Prior Authorization : Services Requiring Prior Authorization

Stelara IV for Crohn's Disease and Ulcerative Colitis

Stelara IV is a physician-administered drug that requires clinical PA.

All PA requests for Stelara IV must be submitted with a specific HCPCS "J" code, J3358 (Ustekinumab, for intravenous injection, 1 mg).

PA requests for Stelara IV must be completed, signed, and dated by the prescriber. PA requests for Stelara IV must be submitted using Section V (Clinical Information for Physician-Administered Drugs With Specific PA Criteria Addressed in the ForwardHealth Online Handbook) on the PA/PAD form. Clinical documentation supporting the use of Stelara IV must be submitted with the PA request.

Prescribers are required to submit the completed PA/PAD form and a completed PA/RF to ForwardHealth. PA requests for Stelara IV may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Conditions for Which PA Requests for Use of Stelara Intravenous Will Be Considered for Review

ForwardHealth will only consider PA requests for Stelara IV to treat the following identified clinical conditions:

• Crohn's disease
• Ulcerative colitis

Clinical Criteria for Stelara IV for Members With Crohn's Disease

Clinical criteria that must be documented for approval of a PA request for Stelara IV for members with Crohn's disease are all of the following:

• The member has Crohn's disease.
• The member has been diagnosed by a gastroenterologist.
• The member has taken Humira for at least three consecutive months and experienced an unsatisfactory therapeutic response or experienced a clinically significant adverse drug reaction.
• The prescriber has indicated the clinical reason(s) why Stelara IV is being requested.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for Stelara IV. The supporting clinical information and medical records must document the following:

If the clinical criteria for Stelara IV are met, PA requests will only be approved for the IV induction dose.

Note: A separate PA request must be obtained for maintenance treatment with Stelara subQ solution. PA requests for Stelara subQ solution must be obtained through the pharmacy PA process.

Clinical Criteria for Stelara IV for Members With Ulcerative Colitis

Clinical criteria that must be documented for approval of a PA request for Stelara IV for members with ulcerative colitis are all of the following:

• The member has ulcerative colitis.
• The member has been diagnosed by a gastroenterologist.
• The member has taken Humira for at least three consecutive months and experienced an unsatisfactory therapeutic response or experienced a clinically significant adverse drug reaction.
• The member has taken Xeljanz for at least three consecutive months and experienced an unsatisfactory therapeutic response or experienced a clinically significant adverse drug reaction.
• The prescriber has indicated the clinical reason(s) why Stelara IV is being requested.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for Stelara IV. The supporting clinical information and medical records must document the following:

If the clinical criteria for Stelara IV are met, PA requests will only be approved for the IV induction dose.

Note: A separate PA request must be obtained for maintenance treatment with Stelara subQ solution. PA requests for Stelara subQ solution must be obtained through the pharmacy PA process.