GREENSBORO, N.C., March 30, 2011 /PRNewswire/ -- Merz Pharmaceuticals, LLC announced today that the Centers for Medicare and Medicaid Services (CMS) has granted a unique Healthcare Common Procedure Coding System (HCPCS) billing code, Q2040, for Xeomin® (incobotulinumtoxinA). Merz expects that this unique billing code, which will become effective on April 1, 2011, will help simplify the billing and reimbursement process for prescribers of XEOMIN.
The U.S. Food and Drug Administration (FDA) approved XEOMIN on July 30, 2010, for the treatment of adults with cervical dystonia (CD), to decrease the severity of abnormal head position and neck pain in both botulinum toxin-naive and previously treated patients, and blepharospasm in adults who have been previously treated with Botox® (onabotulinumtoxinA).
“Merz is pleased to report broad interest in XEOMIN at the provider level as well as strong reimbursement coverage by private and public payors,” said Jack Britts, President and CEO of Merz Pharmaceuticals, LLC. “We are confident that the addition of this unique billing code will assist in streamlining billing and reimbursement for XEOMIN.”
As permanent national codes are issued annually, CMS awards Q-codes when it identifies a need to provide a unique code in order to reduce billing confusion before the next national update on January 1 of the following year. Merz has applied for and anticipates receiving a permanent J-code for XEOMIN on January 2, 2012.
For providers and payors, utilizing a unique Q-code is in most circumstances administratively identical to billing under a permanent J-code. The availability of this unique code, Q2040, means that in most instances XEOMIN will no longer be billed under a miscellaneous code.
“This is a significant milestone for the dystonia community and we are so pleased that CMS granted this product-specific code for XEOMIN,” said Janet Hieshetter, Executive Director of the Dystonia Medical Research Foundation (DMRF). “This news follows a recent meeting that several representatives from the dystonia advocacy community had with government officials late last year about the importance of ensuring access to all available treatment options, and we’re all quite grateful that our voices were heard.”
Merz also recently introduced two comprehensive programs to provide patients with financial assistance for XEOMIN. The XEOMIN Patient Co-payment Program is easy-to-use and 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.
Additionally, the XEOMIN Patient Assistance Program provides XEOMIN at no cost to eligible patients who are experiencing financial hardship, do not have third-party drug coverage, and who are not eligible for government-funded drug programs.
For more information about reimbursement support and financial assistance programs for XEOMIN, visit www.Xeomin.com or call 1-888-4-XEOMIN (1-888-493-6646). Dedicated support representatives are available from 8 a.m. until 8 p.m. (EST), Monday through Friday.
In nature, Clostridium botulinum produces the toxin in association with ancillary accessory proteins. Manufacturers utilize this naturally occurring protein complex to produce therapeutic botulinum toxin products. XEOMIN (incobotulinumtoxinA) is manufactured using a proprietary process that isolates the therapeutic component and eliminates accessory proteins.
More than 84,000 patients have been treated with XEOMIN worldwide since 2005. The U.S. is the 20th country to approve XEOMIN for the treatment of cervical dystonia and blepharospasm.
XEOMIN is the only botulinum toxin that does not require refrigeration prior to reconstitution. XEOMIN is available in 50-unit and 100-unit vials, which Merz believes may allow for more precise billing and reduce wastage.
IMPORTANT SAFETY INFORMATION
WARNING: Distant Spread of Toxin Effect
Postmarketing reports indicate that 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 may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. 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 treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses.
XEOMIN is contraindicated in patients with a known hypersensitivity to the active substance botulinum toxin type A or to any of the components in the formulation and in the presence of infection at the proposed injection site(s).
WARNINGS AND PRECAUTIONS
- The potency units of XEOMIN 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.
- 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 further injection of XEOMIN should be discontinued and appropriate medical therapy immediately instituted.
- 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. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or swallowing. When distant effects occur, additional respiratory muscles may be involved [See Boxed Warning]. Deaths as a complication of severe dysphagia have been reported after treatment with botulinum toxin. Dysphagia may persist for several months, and require use of a feeding tube to maintain adequate nutrition and hydration. Aspiration may result from severe dysphagia and is a particular risk when treating patients in whom swallowing or respiratory function is already compromised. These reactions can occur within hours to weeks after injection with botulinum toxin.
- Cervical Dystonia: 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. Lower lid injections should not be repeated if diplopia occurred with previous botulinum toxin injections.
- Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia and respiratory compromise from typical doses of XEOMIN.
Cervical Dystonia: The most commonly observed adverse reactions (incidence greater than or equal to 10% of patients and twice the rate of placebo) for XEOMIN 120 Units and XEOMIN 240 Units, respectively, were: dysphagia (13%, 18%), neck pain (7%, 15%), muscle weakness (7%, 11%), and musculoskeletal pain (7%, 4%).
Blepharospasm: The most common adverse reactions (incidence greater than or equal to 10% of patients and twice the rate of placebo) for XEOMIN were eyelid ptosis (19%), dry mouth (16%), visual impairment (12%), diarrhea (8%), and headache (7%).
Concomitant treatment of XEOMIN and aminoglycoside antibiotics, spectinomycin, or other agents that interfere with neuromuscular transmission (e.g., tubocurarine-like agents), or muscle relaxants, should be observed closely because the effect of XEOMIN may be potentiated.
USE IN PREGNANCY
Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. XEOMIN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Please see full Prescribing Information for XEOMIN, including Boxed WARNING, available at www.XEOMIN.com.
Merz Pharmaceuticals, LLC is a part of the Merz Group of companies and was established in 1995 to develop and commercialize products for the Merz Group. Areas of therapeutic focus include Neurology, Dermatology, and Podiatry.
With a 102 year heritage, the Merz Group is known worldwide for its development of original compounds and formulations for medical professionals and consumers in 90 countries. Globally, Merz is a leader in the development of pharmaceuticals for the treatment of neurological and psychological disorders as well as for aesthetic medicine. Global research is concentrated in fields that have a strong need for therapeutic innovation such as Alzheimer's disease, Parkinson's disease, tinnitus, chronic pain conditions, addictions, and neuromuscular disturbances
XEOMIN is a registered trademark of MerzPharma GmbH & Co KGaA.
Botox® is a registered trademark of Allergan, Inc.
SOURCE Merz Pharmaceuticals, LLC