Metabolic dysfunction-associated steatohepatitis (MASH/NASH): cross-border specialty drug access for international patients

Quick orientation

MASH (formerly NASH) affects an estimated 3 to 5 percent of adults globally, with substantially higher prevalence among people with obesity and type 2 diabetes.

Typical age of onset. Most commonly diagnosed in middle adulthood, often as an incidental finding or during workup for elevated liver enzymes.

Severity tiers. Severity is graded by histology (fibrosis stages F0-F4) and increasingly by non-invasive markers. Advanced fibrosis (F3-F4) carries cardiovascular and liver-related mortality risk.

Why specialty drugs for Metabolic dysfunction-associated steatohepatitis (MASH/NASH) are hard to access internationally

Rezdiffra (resmetirom) is the first FDA-approved therapy specifically for MASH with moderate to advanced fibrosis (2024). International registration is in early stages. Cross-border supply has become a meaningful access route for international patients.

Treatments approved by the FDA

• Rezdiffra (resmetirom) — FDA approval: 2024. Mechanism: Liver-directed thyroid hormone receptor beta agonist. Route: Oral once daily. US WAC ballpark: Approximately USD 47,000 per year. Country pricing: UAE · Saudi Arabia · India · Egypt.

Cross-border pathways used for Metabolic dysfunction-associated steatohepatitis (MASH/NASH)

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 MASH with moderate to advanced fibrosis (F2-F3) by biopsy or non-invasive markers.
• Document concurrent metabolic comorbidities and their management.
• Hepatologist or gastroenterologist co-management is recommended.
• Liver function monitoring per label.
• Address weight management, glycemic control, and cardiovascular risk concurrently.

Common questions

Is Rezdiffra approved in my country?

International registration is in early stages.

Will it reverse fibrosis?

Trial data showed fibrosis improvement in a subset of patients. Individual response varies.

Is it for patients with cirrhosis?

The label is for F2-F3 fibrosis, not decompensated cirrhosis.

How long is treatment?

Treatment is intended as long-term management. Duration in clinical practice continues to be defined.

What documents are required?

Hepatologist's prescription, biopsy or non-invasive fibrosis assessment, and clinical summary.

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 Metabolic dysfunction-associated steatohepatitis (MASH/NASH), 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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