Access & Patient Support| CIMZIA® (certolizumab pegol) In-Office Injection

The majority of patients have preferred access through medical benefit for CIMZIA In-Office Injection^1*

>91% Commercial patients have first- and second-line access

>96% Medicare Part B patients have first- and second-line access

*MMIT (Managed Markets Insights & Technology) Analytics Platform, data as of August 2023, accessed August 1, 2023. First- and second-line coverage 91% commercial and 96% Medicare Part B.

Your eligible^† patients pay

out-of-pocketfor their CIMZIA prescription with the CIMplicity Savings Program

Enroll patients and manage their copay claims on the copay portal

Contact your Field Reimbursement Manager (FRM) or download the copay brochure for more information.

†Eligibility: Available to individuals with commercial prescription insurance coverage for a valid prescription of an FDA-approved indication for CIMZIA. Not valid for prescriptions that are reimbursed, in whole or in part, under Medicare (including Medicare Part D), Medicaid, similar federal- or state-funded programs (including any state prescription drug assistance programs and the Government Health Insurance Plan available in Puerto Rico), or where otherwise prohibited by law. Product dispensed pursuant to program rules and federal and state laws. Claims should not be submitted to any public payor (ie, Medicare, Medicaid, Medigap, TRICARE, VA, and DoD) for reimbursement. The parties reserve the right to amend or end this program at any time without notice.

Supporting your patients every step of the way

Comprehensive Insurance Support

Enrollment in CIMplicity^‡ offers the insurance support needed to start patients on treatment as soon as possible

Same-day verification of patient benefits

Prior authorization support

Copay assistance

Experienced case managers

Nurse Support

Starting patients with CIMplicity automatically enrolls them in the CIMplicity Nurse Support program,^§ which offers assistance with:

Nutrition and wellness training

Stress management and/or smoking cessation

Goal overview and patient satisfaction check-ups

Appointment reminders

Information on the disease state and CIMZIA

^‡The CIMplicity program is provided as a service of UCB, Inc. and is intended to support the appropriate use of CIMZIA. The CIMplicity program may be amended or canceled at any time without notice. Eligibility and restrictions apply.

^§The program does not replace the care and medical advice of your patient's healthcare provider. CIMplicity Nurses do not give medical advice and will direct your patients to share their treatment-related questions with their healthcare provider.

Enroll your patients in CIMplicity

First, contact your Field Reimbursement Executive to set up your CIMplicity account. Then you can enroll your patients in CIMplicity by following the steps at CIMplicityCares.com or fax a completed Patient Enrollment form to 1-866-949-2469.

Enroll your patients

Contact a CIMZIA representative to learn more about access and savings for your patients

A CIMZIA representative can answer specific questions about local access and patient support with CIMplicity.

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IMPORTANT SAFETY INFORMATION

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). Patients should be closely monitored for the signs and symptoms of infection during and after treatment with CIMZIA. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which CIMZIA is a member. CIMZIA is not indicated for use in pediatric patients.

INDICATIONS

CIMZIA is indicated for:

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
Treatment of adults with moderately to severely active rheumatoid arthritis (RA)
Treatment of adult patients with active psoriatic arthritis (PsA)
Treatment of adult patients with active ankylosing spondylitis (AS)
Treatment of adults with moderate-to-severe plaque psoriasis (PSO) who are candidates for systemic therapy or phototherapy
Treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation

IMPORTANT SAFETY INFORMATION (CONTINUED)

CONTRAINDICATIONS

CIMZIA is contraindicated in patients with a history of hypersensitivity reaction to certolizumab pegol or to any of the excipients. Reactions have included angioedema, anaphylaxis, serum sickness, and urticaria.

SERIOUS INFECTIONS

Patients treated with CIMZIA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Discontinue CIMZIA if a patient develops a serious infection or sepsis.

Reported infections include:

Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before CIMZIA use and during therapy. Initiate treatment for latent TB prior to CIMZIA use.
Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.
Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

Carefully consider the risks and benefits of treatment with CIMZIA prior to initiating therapy in the following patients: with chronic or recurrent infection; who have been exposed to TB; with a history of opportunistic infection; who resided in or traveled in regions where mycoses are endemic; with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with CIMZIA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

Do not start CIMZIA during an active infection, including localized infections.
Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection.
If an infection develops, monitor carefully and initiate appropriate therapy.

MALIGNANCY

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which CIMZIA is a member. CIMZIA is not indicated for use in pediatric patients.

Consider the risks and benefits of CIMZIA treatment prior to initiating or continuing therapy in a patient with known malignancy.
In clinical trials, more cases of malignancies were observed among CIMZIA-treated patients compared to control patients.
In CIMZIA clinical trials, there was an approximately 2-fold higher rate of lymphoma than expected in the general U.S. population. Patients with rheumatoid arthritis, particularly those with highly active disease, are at a higher risk of lymphoma than the general population.
Malignancies, some fatal, have been reported among children, adolescents, and young adults being treated with TNF blockers. Approximately half of the cases were lymphoma, while the rest were other types of malignancies, including rare types associated with immunosuppression and malignancies not usually seen in this patient population.
Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including CIMZIA. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis, and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. Carefully assess the risks and benefits of treating with CIMZIA in these patient types.
Cases of acute and chronic leukemia were reported with TNF blocker use.

HEART FAILURE

Worsening and new onset congestive heart failure (CHF) have been reported with TNF blockers. Exercise caution and monitor carefully.

HYPERSENSITIVITY

Angioedema, anaphylaxis, dyspnea, hypotension, rash, serum sickness, and urticaria have been reported following CIMZIA administration. If a serious allergic reaction occurs, stop CIMZIA and institute appropriate therapy. The needle shield inside the removable cap of the CIMZIA prefilled syringe contains a derivative of natural rubber latex which may cause an allergic reaction in individuals sensitive to latex.

HEPATITIS B VIRUS REACTIVATION

Use of TNF blockers, including CIMZIA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal.
Test patients for HBV infection before initiating treatment with CIMZIA.
Exercise caution in patients who are carriers of HBV and monitor them before and during CIMZIA treatment.
Discontinue CIMZIA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming CIMZIA after HBV treatment.

NEUROLOGIC REACTIONS

TNF blockers, including CIMZIA, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, seizure disorder, optic neuritis, peripheral neuropathy, and Guillain-Barré syndrome.

HEMATOLOGIC REACTIONS

Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with CIMZIA.
Consider stopping CIMZIA if significant hematologic abnormalities occur.

DRUG INTERACTIONS

Do not use CIMZIA in combination with other biological DMARDS.

AUTOIMMUNITY

Treatment with CIMZIA may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.

IMMUNIZATIONS

Patients on CIMZIA should not receive live or live-attenuated vaccines.

ADVERSE REACTIONS

The most common adverse reactions in CIMZIA clinical trials (≥8%) were upper respiratory infections (18%), rash (9%), and urinary tract infections (8%).

Please see full Prescribing Information.

CIMZIA In-Office Injection is the only BRANDED in-office injection available through medical benefits

The majority of patients have preferred access through medical benefit for CIMZIA In-Office Injection^1*