Melanoma: cross-border specialty drug access for international patients

Quick orientation

Melanoma is the most aggressive form of skin cancer, with approximately 325,000 new cases per year globally (Globocan 2022). Incidence is highest in fair-skinned populations and continues to rise.

Typical age of onset. All adult ages; rising incidence in older adults.

Severity tiers. Severity depends on stage and molecular profile (BRAF, NRAS, c-KIT).

Why specialty drugs for Melanoma are hard to access internationally

Checkpoint inhibitors and BRAF/MEK combinations have transformed melanoma care. Several newer products including TIL therapy (Amtagvi) require qualified centers. International registration varies, particularly for cell-based products.

Treatments approved by the FDA

• Amtagvi (lifileucel) — FDA approval: 2024. Mechanism: Autologous tumor-infiltrating lymphocyte (TIL) therapy for advanced melanoma. Route: One-time intravenous infusion of autologous TIL after conditioning. US WAC ballpark: Approximately USD 515,000 one-time. Country pricing: Saudi Arabia · Kuwait · Jordan.
• Keytruda (pembrolizumab) — FDA approval: 2014. Mechanism: Anti-PD-1 monoclonal antibody. Route: Intravenous infusion every 3 or 6 weeks. US WAC ballpark: Approximately USD 175,000 per year. Country pricing: India · Egypt · Jordan.
• Opdivo (nivolumab) — FDA approval: 2014. Mechanism: Anti-PD-1 monoclonal antibody. Route: Intravenous infusion every 2, 4, or 6 weeks. US WAC ballpark: Approximately USD 150,000 per year.

Cross-border pathways used for Melanoma

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

• Named Patient Program (NPP)
• Expanded Access Program (EAP)
• Compassionate Use
• Medical Tourism Access

What your physician needs to know

• Confirm melanoma stage and molecular profile (BRAF, NRAS).
• Document prior systemic therapy.
• TIL therapy requires qualified center administration.
• Watch for immune-related adverse events.
• Multidisciplinary melanoma team co-manages.

Common questions

Can I receive Amtagvi abroad?

Amtagvi is administered at qualified centers, primarily in the US. Reserve Meds supports medical-tourism access.

Are checkpoint inhibitors available locally?

Pembrolizumab and nivolumab are widely registered globally.

How long does shipment take?

Five to fifteen business days for oral and IV products; cell therapies require travel.

Is BRAF/MEK combination an option?

Yes, for BRAF V600-mutated disease. Multiple FDA-approved combinations exist.

What documents are required?

Oncologist's prescription, pathology with BRAF status, imaging, and treatment history.

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 Melanoma, 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.

Start a request

Request a drug for Melanoma

Reserved for you.