Asthma: cross-border specialty drug access for international patients

Quick orientation

Asthma affects approximately 262 million people globally according to the World Health Organization, with substantial regional variation. Severe asthma represents 5 to 10 percent of all asthma cases.

Typical age of onset. Childhood-onset and adult-onset forms both exist. Severe and biologic-eligible asthma typically presents in adolescence or adulthood.

Severity tiers. Severity is classified from intermittent to severe persistent. Severe asthma includes eosinophilic, allergic, and T2-low phenotypes; treatment choice depends on biomarkers.

Why specialty drugs for Asthma are hard to access internationally

Biologic therapies for severe asthma have transformed care since 2015, but most are administered in specialty settings and require specialist initiation. Several newer biologics and a needle-free emergency epinephrine option are still rolling out internationally, and many are not yet locally reimbursed in MENA and South Asia despite registration in the US and EU.

Treatments approved by the FDA

• Xolair (omalizumab) — FDA approval: 2003. Mechanism: Anti-IgE monoclonal antibody for allergic asthma. Route: Subcutaneous injection. US WAC ballpark: Approximately USD 3,000 to 5,000 per month.
• Dupixent (dupilumab) — FDA approval: 2018 (asthma indication). Mechanism: IL-4 and IL-13 receptor alpha antagonist. Route: Subcutaneous injection every 2 weeks. US WAC ballpark: Approximately USD 3,400 per month. Country pricing: UAE · Saudi Arabia · India · Egypt.
• Fasenra (benralizumab) — FDA approval: 2017. Mechanism: IL-5 receptor alpha antagonist. Route: Subcutaneous injection every 4 to 8 weeks. US WAC ballpark: Approximately USD 5,500 per dose.
• Tezspire (tezepelumab) — FDA approval: 2021. Mechanism: Anti-TSLP monoclonal antibody. Route: Subcutaneous injection every 4 weeks. US WAC ballpark: Approximately USD 3,800 per month.
• Neffy (epinephrine nasal spray) — FDA approval: 2024. Mechanism: Needle-free epinephrine for anaphylaxis associated with severe exacerbations and food-allergy comorbidity. Route: Intranasal. US WAC ballpark: Approximately USD 750 per two-pack. Country pricing: Saudi Arabia · India · Qatar · Lebanon.

Cross-border pathways used for Asthma

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

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

What your physician needs to know

• Confirm phenotype: allergic IgE-mediated, eosinophilic, T2-low, or mixed.
• Baseline FEV1, FeNO, blood eosinophil count, and total IgE inform biologic selection.
• Document failure or intolerance of high-dose inhaled corticosteroid plus a second controller before initiating biologic therapy.
• Confirm vaccination status and screen for chronic infections before starting an immunomodulator.
• Some destination countries require pulmonologist or allergist co-sign on the international supply request.

Common questions

Are asthma biologics available locally?

Some are, some are not. Xolair and Dupixent are widely registered. Tezspire and the newer eosinophil-targeted agents have narrower international footprints. We confirm by destination.

Does Reserve Meds help with inhalers?

Our focus is on specialty drugs that are unregistered or not reimbursed locally. Standard inhalers are typically available through normal channels and not part of our core scope.

How long does a request take?

Five to ten business days from prescription receipt for most biologics, subject to destination-country import requirements.

Can my child receive an asthma biologic?

FDA pediatric labels vary. Dupixent and Xolair are approved down to age 6 for asthma; Fasenra and Tezspire have older minimum ages. Your physician confirms eligibility.

What if my patient needs Neffy as an emergency anaphylaxis option?

Neffy is a needle-free epinephrine option approved by the FDA in 2024. Cross-border supply is supported through personal-import and named-patient pathways depending on destination.

Do I need to switch biologics if one stops working?

Sometimes. Phenotype reassessment and biomarker check guide switches. Reserve Meds supports sequential supply when the regimen changes.

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 Asthma, 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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