Is Skyrizi (Risankizumab) 360 mg subcutaneously (subq) every 8 weeks medically necessary for a patient with ulcerative colitis?

Medical Necessity of Skyrizi (Risankizumab) 360 mg Subcutaneously Every 8 Weeks for Ulcerative Colitis

Yes, Skyrizi 360 mg subcutaneously every 8 weeks is medically necessary for this patient with ulcerative colitis who has achieved clinical response and remission on therapy, as it represents FDA-approved maintenance treatment with demonstrated efficacy in maintaining remission.

FDA-Approved Indication and Dosing

• Skyrizi is FDA-approved for maintenance treatment of ulcerative colitis at either 180 mg or 360 mg subcutaneously every 8 weeks, following induction therapy 1
• The FDA label explicitly states: "The recommended maintenance dosage of SKYRIZI is 180 mg or 360 mg administered by subcutaneous injection at Week 12, and every 8 weeks thereafter. Use the lowest effective dosage needed to maintain therapeutic response" 1
• J3590 is the appropriate billing code for subcutaneous risankizumab administration, as this is a miscellaneous injection code used when a specific J-code is not yet established 1

Clinical Evidence Supporting Medical Necessity

Efficacy in Ulcerative Colitis Maintenance

• In the pivotal JAMA trial (2024), risankizumab 360 mg every 8 weeks achieved 37.6% clinical remission at week 52 versus 25.1% with placebo (adjusted difference 14.2%, P=0.002) 2
• The 180 mg dose achieved 40.2% clinical remission versus 25.1% placebo (adjusted difference 16.3%, P<0.001) 2
• Both doses demonstrated superior efficacy over placebo for maintaining remission in patients who responded to induction therapy 2

Guideline Support

• The 2020 AGA guidelines recommend treating moderate-severe ulcerative colitis with ustekinumab (another IL-23 inhibitor) for induction and maintenance of remission (strong recommendation, moderate quality evidence) 3
• The 2025 British Society of Gastroenterology guidelines note that ustekinumab 90 mg every 8 weeks showed small benefit for clinical remission in ulcerative colitis maintenance (low certainty) 3
• The 2019 BSG guidelines reported that ustekinumab maintenance at 8-weekly dosing achieved 43.8% remission at week 44 versus 24% with placebo (P<0.001), with numerical benefits of 8-weekly dosing restricted to anti-TNF refractory populations 3

Patient-Specific Clinical Justification

Evidence of Treatment Response

• This patient has achieved excellent clinical response: 1-2 formed stools daily without rectal bleeding, urgency, tenesmus, or nocturnal stools [@clinical documentation@]
• Colonoscopy demonstrates inactive disease (Mayo Score 0) with quiescent ulcerative colitis [@clinical documentation@]
• Patient no longer requires additional medications and reports feeling "much better" since starting therapy [@clinical documentation@]

Risk of Treatment Interruption

• Discontinuing effective biologic therapy in ulcerative colitis leads to disease relapse, potential antibody formation, and loss of response 4
• The patient has failed "variety of medications" previously, indicating limited remaining therapeutic options [@clinical documentation@]
• Maintaining consistent treatment is essential to prevent flare-ups and complications in inflammatory bowel disease 4

Dosing Considerations: 360 mg vs 180 mg

• The FDA label recommends using "the lowest effective dosage needed to maintain therapeutic response" 1
• In clinical trials, both 180 mg and 360 mg doses were superior to placebo, with the 180 mg dose showing numerically higher remission rates (40.2% vs 37.6%) 2
• The 360 mg dose may be more appropriate for patients with prior anti-TNF failure or more severe disease, though both doses are FDA-approved 1, 2
• Given this patient's excellent response and inactive disease on colonoscopy, the 180 mg dose could be considered, but the 360 mg dose remains medically appropriate and FDA-approved 1

Safety Profile

• Risankizumab was well-tolerated with no new safety signals detected in ulcerative colitis trials 2
• Adverse event rates were similar between risankizumab and placebo groups 2
• The patient has negative TB screening as required prior to initiation [1, clinical documentation@]

Common Pitfalls to Avoid

• Do not confuse J-codes: J2327 was used for intravenous induction dosing; J3590 is correct for subcutaneous maintenance administration [@10@]
• Do not require switching to biosimilars or other agents when a patient is doing well on current therapy, as this increases risk of loss of response and antibody formation [@9