BCBSNJ Medical Policy for - (Drugs) Policy Number

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Horizon BCBSNJ
Uniform Medical Policy Manual	Section:	Drugs
	Policy Number:	071
	Effective Date:	09/11/2020

	Original Policy Date:	11/10/2009
	Last Review Date:	09/08/2020
	Date Published to Web:	07/29/2011

Subject:
Ustekinumab (Stelara)

Description:
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IMPORTANT NOTE:

The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.

Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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Psoriasis is a chronic immune-mediated disease of the skin that affects an estimated 4.5 million adults in the U.S. The most common age for the onset of psoriasis is between 15 and 35 years of age. In psoriasis, the skin cells multiply several times faster than the normal rate causing scaling and inflammation. Excess cells pile up on the skin's surface forming red, raised, scaly plaques. Psoriasis of the skin is often itchy and painful. It can cause discomfort, restriction of joint motion, and emotional distress. There are five different types of psoriasis. The most common form of psoriasis is called "plaque psoriasis" which is characterized by well-defined patches of red, raised skin. About 80% to 90% of patients with psoriasis have this type. Most cases are mild and recurrent, however about 20-25% of patients diagnosed with plaque psoriasis have moderate to severe disease. Other forms of the disease include guttate psoriasis,erythrodermic psoriasis and pustular psoriasis.

Evaluation of the extent of the psoriasis may be measured using the PASI (Psoriasis Area and Severity Index) which combines assessments on the percentage of body area affected, erythema desquamation and induration. Scores range from 0 to 72. PASI of 8-12 roughly correlates to 8-12% body surface area and moderate-severe disease. PASI score is generally used only as a research tool and not widely used in clinical practice. However, a decrease in PASI score supports claims of efficacy. Efficacy in those with a severe form of psoriasis is often measured as a 75% improvement in PASI score. The Physician Global Assessment (PGA) may also be used to measure the severity of disease. It employs a seven-point scale, with 0=clear, 1=almost clear and 6=very marked plaque elevation, scaling or erythema.

Treatment options for psoriasis includes topical therapy (steroids, coal tar, calcipotriene, vitamin A, vitamin D derivatives, anthralin, salicylic acid, sunlight, etc.); phototherapy (ultraviolet light B, PUVA -psoralen plus exposure to ultraviolet light A); systemic medications (methotrexate, oral retinoids, cyclosporine, biologics); combination therapy (combination of treatments, such as narrowband UV-B therapy used in conjunction with ustekinumab to boost psoriasis clearance, can be used when psoriasis is resistant to one therapy); and rotational therapy (rotating the treatments every 12 to 36 months minimizes exposure to the toxic properties of certain treatments as well as the development of resistance to a particular therapy.

Stelara^TM (ustekinumab) is a biologic treatment approved by the FDA for treatment of adult patients (over 18 years of age) with moderate to severe chronic plaque psoriasis who are candidates for phototherapy or systemic therapy. Ustekinumab inhibits the action of IL-12 and IL-23, two proteins found in psoriatic skin plaques, which slow down production of skin cells, decreasing inflammation. The drug is administered as subcutaneous injection under the supervision of a healthcare provider at a starting dose of 45 mg and a second dose at week four followed by a maintenance dose 12 weeks thereafter. The dose can be increased to a dose of 90 mg for patients who weigh greater than 100 kg. Stelara^TM (ustekinumab) is also FDA approved for the treatment of adult patients with active psoriatic arthritis, alone or in combination with methotrexate. The recommended dose is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks. For patients with coexistent moderate-to-severe plaque psoriasis weighing >100 kg, the dose can be increased to 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks.

Two pivotal studies were conducted for the indication of psoriasis. The PHOENIX 1 trial was a multicenter, randomized, double-blind, placebo-controlled study of patients 18 years of age and older with chronic (> 6 months) plaque psoriasis. Seven hundred sixty-six patients were randomized to either placebo, 45 mg or 90 mg of ustekinumab treatment. The primary endpoint was a reduction in PASI score of at least 75% from baseline at week 12. A PASI 75 response was achieved by 67% of patients receiving ustekinumab therapy vs. 3% of patients receiving placebo (p<0.0001). Thirty-nine percent of patients achieved PASI score at week 12 vs 2 % for placebo (p<0.0001). The PHOENIX II trial was a multicenter, randomized, double-blind, placebo-controlled study of 1230 patients 18 years of age or older with chronic (>6 months) plaque psoriasis affecting a body surface area of ≥ 10%. Patients received either placebo, ustekinumab 45 mg or 90 mg. The primary endpoint was a reduction in score of at least 75% from baseline at Week 12 by the PASI (PASI 75). PASI 75 was achieved at week 12 by 71% of patients receiving ustekinumab vs. 4 % of patients receiving placebo (p<0.0001). The most common adverse reactions during both studies were nasopharyngitis and upper respiratory infection.

The expanded indication for psoriatic arthritis is supported by two pivotal studies. PSUMMIT I and PSUMMIT II evaluated the safety and efficacy of subcutaneously administering ustekinumab at week 0, 4, and then every 12 weeks. The PSUMMIT 1 trial was a phase 3 multicenter, double-blind, placebo-controlled study of adults with active psoriatic arthritis defined as ≥ 5 tender and ≥ 5 swollen joints, and C-reactive protein ≥ 3.0 mg/L. In this study, 615 patients were randomly assigned to either placebo, 45 mg or 90 mg of ustekinumab treatment. The primary endpoint was 20% or greater improvement in the American College of Rheumatology (ACR20) criteria at week 24. At week 24, 42.4% in the ustekinumab 45 mg treated group and 49.5% in the 90 mg treated group achieved ACR20, compared to 22% of the placebo-treated group (p<0.0001 for both comparisons). The responses were maintained at week 52. The rates of adverse events in both the ustekinumab and placebo groups were similar. PSUMMIT 2 was also a randomized, double blind, placebo-controlled study of 312 adults 18 years of age and older with active psoriatic arthritis. In PSUMMIT 2, 58% of subjects had been previously treated with an anti-TNF alpha agent, of whom 70% had discontinued that treatment or lack of efficacy or intolerance. Subjects were randomly assigned to either placebo, 45 mg or 90 mg of ustekinumab treatment. The primary endpoint was 20% or greater improvement in the American College of Rheumatology (ACR20) criteria at week 24. In both active drug groups, 44% of subjects achieved ACR 20 response at week 24 compared to 20% of subjects in the placebo group. The most common adverse reactions during both studies were nasopharyngitis and upper respiratory infection.

The safety of Stelara was assessed in three randomized, double-blind, placebo-controlled clinical studies. The trials were conducted in adult patients with moderately to severely active Crohn’s disease (Crohn’s Disease Activity Index [CDAI] score of 220 to 450). There were two 8-week intravenous induction studies (UNITI-1 (n=741) and UNITI-2 (n=627)) followed by a 44-week subcutaneous randomized withdrawal maintenance study, representing 52 weeks of therapy. In clinical studies of patients who were either new to, experienced with, or failed biologic therapy (TNF blockers), between 34% (UNITI-1 study) and 56% (UNITI-2 study) of patients experienced relief from their Crohn's disease symptoms in six weeks after receiving the one-time intravenous (IV) infusion of Stelara. Noticeable improvement was observed as early as three weeks. Additionally, the majority of those who responded to induction dosing and continued treatment with Stelara subcutaneous maintenance doses every 8 weeks were in remission at the end of 44 weeks (52 weeks from initiation of the induction dose). Patients in these 3 studies may have received other concomitant therapies including aminosalicylates, immunomodulatory agents [azathioprine (AZA), 6-mercaptopurine (6-MP), methotrexate (MTX)], oral corticosteroids (prednisone or budesonide), and/or antibiotics for their Crohn’s Disease. The overall safety profile of Stelara was consistent with the safety profile seen in the psoriasis and psoriatic arthritis clinical studies. The most common adverse events associated with the use of Stelara in Crohn’s disease were vomiting, nasopharyngitis, injection site erythema, vulvovaginal candidiasis, pruritus, and urinary infection.

The safety and efficacy of Stelara for plaque psoriasis in the pediatric population was studied in a phase 3 multicenter, randomized, double blind, placebo controlled trial that enrolled 110 adolescent patients aged 12 to 17 years of age. Patients enrolled had plaque-type psoriasis with or without psoriatic arthritis for 6 months and were candidates for phototherapy or systemic treatment of psoriasis. Excluded patients were those who had the non-plaque forms of psoriasis, those who had previously used an IL-12 or IL-23 targeted agent, patients who received systemic or phototherapies within the last 4 weeks, and those who received biologic therapies within the last 3 months. Patients were randomized to either placebo, the recommended dose of Stelara (RD), or one half the recommended dose (HRD) of Stelara. At week 12, 69.4% of the Stelara recommended dose group had a physician’s global assessment (PGA) score of 0 to 1, compared to 5.4% of placebo. Additionally, 61.1% of the Stelara group was Psoriasis Area and Severity Index (PASI) 90% responders, compared to 2% of the placebo group. There were no patients in either the placebo or Stelara standard dosage group at who discontinued therapy at week 12. The most common adverse events were nasopharyngitis (13.5% vs. 2.8%, SD vs. placebo), headache (8.3% vs. 5.4%).

In October 2019, Stelara was approved for the treatment of moderately to severely active ulcerative colitis in adults. The pivotal trial included an initial induction study (UNIFI-I) where patients received a single dose of Stelara 6 mg/kg intravenous (IV) infusion. It was followed 8 weeks later by a maintenance study (UNIFI-M) where patients received Stelara 90 mg subcutaneous (SC) injections every 8 weeks for 44 weeks. Both studies demonstrated the safety and efficacy of Stelara as a treatment option for patients with moderately to severely active UC. In the induction study, 19 percent of patients receiving Stelara achieved clinical remission in just 8 weeks. In addition, Stelara provided patients with rapid relief of their symptoms as 58 percent of patients receiving Stelara experienced a clinical response at Week 8. In the maintenance study, 45 percent of patients receiving Stelara were in remission at one year. Stelara also helped patients achieve clinical remission without the use of corticosteroids. At 1 year, 43 percent of patients treated with Stelara were in clinical remission and not receiving steroids.

In July 2020, the FDA approved an expanded indication for Stelara (ustekinumab) as a treatment for pediatric patients (6-11 years of age) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

[INFORMATIONAL NOTE: There have been post marketing reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving Stelara who had pre-existing risk factors for developing non-melanoma skin cancer. All patients receiving STELARA should be monitored for the appearance of non-melanoma skin cancer. Patients greater than 60 years of age, those with medical history of prolonged immunosuppressant therapy and those with a history of PUVA treatment should be followed closely]

Policy:
(Note: For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance.)

The requirements of the Horizon BCBSNJ Ustekinumab (Stelara) Program may require a precertification/prior authorization via MagellanRx Management. These requirements are member-specific: please verify member eligibility and requirements through the Horizon Provider Portal (www.horizonblue.com/provider). Ordering clinicians should request pre-certification from MagellanRx Management at ih.magellanrx.com or call 1-800-424-4508 (when applicable).

1. Please refer to a separate policy on Site of Administration for Infusion and Injectable Prescription Medications (Policy #142) under the Drug Section

2. Prior to starting therapy with ustekinumab (Stelara) the following must be documented:

AND

3. Ustekinumab (Stelara) is medically necessary for the following FDA-approved indications when all of the following criteria are met:

I. Moderate- to- severe chronic (i.e., extensive and/or disabling) plaque psoriasis when:

AND

Moderate to severe active

Psoriatic arthritis

(PsA)

AND

[INFORMATIONAL NOTE: In the phase 3, PSUMMIT 1 trial, patients with 3% or more of body surface area affected by psoriasis at baseline, significantly greater proportions of patients in the ustekinumab groups than in the placebo group achieved at least a 75% improvement in the psoriasis area and severity index (p<0.0001 for all comparisons). Methotrexate was used by roughly 50% of patients.]

Moderately to severely active Crohn’s disease (CD)

AND

Moderately to severely active ulcerative colitis (UC)

AND

Moderate- to- severe

chronic plaque psoriasis

45 mg initially and 4 weeks later, then maintenance dose, 45 mg every 12 weeks; OR
90 mg initially and 4 weeks later, then maintenance dose, 90 mg every 12 weeks if:
1. The member weighs >100 kg OR
2. For members with coexistent diagnosis of psoriatic arthritis weighing >100 kg

<60 kg: 0.75 mg/kg at weeks 0 & 4, then maintenance dose 12 weeks later
60 – 100 kg: 45 mg at weeks 0 & 4, then maintenance dose 12 weeks later
>100 kg: 90 mg at weeks 0 & 4, then maintenance dose 12 weeks later

II. For psoriatic arthritis:

45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks
For members with coexistent diagnosis of moderate-to-severe plaque psoriasis weighing >100 kg: 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks

Crohn's disease (CD)

and ulcerative colitis (UC)

SINGLE

5. Continued therapy with ustekinumab (Stelara) will be considered annually if the following criteria are met:

Member has shown clinical improvement in signs and symptoms compared to baseline with the requested agent (i.e. slowing of disease progression or decrease in symptom severity and/or frequency); AND
Absence of unacceptable toxicity from the drug (e.g.: serious infections, malignancies, reversible posterior leukoencephalopathy syndrome (RPLS)); AND
Member will NOT be using the requested agent in combination with another biologic immunomodulator agent or Otezla AND
If a subcutaneous form of the drug is requested, the requested drug will be administered in an office/outpatient setting by a healthcare professional or home infusion by a home-health nurse and is there is documentation that member will not be self-administering. Documentation must be provided stating the member is unable to self-administer due to one of the following reasons:
· Member has a history of anaphylaxis to prior therapy with a related pharmacologic or biologic agent despite standard premedication; or
· Member is unable to successfully self-administer with proper technique due to a motor/dexterity condition; or
· Member has acute mental status/cognitive changes or physical impairment due to another condition; or
· Member has in the past demonstrated compliance issues and therefore needs medical supervision to adequately receive the drug; or
· Member has clinically diagnosed needle phobia (supported by documentation including a psychiatric evaluation) and therefore cannot self-administer; or
· Member’s age prohibits them to successfully administer the medication and their medications cannot adequately be managed by a caregiver

6. Other uses of ustekinumab (Stelara) are considered investigational including, but not limited to atopic dermatitis, graft versus host disease, uveitis, multiple sclerosis, palmo-plantar pustulosis, primary biliary cirrhosis, active ankylosing spondylitis, and sarcoidosis.

[INFORMATIONAL NOTE: Stelara® (ustekinumab) has been studied in a phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of ustekinumab therapy in subjects with moderately to severely active Crohn's disease previously treated with TNF antagonist therapy. All patients were randomized at week 0 to be in one of 4 groups (Grp 1-placebo, Grp 2-active drug 1mg/kg IV, Grp 3-active drug 3mg/kg IV, Grp 4-active drug 6mg/kg IV). At week 0 the study drug was given by IV administration and at weeks 8 and 16 by subcutaneous injection. The proportion of patients who had a clinical response at week 6 was significantly greater among patients receiving 6mg/kg of ustekinumab than among those receiving placebo (39.7% vs. 23.5%; p=0.005). Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of < 150 was attained. The proportion of patients who had a clinical response at week 22 was significantly greater in the ustekinumab group than in the placebo group (69.4% vs. 42.5%; p<0.001). Among patients with a response to ustekinumab in the induction phase, 41.7% of patients receiving 90mg of ustekinumab in the maintenance phase were in clinical remission at week 22, as compared with 27.4% of patients receiving placebo (p=0.03). Among patients who did not have a response to ustekinumab as induction therapy, the rates of clinical response at week 22 were similar in the group receiving maintenance therapy with 90mg of ustekinumab and the placebo group (20.2% and 18.2% respectively, p=0.71). Additional efficacy data are needed for the assessment of ustekinumab as maintenance therapy in patients with Crohn’s disease. It is unclear whether results can be extrapolated to the broader Crohn’s disease population.]

Medicare Coverage

There is no National Coverage Determination (NCD) or Local Coverage Determination (LCD) for jurisdiction JL for these drugs. Therefore, Medicare Advantage will follow the Horizon Policy.

**Note: Bullet 1 of the policy section referring to Site of Administration for Infusion and Injectable Prescription Medications (Policy #142) does not apply for Medicare Advantage Products.

Medicaid Coverage

For Horizon NJ Health members, please follow this link for the corresponding HNJH drug policy https://services3.horizon-bcbsnj.com/ddn/NJhealthWeb.nsf

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Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

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Index:
Ustekinumab (Stelara)
Stelara (Ustekinumab)

References:

1. Stelara ^TMProduct Information, Horsham PA: Janssen Biotech Inc. July 2020.

2. National Psoriasis Foundation. Psoriasis Facts. 2009. Available from URL: http://psoriasis.org/facts/psoriasis/

3. National Institute of Arthritis and Musculoskeletal and Skin Diseases. Health Topics: Questions and Answers About Psoriasis. 2002 January [cited 2003 April 3] [8 screens] Available from URL: http://www.niams.nih.gov/hi/topics/psoriasis/psoriafs.htm

4. Biogen Inc. The Science of Psoriasis.2003 March [cited 2003 April 24] [6 screens]. Available from URL: http://www.Amevive .com

5. Ellis CN, Krueger GG. Treatment of Chronic Plaque Psoriasis by Selective Targeting of Memory Effector T Lymphocytes. New England Journal of Medicine 2001 July 26; 345(4):248-255.

6 Han NH, Nowakowski PA, et al. Acne and Psoriasis. In: DiPiro JT, Talbert RL, editors. Pharmacotherapy: A Pathophysiologic Approach. 4th Edition, Connecticut: Appleton & Lange: 1999. P.1496-1503.

7 Halpern SM, Vanstey AV, et al. Guidelines for topical PUVA: a report of a workshop of he British Photodermatology Group. British Journal of Dermatology 2000; 142:22-31.

8 Koo J, Lebwohl M. Duration of Remission of psoriasis therapies. . Journal of the American Academy of Dermatology 1999; 41:51-9.

9 Kostovic K, Situm M, and Nola I. Phototherapy and Photochemotherapy (PUVA) for Psoriasis. Acta Clinic Croat 2002; 41:103-112.

10 Krueger G, Koo J, Lebwohl M, et al. The Impact of Psoriasis on Quality of Life: Results of a 1998 National Psoriasis Foundation Patient-Membership Survey. Archives of Dermatology 2001; 137(3): 280-284.

11 Pardasani AG, Feldman SR, et al. Treatment of Psoriasis: An Algorithm-Based Approach for Primary Care Physicians. American Family Physician 2000; 61 (3):725-733.

12 Psoriasis and Other Papulosquamous Diseases. In Habif, editor. Clinical Dermatology. 3rd Edition: Mosby-Year Book: 1996. P. 190-213.

13. Ellis CN, Krueger GG. Treatment of chronic plaque psoriasis by selective targeting of memory effector T lymphocytes. NEJM 2001 Jul;345(4):248-255.

14. Gottlieb A, Korman, NJ, Gordon, KB, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. Journal of the American Academy of Dermatology 2008 May;58(5):851-64.

15. Feldman SR, Koo JYM, Menter A, et al. The psoriasis and psoriatic arthritis pocket guide: Treatment algorithms and management options. August 2005.

16. Leonardi CL, Kimball AB, Papp KA, et al; Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomized, double-blind, placebo-controlled trial (PHOENIX 1). Lancet. 2008; 371(9625): 1665-1674.

17. Papp KA, Langley RG, Lebwohl M, et al; Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomized, double-blind, placebo-controlled trial (PHOENIX 2). Lancet. 2008; 371 (9625): 1675-1684.

18. Sandborn WJ, Feagan BG, Fedorak RN, et al. A randomized trial of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with moderate-to-severe Crohn's disease. Gastroenterology. 2008 Oct;135(4):1130-41

19. Gottlieb A, Menter A, Mendelsohn A, et al. Ustekinumab, a human interleukin 12/23 monoclonal antibody, for psoriatic arthritis: randomized, double-blind, placebo-controlled, crossover trial. Lancet. 2009 Feb 21; 373(9664): 633-640.

20. Griffiths CE, Strober BE, van de Kerkhof P, et al. Comparison of ustekinumab and etanercept for moderate-to-severe psoriasis. N Engl J Med. 2010;362(2):118-28.

21. Toedter GP, Blank M, Lang Y, et al. Relationship of C-reactive protein with clinical response after therapy with ustekinumab in Crohn's disease. Am J Gastroenterol. 2009;104(11):2768-73.

22. Gordon K, Leonardi C, Lebwohl M, et al. The ustekinumab safety experience in patients with moderate-to-severe psoriasis: results from pooled analyses of phase 2 and phase 3 clinical trial data [poster]. European Academy of Dermatology and Venereology, October 7-11, 2009. Berlin, Germany.

23. A Phase II, Double-blind, Placebo-Controlled, Randomized, Dose-ranging Study of Multiple Subcutaneous Injections of Human Monoclonal Antibody to IL-12p40(CNTO1275) in Subjects With Relapsing-remitting Multiple Sclerosis. Study NCT00207727. Available at: www.clinicaltrial.gov.

24. Menter A, Gottlieb A, Feldman SR, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol 2008 May;58(5):826-50.

25. Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 6. Case-based presentations and evidence-based conclusions. American Academy of Dermatology Online publication, 7 February 2011.

26. Guidelines of care for the management and treatment of psoriasis with topical therapies. J Am Acad Dermatol. 2009 Apr;60(4):643-59.

27. Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 4. Guidelines of care for the management and treatment of psoriasis with traditional systemic agents. J Am Acad Dermatol. 2009 Sep;61(3):451-85.

28. Griffiths CE, Strober BE, van de Kerkhof, et al. Comparison of ustekinumab and etanercept for moderate-to-severe psoriasis. N Eng J Med. 2010 Jan;362(2):118-28.

29. Clinical Trials Web site. http://clinicaltrials.gov/ct2/results?term=ustekinumab. Accessed: March 25, 2014.

30 . Sandborn WJ, Gasink C, Gao LL, et al. Ustekinumab induction and maintenance therapy in refractory Crohn’s disease. N Engl J Med. 2012;367:1519-1528.

31. McInnes IB, Kavanaugh A, Gottlieb AB, et al. Efficacy and safety of ustekinumab in patients with active psoriatic arthritis: 1 year results of the phase 3, multicenter, double-blind, placebo-controlled PSUMMIT 1 trial. Lancet 2013; 382:780-89

32. Hsu S, Papp KA, Lebwohl MG, et al. Consensus guidelines for the management of plaque psoriasis. Arch Dermatol. 2012 Jan;148(1):95-102.

33. MICROMEDEX® 2.0 (Healthcare Series). DRUGDEX® Evaluations. Ustekinumab. Available at: http://www.thomsonhc.com. Accessed March 04, 2015.

34. Clinical Pharmacology [database online]. Ustekinumab. Gold Standard; 2009. Updated September 24, 2013. Accessed March 09, 2015.

35. Ustekinumab. In: McEvoy GK, editor. AHFS: Drug Information (2015). Bethesda, MD: American Society of Health-System Pharmacists; 2015. Updated December 12, 2014. Accessed March 09, 2015 http://online.statref.com/Document.aspx?fxId=1&docId=1489

36. Gossec L, Smolen JS, Ramiro S, et al. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update. Ann Rheum Dis. 2015 Dec 7. pii: annrheumdis-2015-208337. doi: 10.1136/annrheumdis-2015-208337.

37. A study to Evaluate the Safety and Efficacy of Ustekinumab in Patients with Moderately to Severely Active Crohn’s Disease Who have failed or Are intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy (UNIT-1). Available at: www.clinicaltrials.gov.

38. A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients with Moderately to Severely Active Crohn’s Disease (UNIT1-2). Available at: www.clinicaltrials.gov.

39. A study of the Safety and Efficacy of Ustekinumab (CNTO 1275) in Participants with Crohn’s Disease. Available at: www.clinicaltrials.gov.

40. Landells I, Marano C, Hsu MC, et al. Ustekinumab in adolescent patients age 12 to 17 years with moderate-to-severe plaque psoriasis: results of the randomized phase 3 CADMUS study. J Am Acad Dermatol. 2015;73(4):594-603.

41. A Study of the Safety and Efficacy of Ustekinumab in Adolescent Patients With Psoriasis (CADMUS). Clinicaltrials.gov. Accessed October 2017. Available at: https://clinicaltrials.gov.

42. Singh JA, Guyatt G, Ogdie A, et al. 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis. Arthritis & Rheumatology, vol. 71, no. 1, 2018, pp. 5–32., doi:10.1002/art.40726.

43. Sands BE, Sandborn WJ, Panaccione R,et al. UNIFI Study Group. Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2019 Sep 26;381(13):1201-1214.

44. Clinicaltrials.gov. A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UNIFI). NCT02407236. Available at: https://clinicaltrials.gov/ct2/show/NCT02407236

Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

HCPCS
J3358

J3357

* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.

The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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