Criteria for Prior Authorization — Atopic Dermatitis (AD) Agents
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Rules and medical necessity criteria that govern prior authorization (PA) for topical and systemic medications used to treat atopic dermatitis for KDHE members; affects prescribers requesting PA for listed agents.
Newly listed FDA-approved agents and updated package insert references through 2024 (e.g., nemolizumab-ilto, lebrikizumab-lbkz, roflumilast, tapinarof).
General PA criteria require meeting indication, age, and dosing limits in Tables 1 and 2 and preferred PDL use unless non-preferred criteria met.
Renewal criteria specified including requirement for clinical benefit or EASI improvement ≥75% for certain agents.
Revised dates listed including January 22, 2025 and prior revision history.
Coverage Criteria
Initial Therapy
Covered when ALL of the following are met:
Initial PA general requirements
- Topical trial or sensitive area requirement (for crisaborole, pimecrolimus, roflumilast, tacrolimus, tapinarof): Either an adequate trial (at least 3 weeks) of at least one prescription-strength topical corticosteroid OR a documented contraindication to all agents listed in Table 3 OR atopic dermatitis located on the face, neck, genitalia, skin folds, and/or axillae.>=3 weeks
- Ruxolitinib-specific requirements: Patient must have had an adequate trial (at least 3 weeks) of one (or documented contraindication to all) topical calcineurin inhibitor AND one phosphodiesterase-4 inhibitor listed in Table 1; ruxolitinib must not be used concurrently with other immunosuppressive agents such as topical calcineurin inhibitors listed in Table 1 or any agents listed in Table 4 or Table 5.>=3 weeks
- Systemic agents (Table 2) prescriber and baseline requirements: Agent must be prescribed by or in consultation with a dermatologist, allergist, or immunologist; patient must have had an adequate trial of at least 21 days of one (or contraindication to all) topical therapy listed in Table 1; prescriber must provide baseline Eczema Area and Severity Index (EASI) score ≥16.EASI >=16
- Abrocitinib/Upadacitinib additional requirement: For abrocitinib or upadacitinib the patient must have had an adequate trial of at least 8 weeks of one systemic conventional agent listed in Table 4 OR an adequate trial of at least 8 weeks of one biologic agent listed in Table 2, or a documented contraindication.>=8 weeks
Renewal Therapy
Covered when ALL of the following are met:
Concurrency Restrictions
Concurrency/exclusion rules applied to requests for immunomodulating biologics and JAK inhibitors:
Medications used for cosmetic purposes or for any other non-covered FDA-approved indications are excluded under this policy in accordance with Section 1927 of the Social Security Act (42 USC § 1396R-8(D)(2)), as amended. PA requests for drugs with existing PA requirements will be reviewed against package insert information for indication, age, dose, and any prerequisite treatments; exclusions for cosmetic or other non-covered indications apply unless state policy specifies otherwise.
Requests that do not meet the FDA‑approved indication, age, or dosing limits listed in Tables 1 and 2, or that lack required prerequisite therapy or supporting documentation, are considered not medically necessary and may be denied. In addition, when a preferred PDL agent exists for the PA indication, the preferred agent must be used unless the member meets the non‑preferred PDL PA criteria; failure to follow these requirements will trigger denial of the request.
Agents & Coding / Thresholds
| Abrocitinib (Cibinqo) | Janus kinase inhibitor (systemic) listed in Table 2 |
| Crisaborole (Eucrisa) | Topical PDE-4 inhibitor listed in Table 1 |
| Dupilumab (Dupixent) | Interleukin-4 receptor antagonist listed in Table 2 |
| Lebrikizumab-lbkz (Ebglyss) | Interleukin-13 receptor antagonist listed in Table 2 |
| Nemolizumab-ilto (Nemluvio) | Interleukin-31 receptor alpha antagonist listed in Table 2 |
| Pimecrolimus (Elidel) | Topical calcineurin inhibitor listed in Table 1 |
| Roflumilast cream (Zoryve) | Topical PDE-4 inhibitor listed in Table 1 |
| Ruxolitinib (Opzelura) | Topical JAK inhibitor listed in Table 1 |
| Tacrolimus (Protopic) | Topical calcineurin inhibitor listed in Table 1 |
| Tapinarof (Vtama) | Topical aryl hydrocarbon receptor agonist listed in Table 1 |
Provider Actions / Prior Authorization Requirements
Prior authorization required for listed AD agents
Prior authorization is required for all current and future dose forms of the listed atopic dermatitis agents and the request must meet the indication, age, and dosing limits in Tables 1 and 2. If a preferred PDL agent that treats the PA indication exists, that preferred agent must be used unless the patient meets non‑preferred PDL PA criteria.
- Applies to all agents listed in Tables 1 and 2.
- Provider must ensure dosing and age match the Tables.
Topical step‑therapy: trial of topical corticosteroid (≥3 weeks)
Before coverage of crisaborole, pimecrolimus, roflumilast, tacrolimus, or tapinarof, the patient must have had an adequate trial of at least one prescription‑strength topical corticosteroid for at least 3 weeks, or documentation of contraindication to all agents in Table 3, or documentation that AD involves sensitive areas (face, neck, genitalia, skin folds, axillae).
- Adequate trial defined as at least 3 weeks.
- Sensitive‑area location (face/neck/genitalia/folds/axillae) satisfies the requirement.
- Document contraindications to agents in Table 3 if applicable.
Ruxolitinib: dual topical trials (calcineurin + PDE‑4) or documented contraindication
For ruxolitinib (topical), the patient must have had an adequate trial of a topical calcineurin inhibitor AND a topical phosphodiesterase‑4 (PDE‑4) inhibitor for at least 3 weeks each, or documented contraindications to these agents. Ruxolitinib must not be used concurrently with other immunosuppressive agents listed in Tables 1, 4, or 5.
- Adequate trial defined as ≥3 weeks of each: a topical calcineurin inhibitor and a PDE‑4 inhibitor.
- Must not be used concurrently with topical calcineurin inhibitors or any agents in Table 4 or Table 5.
Systemic JAK inhibitors require prior adequate systemic trial (≥8 weeks)
For systemic JAK inhibitors (abrocitinib, upadacitinib), the patient must have had an adequate trial of at least 8 weeks of one systemic conventional agent (Table 4) OR at least 8 weeks of one biologic agent listed in Table 2, unless contraindicated.
- Adequate trial defined as ≥8 weeks of one systemic conventional agent (Table 4) or one biologic (Table 2).
- Applies specifically to abrocitinib and upadacitinib per Table 2 requirements.
Document required therapy trials and baseline EASI (≥16) for systemic agents
Prescriber must document trials of the prerequisite topical and systemic therapies as required by Tables 1, 4, and 2, and for systemic agents provide a baseline EASI score of ≥16. For renewal of certain agents, prescriber must supply evidence of clinical benefit or EASI improvement where required.
- Document trial details (agent, duration, response) for topical therapies per Table 1 and systemic per Table 4.
- Provide baseline EASI score ≥16 for agents in Table 2.
- For renewal, supply documentation of clinical benefit or EASI improvement when specified.
Nemolizumab‑ilto maintenance attestation (topical therapy)
For nemolizumab‑ilto, the provider must attest the patient will be maintained on topical corticosteroid and/or a topical calcineurin inhibitor until disease has sufficiently improved.
Denial risk if general PA requirements not met (indication/age/dosing/PDL)
Failure to meet the indication, age, or dosing limits in Tables 1 and 2, or failure to use a preferred PDL agent when applicable (unless non‑preferred PDL PA criteria are met), will result in denial of the PA request.
- Check indication, age, and dosing against Tables 1 and 2 before submitting PA.
- Use preferred PDL agent when available unless non‑preferred criteria are documented.
Concurrent immunomodulator/JAK use prohibited — triggers denial
For any requested immunomodulating biologic or JAK inhibitor, the patient must not be concurrently on another immunomodulating biologic or JAK inhibitor listed in Table 5; concurrent use will lead to denial. After discontinuation, a new biologic or JAK will not be authorized until the next scheduled dose of the prior agent.
- Concurrent use with agents listed in Table 5 is prohibited and will trigger denial.
- Authorization for a new biologic/JAK may only occur at the next scheduled dose after discontinuation of the prior agent.
Background
Management of atopic dermatitis (AD) encompasses a stepped approach ranging from topical therapies to advanced systemic agents. Topical options include topical corticosteroids, nonsteroidal topical agents such as PDE‑4 inhibitors and topical calcineurin inhibitors, and topical JAK inhibitors. For more severe or refractory disease, systemic therapies— including biologics and systemic JAK inhibitors—are used; authorization for systemic agents requires specialty prescribing or consultation and baseline disease severity assessment using the Eczema Area and Severity Index (EASI) with a baseline requirement of EASI ≥16.
Definitions
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