Prior authorization required — document indication‑specific criteria

Prior authorization is required. The provider must document that the member meets the indication‑specific initial or continuation criteria including prescriber specialty, prior therapy failures, age/weight requirements, dosing limits, and that dupilumab is not prescribed concurrently with another biologic immunomodulator or a JAK inhibitor.

• Provider attestation that member meets all listed approval criteria (diagnosis confirmation, prior treatment failures, age/weight, prescriber specialty).
• Dose requested does not exceed indication‑specific limits.

Prior authorization requirements — therapy status, response, and no concurrent biologics/JAK inhibitors

PA requests must state current therapy status and evidence of clinical response for continuation requests, and confirm the member is not receiving another biologic immunomodulator or a JAK inhibitor. Approvals are typically issued for 6 months or to the member's renewal date.

• Document current therapy status and positive response to therapy.
• Confirm absence of concurrent biologic or JAK inhibitor therapy.
• Note typical approval duration: 6 months or to renewal date.

PA must include indication and weight‑based dosing for pediatric requests

For pediatric requests, the prior authorization must specify the exact diagnosis and the patient’s weight and indicate the requested dupilumab regimen consistent with labeled, weight‑based dosing bands.

• Provide patient weight for pediatric weight bands (e.g., 15–<30 kg, 30–<60 kg) to determine loading and maintenance doses.
• Specify the indication to match label‑specific dosing.

Prior authorization and coding — applies to dupilumab and unclassified biologic codes

Include the HCPCS/J codes being billed with the prior authorization; the policy applies to dupilumab and related unclassified biologic drug codes (e.g., C9399, J3590), but listing a code does not guarantee coverage.

• C9399 and J3590 are referenced for unclassified/biologic drugs.
• Code inclusion is informational and does not ensure payment — follow professional coding guidance.

Step therapy/failure requirements — prior failures of specified standard therapies

Many indications require documented failure of specified standard therapies before dupilumab will be authorized (e.g., topical non‑steroidal therapy and medium‑to‑very high potency topical corticosteroid for atopic dermatitis; ≥2 intranasal corticosteroids for CRSwNP; PPI or corticosteroid for EoE; antihistamines and LTRA for CSU; corticosteroid plus non‑steroidal immunosuppressant for BP).

• Atopic dermatitis: failure of one non‑steroidal topical therapy ≥4 weeks and one medium‑to‑very high potency topical corticosteroid ≥2 weeks.
• CRSwNP: failure of ≥2 intranasal corticosteroids (one Xhance in adults) each ≥4 weeks.
• EoE: failure of a proton pump inhibitor or corticosteroid unless contraindicated.

Therapeutic alternatives — preferred alternatives and step options

Preferred therapeutic alternatives and step options are listed in Appendix B and should be tried or documented as contraindicated before dupilumab (examples include topical corticosteroids and calcineurin inhibitors for AD; inhaled corticosteroid/LABA for asthma; intranasal corticosteroids for CRSwNP; systemic immunosuppressants for BP).

• Appendix B lists specific topical corticosteroids and other preferred alternatives.
• Asthma: ensure adherence to controller therapy (e.g., medium‑ to high‑dose ICS plus LABA) per guideline context before biologic consideration.

Clinical guidance context — asthma and CSU references (GINA, omalizumab placement)

Clinical guideline context is provided for asthma and CSU. GINA recommends considering dupilumab as adjunct therapy for patients ≥6 years with severe/difficult‑to‑treat asthma despite high‑dose ICS/LABA and eosinophilic biomarkers; CSU guidance references omalizumab placement in stepwise algorithms.

• Refer to GINA for severe asthma placement and requirement for prior high‑dose ICS/LABA.
• CSU guidance notes omalizumab as a later‑line option in stepwise care; dupilumab is not yet in guideline algorithms for CSU but trial data exist.

Step therapy adjustment for Atopic Dermatitis — topical agent step requirement changed

The adaptation changed the topical agent step requirement for atopic dermatitis from a triple‑step to a double‑step redirection and added immunologists to the list of prescriber options; providers should follow the revised step documentation when requesting PA.

• Policy adaptation: topical agent requirement simplified to a double‑step (per adaptation notes).
• Immunologist added as an acceptable prescriber for AD.

Documentation submission requirements — chart notes, labs, pathology reports

Submit office chart notes, relevant lab results (e.g., blood eosinophil counts), endoscopic biopsy reports (EoE eos/hpf), and pathology or serology (BP anti‑BP180/230 ELISA or immunofluorescence) to support the request.

• EoE: biopsy showing ≥15 eosinophils per high‑power field.
• BP: histology, serology (anti‑BP180/anti‑BP230 by ELISA), or immunofluorescence.
• Asthma/COPD: recent blood eosinophil count (examples: asthma ≥150 cells/mcL; COPD ≥300 cells/µL).

Off‑label supporting documentation — immunotherapy‑related pruritus

For immunotherapy‑related pruritus (off‑label) requests, prescribers must submit supporting evidence (practice guidelines or peer‑reviewed literature) when dosing exceeds FDA‑approved regimens or for off‑label justification.

• Prescriber must provide guideline or peer‑reviewed literature support if dose is beyond FDA maximum for any approved indication.
• Regimen must be FDA‑approved or NCCN‑recommended for the off‑label use.

Reference to prescribing information and FDA label as supporting materials

Prescribing information and the FDA label are cited as supporting materials; include relevant sections of the Dupixent Prescribing Information to substantiate dosing and indication claims.

• Reference Dupixent Prescribing Information (Regeneron) and the FDA label when submitting dosing rationale.
• Label contains age‑ and weight‑based dosing bands and maximum dose references.

Policy development and documentation note — adaptation history and operational changes

The policy includes adaptation and operational history notes (e.g., step changes, added indications) from the source policy. Providers should be aware these changes when preparing documentation and PA requests.

• RT4 updates added CSU and BP indications and revised COPD FEV1 threshold to 20–80%.
• Operational notes document adaptation from prior policy CP PHAR.336 and prescriber/step changes.

Denial risk for incomplete requests — missing required documentation

Requests that do not include documentation showing the member meets all listed approval criteria (diagnosis confirmation, prior treatment failures, age/weight, prescriber specialty, dosing limits) may be denied.

• Missing confirmation of diagnosis, required prior therapies, age/weight bands, or prescriber specialty increases denial risk.
• Failure to document absence of concurrent biologic or JAK inhibitor therapy can result in denial.

Denied Indications — acute bronchospasm/status asthmaticus and other exclusions

Dupilumab is not authorized for acute bronchospasm or status asthmaticus; non‑FDA approved indications not addressed in this policy are not authorized unless sufficient off‑label evidence is submitted per off‑label policy.

• Acute bronchospasm/status asthmaticus is an excluded indication.
• Non‑FDA uses require evidence per CP.CPA.09 or may be denied.

Contraindication denial risk — known hypersensitivity to Dupixent or excipients

Known hypersensitivity to Dupixent or any of its excipients is a contraindication and will trigger denial of therapy; verify allergy/hypersensitivity status in submitted documentation.

• Document absence of known hypersensitivity to Dupixent or its excipients.
• Appendix C lists this as a formal contraindication.

Coding and coverage caveat — code inclusion does not guarantee coverage

Codes included in the policy (e.g., C9399, J3590) are informational only; inclusion or exclusion of any code does not guarantee coverage — providers must use up‑to‑date professional coding guidance when submitting claims.

• C9399 and J3590 are cited as unclassified/biologic drug codes.
• Providers must reference current professional coding resources for claim submission.