Pharmacy Prior Authorization Criteria

Omvoh (mirikizumab-mrkz)

Indications for Prior Authorization

Omvoh (mirikizumab-mrkz) IV & SC

• For diagnosis of Crohn’s disease (CD)
  Indicated for the treatment of moderately to severely active Crohn’s disease in adults.

• For diagnosis of Ulcerative Colitis (UC)
  Indicated for the treatment of moderately to severely active ulcerative colitis in adults.

Criteria

Omvoh IV

Prior Authorization

Length of Approval: 3 Month(s)
For diagnosis of Crohn’s disease (CD)

• Diagnosis of moderately to severely active Crohn’s disease (CD)
AND
• One of the following [2, 3]:
• Frequent diarrhea and abdominal pain
• At least 10% weight loss
• Complications such as obstruction, fever, abdominal mass
• Abnormal lab values (e.g., C-reactive protein [CRP])
• CD Activity Index (CDAI) greater than 220
AND
• Prescribed by or in consultation with a gastroenterologist
AND
• Will be administered as an intravenous induction dose

Omvoh SC

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Crohn’s disease (CD)

• Diagnosis of moderately to severely active Crohn’s disease (CD)
AND
• Will be used as a maintenance dose following the intravenous induction doses
AND
• Prescribed by or in consultation with a gastroenterologist

Omvoh IV

Prior Authorization

Length of Approval: 3 Month(s)
For diagnosis of Ulcerative Colitis (UC)

• Diagnosis of moderately to severely active ulcerative colitis
AND
• One of the following [4, 5]:
• Greater than 6 stools per day
• Frequent blood in the stools
• Frequent urgency
• Presence of ulcers
• Abnormal lab values (e.g., hemoglobin, erythrocyte sedimentation rate, C-reactive protein)
• Dependent on, or refractory to, corticosteroids
AND
• Prescribed by or in consultation with a gastroenterologist
AND
• Will be administered as an intravenous induction dose

Omvoh SC

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Ulcerative Colitis (UC)

• Diagnosis of moderately to severely active ulcerative colitis
AND
• Will be used as a maintenance dose following the intravenous induction doses
AND
• Prescribed by or in consultation with a gastroenterologist

Omvoh SC

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of CD & UC

• Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [1-5]:
• Improvement in intestinal inflammation (e.g., mucosal healing, improvement of lab values [platelet counts, erythrocyte sedimentation rate, C-reactive protein level]) from baseline
• Reversal of high fecal output state

P & T Revisions

2025-04-03, 2025-02-09, 2024-12-11, 2024-09-08, 2024-07-30, 2024-06-24, 2024-06-05, 2024-05-30, 2024-04-24, 2024-03-07, 2024-04-26, 2024-01-03

References

1. Omvoh prescribing information. Eli Lilly & Co. Indianapolis, IN. January 2025.
2. Lichtenstein GR, Loftus EV, Isaacs KL, et al. ACG clinical guideline: management of Crohn's disease in adults. Am J Gastroenterol. 2018;113:481-517.
3. Feuerstein JD, Ho EY, Shmidt E, et al. AGA Clinical Practice Guidelines on the Medical Management of Moderate to Severe Luminal and Perianal Fistulizing Crohn's Disease. Gastroenterology. 2021;160(7):2496-2508.
4. Rubin DT, Ananthakrishnan AN, Siegel CA, et al. ACG clinical guideline: ulcerative colitis in adults. Am J Gastroenterol. 2019;114:384-413.
5. Feuerstein JD, Isaacs KL, Schneider Y, et al. AGA clinical practice guidelines on the management of moderate to severe ulcerative colitis. Gastroenterol. 2020;158:1450-1461.

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Revision History

• 2025-04-03: Removed conventional step from CD and UC criteria; addition of new kits
• 2025-02-09: Addition of CD criteria; annual review - no criteria changes for UC
• 2024-12-11: Removed step through TIMS agents
• 2024-09-08: Removed bypass verbiage for UC
• 2024-07-30: Addition of Skyrizi as an additional trial option for UC indication.
• 2024-06-24: Added new 100mg/ml prefilled syringe to existing Omvoh SC criteria; updated background table to specify BI manufacturer for adalimumab-adbm
• 2024-06-05: Added new 100mg/ml prefilled syringe to existing Omvoh SC criteria.
• 2024-05-30: Updated background table to include CalPERS formulary; no criteria changes
• 2024-04-24: Updated verbiage in the step to say, "One formulary adalimumab product manufactured by AbbVie, Amgen, BI, or Sandoz"; added table to background section detailing preferred adalimumab products
• 2024-03-07: Updated verbiage in the step to say, "One formulary adalimumab product manufactured by AbbVie, Amgen, BI, or Sandoz"; added table to background section detailing preferred adalimumab products
• 2024-04-26: New program
• 2024-01-03: New program

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