Coverage Policies

Effective Date:

a)    This policy will apply to all services performed on or after the above Revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Stelara requires pre-authorization. Criteria for IV dosage form is found below. Coverage for subcutaneous dosage form covered under the pharmacy benefit and uses the MagellanRx criteria located on the Pharmacy page of qualchoice.com.

2)    Stelara (Ustekinumab) is an injectable medication to treat moderate to severe psoriasis, psoriatic arthritis, Ulcerative Colitis, and Crohn’s disease.

3)    Stelara SQ must be obtained from the contracted specialty pharmacy.

1)    Stelara (Ustekinumab) is eligible for coverage for moderate to severe plaque psoriasis (L40.0) using the MagellanRx criteria..

2)    Stelara (Ustekinumab) is eligible for coverage for active psoriatic arthritis and uses the MagellanRx criteria.

3)    Stelara (ustekinumab) is eligible for coverage for moderately to severely active Crohn’s disease who:

·         Are 18 years of age or older AND

·         Have had an inadequate response to corticosteroids and/or 6-mercaptopurine

For Crohn’s disease, a single IV loading dose will be approved (weight-based dosing per labeling) followed by 90mg subcutaneous injection every 8 weeks.

4)    Stelara (ustekinumab) is eligible for coverage to treat ulcerative colitis in members who are 18 years of age or older who are refractory to one or more of the following standard therapies. A single IV loading dose will be approved (weight-based dosing per labeling) followed by 90mg subcutaneous injection every 8 weeks:

·         Corticosteroids (prednisone, methylprednisolone).

·         5-aminosalycylic acid agents (sulfasalazine, mesalamine, balsalazide)

·         Immunosuppressants (e.g.azathiorine, cyclosporine, 6-mercaptopurine)

Codes Used In This Policy:

J3357             Ustekinumab, for Subcutaneous Injection, 1 mg

J3358             Ustekinumab, for intravenous injection, 1mg

Stelara dosing is weight-based.   For Crohn’s disease, a single weight-based IV dose is approved, limited to the labeled dose based on the weight of the patient.

1)    FDA New Drug approvals at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails

2)    Shear NH, Prinz J, Papp K, Langley RG, Gulliver WP, Targeting the interleukin-12/23 cytokine family in the treatment of psoriatic disease.; J Cutan Med Surg. 2008 Dec;12 Suppl 1:S1-10.

3)    Clinical Pharmacology. Accessed online 6/22/2018.

Addendum:

1.    Effective 01/01/2017: Removed step therapy requirement of both Humira and Enbrel.

2.    Effective 05/01/2017:  Added indication of Crohn’s disease as covered indication subject to PA criteria noted

3.    Effective 04/01/2017: Added the following codes: C9487 – Ustekinumab IV Injection, 1 mg. This was a new code effective 04/01/17 & deleted on 06/30/17. It was replaced with Q9989 – Ustekinumab IV Injection, 1 mg. This is a new code effective 07/01/17. Updated pre-requisite therapy for treatment of psoriasis.

4.    Effective 06/01/2018: Updated phototherapy requirement.

5.    Effective 07/01/2018: update to include dosing specifications for treating Crohn’s disease.

6.    Effective 10/01/2019: Update to include J3358.

7.    Effective 01/01/2020: Updated criteria for PsA and added coverage criteria for Ulcerative Colitis.

8.    Effective 03/01/2020: Clarified coverage/billing details regarding IV and SC dosage forms. 

9.    Effective 10/01/2021: Updated age for coverage for plaque psoriasis to 6 and older.

10. Effective 01/01/2022: Updated to note the subcutaneous dosage form covered under the pharmacy benefit uses MagellanRx coverage criteria. Criteria for IV dosage form for ulcerative colitis or Crohn’s Disease remains in this policy.

Resource Document:

BI258 Stelara RD