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Financial Assistance Programs

The National Organization for Rare Disorders, Inc. (NORD) is a not-for-profit health agency dedicated to the identification, treatment, and cure of rare “orphan diseases” through advocacy, research, and patient services programs. NORD helps eligible patients—those with medical and financial needs—afford the medications and treatments their health care professionals have prescribed. NORD funds come from corporate donations, grants from concerned companies such as Medtronic, foundation grants, public contributions, and membership dues.

There are two NORD programs available for patients who require intrathecal drug delivery for severe spasticity.

1. Intrathecal Baclofen Therapy Patient Assistance Program

NORD may help you obtain the FDA-approved drug used in intrathecal baclofen therapy, at no cost if you do not have health insurance, or your health insurance does not cover the drug. This program is sponsored by Medtronic, Inc.

How the program works

Applications are reviewed throughout the year. One application will be accepted per patient per year. Benefits are determined by financial need.

To apply for the program, you must:

  • Complete an application provided by NORD, including signed waivers of release of liability against NORD and Medtronic, and signed verification and consent forms.
  • Meet financial and other general eligibility requirements.
  • Provide financial supporting documentation so NORD can examine your monthly household income and available assets and compare them to your household and medical expenses. You are eligible for the program if you meet the following criteria:
    • US citizen or a documented legal alien
    • Implanted with a Medtronic drug delivery system and have a legal prescription for intrathecal baclofen
    • Not a Medicaid recipient or covered under Medicare
    • Diagnosed with severe spasticity due to cerebral palsy, brain injury, stroke, multiple sclerosis, or spinal cord injury/disease
    • Meet the criteria of a financial means test

Indications other than cerebral palsy, brain injury, stroke, multiple sclerosis, or spinal cord injury/disease may be eligible if the condition is listed in one of the compendia used by Medicare, and there is convincing medical evidence in peer-reviewed journals.

2. Intrathecal Drug Delivery for Severe Spasticity Insurance Premium, Deductible, and Co-payment Assistance Fund

If you are eligible, NORD may help pay insurance premiums, deductibles, and co-payments associated with FDA-approved intrathecal drug delivery for severe spasticity.

How the program works

Applications are accepted and reviewed on an ongoing first-come, first-service basis. Benefits are determined based on financial need and the funding that is available to the program. NORD will notify you of its decision by mail within 5 business days of the receipt of your application. Eligibility for NORD assistance is guaranteed up to 12 months as long as you remain compliant with treatment. You must reapply each year.

To apply for the program, you must:

Complete an application provided by NORD, including signed waivers of release of liability against NORD and Medtronic, and signed verification and consent forms.

  • Meet financial and other general eligibility requirements.
  • Provide financial documentation so NORD can examine your monthly household income and available assets and compare them to your household and medical expenses.

If approved, you will receive notification in writing. NORD will work directly with your “in network” provider and/or medical insurance carrier regarding out-of-pocket expenses that would normally be billed to you.

If your application is denied, you can appeal the decision. You will have 30 days from the denial notification to submit an appeal letter along with any new documentation. You must contact NORD whenever there is a change in your financial status.

Contact Information for the Intrathecal Drug Delivery for Severe Spasticity Financial Assistance Programs

NORD patient representatives are available to answer your questions and assist you in completing an application. They can be reached at 1-800-999-6673, extension 216. Telephone lines are staffed Monday through Friday from 9:00 a.m. to 5:00 p.m., Eastern Time (ET ).

 

The Medtronic baclofen pump is part of the Synchromed® Infusion System, which delivers the drug called Lioresal® Intrathecal (baclofen injection) for ITB TherapySM, a treatment for severe spasticity. Please read the following important safety information about ITB Therapy.

IMPORTANT SAFETY INFORMATION FOR ITB THERAPY (Intrathecal Baclofen Therapy)

Please follow your doctor's instruction closely because a sudden stop of intrathecal baclofen therapy can result in serious baclofen withdrawal symptoms such as high fever, changed mental status, muscle stiffness, and in rare cases may result in loss of function of many vital organs and death. It is very important that your doctor be called right away if you experience any of the above symptoms.

It is important for you to keep your scheduled refill visits so you don't run out of medication (baclofen) and to know the early symptoms of baclofen withdrawal. Some patients are at more risk than others for baclofen withdrawal; speak with your doctor about this.

People who suffer from severe spasticity resulting from cerebral palsy, multiple sclerosis, stroke, brain injury, or spinal cord injury may be candidates for ITB Therapy. If you have spasticity due to spinal cord injury or multiple sclerosis, you may be considered for ITB Therapy if oral baclofen has not controlled your spasticity or has resulted in serious side effects that you cannot accept. If you suffered a brain injury due to trauma you must wait until one year after the injury to be considered for ITB Therapy. A trial of ITB Therapy will help to show if ITB Therapy can help you. You should not receive ITB Therapy if you have an infection, are allergic to baclofen, or your body size is too small for the implantable pump.

The implanted pump and catheter (tube that delivers the drug from the pump to the fluid around the spinal cord) are placed under the skin during a surgery. Some complications that you may experience with the surgery include infection, meningitis (infection of the lining of the brain and central nervous system), spinal fluid leak, paralysis, headache, swelling, bleeding, and bruising.

The most common and/or serious drug-related side effects of ITB Therapy include loose muscles, sleepiness, upset stomach, vomiting, headaches, and dizziness. Failure of the pump placed under your skin may cause symptoms due to overdose (receiving too much) or underdose (receiving too little) of intrathecal baclofen. The signs and symptoms of overdose include drowsiness, lightheadedness, dizziness, respiratory depression (difficulty breathing), hypothermia (lower than normal body temperature), seizures, loss of consciousness, and coma. Once the infusion system (the pump and the catheter) is implanted, possible complications include unintended movement of the catheter or pump within the body or breakdown of the skin over the pump. The catheter could leak, tear, kink, or become disconnected from the pump, resulting in underdose or no baclofen infusion. Symptoms of underdose include an increase or return in spasticity, itching, low blood pressure, lightheadedness, and tingling sensation. These symptoms are often early signs of baclofen withdrawal. The pump could stop because the battery has run out or because of a problem with one or more of its inner parts. The pump will sound an alarm when the pump needs to be filled with baclofen, replaced, or if there is a problem with the pump. You or your caregiver should always inform any healthcare personnel that you have an implanted infusion system before any medical or diagnostic procedure such as MRI or diathermy.

For more information, please read the Lioresal® Intrathecal (baclofen injection) Full Prescribing Information and the SynchroMed Infusion System Information.

This therapy is not for everyone. Please contact your doctor. A prescription is required.

Lioresal® is a registered trademark of Medtronic, Inc.

USA Rx Only Rev 0913

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Information on this site should not be used as a substitute for talking with your doctor. Always talk with your doctor about diagnosis and treatment information.

Last updated: 29 Oct 2010

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