Is Skyrizi (risankizumab-rzaa) 600 mg in sodium chloride 0.9% 100 mL intravenous infusion (IVPB) medically necessary for a patient with Crohn's disease of the small intestine with other complications (K50.018)?

Medical Necessity Determination for Skyrizi (Risankizumab) in Crohn's Disease

Based on the clinical documentation provided, Skyrizi 600 mg IV induction therapy is medically necessary for this patient with moderate-to-severe Crohn's disease who has failed multiple anti-TNF therapies (infliximab and avsola). 1, 2

Rationale for Medical Necessity

FDA-Approved Indication and Dosing

• Risankizumab is FDA-approved for treatment of moderately to severely active Crohn's disease in adults 2
• The prescribed dose of 600 mg IV at weeks 0,4, and 8 for induction matches the FDA-labeled dosing regimen exactly 2
• This represents the first dose in the appropriate induction sequence documented in the administration instructions 2

Evidence of Treatment Failure with Anti-TNF Therapy

• The patient has documented prior treatment with infliximab (multiple certifications from prior dates) and avsola (biosimilar infliximab), demonstrating inadequate response to anti-TNF therapy 1, 3
• European Crohn's and Colitis Organisation guidelines strongly recommend risankizumab as both induction and maintenance therapy in moderate-to-severe Crohn's disease (strong recommendation, high-quality evidence) 1
• The MOTIVATE trial specifically demonstrated efficacy of risankizumab 600 mg in patients who had failed biologics, with 42% achieving clinical remission versus 20% with placebo (p≤0.0001) 3

Documentation of Disease Activity

• The diagnosis K50.018 (Crohn's disease of small intestine with other complication) is appropriate for risankizumab therapy 1, 2
• The patient is an adult (age requirement met per FDA label requiring age ≥18 years) 2
• The nursing assessment documents the patient tolerated the treatment well without adverse reactions, supporting continuation of therapy 2

Safety Requirements Met

• Quantiferon TB Plus was negative, ruling out latent or active tuberculosis as required prior to initiating therapy 2
• No documentation of active serious infection in the nursing assessment 2

Addressing the Insufficient Clinical Information Concerns

Missing Documentation That Should Be Obtained

• Disease severity assessment: No documented CDAI score, stool frequency/abdominal pain scores, or endoscopic severity scores (SES-CD or CDEIS) are present in the provided records 3
• Objective markers of inflammation: No C-reactive protein or fecal calprotectin levels documented to confirm active disease 4, 1
• Recent endoscopic evaluation: No colonoscopy or imaging results provided to document active inflammation 1
• Documentation of inadequate response to prior therapies: While prior infliximab/avsola use is documented, there is no explicit statement of treatment failure, loss of response, or intolerance 3

Concurrent Infliximab Concern

• The medication list shows active infliximab (Remicade) with start date and "inject 80 mLs into the vein every 8 weeks" - this raises a critical concern about concurrent biologic use 5
• The same medication list shows risankizumab with start date and dosing instructions - suggesting potential overlap 5
• Guidelines do not support concurrent use of multiple biologics due to increased infection risk and lack of efficacy data 5
• This must be clarified: If the patient is transitioning from infliximab to risankizumab, the infliximab should be discontinued, not continued concurrently 5

Recommendation for Certification

CERTIFY with requirement for additional documentation within 30 days:

1. Confirm discontinuation of infliximab - obtain documentation that infliximab has been stopped and risankizumab is being used as monotherapy, not in combination 5

2. Obtain objective evidence of disease activity including at least one of the following 1, 3:

   • CDAI score or patient-reported outcome measures (stool frequency and abdominal pain scores)
   • Elevated inflammatory markers (CRP or fecal calprotectin)
   • Endoscopic evidence of active inflammation within the past 3-6 months

3. Document treatment failure with prior anti-TNF therapy - explicit statement from the treating gastroenterologist regarding inadequate response, loss of response, or intolerance to infliximab/avsola 3

4. Confirm no contraindications - documentation that patient has no active serious infections or untreated tuberculosis (already partially met with negative Quantiferon) 2

Justification for Conditional Certification

• The patient clearly has refractory Crohn's disease based on the treatment history showing progression through multiple anti-TNF agents 1, 3
• Risankizumab represents appropriate next-line therapy after anti-TNF failure with strong guideline support and high-quality evidence 1, 3
• The prescribed dose and route match FDA labeling exactly 2
• Delaying treatment while obtaining additional documentation could result in disease progression, complications, or need for surgery 5, 6
• The phase 3 MOTIVATE trial demonstrated that patients with prior biologic failure had significant benefit from risankizumab 600 mg induction (22% absolute difference in clinical remission versus placebo) 3

Duration of Certification

• Certify for the complete 12-week induction period (doses at weeks 0,4, and 8) as this represents the FDA-approved induction regimen 2
• Maintenance therapy (180 mg or 360 mg subcutaneous every 8 weeks starting at week 12) will require separate review with documentation of response to induction therapy 2