CurrentNeighborhood Health Plan of Rhode IslandPolicy UM ONC_1493

Drug Policy: Ogsiveo (nirogacestat)

Defines utilization management criteria for coverage and authorization of Ogsiveo (nirogacestat) for members, primarily addressing use in adult patients with desmoid tumors and continuation requests; applies to medications processed by the payer's UM program.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDrug Policy: Ogsiveo (nirogacestat)

Policy CodePolicy UM ONC_1493

Change TypeNo material change

Effective DateDec 27, 2024

Next Review DateDec 12, 2024

Key ActionObtain prior authorization and submit supporting documentation demonstrating adult member has progressing desmoid tumors requiring systemic treatment.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Desmoid tumorsprimary covered indication

150 mgsingle-dose dosing limit

180/56/56monthly tablet limits

C9399, J8999billing codes

Coverage Criteria

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Initial and continuation coverage criteria

Covered when ALL of the following are met

Continuation request exemption criteria: Continuation requests for a not-approvable medication are exempt from this policy provided: (1) the member has not experienced disease progression on the requested medication; (2) the requested medication was used within the last year without a lapse of more than 30 days of having an active authorization; and (3) additional medication(s) are not being added to the continuation request.

Desmoid tumor indication: Member is an adult with progressing desmoid tumors who require systemic treatment.

Coverage is not allowed when any of the exclusion criteria apply. Exclusions include: disease progression while taking Ogsiveo (nirogacestat); concurrent use with other anticancer therapies; dosing that exceeds the single‑dose limit of 150 mg; or treatment that exceeds monthly tablet limits of 180 tablets (50 mg), 56 tablets (100 mg), or 56 tablets (150 mg). Requests meeting any of these conditions are subject to denial.

Ogsiveo (nirogacestat) is considered investigational or not medically necessary when requested for off‑label indications that lack sufficient supporting evidence. The policy defines insufficiency as poor representation of relevant patient or cancer characteristics, inadequate representation of the treatment regimen, outcomes that are not clinically meaningful (for example, not meeting commonly used ASCO thresholds), inappropriate experimental design for the question, reliance solely on uncontrolled case reports, or use of abstracts without a full peer‑reviewed article. Uses not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature therefore do not meet the policy’s evidentiary requirements.

Coding and Quantity Limits

HCPCS/Other CodesHCPCS

C9399	nirogacestat
J8999	nirogacestat

HCPCS/Other Codes (duplicate source format)HCPCS

C9399	nirogacestat
J8999	nirogacestat

inv-05: Maximum single dose

Maximum single dose150 mg

Applicable ruleDosing that exceeds the single-dose limit of 150 mg is an exclusion and may trigger denial

Related quantity limitsMonthly tablet limits also apply (see quantity limits) and separate from single-dose limit

inv-06: Monthly tablet limits

50 mg tablets — monthly limit180 tablets per month

100 mg tablets — monthly limit56 tablets per month

150 mg tablets — monthly limit56 tablets per month

inv-15: Ogsiveo (nirogacestat)

Ogsiveo (nirogacestat) 50 mg180 tablets per month

Ogsiveo (nirogacestat) 100 mg56 tablets per month

Ogsiveo (nirogacestat) 150 mg56 tablets per month

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Ogsiveo (nirogacestat). Coverage is allowed for adult members with progressing desmoid tumors who require systemic treatment. Continuation requests are exempt from prior authorization requirements when ALL of the following are met: the 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 additional medications are not being added to the continuation request.

Adult members with progressing desmoid tumors requiring systemic treatment
Continuation requests exempt when no disease progression, prior use within 1 year with ≤30-day lapse, and no additional meds added

Step Therapy

Step therapy: there is no explicit step therapy sequence required for Ogsiveo (nirogacestat). Providers should not be required to trial alternative agents prior to approval under this policy unless specified elsewhere in payer policy.

Denial Risk

Triggers for Denial

Triggers for denial include disease progression while taking Ogsiveo, concurrent use with other anticancer therapies, dosing that exceeds the single dose limit of 150 mg, and treatment that exceeds the monthly tablet limits (180 tablets of 50 mg, 56 tablets of 100 mg, or 56 tablets of 150 mg). Investigational or off-label uses lacking sufficient evidence as defined by CMS-recognized compendia or acceptable peer-reviewed literature may also be denied.

Disease progression while taking Ogsiveo (nirogacestat)
Concurrent use with other anticancer therapies
Single dose limit exceeded: >150 mg
Monthly tablet limits exceeded: >180 (50 mg), >56 (100 mg), >56 (150 mg)
Investigational or off-label indications without sufficient supporting evidence per CMS compendia or acceptable peer-reviewed literature

Definitions

inv-12: Desmoid tumors

DefinitionDesmoid tumors are locally aggressive soft tissue tumors for which Ogsiveo may be used in adult members with progressing disease who require systemic treatment.

Covered indicationOgsiveo (nirogacestat) may be used in adult members with progressing desmoid tumors who require systemic treatment

Exclusions specific to desmoid tumor useUse may be denied for disease progression while taking Ogsiveo or for concurrent use with other anticancer therapies

Continuation Therapy Criteria

Continuation therapy

Continuation requests exemptions

Continuation exemption: Continuation requests are exempt from this policy if the 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 medication(s) are being added to the continuation request.

Background

Nirogacestat (Ogsiveo) is a gamma‑secretase inhibitor used in the treatment of desmoid tumors that are progressing and require systemic therapy. The payer’s policy applies utilization controls to this agent and emphasizes that continuation of therapy may be allowed only when patients have not experienced disease progression on therapy and other continuation conditions are met; it also restricts concurrent anticancer therapy and enforces single‑dose and monthly tablet limits as part of the clinical context for safe and appropriate use.