BlueCross BlueShield of Tennessee Medical Policy Manual

Ustekinumab

NDC CODE(S)

57894-0060-XX - Stelara 45 mg vial and prefilled syringe (Janssen Biotech)

 

57894-0061-XX - Stelara 90 mg prefilled syringe (Janssen Biotech)

 

57894-0054-XX - Stelara 130 mg (5 mg/mL) single-dose vial (Janssen Biotech)

DESCRIPTION

Ustekinumab is a human IgG1κ monoclonal antibody produced by recombinant DNA technology.  It binds specifically to the p40 protein subunit which is shared by the cytokines interleukin-12 (IL-12) and IL-23.  IL-12 and IL-23 are involved in inflammatory and immune responses such as natural killer cell activation and CD4+ T-cell differentiation and activation.  Ustekinumab has been shown to disrupt IL-12 and IL-23 mediated signaling and cytokine cascades.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

Plaque Psoriasis &

Psoriatic Arthritis with co-existent moderate-severe Plaque Psoriasis

Subcutaneous Loading Dose:

<100 kg: 45 mg at weeks 0 & 4, then begin maintenance dosing 12 weeks later

>100 kg: 90 mg at weeks 0 & 4, then begin maintenance dosing 12 weeks later

 

Subcutaneous Maintenance Dose:

<100 kg: 45 mg every 12 weeks

>100 kg: 90 mg every 12 weeks

Psoriatic Arthritis

Subcutaneous Loading Dose:

45 mg at weeks 0 & 4, then begin maintenance dosing 12 weeks later

 

Subcutaneous Maintenance Dose:

45 mg every 12 weeks

Crohn’s Disease

Intravenous Induction Dose:

≤ 55 kg: 260 mg

> 55 kg to 85 kg: 390 mg

> 85 kg: 520 mg

 

Subcutaneous Maintenance Dose:

90 mg given 8 weeks after the initial IV dose, then every 8 weeks thereafter

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.

ADDITIONAL INFORMATION 

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

The Crohn’s Disease Activity Index (CDAI) scoring reference rates remission of Crohn's disease a CDAI below 150. Moderate disease is scored at 220 and severe disease was defined as a value of greater than 450.

A review of the published literature revealed no evidence that validates the use of ustekinumab in the treatment/prevention of any other conditions/diseases.

SOURCES

Lexi-Comp Online. (2016). AHFS DI. Ustekinumab. Retrieved November 17, 2016 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2016, November). Ustekinumab. Retrieved November 17, 2016 from MICROMEDEX Healthcare Series.

Sandborn, W. J., Gasink, C., Blank, M., Lang, Y., Johanns, J., Gao, L. L., et al. (2016). A multicenter, double-blind, placebo-controlled phase 3 study of ustekinumab, a human IL-12/23P40 mAB, in moderate-service Crohn’s disease refractory to anti-TFNα: UNITI-1. Inflammatory Bowel Disease. 2013 Mar; 22 Suppl. 1: S1. Doi: 10. 1097/MIB.720.

U. S. Food and Drug Administration. (2016, September). Center for Drug Evaluation and Research. Stelara® (ustekinumab). Retrieved November 17, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761044lbl.pdf.

ORIGINAL EFFECTIVE DATE:  3/11/2010

MOST RECENT REVIEW DATE:  12/1/2016

ID_MRx

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

Pharmaceutical Decision Support Tree

Ustekinumab (Stelara ®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #7

  1. Does the individual comply with ALL of the following?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of Crohn’s disease moderate to severely active disease (e.g., CDAI score greater than 220) with documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum (3) month trial of corticosteroids or immunomodulators (e.g. azathioprine, 6-mercaptopurine, or methotrexate)?

If yes, go to question #6

If no, go to question #4

  1. Does the individual have a diagnosis of chronic plaque psoriasis for at least 6 months with ALL of the following?

If yes, go to question #6

If no, go to question #5

  1.  Does the individual have a diagnosis of Psoriatic arthritis (PsA) that is moderately to severely active of ANY ONE of the following types?

If yes, go to question #6

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for ANY ONE of the following?

INDICATION(S)

BILLABLE UNITS

DOSAGE & ADMINISTRATION

Plaque Psoriasis &

Psoriatic Arthritis with co-existent moderate-severe Plaque Psoriasis

Subcutaneous Loading (J3357):

90 billable units at weeks 0 & 4; maintenance dosing 12 weeks later

Subcutaneous Maintenance (J3357):

90 billable units every 12 weeks

Subcutaneous Loading Dose:

<100 kg: 45 mg at weeks 0 & 4, then begin maintenance dosing 12 weeks later

>100 kg: 90 mg at weeks 0 & 4, then begin maintenance dosing 12 weeks later

Subcutaneous Maintenance Dose:

<100 kg: 45 mg every 12 weeks

>100 kg: 90 mg every 12 weeks

Psoriatic Arthritis

Subcutaneous Loading (J3357):

45 billable units at weeks 0 & 4; maintenance dosing 12 weeks later

SQ Maintenance (J3357):

45 billable units every 12 weeks

Subcutaneous Loading Dose:

45 mg at weeks 0 & 4, then begin maintenance dosing 12 weeks later

Subcutaneous Maintenance Dose:

45 mg every 12 weeks

Crohn’s Disease

Intravenous Induction (J3590):

520 mg

Subcutaneous Maintenance (J3357):

90 billable units 8 weeks after induction & every 8 weeks thereafter

Intravenous Induction Dose:

≤ 55 kg: 260 mg

> 55 kg to 85 kg: 390 mg

> 85 kg: 520 mg

Subcutaneous Maintenance Dose:

90 mg given 8 weeks after the initial IV dose, then every 8 weeks thereafter

If yes, this satisfies medical necessity and medical appropriateness criteria for an authorization period of 6 months

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual continue to meet initial approval criteria in questions 2 through 6?

If yes, go to question #8

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual show documentation of absence of unacceptable toxicity from the drug and ongoing monitoring for TB?

If yes, go to question #9

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual show disease response with a diagnosis of ANY ONE of the following?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.