Criteria for Prior Authorization — Axial Spondyloarthritis Agents
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Defines prior authorization requirements for biologic and JAK inhibitor therapies for ankylosing spondylitis and non-radiographic axial spondyloarthritis for KDHE pharmacy benefit management.
Revised dates include October 16, 2024 and other 2024 and 2023 updates.
Coverage Criteria
Initial Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met
Continuation/Renewal Therapy — Covered upon renewal when ALL of the following are met
Covered upon renewal when ALL of the following are met
Concurrent use of more than one biologic or JAK inhibitor listed in Table 3 is prohibited. For all requested biologics or janus kinase (JAK) inhibitors, patient must not concurrently be on another biologic or JAK inhibitor listed in Table 3. After discontinuing the current biologic or JAK inhibitor, the earliest a new biologic or JAK inhibitor will be authorized is at the patient’s next scheduled dose.
Requests that seek to add or continue a second biologic or JAK inhibitor in patients already receiving any agent from Table 3 are not consistent with the coverage criteria and are therefore not covered. Providers must ensure the patient is not concurrently receiving another Table 3 biologic or JAK inhibitor before submitting a prior authorization request; documentation of discontinuation and timing to the next scheduled dose is required when switching agents.
Coding and Agents
| Adalimumab (Humira®, Abrilada™, Amjevita™, Cyltezo®, Hadlima™, Hulio®, Hyrimoz®, Idacio®, Simlandi®, Yuflyma®, Yusimry™) | Tumor Necrosis Factor-Alpha (TNF-alpha) blocker; Age = ≥ 18 years; Dosing Limits = 40 mg SC every other week. |
| Bimekizumab-bkzx (Bimzelx®) | Interleukin-17a and F inhibitor; Age = ≥ 18 years; Dosing Limits = 160 mg SC every 4 weeks or 300 mg per infusion. |
| Certolizumab (Cimzia®) | TNF blocker; Age = ≥ 18 years; Dosing Limits = 400 mg SC initial series (weeks 0,2,4) then 200 mg every other week or 400 mg every 4 weeks. |
| Etanercept (Enbrel®) | TNF blocker; Age = ≥ 18 years; Dosing Limits = 50 mg SC once weekly. |
| Golimumab (Simponi®, Simponi Aria®) | TNF blocker; Age = ≥ 18 years; Dosing Limits = Simponi SC 50 mg once monthly; Simponi Aria IV 2 mg/kg at 0 and 4 weeks, then every 8 weeks. |
| Infliximab (Remicade®, Avsola®, Inflectra®, Renflexis®) | TNF blocker; Age = ≥ 18 years; Dosing Limits = 5 mg/kg IV at 0, 2, and 6 weeks, then every 6-8 weeks as listed. |
| Ixekizumab (Taltz®) | Interleukin-17a inhibitor; Age = ≥ 18 years; Dosing Limits = 160 mg SC initially, then 80 mg SC every 4 weeks. |
| Secukinumab (Cosentyx®, Cosentyx UnoReady™, Cosentyx Sensoready™) | Interleukin-17a inhibitor; Age = ≥ 18 years; Dosing Limits = Nr-axSpA: 80 mg SC every 4 weeks; AS & nr-axSpA subcutaneous: 150 mg SC weekly at weeks 0-4 then every 4 weeks; AS only up to 300 mg every 4 weeks; IV dosing notes per table. |
| Tofacitinib (Xeljanz®, Xeljanz® XR) | Janus kinase (JAK) inhibitor; Age = ≥ 18 years; Dosing Limits = 5 mg orally twice daily (XR 11 mg orally daily). |
| Upadacitinib (Rinvoq®) | Janus kinase (JAK) inhibitor; Age = ≥ 18 years; Dosing Limits = 15 mg orally once daily (table lists 15 mg and 11 mg formulations). |
Provider Actions and Authorization Requirements
Prior authorization required for listed agents and dosing
Prior authorization is required for all axial spondyloarthritis agents and all current and future dose forms. Approvals must meet FDA‑approved indication, age, and dosing limits in Table 1 and preferred PDL requirements; agent must be prescribed by or in consultation with a rheumatologist.
- Must be approved for the indication, age, and not exceed dosing limits listed in Table 1.
- Preferred PDL agent required, if applicable, unless non‑preferred criteria met.
- Prescribed by or in consultation with a rheumatologist.
Conventional therapy and TNF trial requirements
Patient must have had an adequate trial of at least two chemically unique conventional therapies for at least 14 consecutive days each unless contraindicated. For tofacitinib and upadacitinib, the patient must also have had an adequate trial (≥12 weeks) of at least one TNF blocker unless contraindicated.
- At least two chemically unique conventional therapies (Table 2), ≥14 consecutive days each or documented contraindication.
- For tofacitinib/upadacitinib: adequate trial of ≥12 weeks of at least one TNF blocker or documented contraindication.
Required clinical scores and renewal response
Prescriber must document baseline high disease activity defined as ASDAS ≥ 2.1 or BASDAI ≥ 4 prior to initiation. For renewal, the prescriber must document response with either an ASDAS reduction ≥ 1.1 or a BASDAI reduction ≥ 2 compared to baseline and confirm dosing remains within Table 1 limits.
- Baseline: ASDAS score ≥ 2.1 or BASDAI score ≥ 4.
- Renewal: ASDAS reduction ≥ 1.1 or BASDAI reduction ≥ 2 versus baseline; dosing must not exceed Table 1.
Concurrent therapy and prerequisite criteria (denial risk)
Requests may be denied if the patient is concurrently on another biologic or JAK inhibitor listed in Table 3 or if prerequisite trials, age, indication, or dosing limits in Table 1 have not been met.
- Patient must not concurrently be on another biologic or JAK inhibitor listed in Table 3; after discontinuation, new agent authorized only at the next scheduled dose.
- Denial risk if FDA‑approved indication, age, dosing limits, or required trials (conventional therapies / TNF trial where applicable) are unmet.
Definitions
Background
Axial spondyloarthritis, including ankylosing spondylitis and non-radiographic axSpA, is managed initially with conventional therapy. Nonsteroidal anti-inflammatory drugs (NSAIDs) are first-line treatment for symptomatic control. Biologic therapies (TNF and IL-17 inhibitors) and JAK inhibitors are reserved for patients with documented high disease activity who have failed or are intolerant of conventional therapies and meet the policy’s baseline score requirements.
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