J1628, Injection, guselkumab, 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 that the patient is not receiving Tremfya in combination with another targeted immunomodulator (list provided in policy).
- Documented diagnosis of "moderately to severely active ulcerative colitis" or "moderately to severely active Crohn's disease" (as applicable).
- Documentation that Tremfya will be administered as three intravenous induction doses and that induction dosing is "in accordance with the U.S FDA labeled dosing" for the indicated disease (UC or CD).
- Evidence of prior therapy/failure as required by 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 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 or adverse effects experienced OR prior treatment with a targeted immunomodulator FDA‑approved for CD.
Key Coverage Criteria
- Covered when hospital outpatient facility infusion services for specialty medications and IVIG/SCIG therapy are considered medically necessary and the member meets the specific clinical criteria described in the policy.
- Ulcerative Colitis (UC): "Diagnosis of moderately to severely active ulcerative colitis" when all of the following are met: Tremfya is to be administered as three intravenous induction doses; Tremfya induction dosing is in accordance with the U.S FDA labeled dosing for UC; patient is not receiving Tremfya in combination with another targeted immunomodulator (e.g., adalimumab, Cimzia (certolizumab), Enbrel (etanercept), Entyvio (vedolizumab), Olumiant (baricitinib), Omvoh (mirikizumab-mrkz), Oren [...]
- Ulcerative Colitis (UC) — Medically Necessary criteria: "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 (e.g., adalimumab, Entyvio (vedolizumab), Omvoh (mirikizum [...]
- Crohn's Disease (CD): "Diagnosis of moderately to severely active Crohn's disease" when all of the following are met: Tremfya is to be administered as three intravenous induction doses; Tremfya induction dosing is in accordance with the FDA labeled dosing for CD; patient is not receiving Tremfya in combination with another targeted immunomodulator (e.g., adalimumab, Cimzia (certolizumab), Entyvio (vedolizumab), Omvoh (mirikizumab-mrkz), Rinvoq (upadacitinib), Skyrizi (risankizumab), ustekinumab) [...]
- Crohn's Disease (CD) — Medically Necessary criteria: "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 (Imuran), methotrexate (Rheumatrex, Trexall) OR patient has been [...]
- Ulcerative colitis: Guselkumab (Tremfya®) may be considered medically necessary when all policy-specified criteria are met
10 Active Policies
UHC-POL-provider-administered-drugs-soc, Provider Administered Drugs – Site of Care
UHC-POL-tremfya, Tremfya (Guselkumab)
RX501.175, Guselkumab
BCBSIL-RX501.175, Guselkumab
BCBSMT-RX501.175, Guselkumab
Related Codes
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