Botulinum neurotoxin Injections
Dystonia is a Movement Disorder
Botulinum neurotoxin (BNT) injections are a common treatment for several types of dystonia. This therapy is used to treat to dystonia symptoms in a specific group of muscles, for example in the neck or a limb.
Botulinum Neurotoxin Injections
Botulinum neurotoxin injections are a localized treatment to relieve dystonia symptoms. Botulinum neurotoxin (BNT), a biological product, is injected into muscles where it relaxes the muscles and reduces excessive muscle contractions. BNT is derived from the bacterium Clostridium botulinum. Ironically this is the same bacterium responsible for botulism, a disease associated with eating contaminated food. BNT is used as a therapeutic agent to block the release of chemicals that activate muscle contractions.
Although a medication with the word “toxin” in the name may seem confusing, BNT injections have decades of research and clinical experience demonstrating that they are a safe and effective medical therapy. When used medically, BNT are transformed into a therapeutic agent by complex manufacturing processes. The doses used to treat dystonia are far less than the amount that would even begin to make a person ill from botulism.
When BNT is injected into muscles affected by dystonia, it blocks the neurotransmitter chemicals that signal the muscles to contract and spasm excessively. The muscle is weakened and therefore relaxes, reducing the dystonia.
Prior to the introduction of BNT in the United States during the 1980s, there was essentially no treatment for focal dystonias, and generalized dystonias were managed with oral medications and irreversible brain surgery.
Botulinum neurotoxin injections is used for both medical and cosmetic purposes. The doses and muscles injected may be vastly different, depending on the patient.
Seven types of BNT have been purified for medical purposes. Each is designated by a letter: A, B, C, D, E, F, G. The only types of BNT available for therapeutic purposes are A and B.
There are four brands of BNT approved for use in the United States:
Botox® by Allergan, Inc., Approved 1989
(Type A – onabotulinumtoxinA)
Myobloc® by Solstice Neurosciences/U.S. WorldMeds, Approved 2000
(Type B – rimabotulinumtoxinB)
Dysport™ by Ipsen, Ltd., Approved 2009
(Type A – abobotulinumtoxinA)
Xeomin® by Merz Pharmaceuticals, Approved 2010
(Type A – incobotulinumtoxinA)
Your doctor can recommend which brand of BNT is appropriate for you.
In all but the most unusual cases, individuals receive BNT injections on an outpatient basis
and there is minimal recovery time following the procedure. Some people experience soreness or bruising at the injection site. Depending on the extent of the dystonia symptoms and areas of the body injected, some individuals prefer to have someone with them to drive or accompany them on the way home following the appointment (especially individuals with blepharospasm or moderate to severe cervical dystonia), while others are comfortable resuming their day on their own. Some individuals notice a benefit just days following a BNT injection, and most will experience significant effects within about a week. It may take up to four weeks for patients to experience the full benefit of the treatment.
Temporary side effects may include muscle weakness, flu-like symptoms, pain at the injection site, and dry mouth. Ask your doctor about additional side effects that may be specific to your situation. If you experience side effects, be sure to discuss them in detail with your doctor. Adjusting the dosage or site of injection may help avoid these effects in the future. Over a decade of clinical experience suggests that people who respond well to BNT therapy may continue treatment for many years without side effects from long-term use.
Yes. BNT therapy is an ongoing treatment that must be repeated every three to four months for the majority of dystonia patients. The fact that BNT injections must be repeated is one of the advantages of the therapy. Each session of injections provides an opportunity to adjust the dose and muscles injected, therefore customizing the treatment to the individual.
As a rule injections are repeated no sooner than every three to four months as a precaution against the risk of developing antibodies to the neurotoxin. Patients who develop antibodies may not experience as much benefit as those without antibodies.
It is extremely important that patients receive BNT injections from an experienced and knowledgeable doctor. In general, the specialist who is trained to treat dystonia is a movement disorder neurologist. Otolaryngologists, neuro-ophthalmologists, and ophthalmologists may give BNT injections for focal dystonias that fall under their specialties, for example laryngeal dystonia/spasmodic dysphonia and cranial dystonias.
Electromyography, or EMG, is a technique that measures muscle activity. During EMG, a small electrode needle is inserted into the muscle to measure the electrical activity of the muscle. Doctors who inject patients with BNT may use EMG to help identify the muscles and precise targets within the muscle to be treated. Individuals with some forms of dystonia, such as blepharospasm which affects the small muscles around the eyes, may not require EMG.
Ultrasound (sonography) may also be used to visualize muscles targeted for BNT injections, providing a non-invasive alternative to EMG.
Some individuals notice a benefit days following a BNT injection, and most will experience significant effects within about a week. It may take two to four weeks for patients to experience the full benefit of this therapy.
Because BNT are injected into the muscles, some level of discomfort or pain can be expected. The degree of discomfort may depend on the muscles being treated, the number of injection sites, and on the individual person. Some people treated with BNT experience soreness or bruising at the injection site(s). Once the BNT begins to work (typically within a week of the injection), it often reduces dystonia-related pain.
Medicare, Medicaid, and most insurance companies cover BNT injections for medical purposes. Contact your health insurance provider to confirm your insurer covers this therapy. The manufacturers of BNT products provide reimbursement hotlines and resources that may also help you determine coverage for this therapy. See below to learn more about these resources.
Like all medications and medical procedures approved by the Food & Drug Administration (FDA), BNT products are approved for specific illnesses or conditions. BNT are officially approved for certain forms of dystonia. Physicians are also permitted to use BNT ‘off-label’ for additional dystonias. Off-label use of BNT is covered by most health insurers.
There are programs in place to help people afford botulinum neurotoxin therapy.
These programs also help patients with or without medical insurance achieve appropriate reimbursement for their treatment.
Botox Reimbursement Solutions & Patient Assistance Programs
Allergan, the manufacturer of Botox, sponsors a comprehensive reimbursement program for patients and providers called the Botox Reimbursement Solutions Program. This program includes a Botox Hotline and Botox Patient Assistance Program to assist patients who are receiving Botox injections. The Hotline is designed to respond to reimbursement questions and help individuals access Botox. For more information about this program go to:
Visit: Botox One
Phone: 1-800-442-6869, Option 4.
The Botox Patient Assistance Program is dedicated to helping financially eligible patients gain access to Botox. A special website offers information about the program, who may qualify, and how to apply.
Apply: BOTOX Patient Assistance Program Support
Phone: 1-800-442-6869, Option 4.
Solstice Service & Support Center (Myobloc)
Solstice Neurosciences has created a Service & Support Center to provide information and address questions regarding reimbursement for their product, Myobloc. The Service & Support Center can be reached at 888-461-2255. Certified Medical Insurance Specialists who understand the regional nuances of Myobloc reimbursement staff the Service & Support Center.
Ipsen CARES Program (Dysport)
Ipsen CARES Program (Coverage, Access, Reimbursement & Education Support) is designed to help patients get access to Dysport therapy they are prescribed quickly.
The program can help with the following things:
- Benefit Verification – the program can research the patient’s insurance coverage including if the drug is covered, are there restrictions, and what is the patient out-of-pocket cost. The team will research coverage under both Pharmacy and Medical Benefits.
- Restrictions – if there is a restriction, the program can research the specifics behind it. If there is a Prior Authorization, then we can determine what the requirements are and pull the form if one is required. We can provide both of these to the HCP. The HCP will be required to complete the clinical portion of the form and sign it.
- Copay Assistance – If the patient is an eligible, commercially insured patients, then we can enroll them into the Copay Assistance Program. This program will help reduce the patient’s out-of-pocket responsibility by up to $500/Rx with an annual max of $2,000/year.
- Patient Assistance Program – a couple types of assistance for patients: Traditional PAP – for uninsured patients who meet financial criteria OR Functionally Uninsured PAP – for patients with insurance, but Dysport is not covered, who meet financial criteria.
- Specialty Pharmacy coordination (if requested by the office) – the program will coordinate with the appropriate Specialty Pharmacy to ensure that product gets delivered to the office.
The Xeomin Patient Co-payment Program offers eligible patients assistance for their actual out-of-pocket costs for therapeutic treatment with Xeomin. Eligible treatment-related costs may include the cost of Xeomin, associated guidance therapy, and related administration fees.
Merz also offers the Xeomin Patient Assistance Program to provide Xeomin at no cost to eligible patients who are experiencing financial hardship and who do not have third party drug coverage.
Enrollment in the Xeomin Patient Co-payment Program or the Xeomin Patient Assistance Program is simple. Patients who want to learn more about the programs and secure an application form can do so by calling 888-4-XEOMIN (888-493-6646) or by speaking with their healthcare provider. Support representatives are available from 8 am until 8 pm (EST), Monday through Friday.