Primary biliary cholangitis (PBC): cross-border specialty drug access for international patients

Quick orientation

Primary biliary cholangitis affects an estimated 30 to 50 per 100,000 women in some populations. Female predominance is approximately 10 to 1.

Typical age of onset. Most commonly diagnosed between ages 40 and 60.

Severity tiers. Severity ranges from asymptomatic disease to progressive cholestatic liver disease and cirrhosis.

Why specialty drugs for Primary biliary cholangitis (PBC) are hard to access internationally

Two newer FDA-approved second-line agents (Livdelzi, Iqirvo) treat patients with inadequate response to or intolerance of ursodeoxycholic acid. International registration is in early stages.

Treatments approved by the FDA

• Livdelzi (seladelpar) — FDA approval: 2024. Mechanism: Selective PPAR-delta agonist. Route: Oral once daily. US WAC ballpark: Approximately USD 100,000 per year. Country pricing: Kuwait · Egypt · Bahrain · Oman.
• Iqirvo (elafibranor) — FDA approval: 2024. Mechanism: PPAR alpha and delta agonist. Route: Oral once daily. US WAC ballpark: Approximately USD 100,000 per year. Country pricing: Qatar · Jordan · Bahrain.

Cross-border pathways used for Primary biliary cholangitis (PBC)

Most patients use one or more of the following regulatory pathways, depending on the destination country and the specific drug:

• Named Patient Program (NPP)
• Personal Import Scheme
• Cross-border Prescription

What your physician needs to know

• Confirm PBC diagnosis (AMA-positive or characteristic histology).
• Document UDCA response or intolerance.
• Liver function monitoring per label.
• Hepatologist co-management is recommended.
• Address itch, fatigue, and bone health concurrently.

Common questions

How do Livdelzi and Iqirvo compare?

Both are PPAR agonists with overlapping but distinct profiles. Your hepatologist selects based on clinical factors.

Are they available in my country?

Registration is in early stages outside the US.

Will they cure PBC?

They improve biochemical markers and may slow progression; they do not cure the underlying autoimmune process.

How long is treatment?

Long-term, in most patients with active disease.

What documents are required?

Hepatologist's prescription, AMA status or histology, UDCA history, and recent labs.

Where Reserve Meds fits in

Reserve Meds is a cross-border specialty drug access platform. We support international patients whose prescribed FDA-approved medicine is not registered locally, is not reimbursed by their payer, or is otherwise unavailable through standard channels. For Primary biliary cholangitis (PBC), our role is to coordinate the regulatory pathway, source the medicine from a DSCSA-compliant US wholesaler, and arrange validated cold-chain or controlled-temperature shipment to the destination country.

We do not replace your treating physician. We do not bill insurance. We operate a cash-pay model, and we work alongside the clinical team that knows your case. Every prescription is reviewed by a US-licensed pharmacist before dispense, and a US-licensed physician reviews the supply request before shipment.

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