J2267 — Injection, mirikizumab-mrkz, 1 mg
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
Documentation Required
- Documentation of diagnosis: "Diagnosis of moderately to severely active ulcerative colitis" or "Diagnosis of moderately to severely active Crohn's disease."
- Documentation that Omvoh will be administered as three intravenous induction doses and that dosing will follow the U.S. FDA labeled dosing for the relevant indication.
- For UC: documentation of prior or concurrent inadequate response to a therapeutic course of oral corticosteroids and/or immunosuppressants (e.g., azathioprine, 6-mercaptopurine), OR documentation of prior treatment with a targeted immunomodulator FDA‑approved for UC.
- For CD: documentation of history of failure to one of the listed conventional therapies at up to maximally indicated doses unless contraindicated (corticosteroids, 6‑mercaptopurine, azathioprine, methotrexate), OR documentation of prior treatment with a targeted immunomodulator FDA‑approved for CD.
Key Coverage Criteria
- Omvoh is proven for the treatment of ulcerative colitis when all of the following criteria are met: - Diagnosis of moderately to severely active ulcerative colitis; and - Omvoh is to be administered as three intravenous induction doses; and - Omvoh induction dosing is in accordance with the United States Food and Drug Administration (FDA) labeled dosing for UC; and - Patient is not receiving Omvoh in combination with another targeted immunomodulator [e.g., Enbrel (etanercept), Cimzia (certolizum [...]
- Omvoh is medically necessary for the treatment of ulcerative colitis when all of the following criteria are met: - Diagnosis of moderately to severely active ulcerative colitis; and - One of the following: Patient has had prior or concurrent inadequate response to a therapeutic course of oral corticosteroids and/or immunosuppressants (e.g., azathioprine, 6-mercaptopurine); or Patient has been previously treated with a targeted immunomodulator FDA-approved for the treatment of ulcerative colitis [...]
- Omvoh is proven for the treatment of Crohn's disease (CD) when all of the following criteria are met: - Diagnosis of moderately to severely active Crohn's disease; and - Omvoh is to be administered as three intravenous induction doses; and - Omvoh induction dosing is in accordance with the United States Food and Drug Administration (FDA) labeled dosing for CD; and - Patient is not receiving Omvoh in combination with another targeted immunomodulator [e.g., adalimumab, Cimzia (certolizumab), Enbre [...]
- Omvoh is medically necessary for the treatment of Crohn's disease (CD) when all of the following criteria are met: - Diagnosis of moderately to severely active Crohn's disease; and - One of the following: History of failure to one of the following conventional therapies at up to maximally indicated doses unless contraindicated or clinically significant adverse effects are experienced: Corticosteroids (e.g., prednisone, methylprednisolone, budesonide) 6-mercaptopurine (Purinethol) Azathioprine (I [...]
- FDA indication (informational): "Omvoh is an interleukin-23 antagonist indicated for the treatment of moderately to severely active ulcerative colitis and moderately to severely active Crohn's disease in adults."
- Pharmacy vs medical benefit note: "Omvoh (mirikizumab-mrk2) for self-administered subcutaneous injection is obtained under the pharmacy benefit, unless otherwise specified in the member's benefit plan documents. Exception: For members enrolled in UnitedHealthcare of California plans with a delegated provider group conducting the prior authorization review, the self-administered Omvoh may be obtained under the medical benefit."
10 Active Policies
UHC-POL-omvoh — Omvoh (Mirikizumab-Mrkz)
UHC-POL-provider-administered-drugs-soc — Provider Administered Drugs – Site of Care
UMR-POL-UMR-omvoh — Omvoh (Mirikizumab-Mrkz)
UMR-POL-UMR-provider-administered-drugs-soc — Provider Administered Drugs – Site of Care
SUREST-POL-SUREST-omvoh — Omvoh (Mirikizumab-Mrkz)
Related Codes
Have a follow-up question?
Ask Verity about documentation requirements, denial risks, or coverage in your state.