BIMZELX Navigate® Bridge

BIMZELX Navigate Bridge: BIMZELX Navigate Bridge (the “Program”) provides BIMZELX^® (bimekizumab-bkzx) to eligible patients for $15 per dose for up to two (2) years or until the patient’s commercial insurance plan approves coverage for the drug, whichever comes first. Eligible patients must be 18 years of age or older with commercial insurance and a valid prescription consistent with FDA-approved product labeling. For initial enrollment into the Program, the patient must be experiencing a delay in, or have been denied, coverage for BIMZELX by their commercial insurance plan.   

To maintain eligibility in the Program, the following are required: (1) a prior authorization request has been submitted and/or coverage remains unavailable for the patient; and (2) if the prior authorization is denied by the payer, the prescriber must submit an appeal within the first sixty (60) days of the prior authorization denial and a prior authorization (or documentation as may otherwise be required by the payer) must be submitted every six (6) months thereafter. Program is not available (1) to patients whose prescriptions are reimbursed, in whole or in part, under Medicare (including Medicare Part D), Medicaid, or any other federal- or state-funded healthcare programs (including any state prescription drug assistance programs and the Government Health Insurance Plan available in Puerto Rico), (2) where a patient’s insurance covers the drug, (3) to uninsured or cash-paying patients, or (4) where otherwise prohibited by law. Product shall be dispensed pursuant to Program rules and federal and state laws. Patients may be asked to re-verify insurance coverage status during participation in the Program.   

No purchase necessary. Program is not health insurance, nor is participation a guarantee of insurance coverage. Limitations may apply. This Program cannot be combined with any other savings, free trial, or similar offer for the specified prescription. The patient, or healthcare provider on the patient’s behalf, must not submit any claim for reimbursement for product provided under this Program to any third-party payer. UCB, Inc. reserves the right to end or amend this Program without notice.  

View complete eligibility requirements and terms at www.bimzelx.com/patient-support/navigate-benefits.

INDICATIONS

BIMZELX is indicated for the treatment of adult patients with active psoriatic arthritis, active non-radiographic axial spondyloarthritis with objective signs of inflammation, active ankylosing spondylitis, and moderate-to-severe plaque psoriasis patients who are candidates for systemic therapy or phototherapy.

IMPORTANT SAFETY INFORMATION

Suicidal Ideation and Behavior

BIMZELX may increase the risk of suicidal ideation and behavior (SI/B). A causal association between treatment with BIMZELX and increased risk of SI/B has not been established. Prescribers should weigh the potential risks and benefits before using BIMZELX in patients with a history of severe depression or SI/B. Advise monitoring for the emergence or worsening of depression, suicidal ideation, or other mood changes. If such changes occur, advise to promptly seek medical attention, refer to a mental health professional as appropriate, and re-evaluate the risks and benefits of continuing treatment.

Infections

BIMZELX may increase the risk of infections. Do not initiate treatment with BIMZELX in patients with any clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing BIMZELX. Instruct patients to seek medical advice if signs or symptoms suggestive of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, monitor the patient closely and do not administer BIMZELX until the infection resolves.

Tuberculosis

Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with BIMZELX. Avoid the use of BIMZELX in patients with active TB infection. Initiate treatment of latent TB prior to administering BIMZELX. Consider anti-TB therapy prior to initiation of BIMZELX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Closely monitor patients for signs and symptoms of active TB during and after treatment.

Liver Biochemical Abnormalities

Elevated serum transaminases were reported in clinical trials with BIMZELX. Test liver enzymes, alkaline phosphatase, and bilirubin at baseline, periodically during treatment with BIMZELX, and according to routine patient management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt BIMZELX until a diagnosis of liver injury is excluded. Permanently discontinue use of BIMZELX in patients with causally associated combined elevations of transaminases and bilirubin. Avoid use of BIMZELX in patients with acute liver disease or cirrhosis.

Inflammatory Bowel Disease

Cases of inflammatory bowel disease (IBD) have been reported in patients treated with IL-17 inhibitors, including BIMZELX. Avoid use of BIMZELX in patients with active IBD. During BIMZELX treatment, monitor patients for signs and symptoms of IBD and discontinue treatment if new onset or worsening of signs and symptoms occurs.

Immunizations

Prior to initiating therapy with BIMZELX, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid the use of live vaccines in patients treated with BIMZELX.

MOST COMMON ADVERSE REACTIONS

Most common (≥1%) adverse reactions in plaque psoriasis include upper respiratory tract infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, Herpes Simplex infections, acne, folliculitis, other candida infections, and fatigue.

Most common (≥2%) adverse reactions in psoriatic arthritis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, and urinary tract infections.

Most common (≥2%) adverse reactions in non-radiographic axial spondyloarthritis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, cough, fatigue, musculoskeletal pain, myalgia, tonsillitis, transaminase increase, and urinary tract infections.

Most common (≥2%) adverse reactions in ankylosing spondylitis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, injection site pain, rash, and vulvovaginal mycotic infections.

Please see the full Prescribing Information.

Most common (≥2%) adverse reactions in PsA, nr-axSpA, and AS include upper respiratory tract infections, oral candidiasis, headache, diarrhea, and urinary tract infections. Other most common (≥2%) adverse reactions specific to each indication include: urinary tract infections (PsA); cough, fatigue, musculoskeletal pain, myalgia, tonsillitis, transaminase increase, and urinary tract infections (nr-axSpA); injection site pain, rash, and vulvovaginal mycotic infections (AS).