Criteria for Prior Authorization: Crohn's Disease Agents
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Prior authorization criteria for biologic and JAK inhibitor therapy for moderate to severely active Crohn's disease, including initial, renewal, and therapeutic drug monitoring requirements for prescribers requesting drug PA.
Revised general and renewal PA criteria including therapeutic drug monitoring and specific induction/maintenance definitions.
Updated references and package insert citations through 2025 for multiple agents and biosimilars.
Coverage Criteria for Crohn's Disease Agents
Initial Therapy
Covered when ALL of the following initial criteria are met
Continuation / Renewal Therapy
Renewal covered when ALL of the following are met
Dose optimization / TDM
Therapeutic drug monitoring and dosing exceptions
Supporting documentation of TDM/antibody levels is required for consideration of alternative dosing; biosimilars are considered per Table 4 guidance.
For all requested immunomodulating biologics and janus kinase (JAK) inhibitors, concurrent use of another immunomodulating biologic or JAK inhibitor is not permitted. The supplement titled “Immunomodulating Biologic Agents/Janus Kinase Inhibitors Supplementary Table” lists the agents to which this prohibition applies. After discontinuing a current immunomodulating biologic or JAK inhibitor, authorization for a different immunomodulating biologic or JAK inhibitor will be issued no sooner than the patient’s next scheduled dose of the new agent.
Requests that do not meet required prior trial or documentation standards are not medically necessary under this policy. Examples include failure to document an adequate induction trial (e.g., ≥2 weeks of an oral systemic corticosteroid equivalent to 40–60 mg/day prednisone with planned taper or inadequate response to IV corticosteroid within 3–5 days) or failure to document an adequate maintenance trial (e.g., ≥8 weeks continuous conventional therapy) or documented contraindications to conventional therapies.
Approval may also be denied when required baseline or renewal objective measures are missing. Initial requests must include prescriber documentation of induction status or baseline disease activity (e.g., SES-CD, Rutgeert's score). Renewal requests must demonstrate maintenance of remission by endoscopic criteria (SES-CD ≤2 or Rutgeert's ≤ i1) or, when endoscopy is not available, acceptable surrogate lab thresholds (for adults, fecal calprotectin <150 mcg/g, or the collective surrogate set: FC <250 mcg/g AND CDAI <150 [or pCDAI <10 if ≤19 years] AND CRP <5 mg/L).
Dosing that exceeds the Table 1 limits without submission of therapeutic drug monitoring (drug and antibody levels) to justify alternative dosing will be considered not meeting criteria. Additionally, failure to prescribe by or in consultation with a gastroenterologist or to follow step-therapy requirements for certain agents (for example, adequate trial of a TNF blocker for natalizumab or upadacitinib) may result in denial.
Covered Agents, Testing, and Surrogate Thresholds
| Adalimumab (Humira®, Abrilada™, Amjevita®, Cyltezo®, Hadlima™, Hulio®, Hyrimoz®, Idacio®, Simlandi®, Yuflyma®, Yusimry®) | TNF-α blocker; dosing and ages specified in Table 1 |
| Certolizumab (Cimzia®) | TNF-α blocker; dosing and ages specified in Table 1 |
| Guselkumab (Tremfya®) | IL-23 inhibitor; dosing limits in Table 1 |
| Infliximab (Remicade®, Inflectra®, Renflexis®, Avsola®) | Anti-TNF IV agents; dosing and pediatric ages specified |
| Infliximab-dyyb (Zymfentra®) | Anti-TNF IV biosimilar; dosing specified in Table 1 |
| Mirikizumab-mrkz (Omvoh®) | IL-23 inhibitor; dosing limits in Table 1 |
| Natalizumab (Tysabri®) | Selective adhesion-molecule inhibitor; dosing limits in Table 1 |
| Risankizumab-rzaa (Skyrizi®) | IL-23 inhibitor; listed in Table 1 |
| Upadacitinib (Rinvoq®) | JAK inhibitor; induction/maintenance dosing in Table 1 |
| Ustekinumab (Stelara®, Imuldosa®, Otulfi®, Pyzchiva®, Selarsdi™, Steqeyma®, Yesintek™) | Interleukin-12/23 inhibitor; IV induction weight-based and SC maintenance dosing in Table 1 |
Prior Authorization, Step Therapy, and Documentation Requirements
Prior authorization required for listed agents
Prior authorization is required for all listed Crohn's disease agents and all current and future dose forms; medication-specific criteria including indication, age, and dosing limits in Table 1 must be met.
Step therapy: natalizumab and upadacitinib
For natalizumab and upadacitinib, the patient must have had an adequate trial (at least 8 weeks) of a TNF blocker listed in Table 1 or have a documented contraindication to a TNF blocker; the preferred PDL drug must be tried when applicable unless non-preferred criteria are met. Pediatric patients may only be required to fail one TNFα blocker before use of a non-preferred agent.
Required supporting documentation
Prescriber must submit documentation supporting the indication, patient age, requested dosing, baseline disease activity (e.g., SES-CD or Rutgeert's score), prior trials of corticosteroids or conventional therapies, and therapeutic drug monitoring (drug and antibody levels) when alternative dosing is requested.
- Baseline disease activity: SES-CD, Rutgeert's score, or documentation of moderately to severely active disease
- Prior trials: adequate trial (≥2 weeks) of oral systemic corticosteroid or inadequate response to IV corticosteroid; ≥8 weeks of conventional therapy trial for maintenance
- TDM: drug and antibody levels to justify alternative dosing (see trough recommendations in Table 4)
Common triggers for denial
Requests may be denied if the patient does not meet the general initial or renewal PA criteria (including indication, age, dosing limits), if required prior trials or induction/renewal measures are not documented, if prescriber specialty/consultation requirements are not met, or if there is concurrent use of another immunomodulating biologic or JAK inhibitor.
- Missing documentation of induction/maintenance response measures (SES-CD, Rutgeert's, FC, CDAI/pCDAI, CRP)
- No evidence of required prior trials of corticosteroids or conventional therapies
- Concurrent immunomodulating biologic or JAK inhibitor listed in the supplementary table
- Prescriber not a gastroenterologist or not in consultation with a gastroenterologist
Key Clinical Definitions
Clinical Background
Moderate to severely active Crohn’s disease that fails to respond to corticosteroids and conventional therapies may require escalation to a biologic or JAK inhibitor for induction and maintenance of remission. Induction options include systemic or IV corticosteroids, surgery, or an approved immunomodulating biologic/JAK agent when induction goals are unmet. Maintenance therapy aims to sustain clinical and endoscopic remission while avoiding corticosteroid dependence.
Key clinical thresholds used by this policy to define disease activity and response include the Simple Endoscopic Score for Crohn’s Disease (SES-CD) and Rutgeert’s score for post‑surgical patients. Baseline moderate to severe activity is documented by an SES‑CD > 7 or Rutgeert’s score > i1. Maintenance of remission requires endoscopic remission (SES‑CD ≤ 2 or Rutgeert’s ≤ i1) or acceptable surrogate measures when endoscopy is not available.
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