Medical Policy


Subject:  Ustekinumab (Stelara®)
Policy #:  DRUG.00042Current Effective Date:  11/18/2013
Status:RevisedLast Review Date:  11/14/2013

Description/Scope

Ustekinumab (Stelara) (Janssen Biotech, Inc., Horsham, PA) is a human monoclonal antibody that binds to interleukin (IL)-12 and IL-23 cytokines involved in inflammatory and immune response. This document addresses the U.S. Food and Drug Administration (FDA) approved indications for ustekinumab, a biologic agent used for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in individuals 18 years of age or older.

Note: Please see the following documents for information concerning other biologic disease-modifying antirheumatic drugs (DMARDs) that may be used for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis:

Position Statement

Medically Necessary:

Ustekinumab is considered medically necessary when the following criteria are met for either indication:

  1. Psoriatic arthritis (PsA) when the following are met:
    1. Individual is 18 years of age or older with active PsA; and
    2. Individual has failed to respond to, is intolerant of, or has a medical contraindication to conventional therapy (such as nonbiologic DMARDs).
      OR
  2. Plaque psoriasis (Ps) when all of the following are met:
    1. Individual is 18 years of age or older with chronic moderate to severe plaque Ps with either of the following:
      1. Plaque Ps involving greater than five percent body surface area (BSA); or
      2. Plaque Ps involving less than or equal to five percent BSA involving sensitive areas or areas that significantly impact daily function (such as palms, soles of feet, head/neck, or genitalia); AND
    2. Individual has failed to respond to, is intolerant of, or has a medical contraindication to phototherapy or other systemic therapy (such as acitretin, cyclosporine, or methotrexate).

Not Medically Necessary:

Ustekinumab is considered not medically necessary for an individual with any of the following:

  1. Use of ustekinumab in combination with other immunosuppressive therapy or phototherapy.
  2. History of reversible posterior leukoencephalopathy syndrome (RPLS).
  3. Tuberculosis, invasive fungal infection, other active serious infections, or a history of recurrent infections.
  4. Individual has not had a tuberculin skin test (TST) or a Centers for Disease Control (CDC)-recommended equivalent test to evaluate for latent tuberculosis.

Investigational and Not Medically Necessary:

Ustekinumab is considered investigational and not medically necessary when the medically necessary criteria are not met and for all other indications, including, but not limited to treatment of Crohn's disease (CD) or relapsing-remitting multiple sclerosis (RRMS).

Rationale

Ustekinumab for Moderate to Severe Plaque Psoriasis

Ustekinumab is a fully human monoclonal antibody that selectively binds with high specificity and affinity to the cytokines IL-12 and IL-23, thereby suppressing IL-12 and IL-23-mediated inflammation associated with psoriasis. These cytokines are abundant in psoriasis skin and are thought to promote the accumulation of the psoriasis-causing T-cells. In September 2009, the FDA approved ustekinumab for use in the treatment of individuals 18 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Comparative efficacy of ustekinumab to placebo is supported by two phase III, multicenter, randomized, double-blind, placebo-controlled trials, PHOENIX 1 and PHOENIX 2 (Leonardi, 2008; Papp, 2008). In these trials enrolling a total of 1996 subjects with moderate to severe plaque psoriasis, significantly more ustekinumab recipients (administered subcutaneous doses of 45 or 90 milligrams as two injections, four weeks apart) than placebo recipients achieved a 75% improvement on the Psoriasis Area and Severity Index (PASI 75) score at 12 weeks. Other measures, including the Physician's Global Assessment (PGA) of clinical response at week 12, demonstrated efficacy of ustekinumab over placebo. Prolonged efficacy measured as psoriatic symptom control was maintained during ustekinumab maintenance therapy (administered once every 12 weeks) for up to 76 weeks; however, intensification of dosing to once every eight weeks with 90 milligrams ustekinumab may be necessary to elicit a full response in individuals who only partially respond to the initial regimen (PHOENIX 2) (Papp, 2008). Adverse events were generally similar across treatment and control groups, including infections, injection-site reactions, psychological disorders, and development of anti-ustekinumab antibodies. Studies are ongoing to assess the long term safety and efficacy profiles.  

A head-to-head industry-sponsored, randomized active-control trial of 903 individuals evaluated the efficacy of ustekinumab compared to high-dose etanercept (Enbrel®, Immunex Corporation, Thousand Oaks, CA) in the treatment of moderate to severe psoriasis (Griffiths, 2010). The ACCEPT study evaluated either 45 milligrams or 90 milligrams of ustekinumab subcutaneous every 12 weeks compared to etanercept 50 milligrams subcutaneous twice weekly. The primary end point was the proportion of individuals with at least 75% improvement in the PASI at week 12, reported as significantly higher with 45 milligrams and 90 milligrams of ustekinumab compared to individuals who received etanercept (68% and 74% to 57%; p=.012 and p<0.001, respectively). Similarly, individuals who received 45 milligrams or 90 milligrams of ustekinumab compared to individuals who received etanercept (65% and 71% to 49%; p<0.001, both comparisons) had cleared or minimal disease according to the PGA. In the crossover portion of the trial, 48% of individuals who did not respond to etanercept had at least 75% improvement in the PASI in response to ustekinumab within 12 weeks. One or more adverse events occurred through week 12 in 66% and 69% of individuals who received 45 milligrams or 90 milligrams of ustekinumab, respectively compared to 70% who received etanercept. Safety patterns were similar before and after crossover from etanercept to ustekinumab.

In a pooled analysis of data from four phase II/III randomized controlled trials, Reich and colleagues (2012) reported on the long-term safety profile of ustekinumab-treated individuals with moderate to severe psoriasis. The safety profile of long-term ustekinumab treatment with up to four years of continuous use was reported as consistent with previous reports, with no evidence of cumulative toxicity.

In a network meta-analysis and Cochrane review, Singh and colleagues (2011) compared the potential adverse effects of the biologic therapies, including ustekinumab, in individuals with any disease condition except human immunodeficiency disease (HIV). The rate of serious adverse events, lymphoma and congestive heart failure were not statistically significantly different between the biologics and control treatment. The authors stated that some biologics (not ustekinumab) had a statistically higher association with certain adverse outcomes compared with control, but there was no consistency across the outcomes so caution is needed in interpreting these results.

Ustekinumab is approved for administration by a healthcare provider as a 45 milligrams or 90 milligrams subcutaneous injection at week 0 and 4 then every 12 weeks. The higher dose is recommended for individuals weighing over 100 kilograms and the lower dose for those under 100 kilograms. In clinical trials, the 45 milligrams dose was found to be efficacious in subjects over 100 kilograms; however, the 90 milligrams dose improved efficacy.

The American Academy of Dermatology (AAD) published a set of evidence-based guidelines, Guidelines of Care for the Management of Psoriasis and Psoriatic Arthritis (AAD, 2008), intended to assist physicians in managing the complexities of the treatment of individuals with psoriasis and psoriatic arthritis. The first guideline, Section 1: Overview of Psoriasis and Guidelines of Care for the Treatment of Psoriasis with Biologics (AAD, 2008) provides an overview of psoriasis classification, co-morbidities, assessment tools, and the use of biologics to treat psoriasis. The work group states that approximately 80% of individuals affected with psoriasis have mild to moderate disease, with 20% having moderate to severe psoriasis, defining the extent of BSA involvement as "affecting more than 5% of the BSA or affecting crucial body areas such as the hands, feet, face, or genitals." "The areas of involvement and types of psoriasis should be considered in evaluating severity of disease because the impact of these types of psoriasis may be quite substantial." Treatment planning for use of an FDA-approved biologic agent for moderate to severe plaque psoriasis considers this definition of BSA involvement with plaque psoriasis. In addition, for individuals with plaque psoriasis involving sensitive areas or areas that would significantly impact daily function (e.g. palms, soles of feet, head/neck, or genitalia), less than or equal to five percent of BSA involvement is considered as moderate to severe disease. Subsequent sections of the guidelines have been published, including Section 4: Guidelines of Care for the Management and Treatment of Psoriasis with Traditional Systemic Agents (Menter, 2009). This section reiterates that treatment planning should consider BSA criteria as recommended in the earlier guidelines. In addition, this section discusses in detail the "efficacy and safety, and offers recommendations for the use of the three most commonly used, and approved, traditional systemic agents: methotrexate, cyclosporine, and acitretin."  

An Agency for Healthcare Research and Quality (AHRQ) (Lee, 2012) review examined the comparative effectiveness of biologic systemic agents, nonbiologic systemic agents and phototherapy, for treatment of chronic plaque psoriasis regarding the effectiveness, safety and any individual characteristics that could modify outcomes of interest. With regard to ustekinumab, a single observational study was found comparing the efficacy of ustekinumab to methotrexate. Based on this study (Gelfand, 2012), achievement of a PGA of "clear" or "minimal" was increased in individuals treated with ustekinumab compared with methotrexate (strength of evidence: low), however, there was insufficient evidence to grade health-related quality of life, BSA and PASI, and no other intermediate health outcomes were reported.

Ustekinumab for Active Psoriatic Arthritis

Gottlieb and colleagues (2009) initially evaluated the safety and efficacy of ustekinumab for psoriatic arthritis in a phase II, multicenter, randomized, double-blind, placebo-controlled, crossover trial. Participants with active psoriatic arthritis were randomized to receive ustekinumab (90 milligrams or 63 milligrams) every week for four weeks (week 0-3) followed by placebo at weeks 12 and 16 (n=76; Group 1) or placebo (weeks 0-3) and ustekinumab (63 milligrams) at weeks 12 and 16 (n=70; Group 2). The first 12 weeks of the study were placebo controlled. Masking was maintained to week 16, and individuals were followed up to week 36. The primary endpoint was American College of Rheumatology 20% (ACR20) improvement response at week 12 with intention-to-treat analysis. At week 12, 32 individuals (42%) in Group 1 and 10 individuals (14%) in Group 2 achieved the primary endpoint (difference 28%, 95% confidence interval [CI] 14.0-41.6; p=0.0002). Of the 124 participants (85%) with psoriasis affecting 3% or more BSA, 33 of 63 (52%) in Group 1 and three of 55 (5%) in Group 2 had a 75% or greater improvement in PASI score at week 12 (46%, range 33.2-60.6; p<0.0001). During the placebo-controlled period (weeks 0-12), adverse events occurred in 46 individuals (61%) in Group 1 and 44 individuals (63%) in Group 2. Serious adverse events were recorded in three Group 2 individuals (4%). The investigators concluded that ustekinumab was well tolerated and significantly reduced signs and symptoms of psoriatic arthritis and diminished skin lesions compared with placebo.

The FDA approved the use of ustekinumab, as a single agent or in combination with methotrexate, for the treatment of adult psoriatic arthritis (Stelara Product Information [PI], September 2013). The safety and efficacy of ustekinumab was assessed in two double-blind randomized controlled trials (PSUMMIT 1 [n=615] and PSUMMIT 2 [n=312]) in 927 participants with active psoriatic arthritis despite prior non-steroidal anti-inflammatory (NSAID) or DMARD therapy. In the phase 3, multicenter PSUMMIT I trial (McInnes, 2013), adults with active psoriatic arthritis (defined as greater than of equal to 5 tender joints and 5 swollen joints, and a C-reactive protein greater than or equal to 3.0 mg/L) were randomly assigned (1:1:1) to 45 mg ustekinumab, 90 mg ustekinumab, or placebo at week 0, week 4, and every 12 weeks thereafter. Approximately 50% of participants continued on stable doses of methotrexate (less than or equal to 25 mg/week). At week 16, participants with less than 5% improvement in both tender and swollen joint counts entered masked early-escape and were given 45 mg ustekinumab (if in the placebo group) or 90 mg ustekinumab (if in the 45 mg group). At week 24, all remaining participants in the placebo group received ustekinumab 45 mg, which they continued at week 28 and every 12 weeks thereafter. The primary endpoint was 20% or greater improvement in ACR20 criteria at week 24. More ustekinumab-treated (87 of 205 [42%] in the 45 mg group and 101 of 204 [50%] in the 90 mg group) than placebo-treated (47 of 206 [23%]) participants achieved ACR20 at week 24 (p<0.0001 for both comparisons); responses were maintained at week 52. At week 16, proportions of participants with adverse events were similar in the ustekinumab and placebo groups (171 of 409 [42%] versus 86 of 205 [42%]).

In the phase 3 PSUMMIT 2 trial, 44% of the participants in both dose groups, including those previously treated with a biologic anti-tumor necrosis factor alpha (anti-TNF-α) agent (of whom 70% had discontinued treatment for lack of efficacy or intolerance at any time) achieved ACR20 at week 24. Improvements in soft tissue components (enthesitis and dactylitis) as measured by the Psoriasis Severity Index (PASI 75) were also associated with use of ustekinumab compared with placebo (Stelara PI, 2013). To date, the PSUMMIT 2 trial results are pending publication in the peer-reviewed medical literature.

An update to a 2007 AHRQ comparative effectiveness review on drug therapy for adult psoriatic arthritis found that the available evidence on biologic DMARDs is limited, although symptom improvement has been reported. The reviewers noted firm conclusions could not be drawn about the comparative efficacy, effectiveness, functional status, health-related quality of life, or tolerability of DMARDs for adult psoriatic arthritis (Donahue, June 2012). This report was published before the FDA review of ustekinumab trials and subsequent FDA approval of ustekinumab for the treatment of adult psoriatic arthritis.

Other Proposed Uses of Ustekinumab

Crohn's Disease

Mannon and colleagues (2004) conducted a randomized double-blind, phase II clinical trial evaluating the safety and efficacy of ustekinumab in 79 individuals with active Crohn's disease. Participants were randomly assigned to receive seven weekly subcutaneous injections of 1 milligrams or 3 milligrams per kilogram of ustekinumab or placebo, with either a four-week interval between the first and second injection (cohort 1) or no interruption between the two injections (cohort 2). Safety was the primary end point and the rates of clinical response and remission (as defined by a reduction in the Crohn's Disease Activity Index [CDAI] score of at least 100 points and 150 points or less, respectively) were secondary end points. After seven weeks of uninterrupted treatment, the participants in the 3 milligrams per kilogram-treated group experienced higher response rates than did the placebo group (75% versus 25%, p=0.03). At 18 weeks of follow-up, the difference in response rates was no longer significant (69% versus 25%, p=0.08). Differences in remission rates between the 3 milligrams per kilogram treatment group and the placebo group in cohort 2 were not significant at either the end of treatment or the end of follow-up (38% and 0%, respectively, at both times; p=0.07). There were no significant differences in response rates among the groups in cohort 1. The rates of adverse events among participants receiving ustekinumab were similar to those participants given placebo, except for a higher rate of local reactions at injection sites in the former group. Limitations of this study include the small sample size and short duration of treatment.

In a phase II/III, randomized, double-blind, crossover trial, Sandborn and colleagues (2008) assessed the clinical effects of ustekinumab for individuals (n=104) with moderate to severe Crohn's disease. In the crossover arm of the trial (population 1), individuals were given either subcutaneous placebo at weeks 0-3, then subcutaneous ustekinumab at weeks 8-11; subcutaneous ustekinumab at weeks 0-3, then placebo at weeks 8-11; intravenous placebo at week 0, then ustekinumab at week 8; or intravenous ustekinumab at week 0, then placebo at week 8. In the open-label phase, the effects of four weekly subcutaneous injections or one intravenous infusion of ustekinumab was evaluated in 27 individuals (population 2) who were primary or secondary nonresponders to infliximab (Remicade®, Centocor Ortho Biotech, Inc., Horsham, PA). In population 1, clinical response rates for the combined groups given ustekinumab and placebo were 53% and 30% (p=.02), respectively at weeks four and six, and 49% and 40% (p=.34), respectively at week eight. In a subgroup of 49 individuals who were previously given infliximab (neither primary nor secondary nonresponders), clinical response to ustekinumab was significantly greater than the group given placebo (p<.05) through week 8. In population 2, the clinical responses at week 8 to subcutaneous and intravenous ustekinumab were 43% and 54%, respectively. There was no increase in the number of adverse or serious adverse events in individuals given ustekinumab through week 8 compared with placebo. The investigators concluded that ustekinumab induced a clinical response in individuals with moderate-to-severe Crohn's disease, especially in individuals previously given infliximab. Further study is indicated in the form of larger, prospective trials evaluating the long-term effects of ustekinumab compared to placebo for the treatment of individuals with moderate to severe Crohn's disease.

Sanborn and colleagues (2012) conducted the phase II trial, ustekinumab induction and maintenance therapy in refractory Crohn's disease. In the maintenance phase (week 8-36) of this trial, 145 participants who had a response to ustekinumab at six weeks underwent a second randomization to receive subcutaneous injections of ustekinumab (90 milligrams) or placebo at weeks 8 and 16. The primary end point was a clinical response at six weeks. The proportions of participants who reached the primary end point were 36.6%, 34.1%, and 39.7% for 1, 3, and 6 milligrams of ustekinumab per kilogram, respectively, as compared with 23.5% for placebo (p=0.005 for the comparison with the 6-milligrams group). The rate of clinical remission with the 6 milligrams dose did not differ significantly from the rate with placebo at 6 weeks. Maintenance therapy with ustekinumab, as compared with placebo, resulted in significantly increased rates of clinical remission (41.7% versus 27.4%, p=0.03) and response (69.4% versus 42.5%, p<0.001) at 22 weeks. Serious infections occurred in seven participants (six receiving ustekinumab) during induction and 11 participants (four receiving ustekinumab) during maintenance. Participants with an initial response to ustekinumab had significantly increased rates of response and remission with ustekinumab as maintenance therapy. However, participants who did not have a response to ustekinumab in the induction phase did not benefit from additional ustekinumab therapy in the maintenance phase. The investigators suggested the inability to identify significant differences in the induction of remission may be explained by the study participants having relatively high baseline CDAI scores, a long disease duration, and a history of failed therapies. Limitations of this study include the relatively small sample size and short duration of the maintenance phase. Additional efficacy data are needed for the assessment of ustekinumab as maintenance therapy in individuals with Crohn's disease. To date, the FDA has not approved ustekinumab for use in individuals in the treatment of moderate to severe Crohn's disease.

Relapsing-Remitting Multiple Sclerosis

A phase II, multicenter, randomized, double-blind, placebo-controlled, dose-ranging clinical trial assessed the efficacy and safety of ustekinumab for individuals with RRMS (Segal, 2008). This trial (n=249 individuals) reported ustekinumab was generally well tolerated but found no clinical or radiologic improvement (such as, a reduction in the cumulative number of gandolinium-enhancing T1-weighted lesions) in any treatment group compared with placebo controls. At week 37, adverse events occurred in 38 (78%) placebo-treated individuals and 170 (85%) ustekinumab-treated individuals, with infections most commonly reported. Serious adverse events occurred in one (2%) placebo-treated individual and six (3%) ustekinumab-treated individuals. Malignant diseases were reported in two individuals shortly after the initiation of ustekinumab treatment; both individuals were withdrawn from the trial and given appropriate treatment, which resulted in complete remission. The advanced disease of the subjects in this study may have partially contributed to the lack of efficacy reported in the study results. Additional study, including a more limited subset of subjects with very early disease, is required to determine if ustekinumab may show a treatment effect in individuals with RRMS. To date, the FDA has not approved ustekinumab for use in individuals in the treatment of RRMS.

Background/Overview

Plaque Psoriasis

Psoriasis is a genetic, multi-system inflammatory disease characterized predominantly by chronic skin and joint manifestations, affecting approximately 2.2% of the United States population. Studies show that between 10-30% of individuals with psoriasis also develop psoriatic arthritis. The major manifestation of psoriasis is chronic inflammation of the skin, characterized by "disfiguring, scaling, and erythematous plaques that may be painful or often severely pruritis and may cause significant quality of life issues" (AAD, 2008). Plaque psoriasis is commonly located over the surfaces of the elbows, knees, scalp, and around or in the ears, navel, genitals or buttocks, but may appear elsewhere; it can be altered by environmental factors and may be associated with other inflammatory disorders such as psoriatic arthritis, inflammatory bowel disease, and coronary artery disease. Plaque psoriasis is a chronic disease that waxes and wanes during an individual's lifetime and is often modified by treatment initiation and cessation with few spontaneous remissions.

For individuals with chronic plaque psoriasis, key metrics for outcome assessment include improvement in the PASI as well as objective assessment of disease via the PGA. The PASI is a measure of overall psoriasis severity and coverage that assesses BSA and erythema, induration, and scaling. PASI is the metric commonly used in the clinical trials for psoriasis treatments, but is rarely used in clinical practice. Therefore, the AAD states that the physician generally uses subjective qualitative assessment of the severity of an individual's psoriasis by combining objective assessment of the BSA involvement, disease location, thickness, and symptoms, presence or absence of psoriatic arthritis with the subjective assessment of the physical, financial, and emotional impact of the diseases on the individual's life. Treatments available to help manage the symptoms of psoriasis include topical therapy (for example, emollients or tar), phototherapy (for example, psoralens in conjunction with ultraviolet A light [PUVA], narrowband and broadband ultraviolet B light [UVB]), systemic therapy (for example, methotrexate, cyclosporine), and biologic DMARDs.

Psoriatic Arthritis

Psoriatic arthritis is an inflammatory seronegative spondyloarthropathy associated with psoriasis. Psoriatic arthritis is characterized by stiffness, pain, swelling, and tenderness of the joints and surrounding ligaments and tendons (dactylitis and enthesitis). Symptoms of psoriatic arthritis can range from mild to very severe. Approximately 15% of people with psoriasis develop psoriatic arthritis. In about 15% of individuals with psoriatic arthritis, the joint disease precedes the psoriasis skin symptoms (NPF, 2012).

Product Information Precautions and Warnings (Stelara PI, 2013)

Drug Interactions

Definitions

Biologic disease modifying anti-rheumatic drugs (DMARDs): A class of drugs thought to work by targeting components of the immune system by blocking specific immune cytokines, blocking other cytokines, binding with cytokines suppressing IL-1ß, IL-12 and/or IL-23, or by directly suppressing lymphocytes. Includes the following:

Disease modifying anti-rheumatic drugs (DMARDs): A variety of drugs that work by altering the immune system function to halt the underlying processes that cause certain forms of inflammatory arthritis including rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis.

Immunosuppressant drugs: A class of immunomodulatory drugs including 6-mercaptopurine (6-MP), azathioprine, cyclophosphamide, cyclosporine, methotrexate, and tacrolimus that reduce inflammation by affecting the immune system.

Interferon gamma (IFN- γ) release assay (IGRA): A test that aids in detecting Mycobacterium tuberculosis infection, both latent infection and infection manifesting as active tuberculosis that may be used for surveillance purposes and to identify persons likely to benefit from treatment. FDA-approved IGRAs include the 1) QuantiFERON-TB Gold test (GFT-G), 2) QuantiFERON-TB Gold In-Tube test (QFT-GIT), and the 3) T-SPOT.TB test (T-Spot).

Monoclonal antibody: A laboratory-produced substance that can locate and bind to specific cells wherever they are in the body. Monoclonal antibodies can be used alone, or they can be used to deliver drugs, toxins, or radioactive material directly to their target cell.

Nonbiologic disease modifying antirheumatic drugs (DMARDs): A class of drugs, also referred to as synthetic DMARDs, thought to work by altering the immune system function to halt the underlying processes that cause certain forms of inflammatory conditions, although their exact mechanisms of action are unknown; includes azathioprine, hydroxychloroquine, leflunomide, methotrexate, minocycline, organic gold compounds, penicillamine, and sulfasalazine.

Psoriasis (Ps): A chronic autoimmune skin disease that is characterized by circumscribed red patches covered with white scales.

Psoriatic arthritis (PsA): A form of arthritis that can affect any joint within the body, either in a single joint or in the same joint on both sides of the body.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member. 

When services may be Medically Necessary when criteria are met: 

HCPCS 
J3357Injection, ustekinumab, 1 mg [Stelara]
  
ICD-9 Diagnosis[For dates of service prior to 10/01/2014]
696.0Psoriatic arthropathy
696.1Other psoriasis
  
ICD-10 Diagnosis[For dates of service on or after 10/01/2014]
L40.0Psoriasis vulgaris
L40.1Generalized pustular psoriasis
L40.2Acrodermatitis continua
L40.3Pustulosis palmaris et plantaris
L40.4Guttate psoriasis
L40.50-L40.59Arthropathic psoriasis
L40.8Other psoriasis
L40.9 Psoriasis, unspecified

When services are Not Medically Necessary:
For situations described in the Position Statement section as not medically necessary. 

When services are Investigational and Not Medically Necessary:
When criteria are not met for the diagnoses indicated above or for all other diagnoses not listed; or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

References

Peer Reviewed Publications:

  1. Buttmann M. Treating multiple sclerosis with monoclonal antibodies: a 2010 update. Expert Rev Neurother. 2010; 10(5):791-809.
  2. Gelfand JM, Wan J, Callis Duffin K, et al. Comparative effectiveness of commonly used systemic treatments or phototherapy for moderate to severe plaque psoriasis in the clinical practice setting. Arch Dermatol. 2012; 148(4):487-494.
  3. Gottlieb A, Menter A, Mendelsohn A, et al. Ustekinumab, a human interleukin 12/23 monoclonal antibody, for psoriatic arthritis: randomised, double-blind, placebo-controlled, crossover trial. Lancet. 2009; 373(9664):633-640.
  4. 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):118-128.
  5. Lebwohl M, Leonardi C, Griffiths CE, et al. Long-term safety experience of ustekinumab in patients with moderate-to-severe psoriasis (Part I of II): Results from analyses of general safety parameters from pooled Phase 2 and 3 clinical trials. J Am Acad Dermatol. 2012; 66(5):731-741.
  6. Lebwohl M, Papp K, Han C, et al. Ustekinumab improves health-related quality of life in patients with moderate-to-severe psoriasis: results from the PHOENIX 1 trial. Br J Dermatol. 2010; 162(1):137-146.
  7. 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 randomised, double-blind, placebo-controlled trial (PHOENIX 1). Lancet. 2008; 371(9625):1665-1674.
  8. Mannon PJ, Fuss IJ, Mayer L, et al. Anti-interleukin-12 antibody for active Crohn's disease. N Engl J Med. 2004; 351(20):2069-2079.
  9. 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, multicentre, double-blind, placebo-controlled PSUMMIT 1 trial. Lancet. 2013; 382(9894):780-789.
  10. 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 randomised, double-blind, placebo-controlled trial (PHOENIX 2). Lancet. 2008; 371(9625):1675-1684.
  11. Reich K, Papp KA, Griffiths CE, et al. An update on the long-term safety experience of ustekinumab: results from the psoriasis clinical development program with up to four years of follow-up. J Drugs Dermatol. 2012; 11(3):300-312.
  12. Robinson D Jr, Zhao N, Gathany T, et al. Health perceptions and clinical characteristics of relapsing-remitting multiple sclerosis patients: baseline data from an international clinical trial. Curr Med Res Opin. 2009; 25(5):1121-1130.
  13. 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; 135(4):1130-1141.
  14. Sandborn WJ, Gasink C, Gao LL, et al. Ustekinumab induction and maintenance therapy in refractory Crohn's disease. N Engl J Med. 2012; 367(16):1519-1528.
  15. Segal BM, Constantinescu CS, Raychaudhuri A, et al. Repeated subcutaneous injections of IL12/23 p40 neutralising antibody, ustekinumab, in patients with relapsing-remitting multiple sclerosis: a phase II, double-blind, placebo-controlled, randomised, dose-ranging study. Lancet Neurol. 2008; 7(9):796-804.
  16. Uhlenhake EE, Feldman SR. Efficacy and safety of ustekinumab and etanercept for the treatment of psoriasis. Expert Opin Biol Ther. 2010; 10(7):1105-1112.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. American Academy of Dermatology (AAD). American Academy of Dermatology Association (AADA). Guidelines of care for management of psoriasis and psoriatic arthritis. May 2008. Available at: http://www.aad.org/education-and-quality-care/clinical-guidelines. Accessed on October 2, 2013.
  2. Centers for Disease Control (CDC) and Prevention. Updated guidelines for using interferon gamma release assays to detect Mycobacterium tuberculosis infection - United States, 2010; 59(No. RR 5):1-28. Available at: http://www.cdc.gov/mmwr/pdf/rr/rr5905.pdf. Accessed on October 2, 2013.
  3. Donahue KE, Jonas JD, Hansen RA, et al. Drug therapy for psoriatic arthritis in adults: update of a 2007 report. Comparative Effectiveness Review No. 54. Agency for Healthcare Research and Quality. AHRQ Publication No. 12-EHC024-EF. Updated June 1, 2012. Available at: http://www.ncbi.nlm.nih.gov/books/NBK95257/pdf/TOC.pdf. Accessed on October 2, 2013.
  4. Lee S, Coleman CI, Limone B, et al. Biologic and nonbiologic systemic agents and phototherapy for treatment of chronic plaque psoriasis. Comparative Effectiveness Review No. 85. Agency for Healthcare Research and Quality. AHRQ Publication No.12(13)-EHC144-EF. November 27, 2012. Available at: http://www.effectivehealthcare.ahrq.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productid=1326. Accessed on October 2, 2013.
  5. 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; 58(5):826-850.
  6. 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; 61(3):451-485.
  7. Singh JA, Wells GA, Christensen R, et al. Adverse effects of biologics: a network meta-analysis and Cochrane overview. Cochrane Database Syst Rev. 2011; (2):CD008794.
  8. Stelara [Product Information], Horsham, PA. Janssen Biotech, Inc.; September 2013. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125261s103lbl.pdf. Accessed on October 2, 2013.
  9. Ustekinumab. In: DrugPoints® System (electronic). Truven Health Analytics, Greenwood Village, CO. Updated September 24, 2013. Available at: http://www.micromedexsolutions.com. Accessed on October 2, 2013.
Web Sites for Additional Information
  1. National Psoriasis Foundation (NPF). Available at: http://www.psoriasis.org/NetCommunity/Page.aspx?pid=322. Accessed on October 2, 2013.
  2. U.S. National Library of Medicine. Health Topics. Available at: http://www.nlm.nih.gov/medlineplus/healthtopics.html. Accessed on October 2, 2013.
Index

QuantiFERON-TB Gold Test (GFT-G)
QuantiFERON-TB Gold In-Tube Test (QFT-GIT)
T-SPOT.TB test (T-Spot)

The use of specific product names is illustrative only.  It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. 

Document History

Status

Date

Action

Revised11/14/2013Medical Policy & Technology Assessment Committee (MPTAC) review. Revised medically necessary statement, adding criteria for new FDA approved indication for adult active psoriatic arthritis. Format change to plaque psoriasis statement without a change to criteria. Revised and clarified investigational and not medically necessary statement. Updated Rationale, Background, Definitions, Coding, References, and Web Sites for Additional Information sections.
Reviewed02/14/2013MPTAC review. Updated Rationale, Background, Definitions, References, and Index.
Revised02/16/2012MPTAC review. Clarified not medically necessary criteria. Updated Rationale, Coding, References and Web Sites for Additional Information.
Revised02/17/2011MPTAC review. Revised not medically necessary Position Statement, deleting: Genetically deficient in IL-12/IL-23. Revised Medical Management Information with updated FDA label warnings and precautions. Added Definition for interferon gamma (IFN- γ) release assay (IGRA). Updated Rationale, Discussion, References and Index.
 01/01/2011Updated Coding section with 01/01/2011 HCPCS changes; removed C9261 deleted 12/31/2010.
New02/25/2010MPTAC review. Initial document development.