STELARA (USTEKINUMAB) - Oxford Health Plans

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associated with CD in the colon and ileum as reflected by higher CRP concentrations. The investigators stated that potential benefit of ustekinumab in CD is supported by serum CRP reductions. Evidence suggests that increased systemic inflammation as manifested by higher baseline CRP values leads to larger treatment effects with ustekinumab, especially in infliximabexperienced patients. Despite these conclusions, further study is needed to confirm whether change in serum CRP correlates with long-term clinical efficacy in the treatment of Crohn’s disease. Multiple Sclerosis Kasper et al. conducted a phase I, double-blind, placebo-controlled, sequential dose escalation study in 20 subjects with multiple sclerosis (MS). 9 Subjects were randomized (4:1) to receive a single subcutaneous injection of either ustekinumab (0.3, 0.75, 1.5, and 3 mg/kg) or placebo. Clinical and laboratory evaluations were performed through 16 weeks following administration. Single subcutaneous administrations of ustekinumab in this first study of relapsing MS were generally well tolerated. Adverse events were generally mild or moderate, with no apparent doserelated trends. There was a large degree of variability in T2 lesion volume and total number of gadolinium-positive lesions, both unaffected by dose escalation. Three relapses of MS occurred in two placebo-treated subjects. Over the range of single doses studied, the median Tmax ranged from 9.0 to 16.5 days, and the median T1/2 ranged from 20.2 to 30.9 days. The authors concluded that safety of ustekinumab in MS needs to be tested in a study of longer duration and involving a larger cohort of subjects. In a phase II, multicenter, randomized, double-blind, placebo-controlled trial, Segal et al. studied repeated injections of ustekinumab in patients (n=249) with relapsing-remitting multiple sclerosis (RRMS). 10 Subjects aged 18-65 years were assigned to one of five groups: placebo (n=49) or four different ustekinumab dosages (n=50 for all) at weeks 0, 1, 2, 3, 7, 11, 15, and 19. Ustekinumab doses were 27 mg, 90 mg q8w, 90 mg, or 180 mg; the 90 mg q8w dosage group received placebo substitute at weeks 7 and 15. The primary endpoint was the cumulative number of new gadolinium-enhancing T1-weighted lesions on serial cranial MRI through week 23. Patients were followed up through week 37. In the intent to treat analysis, ustekinumab treatment did not show a significant reduction in the primary endpoint for any dosage groups versus placebo. At week 37, adverse events occurred in 38 (78%) placebo-treated patients and 170 (85%) ustekinumab-treated patients, with infections most commonly reported. Serious adverse events occurred in one (2%) placebo-treated patient and six (3%) ustekinumab-treated patients. Malignant diseases were reported in two patients shortly after the initiation of ustekinumab treatment; both patients were withdrawn from the trial and given appropriate treatment, which resulted in complete remission. No serious infections, cardiovascular events, or exacerbation of demyelinating events occurred. A dose-dependent increase in serum concentrations of ustekinumab was recorded. The investigators concluded that ustekinumab is generally well tolerated but does not show efficacy in reducing the cumulative number of gadolinium-enhancing T1-weighted lesions in multiple sclerosis. Professional Societies The American Academy of Dermatology guidelines of care for the management of psoriasis and psoriatic arthritis (PsA) state that patients with limited skin disease should not automatically be treated with systemic treatment if they do not improve, because treatment with systemic therapy may carry more risk than the disease itself. 11 The strength of AAD recommendations for the treatment of moderate to severe plaque psoriasis using ustekinumab is A (highest recommendation; level I evidence). Compared with the TNF-alfa inhibitors, the most comprehensive ustekinumab safety data to date come from a pooled analysis of phase II and phase III clinical trials involving slightly more than 3,000 patients with just over 3 years of continuous therapy. Therefore, the use of registries to monitor the long-term safety of ustekinumab and other new agents currently under development, and to monitor the long-term safety of all of the systemic agents available, is an essential step in defining the long-term adverse effects of ustekinumab and other new agents. 12 Stelara (Ustekinumab): Clinical Policy (Effective 02/15/2013) ©1996-2013, Oxford Health Plans, LLC 6
When considering the use of ustekinumab for PsA, the AAD states that until the results of ongoing phase III trials of ustekinumab for PsA become available, the TNF-alfa inhibitors should be considered the biologic class of choice for these patients. 12 U.S. FOOD AND DRUG ADMINISTRATION (FDA) Stelara (ustekinumab) is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. 1 APPLICABLE CODES The codes listed in this policy are for reference purposes only. Listing of a service or device code in this policy does not imply that the service described by this code is a covered or non-covered health service. Coverage is determined by the Member’s plan of benefits or Certificate of Coverage. This list of codes may not be all inclusive. HCPCS Code Description J3357 Injection, ustekinumab, 1 mg ICD-9 Code Description 696.1 Other psoriasis ICD-10 Codes (Preview Draft) In preparation for the transition from ICD-9 to ICD-10 medical coding on October 1, 2014 * , a sample listing of the ICD-10 CM and/or ICD-10 PCS codes associated with this policy has been provided below for your reference. This list of codes may not be all inclusive and will be updated to reflect any applicable revisions to the ICD-10 code set and/or clinical guidelines outlined in this policy. *The effective date for ICD-10 code set implementation is subject to change. ICD-10 Diagnosis Code (Effective 10/01/14) Description L40.0 Psoriasis vulgaris L40.1 Generalized pustular psoriasis L40.2 Acrodermatitis continua L40.3 Pustulosis palmaris et plantaris L40.4 Guttate psoriasis L40.8 Other psoriasis L40.9 Psoriasis, unspecified REFERENCES The foregoing Oxford policy has been adapted from an existing UnitedHealthcare Pharmacy Clinical Pharmacy Program that was researched, developed and approved by the UnitedHealth Group National Pharmacy & Therapeutics Committee 1. Stelara [package insert]. Horsham, PA: Janssen Biotech, Inc; August 2011. 2. Kavanaugh A, Menter A, Mendelsohn A, et al. Effect of ustekinumab on physical function and health-related quality of life in patients with psoriatic arthritis: a randomized, placebocontrolled, phase II trial. Curr Med Res Opin. 2010 Oct;26(10):2385-92. 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 Feb 21;373(9664):633-40. Epub 2009 Feb 11. 4. 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. Epub 2008 Jul 17. Stelara (Ustekinumab): Clinical Policy (Effective 02/15/2013) ©1996-2013, Oxford Health Plans, LLC 7
Page 1 and 2: Policy Number: PHARMACY 218.2 T2 Ef
Page 3 and 4: For Information regarding coverage
Page 5: function and HRQoL in patients with

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