BOTOX Injection (Onabotulinumtoxin A) for Migraine Headaches [Preauthorization Required]

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1 BOTOX Injection (Onabotulinumtoxin A) for Migraine Headaches [Preauthorization Required] Medical Policy: MP-RX Original Effective Date: March 24, 2011 Reviewed: Revised: This policy applies to products subscribed by the following corporations, MCS Life Insurance Company (Commercial), MCS Health Management Options, Inc. (HMO) and MCS Advantage, Inc. (Classicare) and, provider s contract; unless specific contract limitations, exclusions or exceptions apply. Please refer to the member s benefit certification language for benefit availability. Managed care guidelines related to referral authorization, and precertification of inpatient hospitalization, home health, home infusion and hospice services apply subject to the aforementioned exceptions. The U.S. Food and Drug Administration (FDA) approved Botox injection (Onabotulinumtoxin A) to prevent headaches in adult patients with chronic migraine. Chronic migraine is defined as having a history of migraine and experiencing a headache on most days of the month. Chronic migraine is one of the most disabling forms of headache. Patients with chronic migraine experience a headache more than 14 days of the month. Migraine headaches are described as an intense pulsing or throbbing pain in one area of the head. The headaches are often accompanied by nausea, vomiting, and sensitivity to light and sound. Migraine is three times more common in women than in men. Migraine usually begins with intermittent headache attacks 14 days or fewer each month (episodic migraine), but some patients go on to develop the more disabling chronic migraine. To treat chronic migraines, Botox is given approximately every 12 weeks as multiple injections around the head and neck to try to dull future headache symptoms. Botox has not been shown to work for the treatment of migraine headaches that occur 14 days or less per month, or for other forms of headaches. The most common adverse reactions reported by patients being treated for chronic migraine were neck pain and headache. Onabotulinumtoxin A, marketed as Botox has a boxed warning that states the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism. Those symptoms include swallowing and breathing 1

2 difficulties that can be life-threatening. There has not been a confirmed serious case of spread of toxin effect when Botox has been used at the recommended dose to treat chronic migraine. COVERAGE Benefits may vary between groups and contracts. Please refer to the appropriate member certificate and subscriber agreement contract for applicable diagnostic imaging, DME, laboratory, machine tests, benefits and coverage. INDICATIONS, (MCS) will consider medically necessary the administration of BOTOX Injection (Onabotulinumtoxin A) for prophylactic (preventive) treatment of headaches in adults with Chronic Migraines when all of the following criteria s are met: 1. The member must have a diagnosis of chronic migraines (history of migraine suffering from headaches on 15 or more days per month with headaches lasting four (4) hours a day or longer). 2. Member must be in a treatment for migraines headaches by a neurologist. 3. The order for Botox Therapy must have documentation that traditional methods of treatment have been tried and proven unsuccessful. The documentation must demonstrate the following: Documentation of failed trials of at least three (3) therapeutic groups of preventive medications such as (beta-blockers, calcium channel blockers and/or anti-depressants) with or without concomitant behavioral and/or physical therapies, after titration to maximum tolerated doses. The trial period of each therapeutic group should have been at least three (3) months. Should a Member have a contraindication to a specific treatment or medications, this is considered as a treatment failure, and must be documented within the progress notes. 4. Botox Injection should be recommended, monitored and administered by the treating neurologist. 5. For continuation of Botulism toxin therapy the Member must demonstrate a significant decrease in the number and frequency of headaches and an improvement in function upon receiving Botulinum Toxin. 2

3 MCS will NOT consider the following medical conditions for Botox Therapy due to insufficient literature to support clinical effectiveness: As a first line management for migraine headaches Muscle tension headaches Cluster headaches Muscle spasms (strain/sprain of spine) Myofascial pain Fibromyalgia Tremors Tics related to Tourrette syndrome LIMITATIONS 1. MCS WILL allow coverage for one (1) injection per site regardless of the number of injections made into the site. (A site is defined as including muscles of a single contiguous body part, such as, a single limb, eyelid, face, neck, etc). 2. Members will NOT receive continued injections of botulinum toxin if treatment failure occurs after two (2) consecutive injections, using maximum dose for the size of the muscle. 3. Botox is NOT covered for the treatment of muscle pain, spasm or tension related to musculoskeletal sprains/strains because such intervention is any more efficacious than other standard therapies already approved. 4. Treatment of wrinkles using Botulinum toxins is considered to be cosmetic, and NOT covered. 5. When the recipient does NOT meet the medical necessity criteria as stated in this policy. 6. When Botox (onabotulinumtoxin A) is used for the indication of prophylaxis of headaches in adult patients with chronic migraine ( 15 days per month with headache lasting 4 hours a day or longer), the documentation must support these specific symptom parameters. 7. Safety and effectiveness have not been established for the prophylaxis of episodic migraine (14 headache days or fewer per month). 8. The recommended re-treatment schedule is every 12 weeks. 3

4 CONTRAINDICATIONS 1. Inflammation or infection at the site of injection is presented. 2. Allergy to drug was observed. 3. When administered at conditions such as Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, peripheral neuropathy, and motor neuron disease. 4. When some drugs like aminoglycosidess antibiotics or other drugs that alter neuromuscular transmission are administered. CODING INFORMATION CPT Codes CPT Codes Chemodenervation of muscle(s); Muscle(s) innervated by facial nerve (e.g., for Blepharospasm, Hemifacial spasm) Cheomodenervation of muscle(s); Neck muscle(s) (e.g., for spasmodic torticollis, spasmodic dyshonia) *Current Procedural Terminology (CPT ) 2010 American Medical Association: Chicago, IL. ICD-9 CM Diagnosis Codes ICD-9 CM CODES CHRONIC MIGRAINE WITHOUT AURA, WITH INTRACTABLE MIGRAINE, SO STATED, WITHOUT MENTION OF STATUS MIGRAINOSUS CHRONIC MIGRAINE WITHOUT AURA, WITH INTRACTABLE MIGRAINE, SO STATED, WITH STATUS MIGRAINOSUS 2010 ICD-9-CM For Physicians, VOLUMES I & II, Professional Edition (American Medical Association) 4

5 HCPCS CODES HCPCS CODES J0585 Injection, onabotulinumtoxin A, 1 unit *2010 HCPCS LEVEL II Professional Edition (American Medical Association). REFERENCES 1. Allergan Pharmaceuticals Package Insert. Botox (Botulinum Toxin Type A) purified Neurotoxin Complex. 2. Allergan, Inc. Botox Fact Sheet. 2010, Irvine, CA American Academy of Neurology. Assessment: Botulinum neurotoxin in the treatment of autonomic disorder and pain (an evidence based review): Report of the therapeutic and technology assessment subcommittee of the American Academy of Neurology. M. Naumann, Y. So, C.E. Argoff, etal., Neurology 2008; 70; Information current as of February 2, Accessed March 7, American Academy of Neurology. Practice parameter: Evidence-based guidelines for mirgraine headache (an evidence-based review). Report of the Quality Standards Subcommittee of the American Academy of Neurology. Stephen D. Silberstein, MD, FACP, for the US Headache Consortium. Published in Neurology 2000; 55: Accessed March 7, Aurora S. Botulinum Toxin Type A for the treatment of migraine. Expert opinion Pharmacotherapy. 2006;7 (8) Botox (onabotulinumtoxin A) Insert. Revised 10/ Centers for Medicare and Medicaid Services (CMS) First Coast Service Options, Inc. LCD for Botulinum Toxins (L29103). Original Determination Effective Date: 03/02/2009. Revision Effective Date: March 10, Accessed March 7, ECRI Institute. Botulinum Toxin for Prevention and Treatment of Migraine. Published: 02/27/ EMedicine from the web. Botulinum Toxin, Overview. Updated August 6,

6 10. Evers S. Vollmer-Haase J, Schwaag S, et al. Botulinum toxin A in the prophylactic treatment of migraine- a randomized, double-blind, and placebo controlled study. Cephalagia. 2004;24(10) , 11. National Institute of Health. Headache: Hope through Research. October National Clearing House. Institute for Clinical Systems Improvement (ICSI). Diagnosis and treatment of headache. Bloomington (MN): Institute for Clinical Systems Improvement (ICSI); 2009 Mar. 76 p. [141 references] 13. Up to Date. Preventive treatment of migraine in adults: Prophylactic treatment of migraine and tension type headache. September Bajwa, Zhid, M.D., Sabahat, Ashraf, M.D. Accessed March 7, U.S. Food and Drug Administration. FDA approves Botox to treat spasticity in flexor muscles of the elbow, wrist, and fingers. (March 9, POLICY HISTORY DATE ACTION COMMENT March 24, 2011 Origination of Policy This document is for informational purposes only. It is not an authorization, certification, explanation of benefits, or contract. Receipt of benefits is subject to satisfaction of all terms and conditions of coverage. Eligibility and benefit coverage are determined in accordance with the terms of the member s plan in effect as of the date services are rendered., (MCS) medical policies are developed with the assistance of medical professionals and are based upon a review of published and unpublished information including, but not limited to, current medical literature, guidelines published by public health and health research agencies, and community medical practices in the treatment and diagnosis of disease. Because medical practice, information, and technology are constantly changing, Medical Card System, Inc., (MCS) reserves the right to review and update its medical policies at its discretion, (MCS) medical policies are intended to serve as a resource to the plan. They are not intended to limit the plan s ability to interpret plan language as deemed appropriate. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment they choose to provide. 6