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.

Eligible,^† commercially insured patients may pay as little as

per dosewith the CIMplicity Savings Program

Enroll patients and manage their copay claims on the copay portal

Contact your Field Reimbursement Executive (FRE) or download the copay brochure for more information.

†Eligibility: For eligible, commercially insured patients only. Eligible patients with approved insurance coverage will receive CIMZIA for as little as $0 per dose. View complete eligibility requirements and terms at cimzia.com/cimplicity-program.

Supporting your patients every step of the way

Comprehensive Reimbursement 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

Help your patients save with the CIMplicity Savings Program

Reimbursement for CIMZIA

With the CIMplicity Savings Program, eligible patients with commercial insurance can save on out-of-pocket expenses for CIMZIA Lyophilized Powder.*

Now offering reimbursement for administrative costs

With the CIMplicity Administration Savings program, eligible patients can be reimbursed for certain out-of-pocket expenses related to the in-office administration of CIMZIA Lyophilized Powder (subject to annual cap).**

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

For more information on the CIMplicity Savings and Administration Savings Program

Program website:

• CIMZIASavingsProgram.com

• Fax: 908-809-6248

CIMplicity Savings support phone line

• For questions, please call 1-877-705-4119 toll-free

• Mon. — Fri. from 8:00 AM — 8:00 PM ET

*CIMplicity^® Savings Program

CIMplicity^® Savings (the “Program”) provides CIMZIA^® (certolizumab pegol) Prefilled Syringe or Lyophilized Powder to eligible patients for as little as $0 per dose. Eligible patients must have commercial insurance coverage and a valid prescription for CIMZIA Prefilled Syringe or Lyophilized Powder consistent with FDA-approved product labeling. The Program is not valid (1) for prescriptions that are reimbursed, in whole or in part, under Medicare (including Medicare Part D), Medicaid, or any other federal- or state-funded healthcare programs (including but not limited to any state prescription drug assistance programs and the Government Health Insurance Plan available in Puerto Rico), (2) where a patient’s commercial insurance plan reimburses for the entire cost of the drug, (3) for uninsured or cash-paying patients, (4) where the product is not covered by patient’s insurance, or (5) where otherwise prohibited by law. Product shall be dispensed pursuant to Program rules and federal and state laws. The value of the Program is exclusively for the benefit of patients and is intended to be credited in full toward patient out-of-pocket obligations and maximums, including applicable co-payments, coinsurance and deductibles. Patient may not seek reimbursement for the value received from this Program from other parties, including any health insurance program or plan, government healthcare program, flexible spending account, or healthcare savings account. Patient is responsible for complying with any applicable limitations and requirements of their health plan related to the use of the Program. Valid only in the U.S. and Puerto Rico. This Program is not health insurance. Proof of purchase may be required. This Program is not transferable and cannot be combined with any other savings, free trial, or similar offer. UCB, Inc. reserves the right to amend or end this Program at any time without notice. Subject to the prior sentence, this Program expires at 11:59 P.M. on December 31. Patients that meet the above requirements may re-enroll in the Program each year.

**CIMplicity^® Administration Savings Program

The CIMplicity^® Administration Savings Program (the “Program”) provides eligible patients with reimbursement for in-office administration-related costs (subject to an annual cap) for CIMZIA^® (certolizumab pegol) Lyophilized Powder, subject to submission of an Evidence of Benefit form to CIMplicity. Eligible patients must have commercial insurance coverage and a valid prescription for CIMZIA Lyophilized Powder consistent with FDA-approved product labeling. The total patient out-of-pocket cost under the Program is dependent on the patient’s health insurance plan. The Program assists with costs related to the administration of CIMZIA Lyophilized Powder only. The Program does not assist with the cost of other administrations, medications, procedures, or office visit fees. After reaching the maximum Program’s benefit amounts, the patient will be responsible for all remaining out-of-pocket expenses. The Program’s benefit amounts cannot exceed the patient's out-of-pocket expenses for administration of CIMZIA Lyophilized Powder. The Program is not valid (1) for prescriptions that are reimbursed, in whole or in part, under Medicare (including Medicare Part D), Medicaid, or any other federal- or state-funded healthcare programs (including but not limited to any state prescription drug assistance programs and the Government Health Insurance Plan available in Puerto Rico), (2) where a patient’s commercial insurance plan reimburses for the entire cost of the drug, (3) for uninsured or cash-paying patients, (4) where the product is not covered by patient’s insurance, or (5) where otherwise prohibited by law. Product shall be dispensed pursuant to Program rules and federal and state laws. The value of the Program is exclusively for the benefit of patients and is intended to be credited in full toward patient out-of-pocket obligations and maximums, including applicable co-payments, coinsurance and deductibles. Patient may not seek reimbursement for the value received from this Program from other parties, including any health insurance program or plan, government healthcare program, flexible spending account, or healthcare savings account. Patient is responsible for complying with any applicable limitations and requirements of their health plan related to the use of the Program. Valid only in the U.S. and Puerto Rico. This Program is not health insurance. This Program is not transferable and cannot be combined with any other savings, free trial, or similar offer. UCB, Inc. reserves the right to amend or end this Program at any time without notice. Subject to the prior sentence, this Program expires at 11:59 P.M. on December 31. Patients that meet the above requirements may re-enroll in the Program each year.

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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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 adults 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 (CONT'D)

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 refer to 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*