How to access Augtyro from the UAE, the named-patient import pathway, 2026

By Reserve Meds, Clinical and regulatory team. Last reviewed 2026-05-13.

A UAE patient with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC), in either TKI-naive or post-TKI settings, or an adult or pediatric patient age 12 years and older with an NTRK fusion-positive solid tumor that is locally advanced or metastatic and where surgical resection is likely to result in severe morbidity and where there is no satisfactory alternative therapy, may receive a prescription for Augtyro (repotrectinib) from their treating oncologist. Augtyro is FDA-approved in the United States and manufactured by Bristol Myers Squibb (originally developed by Turning Point Therapeutics). It is a next-generation tyrosine kinase inhibitor administered orally with CNS penetration and activity against common resistance mutations. Local availability of Augtyro in the United Arab Emirates can be inconsistent: the drug may not be on every oncology pharmacy's standing formulary, the specific indication may not match what is locally registered, or the strength required may be back-ordered. When that happens, a named-patient import pathway through MoHAP remains a legitimate route for the patient whose physician has already prescribed the drug.

This guide explains the pathway, the documentation your physician needs, typical costs and indicative timing, and where Reserve Meds fits in.

The clinical situation

Augtyro is a next-generation small-molecule tyrosine kinase inhibitor of ROS1 and TRKA/B/C with CNS penetration and activity against common solvent-front resistance mutations including ROS1 G2032R and TRK G595R. Standard adult dosing is 160 mg orally once daily for 14 days, then 160 mg twice daily. Confirmation of a ROS1 fusion (for NSCLC) or an NTRK1, NTRK2, or NTRK3 gene fusion (for tumor-agnostic indication) by an FDA-approved companion diagnostic, or an equivalent locally accredited NGS test, is required before initiation. Baseline workup per FDA labeling includes complete blood count, hepatic function, renal function, uric acid, ECG (QTc prolongation is a known signal), creatine phosphokinase, and pregnancy testing where applicable. Important warnings include CNS effects (dizziness, cognitive impairment, ataxia, mood disorders, sleep disturbance), interstitial lung disease and pneumonitis, hepatotoxicity, myalgia with CPK elevation, hyperuricemia, skeletal fractures, embryo-fetal toxicity, and QTc prolongation. Your oncologist will discuss the risk-benefit profile and schedule monitoring before initiating therapy.

Is Augtyro legally importable into the UAE?

Yes, through the UAE Ministry of Health and Prevention (MoHAP) named-patient and personal-use import framework, coordinated with the treating facility's pharmacy. Parallel authority in the Emirate of Abu Dhabi operates through the Department of Health (DoH) and in Dubai through the Dubai Health Authority (DHA). The UAE has an established pathway for specialty oncology medicines approved by reference authorities (US FDA, EMA, MHRA) but not stocked or registered for the specific indication locally.

The MoHAP named-patient route allows a UAE-licensed physician to request import of a medicine when: (a) the medicine is approved by a recognised reference authority, (b) no clinically equivalent locally registered alternative is suitable for the patient's indication and history, (c) the treating physician takes clinical responsibility for use, and (d) chain of custody is documented from the US source to the administering facility.

How the pathway works, step by step

  1. Consultation with your treating oncologist. The prescribing decision is clinical. Your oncologist documents the indication, ROS1 or NTRK fusion status (with NGS report, ideally including any resistance mutations identified after prior TKI therapy), prior therapies, and rationale for Augtyro.
  2. Baseline screening. CBC, LFTs, renal function, uric acid, CPK, ECG, neurologic baseline, and pregnancy testing where applicable are confirmed and documented.
  3. MoHAP named-patient application. Your oncologist or the hospital's import pharmacy files the application with clinical rationale, fusion status documentation, patient reference, product strength (40 mg or 160 mg capsules), quantity requested, and chain-of-custody plan.
  4. US-side sourcing. Reserve Meds coordinates with our US-licensed specialty wholesale partner to secure product from Bristol Myers Squibb's authorised distribution under DSCSA chain-of-custody.
  5. Shipment. Augtyro is an oral capsule with controlled-room-temperature storage requirements. Shipments include temperature-monitored packaging and tamper-evident seals.
  6. Arrival and first dose. The dispensing pharmacy releases product against the physician's prescription, and your oncologist initiates therapy with the 14-day lead-in dose, then escalates to twice-daily dosing with scheduled lab and ECG follow-up.

What documentation your physician needs

Your physician will typically need to provide:

  • A clinical rationale letter confirming diagnosis, ROS1 or NTRK fusion status (with NGS or companion diagnostic report and any documented resistance mutations), prior therapy history, and Augtyro as the indicated next step
  • Verification of their UAE medical licence
  • A patient identifier, anonymised reference where privacy is preferred
  • Documented pre-treatment screening (CBC, LFTs, renal, uric acid, CPK, ECG, neurologic exam) consistent with FDA labeling
  • The planned dosing schedule (160 mg once daily for 14 days, then 160 mg twice daily)
  • A discussion note on the QTc, CNS, and ILD monitoring plan

Reserve Meds provides a physician documentation kit that bundles the templates MoHAP reviewers expect to see for ROS1 and TRK targeted therapy.

Typical costs and indicative timing

Reserve Meds gives you a drug-only reference range plus a transparent delivered quote at intake. As an illustrative composite case, the US cash-pay reference range for a 30-day supply of Augtyro at steady-state dosing sits in an indicative 2026 band of roughly USD 24,000 to 28,500. International logistics, MoHAP documentation handling, shipping, and concierge coordination add incremental cost. The delivered quote we issue at intake shows each line separately.

Indicative timing for first dose after cohort intake opens is approximately 2 to 5 weeks from the moment a complete application is submitted to MoHAP, assuming the documentation package and ROS1/NTRK fusion report are clean on first pass. Refills ship on a rolling cadence aligned to your monthly supply.

Reserve Meds is in pre-launch. Service availability is limited to our first cohort. All timelines are indicative, not guarantees.

Where Reserve Meds fits in

Reserve Meds is a US-based concierge coordinator for cross-border specialty medicine. For Augtyro specifically, we provide:

  • Sourcing. Through our US-licensed specialty wholesale partner, operating under DSCSA chain-of-custody from manufacturer to export.
  • Documentation. Regulatory package tailored for your physician and for MoHAP review, including ROS1 and TRK inhibitor monitoring templates.
  • Logistics. Temperature-monitored, internationally tracked shipment to your named dispensing facility.
  • Concierge case lead. A named point of contact for your family and your physician across the full case arc.

We are a coordinator. We are not the prescriber, not a pharmacy, and not a dispensing facility. All clinical decisions remain with your treating oncologist, and dispensing sits with the licensed UAE pharmacy of record. Reserve Meds operates on cash-pay only and does not bill insurance.

Frequently asked

Is this legal in the UAE? Yes, when executed through the MoHAP (or DoH/DHA) named-patient framework with appropriate documentation, clinical rationale, and a licensed dispensing facility. The pathway is routinely used across UAE oncology.

How does Augtyro compare with crizotinib or Rozlytrek (entrectinib) for ROS1-positive NSCLC? Augtyro retains activity against common ROS1 resistance mutations (G2032R) that emerge after first-generation TKI therapy, and has documented CNS penetration. Your oncologist makes that determination based on TKI history, resistance mutation status, and brain metastasis status.

What about the CNS side effects? Dizziness, cognitive change, and mood effects are recognised class effects of CNS-penetrant TKIs. Your oncologist will counsel the patient and monitor symptoms per labeling, with dose modifications as needed. Reserve Meds does not make that clinical judgement, your physician does.

Will my private health insurance cover this? Cash-pay is the default posture. Some UAE private insurers reimburse named-patient oncology imports on a case-by-case basis when the documentation package is strong. We supply documentation for your submission but do not process insurance claims.

What if my oncologist has not filed a named-patient request before? Named-patient import is an institutional process most major UAE oncology centers (Cleveland Clinic Abu Dhabi, American Hospital Dubai, Mediclinic City Hospital, Tawam Hospital) have encountered. Our documentation kit is written for first-time applicants and tracks what MoHAP reviewers commonly ask for.

Join the waitlist

Reserve Meds is opening to a limited first cohort in 2026. Add your case to the waitlist and our concierge case lead will reach out when we are ready to enter intake for Augtyro coordination in the UAE.

Add me to the Augtyro waitlist

Composite case examples. Reserve Meds is in pre-launch. This content is for general information and does not constitute medical advice. Reserved for you.