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Horizon BCBSNJ
Uniform Medical Policy ManualSection:Drugs
Policy Number:179
Effective Date: 05/27/2018
Original Policy Date:04/24/2018
Last Review Date:
Date Published to Web: 04/25/2018
Subject:
Tildrakizumab (Ilumya)

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.

Ilumya is a monoclonal antibody approved by the FDA for treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Ilumya inhibits the IL-23 receptor.

In two multicenter, randomized, double-blind, placebo-controlled trials, Trial 2 and Trial 3, 926 subjects were treated with Ilumya 100 mg or placebo. Subjects had a Physician Global Assessment (PGA) score of ≥3 (moderate) on a 5-point scale of overall disease severity, Psoriasis Area and Severity Index (PASI) score ≥12, and a minimum body surface area (BSA) involvement of 10%. Subjects with guttate, erythrodermic, or pustular psoriasis were excluded. In both trials, subjects were randomized to either placebo or Ilumya at week 0, Week 4, and every twelve weeks thereafter up to 64 weeks. Co-primary endpoints were PASI 75, the proportion of subjects who achieved at least a 75% reduction in the PASI composite score and PGA of 0 (“cleared”) or 1 (“minimal”), the proportion of subjects with a PGA of 0 or 1 and at least a 2-point improvement.

In both trials, approximately 34% had received prior phototherapy, 39% had received prior conventional systemic therapy, and 18% had received prior biologic therapy for the treatment of psoriasis.
Trial 2 had a PASI 75 rate of 64% and placebo had a rate of 6%. Trial 3 had a PASI 90 rate of 61% and placebo had a rate of 6%.

In Trial 2, subjects originally randomized to Ilumya and who were responders at Week 28 (i.e., PASI 75) were re-randomized to an additional 36 weeks of either maintaining the same dose of Ilumya once every 12 weeks or placebo. At Week 28, 229 (74%) subjects treated with Ilumya 100 mg were PASI 75 responders. At Week 64, 84% of subjects who continued on Ilumya 100 mg Q12W maintained PASI 75 compared to 22% of subjects who were re-randomized to placebo. In addition, for subjects who were re-randomized and also had a PGA score of 0 or 1 at Week 28, 69% of subjects who continued on Ilumya 100 mg Q12W maintained this response (PGA 0 or 1) at Week 64 compared to 14% of subjects who were rerandomized to placebo.

For PASI 75 responders at Week 28 who were re-randomized to treatment withdrawal (i.e., placebo), the median time to loss of PASI 75 was approximately 20 weeks. In addition, for subjects who were re-randomized to placebo and also had a PGA score of 0 or 1 at week 28, the median time to loss of PGA score of 0 or 1 was approximately 16 weeks.

Policy:
1. Prior to starting therapy with tildrakizumab (Ilumya) the following must be documented:
    a. Member has been screened for the presence of latent tuberculosis (TB) infection; AND
    b. Member is free of any clinically important active infections; AND
    c. Drug will not be administered concurrently with live vaccines; AND
    d. Member is not on concurrent treatment with any other biological response modifier or biologic DMARDs; AND
    e. Drug must be prescribed by the treating physician.
2. Tildrakizumab (Ilumya) is medically necessary for the following FDA-approved indication of plaque psoriasis when all of the following criteria are met:
a. Member is 18 years of age or older; AND
    b. Member did not respond adequately (or is not a candidate) to a 3 month minimum trial of at least 1 systemic agents (i.e. immunosuppressives, retinoic acid derivatives, and/or methotrexate);AND
    c. Member had inadequate response to or is not a candidate for phototherapy due to location of psoriasis (PUVA, narrowband UVB or broadband UVB); AND
    d. Member is with at least 10% involvement in body surface area (BSA) or less than 10% but with involvement of palms, soles, head and neck or genitalia which causes disruption of activities of daily living; AND
    e. Member had inadequate response or has contraindications to a topical agent (corticosteroids, retinoic acid derivatives, and/or vitamin D analogues).

3. When tildrakizumab (Ilumya) is considered medically necessary, initial therapy will be eligible at the following FDA approved doses for a period of 6 months:
    a. Inject 100 mg subcutaneously initially at week 0, 4, and every 12 weeks thereafter.

    [INFORMATIONAL NOTE: As per the FDA approved package insert, Ilumya should be administered by a health care professional.]

4. Continued therapy with tildrakizumab (Ilumya) will be considered annually if the following criteria are met:
    Member had Disease response indicated by improvement in signs and symptoms compared to baseline such as redness, thickness, scaliness, and/or the amount of surface area involvement; AND
    Member continues to meet initial review criteria; AND
    Absence of unacceptable toxicity from the drug (e.g.: serious infections, malignancies, reversible posterior leukoencephalopathy syndrome (RPLS); AND
    Ongoing monitoring for signs and symptoms of tuberculosis (e.g.: cough >3 weeks, chest pain, blood in sputum, weight loss)
5. Other uses of tildrakizumab (Ilumya) are considered investigational for all other indications.
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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:
Tildrakizumab (Ilumya)
Ilumya (Tildrakizumab)
Plaque Psoriasis, Ilumya (Tildrakizumab) for

References:
1. Ilumya TM Product Information, County Carlow, Ireland. Merck Sharpe & Dohme Corp. March 2018.

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. 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.

5. 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.

6. 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.

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

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

9. 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.

10. 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.

11. Psoriasis and Other Papulosquamous Diseases. In Habif, editor. Clinical Dermatology. 3rd Edition: Mosby-Year Book: 1996. P. 190-213.
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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
      J3590

    * CPT only copyright 2018 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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