How to access Bylvay from the UAE — the named-patient import pathway, 2026
By Reserve Meds · Clinical & regulatory team · Last reviewed 2026-04-24
A UAE child with progressive familial intrahepatic cholestasis (PFIC) or Alagille syndrome and intractable cholestatic pruritus may receive a prescription for Bylvay (odevixibat) from their treating paediatric hepatologist or paediatric gastroenterologist. Bylvay is FDA-approved in the United States as an oral ileal bile acid transporter (IBAT) inhibitor for reducing cholestatic pruritus in these paediatric genetic cholestatic liver diseases. Because Bylvay is not yet routinely stocked in UAE hospital pharmacies for these ultra-rare indications, your specialist may be coordinating a named-patient import pathway on your behalf.
This guide explains the legal pathway, what documentation your physician needs, typical timing and cost bands, and where Reserve Meds fits in.
The clinical situation
Bylvay is an orally administered IBAT inhibitor that reduces bile-acid reabsorption in the terminal ileum. It is supplied as weight-based capsules or oral pellets given once daily, typically in the morning with food. The manufacturer is Ipsen (which acquired the product from Albireo). Eligibility typically requires genetic or clinical confirmation of PFIC (ABCB11, ATP8B1, or other defined subtypes) or Alagille syndrome (JAG1/NOTCH2), and documented cholestatic pruritus that has not responded adequately to conventional antipruritics. Your paediatric specialist confirms diagnosis, baseline liver function, serum bile acids, growth, and the monitoring plan — which includes LFTs and fat-soluble vitamin status — per FDA labeling.
Is Bylvay legally importable into the UAE?
Yes — through the UAE Ministry of Health and Prevention (MOHAP) named-patient import framework, with parallel coordination through the Department of Health Abu Dhabi where the treating physician is Abu Dhabi-licensed, and through the Dubai Health Authority where the physician is Dubai-licensed.
The framework rests on four anchors: (a) the medicine is approved by a recognised reference authority (FDA qualifies), (b) no clinically equivalent locally registered alternative is suitable for the patient, (c) the treating physician takes clinical responsibility for use, and (d) the importing party documents chain of custody from the US source to the administering facility. For paediatric rare disease, MOHAP reviewers are familiar with the submission pattern for IBAT inhibitors.
How the pathway works, step by step
- Consultation with your treating paediatric specialist. Diagnostic confirmation, pruritus severity documentation, prior therapy history, and a written clinical rationale.
- Treatment-centre identification. A UAE tertiary paediatric liver or gastroenterology service accepts the case and agrees to monitor LFTs, bile acids, vitamins, and growth.
- MOHAP named-patient application. Your physician or the hospital's importing pharmacy files the application including prescription, diagnostic report, weight-based dosing plan, and chain-of-custody documentation.
- US-side sourcing. Reserve Meds coordinates with our US-licensed specialty wholesale partner to secure product from the manufacturer's authorised distribution chain under DSCSA.
- Temperature-controlled shipment. Bylvay ships with protective packaging and chain-of-custody documentation end to end.
- Arrival and dispensing support. Your paediatric specialist remains the treating clinician. Reserve Meds coordinates re-supply ahead of bottle depletion so pruritus control is not interrupted.
What documentation your physician needs
Your physician will typically need to provide:
- A clinical rationale letter confirming PFIC or Alagille diagnosis, pruritus severity, prior antipruritic therapy, and Bylvay as the indicated treatment
- Verification of their UAE medical licence (MOHAP, DOH Abu Dhabi, or DHA)
- A current prescription naming the product, weight-based dose (µg/kg), and dosing schedule
- Patient identifier (anonymised paediatric reference preferred)
- Planned monitoring cadence (LFTs, serum bile acids, fat-soluble vitamins, growth)
Reserve Meds provides a physician documentation kit bundling the templates MOHAP reviewers expect to see for paediatric rare-disease oral therapies under named-patient import.
Costs and timing
Bylvay's US cash-pay reference price is weight-dependent. For a typical paediatric patient, indicative 2026 monthly cost sits in a range of roughly USD 25,000–40,000 per month depending on weight and formulation. Logistics, MOHAP documentation handling, and concierge coordination add incremental cost; Reserve Meds issues a full transparent quote at the start of intake, with a drug-only reference figure separated from service charges so your family can see the breakdown.
Indicative timing — not guaranteed — for first shipment arrival after cohort intake opens is approximately 7–14 days from the moment a complete MOHAP application is submitted. Subsequent re-supply cycles are generally faster once the pathway is established.
Reserve Meds is in pre-launch. Fulfillment availability is limited to our first cohort, and all timelines published on this site are indicative. If your clinical situation is time-sensitive, flag that when you join the waitlist — we triage accordingly.
A culturally-aware note: the UAE has internationally trained paediatric hepatology teams across Abu Dhabi and Dubai. Our concierge team coordinates with whichever hospital your specialist uses, in English or Arabic as your family prefers.
Reserve Meds's role
Reserve Meds is a US-based concierge coordinator for cross-border specialty medicine. For Bylvay specifically, we provide:
- Sourcing. Through our US-licensed specialty wholesale partner, operating under DSCSA chain-of-custody.
- Documentation. Regulatory documentation package for your physician and for MOHAP review, including paediatric diagnostic-attestation templates.
- Logistics. Temperature-protected shipment and chain-of-custody coordination.
- Concierge case lead. A named point of contact for your family and your physician throughout the process.
What we do not do: we are not the prescriber, we do not practise medicine, and we are not the dispensing pharmacy. All clinical decisions remain with your treating paediatric specialist. We operate on a waitlist basis during our pre-launch phase.
Frequently asked
Is this legal in the UAE? Yes, when executed through the MOHAP named-patient framework with appropriate documentation. See our trust and compliance page.
Is Bylvay a cure? No. Bylvay addresses cholestatic pruritus by reducing systemic bile acid exposure. It does not correct the underlying genetic defect, but for many children it substantially reduces itch, improves sleep, and improves quality of life.
How does Bylvay differ from maralixibat (Livmarli)? Both are IBAT inhibitors approved for overlapping paediatric cholestatic indications. Choice between them depends on your child's genetic subtype, weight, formulation preference, and tolerance. Your paediatric specialist will discuss.
What if my child has liver surgery planned? Dosing and monitoring around biliary surgery or transplant are clinical decisions your specialist will manage. Reserve Meds can adjust supply cycles to avoid waste around planned changes in therapy.
Will private insurance cover this? Cash-pay is the default. Some UAE private insurers reimburse named-patient imports for ultra-rare paediatric conditions on a case-by-case basis; we supply documentation for your submission but do not process insurance claims directly.
Next step — join the first-cohort 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 Bylvay coordination in the UAE.
Add me to the Bylvay waitlistExamples and timings above are composite illustrations drawn from published sources and typical named-patient patterns. Your individual case is assessed by your physician and our clinical-regulatory team; Reserve Meds does not guarantee outcomes or timelines.
Clinical & regulatory review: Reserve Meds clinical team and AI regulatory-counsel review pipeline. Last medically reviewed: 2026-04-24.