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Merz Pharmaceuticals, LLC Receives J-Code For Xeomin(R) (incobotulinumtoxinA)


1/4/2012 1:29:53 PM

GREENSBORO, N.C., Jan. 4, 2012 /PRNewswire/ -- Merz Pharmaceuticals, LLC, today announced that the Centers for Medicare and Medicaid Services (CMS) has assigned a product-specific Healthcare Common Procedure Coding System (HCPCS) billing code, J0588 "INJECTION, INCOBOTULINUMTOXIN A, 1 UNIT" for Xeomin® (incobotulinumtoxinA), effective beginning January 1, 2012.

The U.S. Food and Drug Administration (FDA) approved XEOMIN in July 2010 for the treatment of cervical dystonia in adults, 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).

"We are so pleased that CMS granted a permanent product-specific code for XEOMIN," said Janet Hieshetter, Executive Director of the Dystonia Medical Research Foundation (DMRF). "This milestone reinforces the importance of ensuring access to all available treatment options. The DMRF congratulates Merz on this achievement and applauds their ongoing dedication to patient and physician support."

Merz is committed to supporting patients and physicians in the cervical dystonia and blepharospasm community. In addition to offering services such as the industry-leading Co-pay Assistance Program, which helps alleviate patient out-of-pocket expenses, XEOMIN's list price has been reduced by nearly 20 percent, effective October 6, 2011, in an effort to ensure access to therapy for the greatest number of patients.

XEOMIN is the only botulinum neurotoxin that requires no refrigeration prior to reconstitution and can be stored at room temperature for up to 36 months. XEOMIN is also the only type A botulinum neurotoxin that is available in 50-unit single use vials that may allow for a reduction in wastage and may minimize patient out-of-pocket expenses.

"This is a significant milestone for Merz and it complements our ongoing efforts to ensure broad access for patients who have come to rely on this highly refined molecule," said Jack Britts, President and CEO of Merz Pharmaceuticals, LLC. "We are confident that the availability of this product-specific code will assist in streamlining billing and reimbursement for XEOMIN."

When the permanent code, J0588, goes into effect on January 1, 2012, Merz expects most payors will adopt the new code; however, providers are encouraged to verify preferred coding through the XEOMIN Customer Support Program (1-888-4-XEOMIN) or directly with individual payors prior to billing XEOMIN for treatment that occurs on or after January 1, 2012.

Until individual government contractors, state Medicaid agencies and commercial payors update their systems to recognize the newly assigned J-Code, the Q-Code will continue to act as a product-specific reimbursement code for XEOMIN. In most circumstances, utilizing a product-specific Q-Code is administratively identical to billing under a permanent J-Code. Still other payors may not have adopted Q2040 and if they do not have their systems updated by January 1, the use of a miscellaneous J-Code (such as J3590/J3490) may be necessary.

XEOMIN Financial Assistance and Reimbursement Support Services
Merz offers 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, who are appropriate for treatment with XEOMIN as determined by their physician, assistance for their actual out-of-pocket costs for treatment with XEOMIN.

To be eligible, patients must be at least 18 years of age, currently have commercial health insurance that covers treatment costs for XEOMIN, not be enrolled in or eligible for Medicare, Medicare Advantage, Medicaid, Managed Medicaid, TRICARE (i.e., CHAMPUS), or other state or federally funded insurance plan, and not be a resident in the state of Massachusetts. Eligible treatment-related costs may include the cost of XEOMIN, associated guidance therapy and related administration fees.

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.

Merz offers a dedicated XEOMINCustomer SupportProgram for patients, physicians and office staff at 1-888-4-XEOMIN(1-888-493-6646), to help simplify ordering, reimbursement and obtaining additional medical information. Dedicated support representatives are available from 8 a.m. until 8 p.m. (ET), Monday through Friday.

For more information about XEOMIN, visit www.Xeomin.com.

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[see Warnings and Precautions (5.1)].

CONTRAINDICATIONS

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.

ADVERSE REACTIONS

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%).

DRUG INTERACTIONS

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.

About Merz

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, Physiatry, Dermatology, and Podiatry.

With over a century of 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 Merz Pharma GmbH & Co KGaA.

Botox® is a registered trademark of Allergan, Inc.

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SOURCE Merz Pharmaceuticals


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