Polymyalgia rheumatica (PMR): cross-border specialty drug access for international patients

Quick orientation

Polymyalgia rheumatica affects an estimated 50 to 100 per 100,000 people aged 50 and older.

Typical age of onset. Almost always after age 50; mean age at onset is approximately 70.

Severity tiers. Severity ranges from mild and quickly responsive to chronic relapsing forms requiring long-term steroid sparing therapy.

Why specialty drugs for Polymyalgia rheumatica (PMR) are hard to access internationally

Kevzara (sarilumab) is the first FDA-approved IL-6 inhibitor specifically for PMR (2023). International registration of the PMR indication is in early stages.

Treatments approved by the FDA

• Kevzara (sarilumab) — FDA approval: 2017 (PMR indication 2023). Mechanism: IL-6 receptor antagonist with PMR indication. Route: Subcutaneous injection every 2 weeks. US WAC ballpark: Approximately USD 50,000 per year.

Cross-border pathways used for Polymyalgia rheumatica (PMR)

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 PMR diagnosis and rule out giant cell arteritis.
• Document steroid-dependent or relapsing disease.
• Screen for tuberculosis and update vaccinations before IL-6 inhibitor initiation.
• Lipid panel monitoring is required.
• Rheumatologist co-management is recommended.

Common questions

How does Kevzara compare to steroids?

Kevzara is intended as a steroid-sparing agent for relapsing PMR. It does not replace acute steroid therapy in most cases.

Is the PMR indication available globally?

Registration of the PMR-specific indication is in early stages. The drug itself is more broadly available with other indications.

Are there side effects to watch for?

Infections, lipid changes, and gastrointestinal events. Monitoring per label.

How long does shipment take?

Five to ten business days from prescription receipt.

What documents are required?

Rheumatologist's prescription, steroid history, 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 Polymyalgia rheumatica (PMR), 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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