MERZ CONNECT Offers Support Programs to Help You Start and Stay on XEOMIN

Patients Savings Program

Eligible patients save up to $5,000 annually and pay as little as $0 out of pocket*†

Eligible patients with commercial insurance may pay as little as $0 out of pocket for XEOMIN.

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Eligibility Criteria

If Using Specialty Pharmacy

Terms and Conditions and Program Limitations

Patients Assistance Program

Eligible patients may receive XEOMIN at no cost.‡

For eligible uninsured or underinsured patients, Merz may be able to help you get your prescription of XEOMIN at no charge.

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Patient Assistance Program Details

Eligibility Criteria

To be eligible for the XEOMIN Patient Savings program, you must:

  • Be a clinically appropriate patient for therapeutic treatment with XEOMIN, as determined by your doctor
  • Be prescribed by XEOMIN
  • Be at least 2 years of age and less than 65 years of age
  • Have commercial insurance that covers XEOMIN medication costs
  • Not be enrolled in a state-funded or federally funded prescription insurance program*
  • For residents of Massachusetts and Rhode Island, further restrictions apply*
  • Submit claims within 120 days of date of service

The following costs are not eligible and will not be reimbursed:

  • Office visit co-pays not directly associated with XEOMIN treatment
  • Facility co-pays not directly associated with XEOMIN treatment
  • Any other costs excluded by the MERZ CONNECT guidelines not specifically mentioned above, which are subject to change
  • In accordance with state law, the XEOMIN Patient Savings Program does not reimburse injection-related charges for patients residing in Massachusetts and Rhode Island

When using specialty pharmacy, click here.

*Subject to eligibility requirements. Commercial insurance required. Reimbursement limited to out-of-pocket XEOMIN medication costs and related administration fees.

Please see Full Terms and Conditions. Merz reserves the right to change XEOMIN Patient Savings Program Terms and Conditions, including the eligibility requirements, at any time. This is not health insurance.

†You may be required to pay upfront for your co-pay/co-insurance, as determined by your insurance coverage and your healthcare provider’s co-pay collection practice.

Terms and Conditions and Program Limitations

The Program covers eligible patients’ actual out-of-pocket XEOMIN medication costs and, where permissible, related administration fees, up to a maximum amount of $5,000 annually beginning with patients’ acceptance into the Program. The Program does not cover (a) office co-pays not directly associated with XEOMIN treatment; (b) facility co-pays not directly associated with XEOMIN treatment; or (c) any other costs excluded by the Program guidelines not specifically mentioned here, which are subject to change.

Eligible patients must be clinically appropriate patients for therapeutic treatment with XEOMIN. Patient must be prescribed XEOMIN. Eligible patients must be at least 2 years of age and less than 65 years of age.

This offer is valid only in the United States, excluding where it is otherwise prohibited by law. Patients residing in the states of Massachusetts or Rhode Island are eligible for drug co-payment assistance only and are not eligible for other types of co-payment assistance, including but not limited to costs related to administration of the drug.

Eligible patients must have private commercial insurance that covers medication costs for XEOMIN, and acceptance of this offer must be consistent with the terms of that insurer’s drug benefit. Eligible patients must not have coverage for XEOMIN through Medicare, Medicare Advantage, Medicare Part D, Medicaid, Medigap, TRICARE, Veterans Affairs (VA), the Department of Defense (DoD), or other federally funded or state-funded healthcare programs. Patients who move from commercial to federally funded or state-funded insurance will no longer be eligible for the Program. Proof required for receiving payment for out-of-pocket drug costs must be a valid explanation of benefits (EOB) or specialty pharmacy invoice, which must be submitted within 120 days after each treatment.

Patients may not seek reimbursement for value received from the Program from any third-party payers, including flexible spending accounts or healthcare savings accounts. If at any time patient begins receiving coverage under any federal-, state-, or government-funded healthcare program, patient is no longer eligible to participate in the Program and must call 1-855-4MERZTX (1-855-463-7989) between 8am–8pm ET to stop participation. Restrictions may apply. This is not health insurance.

Patient/Guardian and pharmacist are responsible for notifying insurance carriers or any other third party that pays for or reimburses any part of the prescription filled using the Program as may be required by the insurance carrier’s terms and conditions and applicable law.

Enrollment in the Program will be reviewed on an annual basis to determine continued eligibility. This offer may not be combined with any other coupon, discount, prescription savings card, free trial, or other offer for XEOMIN.

This is a limited-time offer, and Merz reserves the right to rescind, revoke, amend, or terminate this offer, or the program in its entirety, at any time, without notice.

Terms and Conditions and Program Limitations

XEOMIN is available at no charge to eligible‡ patients who:

  • Are uninsured or underinsured
  • Meet financial eligibility requirements (based on the Federal Poverty Guidelines)
    • Proof of income is required
    • Eligibility will be determined prior to the first injection for both uninsured and underinsured patients
  • Are residents of the US, Puerto Rico, and other US territories
  • Are not enrolled in Medicare, Medicaid, or any other government program
  • Meet specific medical and clinical guidelines as determined by Merz
  • Eligibility must be re-established every 12 months

If you are underinsured, there are certain steps your doctor must follow before you can receive XEOMIN at no charge. Talk to your doctor if you have any questions.

‡Criteria for the XEOMIN Patient Assistance Program are established by Merz Pharmaceuticals, LLC. Acceptance into the XEOMIN

Patient Assistance Program does not entitle patients to receive assistance indefinitely. Eligibility must be re-established every 12 months, and assistance under the XEOMIN

Patient Assistance Program may be terminated at any time. Please see the application for additional required eligibility information.

IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING
WARNING:
DISTANT SPREAD OF TOXIN EFFECT

See full prescribing information for complete BOXED WARNING.

The effects of XEOMIN and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults, particularly in those patients who have underlying conditions that would predispose them to these symptoms.

INDICATIONS

XEOMIN® (incobotulinumtoxinA) for injection is indicated for the treatment of:

  • Chronic sialorrhea in patients 2 years of age and older
  • Upper limb spasticity in adults
  • Upper limb spasticity in pediatric patients 2 years of age and older, excluding spasticity caused by cerebral palsy
  • Cervical dystonia in adults
  • Blepharospasm in adults
CONTRAINDICATIONS
  • Known hypersensitivity to any botulinum toxin product or to any of the components in the formulation.
  • Infection at the proposed injection site(s) because it could lead to severe local or disseminated infection.
WARNINGS AND PRECAUTIONS
  • The potency units of XEOMIN are specific to the preparation and assay method used and are not interchangeable with other preparations of botulinum toxin products. Therefore, Units of biological activity of XEOMIN cannot be compared to or converted into Units of any other botulinum toxin products.
  • Serious hypersensitivity reactions have been reported with botulinum toxin products (anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea). If serious and/or immediate hypersensitivity reactions occur, discontinue further injection of XEOMIN and institute appropriate medical therapy immediately. The use of XEOMIN in patients with a known hypersensitivity to any botulinum neurotoxin or to any of the excipients (human albumin, sucrose), could lead to a life-threatening allergic reaction.
  • Treatment with XEOMIN and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. When distant effects occur, additional respiratory muscles may be involved. Patients may require immediate medical attention should they develop problems with swallowing, speech, or respiratory disorders. Dysphagia may persist for several months, which may require use of a feeding tube. Aspiration may result from severe dysphagia [See BOXED WARNING].
  • Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) may be at increased risk for severe dysphagia and respiratory compromise from typical doses of XEOMIN.
  • Caution should be taken when XEOMIN is used where the targeted muscle shows excessive weakness or atrophy.
  • Cervical Dystonia: Treatment with botulinum toxins may weaken neck muscles that serve as accessory muscles of ventilation. This may result in critical loss of breathing capacity in patients with respiratory disorders who may have become dependent upon these accessory muscles. There have been post- marketing reports of serious breathing difficulties, including respiratory failure, in patients with cervical dystonia treated with botulinum toxin products. Patients with smaller neck muscle mass and patients who require bilateral injections into the sternocleidomastoid muscles are at greater risk of dysphagia. Limiting the dose injected into the sternocleidomastoid muscle may decrease the occurrence of dysphagia.
  • Blepharospasm: Injection of XEOMIN into the orbicularis oculi muscle may lead to reduced blinking and corneal exposure with possible ulceration or perforation. To decrease the risk for ectropion, XEOMIN should not be injected into the medial lower eyelid area.
  • XEOMIN contains human serum albumin. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD, or vCJD have ever been reported for albumin.
ADVERSE REACTIONS

The most commonly observed adverse reactions at rates specified below and greater than placebo are:

  • Chronic Sialorrhea:
    • in adults (≥4% of patients): tooth extraction, dry mouth, diarrhea, and hypertension.
    • in pediatric patients (≥1% of patients): bronchitis, headache, and nausea/vomiting.
  • Upper Limb Spasticity
    • in adults (≥2% of patients): seizure, nasopharyngitis, dry mouth, and upper respiratory tract infection.
    • in pediatric patients (≥3% of patients): nasopharyngitis and bronchitis.
  • Cervical Dystonia in adults (≥5% of patients): dysphagia, neck pain, muscle weakness, injection site pain, and musculoskeletal pain.
  • Blepharospasm in adults (≥10% of patients): eyelid ptosis, dry eye, visual impairment, and dry mouth.
DRUG INTERACTIONS

Co-administration of XEOMIN and aminoglycoside or other agents interfering with neuromuscular transmission, (e.g., muscle relaxants), should only be performed with caution as these agents may potentiate the effect of the toxin.

Use of anticholinergic drugs after administration of XEOMIN may potentiate systemic anticholinergic effects.

The effect of administering different botulinum toxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.

USE IN PREGNANCY

There are no adequate data on the developmental risk associated with the use of XEOMIN in pregnant women. XEOMIN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

PEDIATRIC USE

Safety and effectiveness of XEOMIN in patients less than 18 years of age have not been established for lower limb spasticity, cervical dystonia, or blepharospasm. Safety and effectiveness have been established in pediatric patients 2 to 17 years of age in patients with chronic sialorrhea and upper limb spasticity. A pediatric assessment for XEOMIN in upper limb spasticity demonstrates that XEOMIN is safe and effective in another pediatric population. However, XEOMIN is not approved for such patient population due to marketing exclusivity for another botulinum toxin.

IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING
WARNING:
DISTANT SPREAD OF TOXIN EFFECT

See full prescribing information for complete BOXED WARNING.

The effects of XEOMIN and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults, particularly in those patients who have underlying conditions that would predispose them to these symptoms.

INDICATIONS

XEOMIN® (incobotulinumtoxinA) for injection is indicated for the treatment of:

  • Chronic sialorrhea in patients 2 years of age and older
  • Upper limb spasticity in adults
  • Upper limb spasticity in pediatric patients 2 years of age and older, excluding spasticity caused by cerebral palsy
  • Cervical dystonia in adults
  • Blepharospasm in adults
CONTRAINDICATIONS
  • Known hypersensitivity to any botulinum toxin product or to any of the components in the formulation.
  • Infection at the proposed injection site(s) because it could lead to severe local or disseminated infection.
WARNINGS AND PRECAUTIONS
  • The potency units of XEOMIN are specific to the preparation and assay method used and are not interchangeable with other preparations of botulinum toxin products. Therefore, Units of biological activity of XEOMIN cannot be compared to or converted into Units of any other botulinum toxin products.
  • Serious hypersensitivity reactions have been reported with botulinum toxin products (anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea). If serious and/or immediate hypersensitivity reactions occur, discontinue further injection of XEOMIN and institute appropriate medical therapy immediately. The use of XEOMIN in patients with a known hypersensitivity to any botulinum neurotoxin or to any of the excipients (human albumin, sucrose), could lead to a life-threatening allergic reaction.
  • Treatment with XEOMIN and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. When distant effects occur, additional respiratory muscles may be involved. Patients may require immediate medical attention should they develop problems with swallowing, speech, or respiratory disorders. Dysphagia may persist for several months, which may require use of a feeding tube. Aspiration may result from severe dysphagia [See BOXED WARNING].
  • Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) may be at increased risk for severe dysphagia and respiratory compromise from typical doses of XEOMIN.
  • Caution should be taken when XEOMIN is used where the targeted muscle shows excessive weakness or atrophy.
  • Cervical Dystonia: Treatment with botulinum toxins may weaken neck muscles that serve as accessory muscles of ventilation. This may result in critical loss of breathing capacity in patients with respiratory disorders who may have become dependent upon these accessory muscles. There have been post- marketing reports of serious breathing difficulties, including respiratory failure, in patients with cervical dystonia treated with botulinum toxin products. Patients with smaller neck muscle mass and patients who require bilateral injections into the sternocleidomastoid muscles are at greater risk of dysphagia. Limiting the dose injected into the sternocleidomastoid muscle may decrease the occurrence of dysphagia.
  • Blepharospasm: Injection of XEOMIN into the orbicularis oculi muscle may lead to reduced blinking and corneal exposure with possible ulceration or perforation. To decrease the risk for ectropion, XEOMIN should not be injected into the medial lower eyelid area.
  • XEOMIN contains human serum albumin. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD, or vCJD have ever been reported for albumin.
ADVERSE REACTIONS

The most commonly observed adverse reactions at rates specified below and greater than placebo are:

  • Chronic Sialorrhea:
    • in adults (≥4% of patients): tooth extraction, dry mouth, diarrhea, and hypertension.
    • in pediatric patients (≥1% of patients): bronchitis, headache, and nausea/vomiting.
  • Upper Limb Spasticity
    • in adults (≥2% of patients): seizure, nasopharyngitis, dry mouth, and upper respiratory tract infection.
    • in pediatric patients (≥3% of patients): nasopharyngitis and bronchitis.
  • Cervical Dystonia in adults (≥5% of patients): dysphagia, neck pain, muscle weakness, injection site pain, and musculoskeletal pain.
  • Blepharospasm in adults (≥10% of patients): eyelid ptosis, dry eye, visual impairment, and dry mouth.
DRUG INTERACTIONS

Co-administration of XEOMIN and aminoglycoside or other agents interfering with neuromuscular transmission, (e.g., muscle relaxants), should only be performed with caution as these agents may potentiate the effect of the toxin.

Use of anticholinergic drugs after administration of XEOMIN may potentiate systemic anticholinergic effects.

The effect of administering different botulinum toxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.

USE IN PREGNANCY

There are no adequate data on the developmental risk associated with the use of XEOMIN in pregnant women. XEOMIN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

PEDIATRIC USE

Safety and effectiveness of XEOMIN in patients less than 18 years of age have not been established for lower limb spasticity, cervical dystonia, or blepharospasm. Safety and effectiveness have been established in pediatric patients 2 to 17 years of age in patients with chronic sialorrhea and upper limb spasticity. A pediatric assessment for XEOMIN in upper limb spasticity demonstrates that XEOMIN is safe and effective in another pediatric population. However, XEOMIN is not approved for such patient population due to marketing exclusivity for another botulinum toxin.