Is Stelara (Ustekinumab) 90mg subcutaneous injections every 4 weeks medically necessary for the treatment of Crohn's disease?

Medical Necessity Assessment for Stelara (Ustekinumab) 90mg Every 4 Weeks in Crohn's Disease

Yes, continuation of Stelara 90mg subcutaneous injections every 4 weeks is medically necessary for this patient with Crohn's disease who has demonstrated clinical and endoscopic improvement on the intensified dosing regimen.

Rationale for Medical Necessity

FDA-Approved Indication and Standard Dosing

• Ustekinumab is FDA-approved for the treatment of Crohn's disease, with standard maintenance dosing of 90mg subcutaneously every 8 weeks following intravenous induction 1
• The British Society of Gastroenterology (2019) strongly recommends ustekinumab for both induction and maintenance of remission in Crohn's disease, including in patients who have failed anti-TNF therapy 2

Evidence Supporting Dose Intensification to Every 4 Weeks

Clinical Efficacy Data:

• A 2021 retrospective study of 110 Crohn's disease patients who had their ustekinumab interval shortened from every 8 weeks to every 4 weeks demonstrated significant improvement: median Harvey Bradshaw Index decreased from 4.5 to 3 (p=0.002), and median CRP decreased from 8 mg/L to 3 mg/L (p=0.031) 3
• Among patients with active disease before dose intensification, 28% achieved clinical remission (HBI ≤4) and 36% achieved endoscopic remission after shortening to every 4 weeks 3
• The study concluded that dose interval shortening to every 4 weeks was both effective and safe for patients who did not respond adequately to standard 8-week dosing 3

This Patient's Clinical Response

Documented Improvement:

• The patient reports overall symptom improvement since shortening the dosing interval from every 6 weeks to every 4 weeks [@patient case@]
• Bowel movements improved by approximately 50% (from baseline to 2-5 per day), representing significant clinical improvement [@patient case@]
• October 2025 colonoscopy showed healthy mucosa except for polyp removal sites with no active inflammation, demonstrating endoscopic remission [@patient case@]
• This represents significant improvement compared to the March 2023 colonoscopy which showed chronic moderately to severely active colitis [@patient case@]
• The patient reports significantly improved quality of life [@patient case@]

Standard of Care Considerations

Guideline Support for Dose Optimization:

• The British Society of Gastroenterology (2019) recognizes that response rates are generally lower in patients with longer disease duration or who have proven refractory to other therapies, supporting the need for dose optimization in such cases 2
• Real-world evidence demonstrates that approximately 50% of Crohn's disease patients undergo ustekinumab dose intensification, which is effective based on multiple studies 4
• A 2017 study established that maintenance trough concentrations of ustekinumab above 4.5 μg/mL were associated with better endoscopic response (75.9% vs 40.7%, p=0.008) and lower CRP levels 5

Safety Profile

• The 2021 dose intensification study found that shortening to every 4 weeks was safe, with no new safety signals identified 3
• Long-term safety data through 104 weeks shows ustekinumab is well-tolerated, with only 7% of patients discontinuing due to adverse drug reactions 6
• The British Society of Gastroenterology notes no unfavorable safety outcomes with ustekinumab therapy 2

Clinical Context Supporting Continuation

Disease Control Achieved

• The patient has achieved both clinical remission (bowel movements 2-5/day, no abdominal pain, no hematochezia) and endoscopic remission (healthy mucosa, no active inflammation) [@patient case@]
• This represents optimal therapeutic outcomes: morbidity reduction through symptom control, mortality risk reduction through mucosal healing, and quality of life improvement as reported by the patient [@patient case@]

Risk of Treatment Discontinuation

• Discontinuing or reducing the frequency back to every 8 weeks risks loss of the achieved remission 3
• The patient's history of chronic moderately to severely active colitis on prior colonoscopy demonstrates the severity of untreated disease [@patient case@]
• Uncontrolled Crohn's disease carries risks of complications including strictures, fistulas, and need for surgery 2

Common Pitfalls to Avoid

Do not:

• Assume standard 8-week dosing is adequate for all patients—approximately 50% require dose intensification 4
• Discontinue or reduce frequency in patients who have achieved remission on intensified dosing without objective evidence of sustained remission on reduced dosing 3
• Overlook the importance of endoscopic remission, which this patient has achieved and which is associated with better long-term outcomes 5

Do:

• Continue monitoring with periodic calprotectin levels and clinical assessment as planned by the gastroenterologist [@patient case@]
• Maintain the current every 4-week regimen that has achieved both clinical and endoscopic remission 3
• Consider checking ustekinumab trough levels if there is future concern about loss of response (target >4.5 μg/mL) 5

Conclusion on Medical Necessity

Both questions answered:

1. Is the treatment plan medically necessary? Yes. The patient has achieved clinical and endoscopic remission on ustekinumab 90mg every 4 weeks after demonstrating inadequate response to less frequent dosing. This represents optimal disease control with documented improvement in morbidity (symptom reduction, mucosal healing) and quality of life [3, @patient case@].

2. Is the treatment plan standard of care? Yes. Ustekinumab is FDA-approved and guideline-recommended for Crohn's disease 1, 2. Dose intensification to every 4 weeks is supported by published evidence demonstrating safety and efficacy in patients with suboptimal response to standard dosing 3. The British Society of Gastroenterology strongly recommends ustekinumab for Crohn's disease maintenance therapy, and real-world practice commonly includes dose optimization based on clinical response 2, 4.