Initiate treatment for latent TB prior to CIMZIA use. Test patients for latent TB before CIMZIA use and during therapy. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Active tuberculosis (TB), including reactivation of latent TB.Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.ĭiscontinue CIMZIA if a patient develops a serious infection or sepsis. Patients treated with CIMZIA are at increased risk for developing serious infections that may lead to hospitalization or death. Reactions have included angioedema, anaphylaxis, serum sickness, and urticaria. Treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammationĬIMZIA is contraindicated in patients with a history of hypersensitivity reaction to certolizumab pegol or to any of the excipients.Treatment of adults with moderate-to-severe plaque psoriasis (PSO) who are candidates for systemic therapy or phototherapy. ![]() Treatment of adult patients with active ankylosing spondylitis (AS).Treatment of adult patients with active psoriatic arthritis (PsA).Treatment of adults with moderately to severely active rheumatoid arthritis (RA).Reducing signs and symptoms of Crohn’s disease (CD) and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.CIMZIA is not indicated for use in pediatric patients. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which CIMZIA is a member. Patients should be closely monitored for the signs and symptoms of infection during and after treatment with CIMZIA. Please check back, as we will continue to update these resources regularly.Serious and sometimes fatal side effects have been reported with CIMZIA, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens (such as Legionella or Listeria). (Data file exchanges are referenced in the CMS, change to COB&R guidance.)Ĭlick the selection that best matches your area of interest. ![]() This document is required for PAs wishing to enter into data file exchanges with CMS to determine which of their beneficiaries are enrolled in Part D plans, in order to ensure separateness of Part D benefits and PAP assistance. The Outside the Benefit Q&A document provides further details and examples relating to CMS' policy on PAPs operating outside the Part D Benefit. This overview page provides important information on CMS policy with respect to PAPs, and also provides some helpful links to other information contained on the Office of the Inspector General's Web site.įor PAPs operating outside of Part D, please review:ĬMS's Coordination of Benefits & Recovery (COB&R) guidance, linked below, provides a useful overview of CMS' policy with respect to PAPs and their interaction with Part D plans. The calculation of TrOOP is important for determining whether an individual has reached the threshold for catastrophic coverage under the Part D benefit. The PAP's assistance on behalf of the PAP enrollee does not count towards a Part D beneficiary's true-out-of-pocket cost (TrOOP). PAPs can provide assistance to Part D enrollees and interface with Part D plans by operating "outside the Part D benefit" to ensure separateness of Part D benefits and PAP assistance. Pharmaceutical manufacturers may sponsor patient assistance programs (PAPs) that provide financial assistance or drug free product (through in-kind product donations) to low income individuals to augment any existing prescription drug coverage.
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