Ogsiveo Shortage: What Providers and Prescribers Need to Know in 2026

Ogsiveo (nirogacestat) is the first and only FDA-approved systemic treatment for adults with progressing desmoid tumors — a rare, locally aggressive soft tissue tumor. Since its approval on November 27, 2023, SpringWorks Therapeutics has made significant investments in patient access support. Nevertheless, prescribers are encountering consistent barriers that can delay treatment initiation and disrupt ongoing therapy.

This article is written for oncologists, sarcoma specialists, and other healthcare providers managing desmoid tumor patients. It covers the current access landscape, formulation changes, prior authorization requirements, and the patient support resources available through SpringWorks CareConnections.

Is Ogsiveo in an FDA Drug Shortage?

No. As of 2026, Ogsiveo is not on the FDA Drug Shortage Database. The drug is being manufactured and distributed without supply-level disruptions. However, prescribers should be aware that individual specialty pharmacies may occasionally face regional inventory constraints, and the transition to new tablet formulations in 2025 created temporary confusion within the distribution network.

The 2025 Formulation Change: What Prescribers Need to Know

Effective January 1, 2025, the 50 mg nirogacestat tablet was discontinued. SpringWorks replaced it with two new tablet strengths:

150 mg tablet: For patients on the standard recommended dose of 150 mg twice daily — simplifies from 3 x 50 mg to a single tablet.

100 mg tablet: For patients requiring dose reduction to 100 mg twice daily (e.g., for Grade 3–4 diarrhea, hepatotoxicity, hypophosphatemia, or hypokalemia).

Prescribers should update their prescribing templates accordingly. Prescriptions written for 50 mg tablets will no longer be fillable. Ensure your EHR templates reflect the current available strengths to avoid prescription rejection at the specialty pharmacy level.

Prior Authorization Requirements by Payer Type

Prior authorization (PA) is required by virtually all commercial plans and Medicare Part D for Ogsiveo. Common coverage criteria include:

Patient is ≥18 years of age

Diagnosis of desmoid tumor confirmed by image-guided core needle or surgical biopsy

Documentation of tumor progression within the prior 12 months (per RECIST criteria or measurable disease progression)

Prescription by or in consultation with an oncologist

Documentation of significant symptoms (e.g., severe pain, functional impairment) or potential for morbidity

Off-label use — including combination with other oncology therapies, use in patients under 18, or use in multiple myeloma or ovarian cancer — does not typically meet coverage criteria at this time. Ensure your documentation clearly reflects the labeled indication.

Specialty Pharmacy Distribution and Routing

Ogsiveo is available exclusively through specialty pharmacies and specialty distributors. It is not available through retail pharmacy channels. Your practice's oncology pharmacy team or SpringWorks CareConnections can provide an up-to-date list of preferred pharmacies.

Insurance plans typically mandate specific specialty pharmacies for their members. When sending a prescription, coordinate with the patient's insurance to determine their designated specialty pharmacy — submitting to the wrong pharmacy can result in claim rejection and significant delays.

SpringWorks CareConnections: What It Offers Your Patients

SpringWorks CareConnections (1-844-CARES-55) is a comprehensive patient support program that can significantly reduce your administrative burden and help patients stay on therapy. Services include:

Insurance benefits verification and PA support

Commercial copay program: eligible patients pay as little as $0 per prescription

Patient Assistance Program for uninsured and underinsured patients

Quick Start bridge program for patients whose insurance decision is pending

Gap Coverage bridge program for patients between insurance coverage periods

Dedicated nurse advocate support throughout treatment

Enrolling your patients in CareConnections at the time of prescribing — rather than waiting for problems to arise — can prevent gaps in therapy.

Clinical Context: NCCN Designation and DeFi Trial Results

Nirogacestat carries NCCN Category 1 Preferred designation for systemic treatment of desmoid tumors (aggressive fibromatosis). This designation, based on uniform consensus of high-level clinical evidence, should support coverage approval arguments in cases of initial PA denial.

In the Phase 3 DeFi trial, nirogacestat achieved a 41% objective response rate versus 8% with placebo, and 76% of patients remained progression-free at two years compared to 44% with placebo. Patient-reported outcomes also significantly favored nirogacestat, with improvements in pain, physical function, and quality of life. These robust data provide strong clinical justification for coverage appeals when initial PAs are denied.

Tools for Helping Patients Locate Their Prescription

If a patient needs help identifying which specialty pharmacy can fill their Ogsiveo prescription, medfinder for providers is a paid service that calls pharmacies on behalf of patients to confirm which ones have the medication in stock. For more background on patient-facing access issues, see our Ogsiveo shortage update article.