Smart PA Criteria Proposal
| Category | Information |
|---|---|
| Drug / Drug Class: | Targeted Immune Modulators, Misc. Allergy and Asthma Related Monoclonal Antibodies PDL Edit |
| First Implementation Date: | July 11, 2019 |
| Revised Date: | October 2, 2025 |
| Prepared For: | MO HealthNet |
| Prepared By: | MO HealthNet/Conduent |
| Criteria Status | Revision of Existing Criteria |
Executive Summary
| Category | Information |
| Purpose: | The MO HealthNet Pharmacy Program will implement a state-specific preferred drug list. |
| Why Issue Selected: | The targeted immune modulators in this class are a diverse group of agents with a range of indications focusing on immune response modulation. The agents vary in both their molecular targets and mechanisms of action, with different agents achieving an immunosuppressive goal via different biological pathways. Indications for agents in this class include a variety of allergy and asthma related conditions including moderate to severe asthma, chronic obstructive pulmonary disease (COPD), moderate to severe atopic dermatitis, chronic rhinosinusitis with nasal polyposis (CRSwNP), chronic idiopathic urticaria, eosinophilic granulomatosis with polyangiitis (EGPA), hypereosinophilic syndrome (HES), eosinophilic esophagitis (EoE), prurigo nodularis (PN), and IgE-mediated food allergy. Total program savings for the PDL classes will be regularly reviewed. |
| Preferred Agents: | • Adbry® • Cinqair® • Ebglyss™ • Fasenra® • Xolair® |
| Non-Preferred Agents: | • Dupixent® • Nemluvio® • Nucala® • Tezspire® |
Setting and Population
- Drug/Drug Class for review: Targeted Immune Modulators, Misc. Allergy & Asthma Related Monoclonal Antibodies
- Age Range: All appropriate MO HealthNet participants
Approval Criteria
Approval criteria for a documented diagnosis of moderate to severe asthma – must meet all of the following:
- Claim is for Cinqair, Dupixent, Fasenra, Nucala, Tezspire, or Xolair;
- Prescribed by or in consultation with a pulmonologist, allergist, or immunologist;
- Participant of age range for requested agent as indicated in chart below;
- Participant must have experienced at least 1 exacerbation in the last 12 months despite continued compliant use of a high dose inhaled corticosteroid in (ICS) combination with either a long-acting beta adrenergic (LABA) or long-acting muscarinic antagonist (LAMA) as evidenced by paid claims. Exacerbations for asthma are defined as one or more of the following:
- One oral corticosteroid burst (for asthma);
- Emergency room (ER) visit (for asthma);
- Hospitalization (for asthma); OR
- Office visit for asthma worsening or emergency, not routine asthma follow-up; AND
- Prescriber attestation of moderate to severe asthma with one of the following:
- Eosinophilic asthma defined as an eosinophil count (EOS) of ≥ 150 cells/µL;
- Claim for Xolair: Documented percutaneous skin test, radioallergosorbent (RAST) allergy test, or in vitro reactivity to at least one perennial aeroallergen; OR
- Non-eosinophilic asthma – must meet one of the following:
- Claim for Tezspire: Participant must have experienced at least 2 asthma exacerbations in the last 12 months despite compliance on maintenance asthma therapy; OR
- Claim for Dupixent: Documented oral corticosteroid dependent asthma.
- Additional approval criteria for non-preferred agents:
- Failure to achieve desired therapeutic outcomes with trial on 2 or more preferred agents, if indicated:
- Documented trial period of preferred agents; OR
- Documented ADE/ADR to preferred agents.
- Failure to achieve desired therapeutic outcomes with trial on 2 or more preferred agents, if indicated:
- Initial approval period: 12 months
- Renewal of prior authorization may be given for up to 12 months following documentation of all of the following:
- Documented compliance to current therapy; AND
- Prescriber attestation of documented response to treatment compared to baseline based on one or more of the following:
- Decreased use of rescue inhalers; OR
- Decreased exacerbations.
Approval criteria for a documented diagnosis of chronic obstructive pulmonary disease (COPD) – must meet all of the following:
- Claim is for Dupixent or Nucala;
- Prescribed by or in consultation with a pulmonologist, allergist, or immunologist;
- Participant aged 18 years or older;
- Documentation of symptomatic presentation with evidence of type 2 inflammation (blood eosinophils ≥ 300 cells/µl); AND
- Failure to achieve desired therapeutic outcomes with 3 month trial on 1 or more of the following:
- LAMA/LABA dual maintenance therapy; OR
- LAMA/LABA/ICS triple maintenance therapy; AND
- Participant must have experienced at least 1 exacerbation in the last 12 months. Exacerbations for COPD are defined as one or more of the following:
- One oral corticosteroid burst (for COPD exacerbation);
- Emergency room (ER) visit (for COPD exacerbation);
- Hospitalization (for COPD exacerbation); OR
- Office visit for COPD worsening or emergency, not routine follow-up.
- Initial approval period: 6 months
- Renewal of prior authorization may be given for up to 12 months following documentation of clinical benefit (e.g., symptom control, decreased exacerbation rate).
Approval criteria for a documented diagnosis of severe atopic dermatitis – must meet all of the following:
- Claim is for Adbry, Dupixent, Ebglyss, or Nemluvio;
- Prescribed by or in consultation with an immunologist, allergist, or dermatologist; AND
- Failure to achieve desired therapeutic outcome with trial of at least any 2 of the following classes of therapy for 60 days each:
- Topical corticosteroid;
- Topical calcineurin inhibitor;
- Topical aryl hydrocarbon receptor agonist (i.e., Vtama®)
- Topical phosphodiesterase-4 (PDE-4) inhibitor (i.e., Zoryve® 0.15% cream or Eucrisa®);
- Topical or oral Janus Kinase (JAK) inhibitor;
- Phototherapy;
- Oral corticosteroid for the treatment of atopic dermatitis; OR
- Oral immunosuppressant for the treatment of atopic dermatitis;
- Additional approval criteria for non-preferred agents - must meet one of the following:
- Failure to achieve desired therapeutic outcomes with 3 month trial on 1 or more preferred agents, if indicated:
- Documented trial period of preferred agents; OR
- Documented ADE/ADR to preferred agents; OR
- Participants aged 6 months to 11 years may access Dupixent without a trial of a preferred agent.
- Failure to achieve desired therapeutic outcomes with 3 month trial on 1 or more preferred agents, if indicated:
- Initial approval period: 12 months
- Renewal of prior authorization may be given for up to 12 months following prescriber attestation of documented response to treatment compared to baseline.
Approval criteria for a documented diagnosis of chronic rhinosinusitis with nasal polyposis (CRSwNP) – must meet all of the following:
- Claim is for Dupixent, Nucala, or Xolair;
- Prescribed by or in consultation with an allergist, pulmonologist, or otolaryngologist;
- Participant aged 12 years or older; AND
- Provider attestation that chronic rhinosinusitis with nasal polyposis is refractory to therapy with at least 2 of the following:
- Intranasal steroids for at least 90 days;
- Systemic corticosteroid therapy burst for nasal polyps; OR
- One or more prior nasal surgeries while on an intranasal steroid to prevent recurrence.
- Additional approval criteria for non-preferred agents – must meet one of the following:
- Failure to achieve desired therapeutic outcomes with 3 month trial on 1 or more preferred agents, if indicated:
- Documented trial period of preferred agents; OR
- Documented ADE/ADR to preferred agents; OR
- Participants aged 12 to 17 years old may access Dupixent without a trial of a preferred agent.
- Failure to achieve desired therapeutic outcomes with 3 month trial on 1 or more preferred agents, if indicated:
- Initial approval period: 12 months
- Renewal of prior authorization may be given for up to 12 months following prescriber attestation of documented response to treatment compared to baseline.
Approval criteria for a documented diagnosis of chronic spontaneous urticaria with evidence of inadequate control – must meet all of the following:
- Claim is for Dupixent or Xolair;
- Participant aged 12 years or older; AND
- Documentation of therapeutic trial of both an H1 and H2 antihistamine at maximum tolerated dose.
- Additional approval criteria for Dupixent:
- Reason of medical necessity why Xolair cannot be utilized.
- Initial approval period: 6 months
Approval criteria for a documented diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA) – must meet all of the following:
- Claim is for Fasenra or Nucala; AND
- Participant aged 18 years or older.
- Additional approval criteria for non-preferred agents:
- Failure to achieve desired therapeutic outcomes with 3 month trial on 1 or more preferred agents, if indicated:
- Documented trial period of preferred agents; OR
- Documented ADE/ADR to preferred agents.
- Failure to achieve desired therapeutic outcomes with 3 month trial on 1 or more preferred agents, if indicated:
Approval criteria for a documented diagnosis of hypereosinophilic syndrome (HES) – must meet all of the following:
- Claim is for Nucala; AND
- Participant aged 12 years or older.
Approval criteria for a documented diagnosis of eosinophilic esophagitis (EoE) – must meet all of the following:
- Claim is for Dupixent;
- Prescribed by or in consultation with a gastroenterologist, immunologist, allergist, or other appropriate specialist;
- Participant aged 1 year or older;
- Diagnosis of eosinophilic esophagitis by endoscopic esophageal biopsy showing the presence of eosinophils (e.g., ≥ 15 eosinophils per high-powered field);
- Signs and current symptoms of esophageal dysfunction present; AND
- Inadequate response, intolerable adverse effects, or contraindications to all of the following treatments:
- High-dose proton pump inhibitor for at least 8 weeks;
- Swallowed topical corticosteroid (e.g., fluticasone, oral budesonide); AND
- Dietary therapy (i.e., avoidance of food allergen triggers).
- Initial approval period: 12 months
- Renewal of prior authorization may be given for up to 12 months following prescriber attestation of documented response to treatment compared to baseline.
Approval criteria for a documented diagnosis of prurigo nodularis (PN) – must meet all of the following:
- Claim is for Dupixent or Nemluvio;
- Prescribed by or in consultation with a dermatologist;
- Participant aged 18 years or older; AND
- Documentation of all of the following:
- ≥ 20 nodular lesions;
- Severe or very severe itch defined as Worst-Itch Numeric Rating Scale (WI-NRS score ≥ 7); AND
- Inadequate response, intolerable adverse effects, or contraindications to at least 1 month of therapy with medium to super-high potency topical corticosteroid.
- Additional approval criteria for Nemluvio:
- Adequate 3 month therapeutic trial of Dupixent.
- Initial approval of prior authorization is 6 months.
- Renewal of prior authorization may be given for up to 12 months following prescriber attestation of documented response to treatment compared to baseline by ≥ 4 point reduction in WI-NRS from baseline.
Approval criteria for a documented diagnosis of IgE-mediated food allergy – must meet all of the following:
- Claim is for Xolair;
- Participant aged 1 year or older;
- Prescribed by or in consultation with an allergist or immunologist;
- Documentation of pretreatment serum IgE levels of ≥ 30 IU/mL; AND
- One of the following:
- For initial therapy – documentation of at least 1 paid claim for self-administered epinephrine in the past 1 year; OR
- For continuation of therapy – documentation of at least 1 paid claim for self-administered epinephrine in the past 2 years.
Approval criteria for a documented diagnosis of bullous pemphigoid – must meet all of the following:
- Claim is for Dupixent;
- Participant aged ≥ 18 years of age;
- Prescribed by or in consultation with a dermatologist or other specialist in the treated disease state;
- Diagnosis of bullosa pemphigoid classified as moderate-to-severe (defined as a Bullous Pemphigoid Disease Area Index [BPDAI] activity score ≥24 and a baseline peak pruritus numerical rating scale (PPNRS; scale 0-10) score for maximum itch intensity ≥4);
- Documented treatment resistance to standard of care topical or systemic corticosteroids or contraindication to continuous corticosteroid treatment;
- Documentation of trial and failure of one steroid-sparing agent or documented ADE/ADR or contraindication to steroid sparing agent (methotrexate, azathioprine, and doxycycline); AND
- Administered in combination with a tapering course of oral corticosteroid.
Additional approval criteria for all indications
- Documentation of appropriate diagnosis and participant age range for requested agent:
| Biologic Agent | Brand | Indication (aged ≥ 18 years unless otherwise indicated) |
|---|---|---|
| benralizumab | Fasenra® |
|
| dupilumab | Dupixent® |
|
| lebrikizumab-lbkz | Ebglyss™ |
|
| mepolizumab | Nucala® |
|
| nemolizumab-ilto | Nemluvio® |
|
| omalizumab | Xolair® |
|
| reslizumab | Cinqair® |
|
| tezepelumab-ekko | Tezspire® |
|
| tralokinumab-ldrm | Tezspire® |
|
Denial Criteria
- Therapy will deny with presence of one of the following:
- Any approval criteria are not met; OR
- Claim exceeds maximum dosing limitation for the following:
| Biologic Agent | Drug Description | Max Dosing Limitation |
|---|---|---|
| BENRALIZUMAB | FASENRA 30 MG/ML SYR | 1 ML EVERY 24 DAYS |
| BENRALIZUMAB | FASENRA PEN 30 MG/ML | 1 ML EVERY 24 DAYS |
| BENRALIZUMAB | FASENRA 10 MG/0.5 ML SYRINGE | 0.5 ML EVERY 24 DAYS |
| DUPILUMAB | DUPIXENT 100 MG/0.67 ML SYRING | 1.34 ML EVERY 24 DAYS |
| DUPILUMAB | DUPIXENT 200 MG/1.14 ML SYRING | 2.28 ML EVERY 24 DAYS |
| DUPILUMAB | DUPIXENT 200 MG/1.14 PEN | 2.28 ML EVERY 24 DAYS |
| DUPILUMAB | DUPIXENT 300 MG/2 ML SYRINGE | 4 ML EVERY 24 DAYS* |
| DUPILUMAB | DUPIXENT 300 MG/2 ML PEN | 4 ML EVERY 24 DAYS* |
| MEPOLIZUMAB | NUCALA 100 MG VIAL | 1 ML EVERY 24 DAYS** |
| MEPOLIZUMAB | NUCALA 100 MG/ML SYRINGE | 1 ML EVERY 24 DAYS** |
| MEPOLIZUMAB | NUCALA 100 MG/ML AUTO-INJECT | 1 ML EVERY 24 DAYS** |
| MEPOLIZUMAB | NUCALA 40 MG/0.4 ML SYRINGE | 0.4 ML EVERY 24 DAYS |
| NEMOLIZUMAB-ILTO | NEMLUVIO 30 MG PEN | 1 ML EVERY 24 DAYS*** |
| OMALIZUMAB | XOLAIR 75 MG/0.5 ML SYRINGE | 1 ML EVERY 24 DAYS |
| OMALIZUMAB | XOLAIR 75 MG/0.5 ML AUTOINJECT | 1 ML EVERY 24 DAYS |
| OMALIZUMAB | XOLAIR 150 MG/ML SYRINGE | 2 ML EVERY 24 DAYS |
| OMALIZUMAB | XOLAIR 150 MG VIAL | 2 ML EVERY 24 DAYS |
| OMALIZUMAB | XOLAIR 150 MG/ML AUTOINJECT | 2 ML EVERY 24 DAYS |
| OMALIZUMAB | XOLAIR 300 MG/2 ML SYRINGE | 4 ML EVERY 24 DAYS**** |
| OMALIZUMAB | XOLAIR 300 MG/2 ML AUTOINJECT | 4 ML EVERY 24 DAYS**** |
| RESLIZUMAB | CINQAIR 100 MG/10 ML VIAL | 50 ML EVERY 24 DAYS |
| TEZEPELUMAB-EKKO | TEZSPIRE 210 MG/1.91 ML SYRING | 1.91 ML EVERY 24 DAYS |
| TEZEPELUMAB-EKKO | TEZSPIRE 210 MG/1.91 ML PEN | 1.91 ML EVERY 24 DAYS |
| TRALOKINUMAB-LDRM | ADBRY 150 MG/ML SYRINGE | 4 ML EVERY 24 DAYS |
| TRALOKINUMAB-LDRM | ADBRY 300 MG/2 ML AUTOINJECT | 4 ML EVERY 24 DAYS |
*Unless ICD10 for EoE is present on claim, then can allow 8 mL every 24 days
**Unless ICD10 for EGPA or HES is present on claim, then can allow 3 mL every 24 days
*** Unless ICD10 for PN is present on claim, then can allow 2 mL every 24 days
****Unless ICD10 for IgE or CRSwNP is present on claim, then can allow 8 mL every 24 days
Disposition of Edit
Denial: Exception Code "0160" (Preferred Drug List)
Rule Type: PDL
Default Approval Period
1 year
References
- Evidence-Based Medicine and Fiscal Analysis: “Therapeutic Class Review: IMMUNOLOGIC AGENTS: Targeted Immune Modulators; Miscellaneous Allergy and Asthma-Related Antibodies”, Gainwell Technologies; Last updated April 9, 2025.
- Evidence-Based Medicine Analysis: “Target Immune Modulators: Allergy and Asthma Related Antibodies”, UMKC-DIC; March 2025.
- Adbry [package insert]. Madison, NJ: LEO Pharma Inc.; June 2024.
- Cinqair [package insert]. West Chester, PA: Teva Respiratory, LLC; February 2020.
- Dupixent [package insert]. Bridgewater, NJ: Sanofi-Aventis U.S. LLC; June 2025.
- Fasenra [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP.; April 2024.
- Nucala [package insert]. Research Triangle Park, NC: GlaxoSmithKline LLC; June 2025.
- Tezspire [package insert]. Thousand Oaks, CA: Amgen Inc.; May 2023.
- Xolair [package insert]. South San Francisco, CA: Genentech, Inc.; February 2024.
- Ebglyss™ [package insert]. Indianapolis, IN: Eli Lilly and Company. May 2025.
- Nemluvio® [package insert]. Dallas, TX: Galderma Laboratories, LP. December 2024.
- USPDI, Micromedex; 2025.
- Clinical Pharmacology [online]. Tampa (FL): Elsevier. 2025.