Blue Cross Blue Shield of Minnesota Medical Policy

 
 

Medical Policy:
II-168-011
Topic:
Ustekinumab
Section:
Medicine
Effective Date:
November 29, 2020
Issued Date:
May 31, 2021
Last Revision Date:
September 2020
Annual Review:
May 2021
 
 

This policy version was replaced September 5, 2022. To find the newest version, go to https://www.bluecrossmn.com/providers/medical-policy-and-utilization-management, read and accept the Blue Cross Medical Policy Statement, then select “Blue Cross and Blue Shield of Minnesota Medical Policies.” This will bring up the Medical Policy search screen. Enter the policy number without the version number (last 3 digits).

 

Ustekinumab is a recombinant, human monoclonal antibody directed against IL-12 and IL-23, both proinflammatory cytokines. Ustekinumab binds to a protein subunit used by both the IL-12 and IL-23 cytokines and inhibits their interaction with receptors, thereby suppressing inflammation and immune cell activation. Ustekinumab is administered by subcutaneous injection or intravenous infusion.

The U.S. Food and Drug Administration (FDA) has approved ustekinumab (Stelara®) for the following indications:

  • Psoriasis
    • Treatment of patients 6 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
  • Psoriatic Arthritis
    • Treatment of adults with active psoriatic arthritis. Ustekinumab can be used alone or in combination with methotrexate.
  • Crohn’s Disease
    • Treatment of adults with moderately to severely active Crohn’s disease.
  • Ulcerative Colitis 
    • Treatment of adults with moderately to severely active ulcerative colitis. 

Serious adverse reactions have occurred in patients receiving ustekinumab, including serious infections and malignancy. Concurrent administration of ustekinumab with other immunosuppressive agents or phototherapy has not been well-studied in patients with psoriasis.

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Policy Position Coverage is subject to the specific terms of the member's benefit plan.

NOTE: When ustekinumab (Stelara®) will be self-administered by subcutaneous injection, please refer to applicable pharmacy benefit plan.

I.   Initial Review for Ustekinumab (Stelara®)

Ustekinumab may be considered MEDICALLY NECESSARY AND APPROPRIATE when ALL of the following criteria are met:

  • Diagnosis of ONE of the following:
    • Moderate to severe plaque psoriasis in a patient 6 years of age or older AND ONE of the following:
      • Previously failed another biologic therapy with FDA approval for the same indication; or
      • Used one conventional agent prerequisite for the indication (see table 2 below); or
      • Documented intolerance, FDA labeled contraindication, or hypersensitivity to ALL conventional agents for the indication; or
      • First line treatment for severe plaque psoriasis (e.g., greater than 10% body surface area involvement, occurring on select locations [i.e., hands, feet, scalp, face, or genitals], intractable pruritis); or
      • First line treatment for moderate to severe plaque psoriasis with concomitant severe active psoriatic arthritis (e.g., erosive disease, elevated markers of inflammation [e.g., ESR, CRP] attributable to psoriatic arthritis, long term damage that interferes with function [i.e., joint deformities], rapid progressive); OR
    • Active psoriatic arthritis in a patient 18 years of age or older AND ONE of the following:
      • Previously failed another biologic therapy with FDA approval for the same indication; or 
      • Used one conventional agent prerequisite for the indication (see table 2 below); or
      • Documented intolerance, FDA labeled contraindication, or hypersensitivity to ALL conventional agents for the indication; or
      • First line treatment for severe active psoriatic arthritis (e.g., erosive disease, elevated markers of inflammation [e.g., ESR, CRP] attributable to psoriatic arthritis, long term damage that interferes with function [i.e., joint deformities], rapid progressive); or
      • First line treatment for active psoriatic arthritis with concomitant severe plaque psoriasis (e.g., greater than 10% body surface area involvement, occurring on select locations [i.e., hands, feet, scalp, face, or genitals], intractable pruritis); OR
    • Moderately to severely active Crohn’s disease in a patient 18 years of age or older AND ONE of the following:
      • Previously failed another biologic therapy with FDA approval for the same indication; or
      • Used one conventional agent prerequisite for the indication (see table 2 below); or
      • Documented intolerance, FDA labeled contraindication, or hypersensitivity to ALL conventional agents for the indication; OR
    • Moderately to severely active ulcerative colitis in a patient 18 years of age or older AND ONE of the following: 
      • Previously failed another biologic therapy with FDA approval for the same indication; or 
      • Used one conventional agent prerequisite for the indication (see table 2 below); or 
      • Documented intolerance, FDA labeled contraindication, or hypersensitivity to ALL conventional agents for the indication; 
  • AND
  • No FDA labeled contraindications to ustekinumab (see table 1 below); AND
  • Not currently being treated with another biologic therapy; AND
  • For patients not currently receiving ustekinumab, the patient has been screened for latent tuberculosis (TB) and started on TB therapy if the patient tests positive; AND
  • Requested dose is within the FDA labeled dose for the labeled indications (see table 3 below); AND
  • For commercial health plan members only, ustekinumab is administered in accordance with site of service criteria (see policy XI-06); AND
  • For commercial health plan members only, step therapy supplement criteria may apply for select conditions (see policy II-242: Step Therapy Supplement).

II.  Renewal Review for Ustekinumab (Stelara®)

Ustekinumab may be considered MEDICALLY NECESSARY AND APPROPRIATE when ALL of the following criteria are met:

  • Previously approved for ustekinumab through the initial review process; AND
  • Demonstrated positive clinical response to ustekinumab therapy (e.g., stabilization and/or slowing of disease progression, or decrease in symptom severity and/or frequency); AND
  • No FDA labeled contraindications to ustekinumab (see table 1 below); AND
  • Not currently being treated with another biologic therapy; AND
  • Requested dose is within the FDA labeled dose for the labeled indications (see table 3 below); AND
  • For commercial health plan members only, ustekinumab is administered in accordance with site of service criteria (see policy XI-06).

III.  Experimental/Investigative Uses

All other uses of ustekinumab are considered EXPERIMENTAL/INVESTIGATIVE due to the lack of clinical evidence demonstrating an impact on improved health outcomes.

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Table 1.  FDA Labeled Contraindications

Agent

FDA Labeled Contraindications

Ustekinumab

Hypersensitivity


Table 2.  Conventional Agent Prerequisites

 

FDA Labeled Indications

Conventional Agent Prerequisites

Psoriatic arthritis (PsA)

methotrexate

leflunomide

sulfasalazine

hydroxychloroquine

cyclosporine

 

Psoriasis (Ps)

methotrexate

topical corticosteroids

coal tar products

anthralin

calcipotriene

calcitriol

acitretin

tazarotene

cyclosporine

methoxsalen

tacrolimus

pimecrolimus

PUVA (phototherapy)

Crohn’s disease (CD)

 

methotrexate

aminosalicylates

corticosteroids (including budesonide EC capsule)

azathioprine

6-mercaptopurine

metronidazole

ciprofloxacin

Ulcerative colitis (UC)

 

aminosalicylates

corticosteroids (including budesonide EC capsule)

azathioprine

6-mercaptopurine

cyclosporine


Table 3.  Dosing

NOTE:  See documentation submission requirements below if the requested dose is higher or more frequent than the dosing criteria provided in this table.

FDA Labeled Indications

Dosing

Psoriasis – adult

 

 

SC (≤100 kg): 45 mg at weeks 0 and 4, then 45 mg every 12 weeks.

 

SC (>100 kg): 90 mg at weeks 0 and 4, then 90 mg every 12 weeks.

Psoriasis – adolescent (6-17 years)

 

SC (<60kg): 0.75 mg/kg at weeks 0 and 4, then 0.75mg/kg every 12 weeks

SC (60 kg to 100 kg): 45 mg/kg at weeks 0 and 4, then 45 every 12 weeks

SC (>100 kg): 90 mg at weeks 0 and 4, then 90 mg every 12 weeks.

Psoriatic arthritis

SC:  45 mg at weeks 0 and 4, then 45 mg every 12 weeks.

SC: Ps and PsA and >100 kg – 90 mg at weeks 0 and 4, then 90 mg every 12 weeks

Crohn’s disease

IV induction: 260 mg for those ≤55 kg, 390 mg for those 56 to 85 kg, and 520 mg for those >85 kg

SC maintenance: 90 mg at week 8, then 90 mg every 8 weeks

Ulcerative colitis

IV induction: 260 mg for those ≤55 kg, 390 mg for those 56 to 85 kg, and 520 mg for those >85 kg

SC maintenance: 90 mg at week 8, then 90 mg every 8 weeks

IV (intravenous), SC (subcutaneous)


Documentation Submission:

Documentation supporting the medical necessity criteria described in the policy must be included in the prior authorization, when prior authorization is required. In addition, the following documentation must also be submitted:

Initial Review

  1. Clinical notes describing the diagnosis and clinical features of the diagnosis.
  2. For patients not currently receiving the ustekinumab, laboratory results for latent tuberculosis (TB) screening. If the test was positive, describe follow-up therapy.
  3. Clinical notes describing current and past medications for the diagnosis, including response to the medications.
  4. The dose being requested, including the patient’s weight if the diagnosis requires weight-based dosing. If the requested dose is higher or more frequent than the dosing guidelines provided in the table above, a clear explanation for the medical necessity of the requested dose MUST be submitted, including prior dosing (strength and frequency) associated with inadequate response.
  5. For commercial health plan members only, the site of service for ustekinumab administration is specified, including CMS place of service code (see policy XI-06). If ustekinumab is administered in a hospital outpatient facility, a clear explanation for the medical necessity of the site of service MUST be submitted, including documentation for one or more of the site of service criteria provided in policy XI-06.
  6. For commercial health plan members only, when step therapy requirements apply for the requested indication, documentation for one or more of the step therapy supplement criteria MUST be provided (see policy II-242).

Renewal Review  

  1. Documentation of prior approval for ustekinumab through the initial review process.
  2. Documentation supporting positive clinical response with ustekinumab therapy (e.g., slowing of disease progression or decrease in symptom severity and/or frequency).
  3. Clinical notes describing current and past medications for the diagnosis, including response to the medications.
  4. The dose being requested, including the patient’s weight if the diagnosis requires weight-based dosing. If the requested dose is higher or more frequent than the dosing guidelines provided in the table above, a clear explanation for the medical necessity of the requested dose MUST be submitted, including prior dosing (strength and frequency) associated with inadequate response.
  5. For commercial health plan members only, the site of service for ustekinumab administration is specified, including CMS place of service code (see policy XI-06).  If ustekinumab is administered in a hospital outpatient facility, a clear explanation for the medical necessity of the site of service MUST be submitted, including documentation for one or more of the site of service criteria provided in policy XI-06.



Denial Statements

No additional statements.



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Blue Cross and Blue Shield of Minnesota medical policies apply generally to all Blue Cross and Blue Plus plans and products. Benefit plans vary in coverage and some plans may not provide coverage for certain services addressed in the medical policies. When determining coverage, reference the member’s specific benefit plan, including exclusions and limitations.

Medicaid products may provide different coverage for certain services, which may be addressed in different policies. For Minnesota Health Care Program (MHCP) policies, please consult the MHCP Provider Manual website.

Medicare products may provide different coverage for certain services, which may be addressed in different policies. For Medicare National Coverage Determinations (NCD), Local Coverage Determinations (LCD), and/or Local Coverage Articles, please consult CMS, National Government Services, or CGS websites. 

Note that services with specific coverage criteria may be reviewed retrospectively to determine if criteria are being met. Retrospective denial of claims may result if criteria are not met.

Blue Cross and Blue Shield of Minnesota reserves the right to revise, update and/or add to its medical policies at any time without notice. Codes listed on this policy are included for informational purposes only and are subject to change without notice. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. 

These guidelines are the proprietary information of Blue Cross and Blue Shield of Minnesota. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

Acknowledgements:

CPT® codes copyright American Medical Association® 2022. All rights reserved.

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