Clinical Policy: Neuromuscular Blocking Agents- Neurotoxins Reference Number: CP.CPA.250 Effective Date: 11.16.16 Last Review Date: 11.17 Line of Business: Medicaid – Medi-Cal Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description The following are neuromuscular blocking agents requiring prior authorization: onabotulinuumtoxin A (Botox®), abobotulinumtoxin A (Dysport®), incobotulinumtoxin A (Xeomin®), rimabotulinum toxin type-B (Myobloc®). FDA approved indication Botox is indicated: • For the treatment of strabismus in patients 12 years and older • For the treatment of blepharospasm associated with dystonia in patients 12 years and older • For the treatment of cervical dystonia in adults to decrease the severity of abnormal head position and neck pain associated with cervical dystonia • For the treatment of severe primary axillary hyperhidrosis that is inadequately managed by topical agents in adult patients • For the treatment of upper limb spasticity in adult patients • To prevent headaches in adult patients with chronic migraine (15 or more days per month with headache lasting 4 hours a day or longer) • For the treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition [e.g., spinal cord injury (SCI), multiple sclerosis (MS)] in adults who have an inadequate response to or are intolerant of an anticholinergic medication • For the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication Dysport is indicated: • For the treatment of adults with cervical dystonia • For the treatment of the temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adult patients <65 years of age • For the treatment of spasticity in adult patients • For the treatment of lower limb spasticity in pediatric patients 2 years of age and older Xeomin is indicated: Page 1 of 13 CLINICAL POLICY Neuromuscular Blocking Agents- Neurotoxins • For the treatment of adults with cervical dystonia, to decrease the severity of abnormal head position and neck pain in both botulinum toxin-naïve and previously treated patients • For the treatment of Blepharospasm in adults previously treated with onabotulinumtoxinA (Botox) • For the treatment of temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients • For the treatment of upper limb spasticity in adult patients Myobloc is indicated: • For the treatment of adults with cervical dystonia (CD) to reduce the severity of abnormal head position and neck pain associated with CD. Policy/Criteria Provider must submit documentation (which may include office chart notes and lab results) supporting that member has met all approval criteria It is the policy of health plans affiliated with Centene Corporation® that Botox, Dysport, Xeomin and Myobloc are medically necessary when the following criteria are met: I. Initial Approval Criteria A. All Indications (must meet all): 1. All requests require the following: a. Condition for which the toxin will be used; b. Anticipated frequency of injection; c. Total dose per visit; d. Previous therapies tried; 2. Confirmed diagnosis of one of the following: a. Strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in patients 12 years of age or older; b. Hemifacial spasm; c. Facial spasm; d. Jaw-closing oromandibular dystonia; e. Spasmodic dysphonia (laryngeal dystonia, lingual dystonia, laryngeal spasm); f. Spasmodic Torticollis (cervical dystonia); g. Focal task-specific dystonia; h. Head and neck tremor; i. Dynamic muscle contractions in pediatric cerebral palsy; j. Limb spasticity; k. Frey’s Syndrome (gustatory sweating) secondary to parotid surgery; l. Sialorrhea in Parkinson’s Disease; m. Detrussor sphincter dyssynergia (lower urinary tract dysfunction); n. Overactive bladder or urinary incontinence due to detrusor overactivity associated with a neurologic condition; Page 2 of 13 CLINICAL POLICY Neuromuscular Blocking Agents- Neurotoxins o. Focal hand dystonias (organic writer’s cramp) when incapacitating and refractive to medical treatment including oral medications; p. Symptomatic patients with primary, idiopathic esophageal achalasia; q. Focal, primary axillary or palmar hyperhidrosis; r. Chronic anal fissure; s. Internal anal sphincter (IAS) achalasia; t. Chronic migraine headache; 3. For overactive bladder or urinary incontinence, failure or clinically significant adverse effects to at least two anticholinergic agents (e.g., oxybutynin immediate and extended release tabs, Oxytrol patch, Gelnique gel,, tolteridine immediate and extended release, Toviaz, Enablex, Vesicare, trospium immediate and extended release); 4. For focal hand dystonias (organic writer’s cramp) both of the following (a and b): a. Documentation of functional limitations; b. Failure or clinically significant adverse effects to oral medications (baclofen, beta-blockers and benzodiazepines); 5. For primary, idiopathic esophageal achalasia, one of the following (a, b, c, d, or e): a. Failure to conventional therapy (e.g., nitrates or calcium channel blockers) unless contraindicated or clinically significant adverse effects are experienced; b. Member is ineligible for surgical treatment due to advance age or multiple co- morbidities (poor surgical risk); c. Member is at high risk of complications of pneumatic dilation or surgical myotomy; d. Failure of prior myotomy or dilation; e. Member has an epiphrenic diverticulum or hiatal hernia, both of which increase the risk of dilation-induced perforation; 6. For axillary or palmar hyperhidrosis both of the following (a and b): a. Failure to topical antiperspirants (e.g., Drysol) unless contraindicated or clinically significant adverse effects are experienced; b. Condition creates a significant disruption to patient’s daily life and ability to work/function or patient has recurrent or chronic irritations and/or infections, dermatitis, skin macerations; 7. For chronic anal fissure, failure to topical nitroglycerin or a topical calcium channel blocker unless contraindicated or clinically significant adverse effects are experienced; 8. For internal anal sphincter (IAS) achalasia both of the following (a and b): a. Member has not responded to treatment with laxatives; b. Member has not responded to or is not a candidate for anal sphincter myectomy; 9. For chronic migraine headache, all of the following: a. Persistent history of chronic, debilitating migraine headaches with frequent attacks on 15 or more days per month for longer than 3 months; b. A neurologist has thoroughly evaluated the patient and has established a diagnosis of chronic migraine headaches; c. Documentation of significant functional disability (e.g., work absenteeism, multiple emergency department visits); Page 3 of 13 CLINICAL POLICY Neuromuscular Blocking Agents- Neurotoxins d. Failure to abortive treatment with at least three (3) different therapy classes listed below in Appendix B, unless contraindicated or clinically significant adverse effects to all; e. Failure to prophylactic therapy from at least two (2) different therapy classes listed below in Appendix B, unless contraindicated or clinically significant adverse effects to all. Approval duration: Length of Benefit B. Other diagnoses/indications 1. Refer to CP.PMN.53 if diagnosis is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) II. Continued Therapy A. All Indications (must meet all): 1. Currently receiving medication via a health plan affiliated with Centene Corporation or member has previously met initial approval criteria; 2. Documentation of positive response to therapy. Approval duration: Length of Benefit B. Other diagnoses/indications (must meet 1 or 2): 1. Currently receiving medication via a health plan affiliated with Centene Corporation and documentation supports positive response to therapy. Approval duration: Duration of request or 12 months (whichever is less); or 2. Refer to CP.PMN.53 if diagnosis is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) III. Diagnoses/Indications for which coverage is NOT authorized: A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off-label use policy – CP.PMN.53 or evidence of coverage documents; B. Cosmetic treatment of hyperfunctional wrinkles of the upper face including glabellar frown lines, deep forehead wrinkles and periorbital wrinkles (crow’s feet). IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key N/A Appendix B: General Information Medications for Abortive Migraine Treatment Class Commonly Used Examples Dose Limit/ Maximum Dose Triptans* Imitrex (sumitriptan), Maxalt (rizatriptan), Varies according to Zomig (zolmitriptan), Amerge (naratriptan), the agent used Axert (almotriptan), Frova (frovatriptan), Relpax (eletriptan) Page 4 of 13 CLINICAL POLICY Neuromuscular Blocking Agents- Neurotoxins Class Commonly Used Examples Dose Limit/ Maximum Dose Ergot derivatives Cafergot (ergotamine/caffeine), D.H.E.-45 Varies according to (dihydroergotamine) the agent used Analgesics*