until disease progression or unacceptable toxicity)

Approval duration (initial)6 months per policy

Nirogacestat (Ogsiveo) — Quantity limits

Quantity limit — daily maximumDose not to exceed 300 mg/day

Typical regimen150 mg PO BID (total 300 mg/day)

Available tablet strengths

Step Therapy Requirements

Step	Requirement
1	Member must use nirogacestat (Ogsiveo) if available unless contraindicated or clinically significant adverse effects are experienced; prescribed regimen must be FDA‑approved or recommended by NCCN; off‑label uses require supporting peer‑reviewed literature.
2	Dose must not exceed 300 mg per day.
3	Requirement applies to initial and continued therapy (initial approval duration: 6 months; continuation approval duration: 12 months).

Definitions

Desmoid tumor (aggressive fibromatosis)

Indication (FDA approved)Progressing desmoid tumors (aggressive fibromatosis) in adults who require systemic treatment

Clinical requirementDocumentation of tumor progression required for initial approval

Prescriber requirementTherapy should be prescribed in consultation with an oncologist per policy criteria

Nirogacestat (Ogsiveo) — Drug classification

Drug classGamma secretase inhibitor

Product nameNirogacestat (Ogsiveo)

Use in policy

Background

Desmoid tumors (aggressive fibromatosis) are locally aggressive soft tissue neoplasms that may require systemic therapy when progressive. Nirogacestat (Ogsiveo) is a gamma secretase inhibitor approved for adult patients with progressing desmoid tumors who require systemic treatment. The approved dosing regimen for desmoid tumors is 150 mg orally twice daily (total 300 mg/day), continued until disease progression or unacceptable toxicity.

Site of Care

Note

Infusion center / site of care

The policy does not specify site‑of‑care requirements (e.g., infusion center); no site restrictions are listed in the policy text.

Site of care: Not specified in policy.

Quantity Limits

Nirogacestat (Ogsiveo) — Quantity limits (duplicate)

Quantity limit — daily maximumDose not to exceed 300 mg/day

Recommended dosing150 mg PO BID (total 300 mg/day)

Available tablet strengths50 mg, 100 mg, 150 mg

Revision History

2024-10-30references_updated

1Q 2025 annual review — no significant clinical policy changes; references reviewed and updated.

2024-05-03dosage_strengths_added

Added new tablet strengths (100 mg and 150 mg) and removed prior specification of 6 tablets for the 300 mg daily dose per product labeling.

2023-12-18policy_createdLatest

Policy created (initial publication).