Dupixent Shortage: What Providers and Prescribers Need to Know in 2026

Dupixent (dupilumab) is not on the FDA's official drug shortage list in 2026, yet clinicians across dermatology, allergy/immunology, pulmonology, gastroenterology, and ENT continue to report that getting patients started on — and maintaining them on — Dupixent is a significant operational burden. Understanding the landscape of access barriers is essential for effective patient management.

The Formal Shortage Status: What the FDA Says

As of 2026, Dupixent is not listed on the FDA Drug Shortage Database. Sanofi and Regeneron continue to manufacture dupilumab at scale. The drug is available in both 200 mg and 300 mg prefilled pens and syringes — there is no documented supply chain disruption affecting either formulation.

The access problem, however, is not manufacturing-driven. It is system-driven — and for most prescribers, the bottlenecks are familiar: prior authorization complexity, step therapy requirements, specialty pharmacy coordination, and high patient cost.

Prior Authorization: The Primary Bottleneck

Prior authorization is required for Dupixent by virtually every commercial plan, most Medicaid plans (approximately 80% of enrollees), and Medicare Part D plans. The PA criteria vary by payer and by indication, which creates a documentation burden for practices that prescribe Dupixent across multiple conditions.

Key documentation elements that support successful PA approval across indications:

Atopic dermatitis: EASI or IGA scoring, documentation of inadequate response to topical corticosteroids and/or calcineurin inhibitors, specialist involvement

Asthma: Eosinophil count ≥150–300 cells/μL (payer-dependent), documented failure on high-dose ICS/LABA therapy, spirometry data

CRSwNP: CT or nasal endoscopy confirming polyp burden, trial of intranasal corticosteroids, documentation of sinus surgery history (for some payers)

EoE: Endoscopic biopsy confirming ≥15 eosinophils/HPF, failure of PPI and/or topical steroids (budesonide/fluticasone)

COPD: Eosinophil count ≥300 cells/μL, inadequate control on dual or triple inhaled therapy, FEV1 data

Step Therapy: Managing Patient Expectations

Step therapy continues to be a significant barrier, particularly for newly diagnosed patients or those transferring from another provider. Documenting prior treatment failures is essential — but the documentation must be specific and time-stamped. Vague notations like "patient tried topicals in the past" are often insufficient for payer medical review.

Best practice: at every relevant visit, record the specific medication used, dates of use, dose, and the objective or subjective reason for inadequate response. This makes PA submission — and any subsequent appeal — straightforward.

Navigating Specialty Pharmacy Routing

Dupixent must be dispensed through a specialty pharmacy. Different insurance plans route to different specialty pharmacy networks. For patients whose plans require a specific specialty pharmacy (e.g., Accredo for Cigna plans, Optum for UHC plans), sending the prescription to the wrong pharmacy causes delays. Your office should maintain an updated reference of which specialty pharmacies partner with the major payers in your region.

DUPIXENT MyWay (1-844-387-4936) can assist with specialty pharmacy routing, PA coordination, and bridge medication for patients in between authorization approvals.

Key 2025–2026 Regulatory Updates Relevant to Prescribers

9th indication (CSU in children 2–11): Approved April 2026. Dosing for ages 2–11 is weight-based. Prior auth requirements for this pediatric indication are still being established by payers; expect variability.

Biosimilar approval: The FDA approved a dupilumab biosimilar. Commercial launch is anticipated but had not occurred as of early 2026. When launched, payers may implement substitution policies requiring biosimilar use before the reference product.

Medicare Part D $2,100 cap: In 2026, Medicare Part D patients have an annual out-of-pocket maximum of $2,100 for covered drugs. This substantially reduces the burden for older patients on Medicare who previously reached catastrophic coverage thresholds.

Managing Appeals Effectively

When a PA is denied, a peer-to-peer review request — where the prescriber speaks directly with the payer's medical reviewer — is the most effective appeal strategy for Dupixent. These calls typically result in approval when the prescriber can articulate:

Specific clinical evidence of disease severity and its functional impact

Why the payer's step therapy requirements have been met or are contraindicated

Why Dupixent is the clinically appropriate next step (vs. JAK inhibitors or alternative biologics)

Helping Your Patients Navigate the Process

Patients who understand the process are better equipped to advocate for themselves. Encouraging enrollment in DUPIXENT MyWay, giving patients clear instructions on what happens after you submit the prescription, and directing them to resources like medfinder for providers can help ensure they reach the specialty pharmacy that carries their medication once authorization is in place.

Summary for Prescribers

Dupixent is not in an FDA shortage in 2026 — supply is stable.

Access barriers are payer-driven: prior auth, step therapy, and specialty pharmacy routing.

Detailed contemporaneous documentation of diagnosis severity and treatment failures is the best insurance against denials.

Peer-to-peer reviews are the most effective PA appeal tool.

Biosimilar availability is expected — prepare patients for potential formulary-driven substitution requirements.