CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Ogsiveo (nirogacestat) — Coverage Criteria

Defines accepted indications, coverage criteria, coding, and exclusions for use of Ogsiveo (nirogacestat) in members receiving care through Evolent-managed benefit lines; applies to providers requesting authorization for this medication.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOgsiveo (nirogacestat) — Coverage Criteria

Policy CodePolicy N/A

Change TypeAdded dosage limitstemplate conversioncoding added (J8999)

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization supporting FDA labeling, CMS compendia, NCCN/ASCO guidelines, or peer‑reviewed literature meeting CMS standards.

SourceLink

POLICY UPDATE CHANGES

Added maximum dosage form quantities to exclusion criteria.

Converted to new Evolent guideline template and replaced prior UM ONC_1493 Ogsiveo (nirogacestat).

Added HCPCS/J-code (J8999) for nirogacestat.

1FDA indication

J8999HCPCS code

150 mgSingle dose limit

Commercial/Exchange/MedicaidLines of business

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Coverage Criteria

Initial therapy coverage criteria

Covered when ALL of the following are met

Indication: Adult member with progressing desmoid tumors who require systemic treatment

Based on stated accepted indication

Supporting evidence: Use is supported by FDA labeling, CMS compendia, NCCN or ASCO guidelines, or peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 standards

Evolent requires one of these sources to support medical necessity

Continuation therapy coverage criteria

Continuation therapy covered when ALL of the following are met

No progression: Member has not experienced disease progression on the requested medication

Continuation condition

Recent use: Requested medication was used within the last year without a lapse of more than 30 days of having an active authorization

Continuation condition

No additions: Additional medication(s) are not being added to the continuation request

Continuation condition

Coverage for Ogsiveo (nirogacestat) is subject to specific clinical and operational limits. Exclusions that affect authorization include disease progression while taking Ogsiveo and concurrent use with other anticancer therapies. Dosing restrictions include a single dose limit of 150 mg and monthly maximum tablet limits of 180 tablets (50 mg), 56 tablets (100 mg), and 56 tablets (150 mg). Requests exceeding these limits will be excluded from coverage. Operationally, continuation authorizations should document absence of progression and adherence to dosing limits; additions of other anticancer agents to a continuation request are not permitted under this policy.

Use of Ogsiveo (nirogacestat) is considered not medically necessary when the indication is investigational or off-label without sufficient supporting evidence as defined by this policy, or when any exclusion criterion is met. Examples that would trigger a non-coverage determination include disease progression while on Ogsiveo, concurrent anticancer therapy, doses exceeding the 150 mg single-dose limit, or treatment that surpasses the stated monthly tablet maximums. The policy defines adequacy of supporting evidence by alignment with CMS-recognized compendia or peer-reviewed literature addressing patient representation, regimen relevance, clinically meaningful outcomes (e.g., ASCO-recommended thresholds such as Hazard Ratio < 0.80 or ≥3 months OS/PFS benefit), and appropriate study design; uncontrolled case reports and meeting abstracts without full peer-reviewed articles are not sufficient.

Regimen	Indication	Dosing / Limits	Exclusions / Notes	Coverage
Ogsiveo (nirogacestat) monotherapy per FDA labeling
Adult members with progressing desmoid tumors who require systemic treatment
Dosing consistent with FDA labeling; single dose must not exceed 150 mg; monthly tablet limits: 180 tablets of 50 mg, 56 tablets of 100 mg, or 56 tablets of 150 mg
Not eligible if disease progression while taking Ogsiveo; concurrent use with other anticancer therapies is prohibited; investigational or off-label indications lacking sufficient evidence are excluded
covered

Coding

HCPCS drug codeHCPCSCovered

J8999

nirogacestat

Operational dosing limits

Maximum tablets per 30 days (50 mg)180 tablets/month

Maximum tablets per 30 days (100 mg)56 tablets/month

Maximum tablets per 30 days (150 mg)56 tablets/month

Maximum single dose150 mg

Provider Actions & Authorization

Prior Authorization

Prior authorization required; authorization criteria summary

Prior authorization is required for Ogsiveo (nirogacestat). Authorization may be granted for adult members with progressing desmoid tumors who require systemic treatment; continuation requests are permitted under the policy's continuity conditions.

Drug code: J8999 (nirogacestat) per coding section.

Step Therapy

Continuation (step) conditions and exemption timing

Continuation (exemption) applies when all three conditions are met: member has not experienced disease progression on the requested medication; the medication was used within the last year without a lapse of more than 30 days of having an active authorization; and no additional medications are being added to the continuation request.

These continuation rules exempt the request from being treated as a new, not-approvable medication request.

Documentation Required

Required supporting evidence standards

Support for medical necessity must come from one of the following sources: FDA-approved product labeling; CMS-recognized compendia; NCCN or ASCO clinical guidelines; or peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 standards.

Peer-reviewed literature must meet CMS Chapter 15 criteria for study design, patient representation, and clinically meaningful outcomes as described in the policy.

Denial Risk

Exclusion criteria that trigger denial

Requests are at risk of denial if any exclusion criterion is met, including disease progression while taking Ogsiveo, concurrent use with other anticancer therapies, exceeding the single-dose limit of 150 mg, exceeding the maximum monthly tablet limits, or investigational/off-label uses lacking sufficient evidence.

Maximum tablet/month limits: 180 (50 mg), 56 (100 mg), 56 (150 mg).
Single dose limit: 150 mg.
Insufficient evidence is defined by the policy's CMS/peer-reviewed literature standards (e.g., inadequate patient representation, weak study design, or lack of clinically meaningful outcomes).

Covered Regimens

Criteria	Requirement / Description	Supporting details	Limitations / Exclusions	Coverage stance
Indication
Adult member with progressing desmoid tumors requiring systemic therapy
Policy permits Ogsiveo monotherapy for progressing desmoid tumors per FDA labeling
Requests excluded if member has disease progression while on Ogsiveo or if concurrent anticancer therapy is used
covered

Definitions

Progressing desmoid tumors — Definition and eligibility

DefinitionDesmoid tumors in adults with radiographic or clinical evidence of progression for which systemic treatment is required.

Clinical requirement for eligibilityMember must have progressing desmoid tumor and require systemic therapy (per accepted indication).

Evidence standardUse must be supported by FDA labeling, CMS compendia, NCCN or ASCO guidelines, or peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 standards.

Line of Therapy

not_specified

Line of therapy: Systemic treatment for progressing desmoid tumors (no specific line-of-therapy sequencing specified)

Policy does not mandate first- vs later-line

Background

Desmoid tumors are locally aggressive soft-tissue neoplasms that can cause significant morbidity despite lacking metastatic potential. Ogsiveo (nirogacestat) is a targeted oral agent indicated for adult patients with progressing desmoid tumors who require systemic therapy. When evaluating requests for Ogsiveo, this policy requires evidence consistent with FDA labeling and accepted clinical sources; requests are reviewed against the exclusions and dosing limits described above.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOgsiveo (nirogacestat) — Coverage Criteria

Policy CodePolicy N/A

Change TypeAdded dosage limitstemplate conversioncoding added (J8999)

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization supporting FDA labeling, CMS compendia, NCCN/ASCO guidelines, or peer‑reviewed literature meeting CMS standards.

SourceLink

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