CurrentCignaPolicy N/A

Oncology - Ogsiveo Prior Authorization Policy

Cigna coverage policy governing prior authorization and medical necessity criteria for Ogsiveo (nirogacestat) for adults with progressing desmoid tumors; applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyOncology - Ogsiveo Prior Authorization Policy

Policy CodePolicy N/A

Change TypeCriterion expanded (radiotherapy added)

Effective DateN/A

Next Review Date12/03/2025

Key ActionObtain prior authorization for Ogsiveo and document medical necessity to support a 1-year approval when criteria are met.

SourceLink

POLICY UPDATE CHANGES

For criterion referring to desmoid tumors not amenable to surgery, added 'or radiotherapy'.

1 yearapproval duration

≥18min patient age

≥20% / 12mprogression definition

Category 1NCCN status

Coverage Criteria for Ogsiveo (nirogacestat)

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ALL of the following

A: Patient is >= 18 years of age.
B: According to the prescriber, the patient has progressing desmoid tumors.Progressing defined as >= 20% progression within 12 months.
C: The desmoid tumors are not amenable to surgery or radiotherapy.
D: According to the prescriber, the patient requires systemic treatment.

Regimen	Indication	Coverage status	Notes / duration
Ogsiveo (nirogacestat)	Progressing desmoid tumors requiring systemic treatment (adults)	Covered	Prior authorization recommended; approvals provided for 1 year when medical necessity criteria are met. NCCN lists Ogsiveo as a Preferred (Category 1) regimen.

Coding and Definitions

Covered Codesmixed

No codes listed

Progression threshold

Progression threshold>= 20% increase in tumor size within a 12-month period

Measurement standardPer RECIST v1.1 as used in the pivotal Phase III trial

Population reference periodProgression assessed within the 12 months before screening/enrollment

Usage in coverage criteriaRequired to qualify as 'progressing desmoid tumors' for Ogsiveo coverage

Provider Actions and Billing

Prior Authorization

Prior Authorization Required

Prior authorization is recommended for Ogsiveo; approvals are provided for the duration noted (1 year) when medical necessity criteria are met.

Documentation Required

General documentation and plan-term requirements

Providers must follow the terms of the applicable benefit plan document and submit prior authorization requests with appropriate supporting clinical information. Coverage determinations depend on the plan in effect on the date of service, applicable laws/regulations, collateral materials (including this coverage policy), and the specific facts of the case. Claims submitted without covered diagnosis or procedure codes, or billed for conditions not covered under the applicable coverage policy, will be denied as not covered. When billing, providers must use the most appropriate codes as of the effective date of submission.

Denial Risk

Denied if billed without covered codes

Claims submitted without covered diagnosis or procedure codes will be denied as not covered.

Key Definitions

Desmoid tumors — definition

TermDesmoid tumors (aggressive fibromatosis)

BehaviorLocally aggressive and invasive soft‑tissue tumors that do not metastasize

Clinical impactCan cause pain, functional impairment, nerve damage, and compression of vital structures

Historical treatmentsSurgery (high recurrence), cytotoxic chemotherapy, tyrosine kinase inhibitors, local ablation, or radiation

Progressing desmoid tumors — definition

Definition of progressing desmoid tumors>= 20% progression within 12 months (per RECIST v1.1) as used in the pivotal Phase III trial

Assessment methodDetermined by RECIST version 1.1 measurements

Time windowProgression must have occurred within the 12 months prior to screening/enrollment

Trial eligibility referenceCriterion used to enroll adults (>=18 years) in the pivotal randomized trial of Ogsiveo

Line(s) of Therapy

First-line

ANY of the following

Indication: Systemic treatment for progressing desmoid tumors not amenable to surgery or radiotherapy.
NCCN lists Ogsiveo as a Preferred (category 1) regimen.

Background

Desmoid tumors (also called aggressive fibromatosis) are rare, locally aggressive soft‑tissue neoplasms that do not metastasize but can cause significant morbidity through local invasion and compression of adjacent structures. Management options historically include observation, surgery (noting high recurrence rates), radiation, cytotoxic chemotherapy, tyrosine kinase inhibitors, and local ablative approaches. Ogsiveo (nirogacestat), a gamma‑secretase inhibitor, is indicated for adults with progressing desmoid tumors that require systemic treatment; progression in the pivotal trial was defined as ≥ 20% increase within 12 months. Prior authorization is recommended and approvals are provided for the duration noted when medical necessity criteria are met.

Revision History

2024-01-03selected revision

Expanded desmoid tumor criterion to add 'or radiotherapy' for tumors not amenable to surgery.

2023-11-29new policy

Policy created (New Policy) with initial review date.

2024-12-11annual revision

Annual revision (no clinical criteria changes).

2025-12-03annual revisionLatest