STELARA (USTEKINUMAB) - Oxford Health Plans

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Special Considerations (continued) COVERAGE RATIONALE Stelara (Ustekinumab): Clinical Policy (Effective 02/15/2013) 3 Precertification is not required when provided in an office or outpatient setting. Ustekinumab is considered medically necessary for the treatment of plaque psoriasis when all of the following criteria are met: Initial Therapy Member has a diagnosis of moderate to severe plaque psoriasis; and Member is not receiving ustekinumab (Stelara) in combination with another infused or self-injected biologic agent (e.g., tocilizumab (Actemra), belimumab (Benlysta), etanercept (Enbrel), adalimumab (Humira), certolizumab (Cimzia), golimumab (Simponi), alefacept (Amevive), rituximab (Rituxan), infliximab (Remicade), or abatacept (Orencia) Initial Approval: 12 months Reauthorization Documentation that Member continues to receive clinical benefit from ongoing treatment with Stelara Reauthorization Approval: 12 months Additional information from the manufacturer’s labeling: 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 Ustekinumab is NOT medically necessary for the treatment of 1. Psoriatic arthritis 2. Crohn’s disease 3. Multiple sclerosis The findings of available studies are limited by short duration and/or relatively small patient population. Larger and longer term phase III studies are needed to further characterize ustekinumab efficacy and safety for treatment of psoriatic arthritis and Crohn’s disease. In available studies, ustekinumab does not demonstrate efficacy in the treatment of multiple sclerosis. BENEFIT CONSIDERATIONS Not all Oxford Members have a pharmacy benefit. For coverage of outpatient prescription drugs and specific exclusions, exceptions, and dispensing limitations, refer to the Member's pharmacy plan, if applicable. Oxford's Pharmacy Benefit Manager (PBM) provides a nationwide network of participating pharmacies that administer prescription drugs on a retail level. Groups that purchase the Outpatient Prescription Drug Rider will have their retail pharmacy benefit administered by the PBM. For information regarding any quantity level limitations, refer to Prescription Drug Quantity Duration (QD) and Quantity Level Limitations (QLL) For information on coverage for Orencia intravenous infusion, refer to: Orencia (abatacept). ©1996-2013, Oxford Health Plans, LLC 2
For Information regarding coverage for Enbrel, Humira, Kineret, Cimzia, Simponi, and Orencia (subcutaneous formulation), refer to: Biologics in the Treatment of Skin, Joint and Gastrointestinal Conditions. Some states mandate benefit coverage for off-label use of medications for some diagnoses or under some circumstances. Some states also mandate usage of other Compendium references. Where such mandates apply, they supersede language in the benefit document or in the notification criteria. BACKGROUND Ustekinumab is a human IgG1κ monoclonal antibody that binds with high affinity and specificity to the p40 protein subunit used by both the interleukin (IL)-12 and IL-23 naturally occurring cytokines. IL-12 and IL-23 are involved in inflammatory and immune responses, such as natural killer cell activation and CD4+ T-cell differentiation and activation. 1 CLINICAL EVIDENCE Medically Necessary Use: Plaque Psoriasis Two multicenter, randomized, double-blind, placebo-controlled studies (PHOENIX-1 and PHOENIX-2) were considered in the approval of ustekinumab for the treatment of plaque psoriasis. 1 Enrollment consisted of a total of 1996 subjects 18 years of age and older with plaque psoriasis who had a minimum body surface area involvement of 10%, and Psoriasis Area and Severity Index (PASI) score ≥12, and who were candidates for phototherapy or systemic therapy. Subjects with guttate, erythrodermic, or pustular psoriasis were excluded from the studies. Leonardi et al. conducted a phase III, parallel, double-blind, placebo-controlled study (PHOENIX- 1) in 766 patients with moderate-to-severe psoriasis. 8 Subjects were randomly assigned to receive ustekinumab 45 mg (n=255) or 90 mg (n=256) at weeks 0 and 4 and then every 12 weeks; or placebo (n=255) at weeks 0 and 4, with subsequent crossover to ustekinumab at week 12. Patients who were initially randomized to receive ustekinumab at week 0 and achieved longterm response (at least 75% improvement in psoriasis area and severity index [PASI 75] at weeks 28 and 40) were randomized a second time at week 40 to maintenance ustekinumab or withdrawal from treatment until loss of response. The primary endpoint was the proportion of patients achieving PASI 75 at week 12. Analyses were by intent to treat and resulted in the following: 171 (67·1%) patients receiving ustekinumab 45 mg, 170 (66·4%) receiving ustekinumab 90 mg, and eight (3·1%) receiving placebo achieved PASI 75 at week 12 (difference in response rate vs placebo 63·9%, 95% CI 57·8–70·1, p
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STELARA (USTEKINUMAB) - Oxford Health Plans

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