This policy addresses only the type A formulation abobotulinumtoxina marketed as Dysport.

Transcription

1 AbobotulinumtoxinA NDC CODE(S) xx Dysport 300 UNIT VIAL (GALDERMA LABORA) XX Dysport 500 UNIT SOLR (IPSEN BIOPHARMACEUTICALS) XX Dysport 300 UNIT SOLR (IPSEN BIOPHARMACEUTICALS) DESCRIPTION Botulinum toxin, produced by the bacterium Clostridium botulinum, is one of the most potent naturally occurring neurotoxins known. It induces chemodenervation by first binding to acceptors on motor nerve terminals. It then enters the terminals and blocks the release of acetylcholine and other neurotransmitters at the neuromuscular junction. This renders smooth and striated muscles incapable of contraction. Acetylcholine also mediates the sympathetic innervation of the sweat glands, explaining how botulinum toxin disrupts the cholinergic outflow to the skin and halts glandular secretion. The minute amount of toxin used clinically produces only partial, localized chemical denervation with transient results. Over time, axons generate temporary sprouts which release acetylcholine and the original nerve terminal is eventually re-established, ending the toxin s therapeutic activity. Seven antigenic-specific serotypes of botulinum toxin have been identified, types A, B, C-1, D, E, F and G, but only botulinum toxin types A and B are commercially available. These commercial preparations of the two serotypes (three of serotype A and one of serotype B) vary widely in potency and dosage. They have been given different names to reinforce these differences and to prevent medication errors. It is emphasized that the use and dosage of different formulations of botulinum toxin is not interchangeable. This policy addresses only the type A formulation abobotulinumtoxina marketed as Dysport. POLICY AbobotulinumtoxinA for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.) o Anal fissure, chronic o Blepharospasms o Cervical dystonia o Hemifacial spasms o Severe primary hyperhidrosis, axillary o Incontinence due to neurogenic detrusor overactivity o Overactive bladder o Sialorrhea associated with neurological disorders o Spasticity AbobotulinumtoxinA for the prevention of chronic migraines is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.) AbobotulinumtoxinA for the treatment of other conditions/diseases is considered investigational. MEDICAL APPROPRIATENESS INITIAL APPROVAL AbobotulinumtoxinA is considered medically appropriate if ALL of the following criteria are met: o Individual is evaluated for any disorders which may contribute to respiratory or swallowing difficulty

2 o o Individual is ANY ONE of the following: 18 years of age or older unless otherwise indicated 2 years of age or older with lower limb spasticity Diagnosis of ANY ONE of the following: Anal fissure, chronic, if individual has failed conventional pharmacologic therapy (e.g. oral/topical nifedipine, diltiazem, and/or topical nitroglycerin, bethanechol, etc.) Blepharospasms with pain and/or functional impairment due to condition Cervical dystonia if ANY ONE of the following Sustained head tilt Abnormal posturing with limited range of motion in neck and history of recurrent involuntary contraction of one or more muscles in the neck Chronic migraine prophylaxis if individual is/has ALL of the following: Utilizing prophylactic intervention modalities (e.g., pharmacotherapy, behavioral therapy, or physical therapy, etc.) Fifteen or more migraine-like headache days per month for at least 3 months Headaches have diagnostic migraine features on at least 8 days per month for at least 3 months (see list of diagnostic migraine features with and without aura below) OR Suspected migraines are relieved by a triptan or ergot derivative medication Failed a minimum of 3 month trial of any two oral medications for the prevention of migraines (see list of prophylactic medications below for examples) Not used in combination with calcitonin gene-related peptide (CGRP) inhibitors (e.g., erenumabaooe, etc.) Hemifacial spasms Hyperhidrosis, severe primary axillary if individual has ALL of the following: Failed with topical agents Failed or has contraindications to oral pharmacotherapy History of medical complications such as skin infections, significant functional impairments OR has had a significant impact to activities of daily living due to condition Incontinence due to neurogenic detrusor overactivity if failed 1 month or longer trial of two medications from either the antimuscarinic (e.g., darifenacin, fesoterodine, oxybutynin, solifenacin, tolterodine or trospium) or beta-adrenergic (e.g., mirabegron) classes Overactive bladder (OAB) if individual has ALL of the following: Symptoms of urge urinary incontinence, urgency, and frequency Failed 1 month or longer trial of two medications from either the antimuscarinic (e.g., darifenacin, fesoterodine, oxybutynin, solifenacin, tolterodine or trospium) or beta-adrenergic classes (e.g., mirabegron) Sialorrhea associated with neurological disorders if individual has ANY ONE of the following: Parkinson s disease Severe developmental delays and failed oral therapy Cerebral palsy and failed oral therapy Spasticity of ANY ONE of the following: Upper or lower limb (e.g., spasticity post stroke, traumatic brain injury or spinal cord injuries) Lower limb(s) related to ANY ONE of the following: o Cerebral palsy with equinus gait if 2 years of age or older o Multiple sclerosis or Schilder s disease Migraine-Prophylaxis Oral Medications (list not all-inclusive) Migraine without aura Recurrent, lasting 4 to 72 hours Antidepressants (e.g., amitriptyline, fluoxetine, nortriptyline, etc.)

3 Beta blockers (e.g., propranolol, metoprolol, nadolol, timolol, atenolol, etc.) Angiotensin converting enzyme inhibitors/angiotensin II receptor blockers (ex. lisinopril, candesartan, etc.) Anti-epileptics (e.g., valproate, topiramate, etc) Calcium channels blockers (e.g., verapamil, etc) Migraine Features Migraine without aura Recurrent, lasting 4 to 72 hours Headache has at least two of the following characteristics: o Unilateral location o Pulsating quality o Moderate or severe pain intensity o Aggravation by or causing avoidance of routine physical activity (e.g., walking or climbing stairs) During headache at least one of the following: o Nausea and/or vomiting o Photophobia and phonophobia Migraine with aura One or more of the following fully reversible aura symptoms: o Visual o Sensory o Speech and/or language o Motor o Brainstem o Retinal At least two of the following characteristics: o At least one aura symptom spreads gradually over 5 minutes, and/or two or more symptoms occur in succession o Each individual aura symptom lasts 5 to 60 minutes o At least one aura symptom is unilateral o The aura is accompanied, or followed within 60 minutes, by headache RENEWAL CRITERIA AbobotulinumtoxinA is considered medically appropriate for renewal if ALL of the following criteria are met: o Individual continues to meet initial approval criteria o Absence of unacceptable toxicity from the agent, e.g., symptoms of a toxin spread effect (e.g. asthenia, diplopia, ptosis, dysphagia, dysphonia, dysarthria, breathing difficulties, etc.) o Disease response as evidenced by ANY ONE of the following: Anal fissure, chronic with complete healing of fissure or symptomatic improvement of persistent fissures Blepharospasms show improvement of severity and/or frequency of eyelid spasms Cervical dystonia shows improvement in the severity and frequency of pain and improvement of abnormal head positioning Chronic migraine prophylaxis, significant decrease in number and frequency of headaches, and improvement in function and individual continues to utilize prophylactic intervention modalities (i.e. pharmacotherapy, behavioral therapy, physical therapy, etc.) Hemifacial Spasms show decrease in frequency and/or severity of spasm, or a decrease in tone and/or improvement in asymmetry to the affected side of the face Hyperhidrosis, severe primary axillary, with significant reduction in spontaneous axillary sweat production and a significant improvement in activities of daily living

4 Incontinence due to detrusor overactivity with significant improvements in weekly frequency of incontinence episodes and post-void residual (PVR) periodically assessed as medically appropriate Overactive bladder (OAB) with significant improvement in daily frequency of urinary incontinence or micturition episodes and/or volume voided per micturition and post-void residual (PVR) periodically assessed as medically appropriate Sialorrhea associated with neurological disorders, shows significant decrease in saliva production Spasticity, including lower limbs, decrease in tone and/or resistance, of affected areas, based on a validated measuring tool (e.g., Ashworth Scale, etc.) INDICATION(S) Chronic anal fissure Blepharospasms Cervical Dystonia Hemifacial Spasms Chronic Migraine Prophylaxis Neurogenic detrusor overactivity - OAB Severe primary axillary hyperhidrosis Sialorrhea Lower Limb Spasticity Upper Limb Spasticity DOSAGE & ADMINISTRATION Up to 150 units divided among the affected muscles every 12 weeks Up to 180 units per affected eye every 12 weeks Initial dose: 500 units divided among the affected muscles Re-treatment: units every weeks or longer as necessary Up to 220 units per treatment session based on sites and severity of the spasm Subsequent injections administered upon recurrence of spasm, every 12 weeks, if needed Up to 240 units divided among the affected muscles every 12 weeks Up to 750 units divided among the affected muscles every 12 weeks Up to 200 units per axilla not more often than every 12 weeks Up to 450 units divided among the affected muscles every 12 weeks Pediatrics - Up to units/kg divided among gastrocnemius-soleus complex muscles, per limb, every 12 weeks. Maximum dose per treatment session is 1000 units, total Adults - Up to 1500 units divided among the affected muscles every 12 weeks Initial dose: units based on muscles affected, severity of muscle spasticity, prior response and adverse reaction history Re-treatment: units every weeks or longer, as necessary LENGTH OF AUTHORIZATION Coverage will be provided for six months and may be renewed Refer to DOSAGE LIMITS below APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS BlueCross BlueShield of Tennessee s Medical Policy complies with Tennessee Code Annotated Section regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the offlabel use is recognized in one of the statutorily recognized standard reference compendia or in the published peerreviewed medical literature. IMPORTANT REMINDER

5 We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern. ADDITIONAL INFORMATION For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ) published by the National Comprehensive Cancer Network, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information). SOURCES BlueCross BlueShield Association. Medical Policy Reference Manual. (10:2017). Botulinum toxin ( ). Retrieved January 22, 2018 from BlueWeb. BlueCross BlueShield Association. Medical Policy Reference Manual. (5:2017). Treatment of hyperhidrosis ( ). Retrieved January 22, 2018 from BlueWeb. Escher, C. M., Paracka, L., Dressler, D., Kollewe, K. (2017). Botulinum toxin in the management of chronic migraine: clinical evidence and experience. Therapeutic Advances in Neurological Disorders. 10(2), Headache Classification Committee of the International Headache Society (IHS). ( ). The International Classification of Headache Disorders, 3rd edition (ICHD-3). Cephalagia. 2018, 38 (1), Retrieved March 22, 2018 from data/3245_ichd-3-cephalalgia-2018-issue-1.pdf. Lexi-Comp Online. (2018). AHFS DI. AbobotulinumtoxinA. Retrieved August 24, 2018 from Lexi-Comp Online with AHFS. Mazlan, M., Rajasegaran, S., Engkasan, J. P., Nawawi, O., Goh, K. J., Freddy, S.J. (2015). A double-blind randomized controlled trial investigating the most efficacious dose of botulinum toxin-a for sialorrhea treatment in Asian adults with neurological diseases. Toxins, 2015(7), MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2018, November). AbobotulinumtoxinA. Retrieved December 5, 2018 from MICROMEDEX Healthcare Series. Møller, E., Pedersen, S. A., Vinicoff, P. G., Bardow, A., Lykkeaa, J., Svendsen, P., Bakke, M. (2015). OnabotulinumtoxinA treatment of drooling in children with cerebral palsy: a prospective, longitudinal open-label study. Toxins, 2015 (7), Sahebally, S. M., Meshkat, B., Walsh, S. R., Beddy, D. (2017). Botulinum toxin injection vs topical nitrates for chronic anal fissure: an updated systematic review and meta analysis of randomized controlled trials. Colorectal Disease, 20 (1), 6-15.

6 Simpson, D. M., Blitzer, A., Brashear, A., Comella, C., Dubinsky, R., Hallett, M., et al. (2008, January). Assessment: Botulinum neurotoxin for the treatment of movement disorders (an evidence-based review): Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology, 2008 (70), U. S. Food and Drug Administration. (2018, November). Center for Drug Evaluation and Research. Dysport (abobotulinumtoxina). Retrieved December 5, 2018 from EFFECTIVE DATE 4/2/2019 ID_MRx