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

For oncologists and prescribers, helping patients access Entrectinib (Rozlytrek) requires navigating specialty pharmacy channels, prior authorization requirements, and a range of patient assistance programs. While Rozlytrek is not currently listed on the FDA Drug Shortages Database, patients routinely face access gaps that require proactive support from their oncology team. This guide summarizes what providers need to know in 2026.

Current Availability and Shortage Status

As of 2026, Rozlytrek (entrectinib) is not listed on the FDA Drug Shortages Database. Genentech distributes the drug through a network of specialty pharmacies, and manufacturing supply is currently stable. However, providers should be aware that access delays are common and typically involve:

Prior authorization processing times (days to weeks depending on payer)

Specialty pharmacy network mismatches between insurer-preferred pharmacies and patient geography

Financial assistance enrollment delays, particularly for new patients

Prior authorization renewal lapses at 12 months, leading to supply gaps if not proactively managed

FDA-Approved Indications Requiring Biomarker Confirmation

All payers require biomarker confirmation before approving entrectinib. Coverage criteria uniformly require:

ROS1-positive metastatic NSCLC: Confirmation by FDA-approved test (tumor tissue preferred; plasma acceptable when tissue unavailable). ECOG PS ≤ 1 typically required.

NTRK gene fusion-positive solid tumors: Confirmed by FDA-approved test; no known acquired resistance mutation; metastatic or surgery would cause severe morbidity; progressed on prior treatment or no satisfactory alternative. Age ≥ 1 month.

Prior Authorization: Key Payer Requirements

Prior authorization for Rozlytrek is required by essentially all commercial payers, Medicare Part D plans, and Medicaid managed care plans. Most plans issue PA approvals for 12-month periods and require renewal documentation before lapse. Typical PA requirements include:

Copy of FDA-approved biomarker test result (FISH, NGS, RT-PCR, or IHC as appropriate)

Diagnosis and stage documentation (pathology report, staging imaging)

Documentation of prior systemic therapy (for NTRK indications) or first-line use justification

ECOG/Karnofsky performance status

Prescribing physician NPI and specialty (oncologist required or consultation with one)

Specialty Pharmacy Access and Distribution

Rozlytrek is dispensed exclusively through specialty pharmacies. Genentech Access Solutions (877-436-3683 or via My Patient Solutions online portal) manages benefits investigations, specialty pharmacy routing, and prior authorization support. Providers should:

Submit both the Prescriber Service Form and Patient Consent Form to Genentech Access Solutions at the time of initiation

Verify the patient's preferred specialty pharmacy before routing the prescription to avoid coverage mismatches

Track PA renewal dates and initiate renewal documentation 30–60 days before expiration to prevent supply gaps

Patient Assistance Programs Available

Genentech offers multiple financial support pathways for entrectinib:

Genentech Oncology Co-pay Assistance Program: Eligible commercially insured patients may pay $0 out-of-pocket, with savings up to $25,000 per product per calendar year.

Genentech Patient Foundation: Provides free Rozlytrek to qualifying uninsured or underinsured patients who cannot afford the medication.

Independent co-pay assistance foundations: Genentech Access Solutions can refer insured patients to CancerCare, Patient Access Network Foundation (PANF), HealthWell Foundation, and others.

When to Consider Alternative Therapies

If entrectinib access is delayed by more than 5–7 days from intended initiation, consider: (1) escalating the PA process through Genentech Access Solutions; (2) checking whether a clinical trial is available; or (3) discussing available alternatives. For ROS1-positive NSCLC, NCCN guidelines list crizotinib (Xalkori), repotrectinib (Augtyro), taletrectinib (Ibtrozi), and ceritinib as options. For NTRK-positive solid tumors, larotrectinib (Vitrakvi) is the other FDA-approved choice.

How medfinder Supports Your Patients' Pharmacy Access

When patients can't find a specialty pharmacy that can fill their Rozlytrek prescription in their area, medfinder can help. medfinder calls pharmacies near the patient to find out which ones can fill the prescription, sending results by text. See our provider guide on how to help your patients find entrectinib in stock for more.