STELARA (USTEKINUMAB) - Oxford Health Plans
STELARA (USTEKINUMAB) - Oxford Health Plans
STELARA (USTEKINUMAB) - Oxford Health Plans
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Special Considerations<br />
(continued)<br />
COVERAGE RATIONALE<br />
Stelara (Ustekinumab): Clinical Policy (Effective 02/15/2013)<br />
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Precertification is not required when provided in an office or<br />
outpatient setting.<br />
Ustekinumab is considered medically necessary for the treatment of plaque psoriasis when all<br />
of the following criteria are met:<br />
Initial Therapy<br />
Member has a diagnosis of moderate to severe plaque psoriasis; and<br />
Member is not receiving ustekinumab (Stelara) in combination with another infused or<br />
self-injected biologic agent (e.g., tocilizumab (Actemra), belimumab (Benlysta),<br />
etanercept (Enbrel), adalimumab (Humira), certolizumab (Cimzia), golimumab (Simponi),<br />
alefacept (Amevive), rituximab (Rituxan), infliximab (Remicade), or abatacept (Orencia)<br />
Initial Approval: 12 months<br />
Reauthorization<br />
Documentation that Member continues to receive clinical benefit from ongoing treatment with<br />
Stelara<br />
Reauthorization Approval: 12 months<br />
Additional information from the manufacturer’s labeling:<br />
Stelara (ustekinumab) is indicated for the treatment of adult patients (18 years or older) with<br />
moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. 1<br />
Ustekinumab is NOT medically necessary for the treatment of<br />
1. Psoriatic arthritis<br />
2. Crohn’s disease<br />
3. Multiple sclerosis<br />
The findings of available studies are limited by short duration and/or relatively small patient<br />
population. Larger and longer term phase III studies are needed to further characterize<br />
ustekinumab efficacy and safety for treatment of psoriatic arthritis and Crohn’s disease.<br />
In available studies, ustekinumab does not demonstrate efficacy in the treatment of multiple<br />
sclerosis.<br />
BENEFIT CONSIDERATIONS<br />
Not all <strong>Oxford</strong> Members have a pharmacy benefit.<br />
For coverage of outpatient prescription drugs and specific exclusions, exceptions, and<br />
dispensing limitations, refer to the Member's pharmacy plan, if applicable.<br />
<strong>Oxford</strong>'s Pharmacy Benefit Manager (PBM) provides a nationwide network of<br />
participating pharmacies that administer prescription drugs on a retail level. Groups that<br />
purchase the Outpatient Prescription Drug Rider will have their retail pharmacy benefit<br />
administered by the PBM.<br />
For information regarding any quantity level limitations, refer to Prescription Drug<br />
Quantity Duration (QD) and Quantity Level Limitations (QLL)<br />
For information on coverage for Orencia intravenous infusion, refer to: Orencia<br />
(abatacept).<br />
©1996-2013, <strong>Oxford</strong> <strong>Health</strong> <strong>Plans</strong>, LLC<br />
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