See Important Reminder at the end of this policy for important regulatory and legal information.

Transcription

1 Clinical Policy: Botulinum Toxins Reference Number: TCHP.PHAR.1812 Effective Date: Last Review Date: Line of Business: Oregon Health Plan Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Goal(s): Approve botulinum toxins for funded OHP conditions supported by evidence of benefit (e.g., dystonia or spasticity associated with certain neurological diseases). Require positive response to therapy for use in chronic migraine headaches or overactive bladder. Length of Authorization: From 90 days to 12 months Requires PA: Use of botulinum toxins (billed as a pharmacy or physician administered claim) without associated dystonia or neurological disease diagnosis in last 12 months. Covered Alternatives: Current Trillium Preferred Drug List listed at: o Approval Criteria 1. Is the request for a renewal of a previously approved prior authorization for management of migraine headache or detrusor over-activity (e.g., overactive bladder)? 2. What diagnosis is being treated? 3. Does the patient have diagnosis of neurological-induced dystonia or spasticity in which a botulinum toxin is a first-line treatment option? Examples: Genetic torsion dystonia (G24.1); Acquired torsion dystonia (G80.3; G24.02; G24.8); Blepharospasm (G24.5); Spasmodic torticollis (G24.3); Yes: Go to Renewal Criteria Record ICD-10 Code Yes: Approve for up to 12 months Page 1 of 9 No: Go to #2 No: Go to #4

2 Other fragments of torsion dystonia (G24.9); Paralysis associated with CVD (I I69.969); Multiple sclerosis (G35); Neuromyelitis optica (G36.0); Spastic hemiplegia, other specified hemiplegia (G81.00-G81.94); Cerebral palsy (G80.0-G80.9); Quadriplegia and quadraparesis (G82.50-G82.54); Paraplegia (G82.20); Diplegia of upper limbs (G83.0); Monoplegia of lower limb (G G83.14); Monoplegia of upper limb (G G83.24); Unspecified monoplegia (G83.30); Other specified paralytic syndrome (G83.81-G83.89); Muscular dystrophies (G71.0-G71.2); or Strabismus in other neuromuscular disorders (H50.89). 4. Does the patient have a diagnosis of chronic migraine with 15 headache days per month, of which 8 days are with migraine? 5. Is the botulinum toxin administered by, or in consultation with, a neurologist or headache specialist? 6. Has the patient had an inadequate response, or has contraindications, to 1 drugs from each of the following 3 drug classes? Beta-blockers: (propranolol; metoprolol; atenolol; nadolol; or timolol) Tricyclic antidepressants: (nortriptyline or amitriptyline) Anticonvulsants: (divalproex sodium/valproic acid; carbamazepine; topiramate; or gabapentin) Calcium channel blockers (diltiazem; verapamil; or nimodipine) 7. Does patient have a diagnosis of idiopathic or neurogenic detrusor over-activity (e.g., overactive bladder syndrome) (ICD-10 N32.81)? Yes: Go to #5 No: Go to #7 Yes: Go to #6 Yes: Record baseline headaches/month Approve no more than 2 treatments given 3 months apart. Additional treatment requires documented positive response to therapy from baseline (see Renewal Criteria). Yes: Go to #8 appropriateness. appropriateness. Recommend trial of preferred alternatives. Go to #9 Page 2 of 9

3 8. Has the patient had an inadequate response to, or is intolerant of 2 incontinence antimuscarinic drugs (e.g., fesoterodine, osybutynin, solifenacin, darifenacin, tolterodine, or trospium)? Yes: Document: Baseline urine frequency/day Baseline urine incontinence episodes/day Approve for up to 90 days. appropriateness. Additional treatment requires documented positive response to therapy from baseline (see Renewal Criteria). 9. RPh only: Medical literature with evidence for use in funded conditions must be submitted and determined to be appropriate for use before approval is granted. Deny for the following conditions; not funded by the OHP Neurologic conditions with none or minimally effective treatment or treatment not necessary (G22.4; G25.89; G25.81; G25.89; G25.9): Facial nerve disorders (G51.0-G51.9); Spastic dysphonia (J38.7); Anal fissure (K60.2); Disorders of sweat glands (e.g., focal hyperhidrosis) (L30.1; L74.0-L75.9; R61); Other disorders of cervical region (M43.6; M48.02; M53.0; M53.1: M53.82; M54.02; M54.12; M54.2: M67.88); Acute and chronic disorders of the spine without neurologic impairment (M54.6; M54.5: M43.27; M43.28; M53.2X7; M53.2X8; M53.3; M43.8X9; M53.9; M54.08; M54.5; M54.30; M54.14-M54.17; M54.89; M54.9); Disorders of soft tissue (M54.10; M60.9; M79.0-M79.2; M79.7); Headaches (G44.209; G44.009, G44.019; G44.029; G44.039; G44.049; G44.059; G44.099; G44.209; G44.219; G44.221; G44.229; G44.309; G44.319; G44.329; G44.41; G G44.53; G44.59; G44.81-G44.89; G44.1; R51); Gastroparesis (K31.84) Deny for medical appropriateness for the following conditions; evidence of benefit is insufficient Dysphagia (R13.0; R13.10-R13.19); Other extrapyramidal disease and abnormal movement disorders (G10; G23.0-G23.8; G24.01; G24.4; G25.0-G26); Other disorders of binocular eye movements (e.g., esotropia, exotropia, mechanical strabismus, etc.) (H49.00-H51.8); Tics (F95.0-F95.2; F95.9) Laryngeal spasm (J38.5); Spinal stenosis in cervical region or brachial neuritis or radiculitis NOS (M48.02; M M54.13); Spasm of muscle in absence of neurological diagnoses (M62.40-M62.838); Contracture of tendon (sheath) in absence of neurological diagnoses (M62.40; M62.838); Page 3 of 9

4 Amyotropic sclerosis (G12.21); Clinically significant spinal deformity or disorders of spine with neurological impairment (M48.00; M48.04; M48.06; M48.08; M54.14-M54.17); Hyperplasia of prostate (N40.0-N40.3; N42.83) Renewal Criteria 1. Is this a request for renewal of a previously approved prior authorization for management of migraine headache? 2. Is there documentation of a reduction of 6 headache days per month compared to baseline headache frequency? 3. Is this a request for renewal of a previously approved prior authorization for management of idiopathic or neurogenic detrusor over-activity? 4. Is there a reduction of urinary frequency of 8 episodes per day or urinary incontinence of 2 episodes per day compared to baseline frequency? I. Yes: Go to #2 No: Go to #3 Yes: Approve for up to 12 months appropriateness No: Go to Approval Criteria Yes: Go to #4 Yes: Approve for up to 12 months. appropriateness. General Information All botulinum toxin products have a black box warning which cautions patients that the effects of the drug may spread from the area of injection and cause symptoms similar to botulism, including potentially life-threatening swallowing and breathing difficulty. The potency units of botulinum toxin products are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of one product cannot be compared to nor converted into units of any other botulinum toxin products assessed with any other specific assay method. Indication specific dosage and administration recommendations should be followed for Botox. When initiating treatment, the lowest recommended dose should be used. In treating adult patients for one or more indications, the maximum cumulative dose should not exceed 400 Units, in a 3 month interval. For detrusor overactivity associated with a neurologic condition there was no additional benefit of Botox 300 Units over 200 Units. Definition and Classification of Dystonia: Dystonia is defined as a movement disorder characterized by sustained or intermittent muscle contractions causing abnormal, often repetitive, movements, postures, or both. Dystonic movements are typically patterned and twisting, and may be tremulous. Dystonia is often initiated or worsened by voluntary action and associated with overflow muscle activation. Page 4 of 9

5 Dystonia is classified along two axes: Clinical characteristics: Age at onset, body distribution, temporal pattern, associated features (additional movement disorders or neurological features) - the clinical characteristics fall into several specific dystonia syndromes that help to guide diagnosis and treatment; Etiology: Nervous system pathology, inheritance. II. Dosage and Administration Medication Indication OnabotulinumtoxinA (Botox) Dosing Regimen Blepharospasm Strabismus Cervical dystonia Oromandibular dystonia* Spasmodic dysphonia* Overactive bladder Spastic muscle contracture of pediatric cerebral palsy* Childhood myoclonus following failure of Baclofen, benzodiazepines, and antiseizure medications* Chronic anal fissure* Internal anal sphincter achalasia* Maximum Dose 5 units per site 200 units total in a 30day period 2.5 to 5 units per muscle (max 25 units 25 units) 200 to 300 units divided 400 units among affected muscles 25 to 50 units per masseter 100 units muscle, 5 to 40 units per temporalis to 10 units per vocal 400 units cord. 5 to 30 units in abductor muscle Total dose 100 Units, as units ml (5 Units) injections across 20 sites into the detrusor. Repeat doses should be 12 apart 3 to 6 units/kg (maximum units units/kg). total dose 82 to 220 units divided among affected muscles 8 to 80 units/kg 400 units 20 units both sides 80 units/kg 15 units to 25 units in each quadrant or up to 50 units on either side of IAS 100 units Page 5 of 9

6 Medication Indication Dosing Regimen Maximum Dose Axillary 50 units per axilla 100 units Hyperhidrosis Migraines 155 to 195 total units given in 5 to 40 units/site 50 units per axilla Neurogenic 200 units given in multiple 200 units bladder sites Upper Limb 12.5 Units-50 Units in one 400 units Spasticity site AbobotulinumtoxinA (Dysport) Cervical dystonia 500 units IM as a divided dose among the affected 1,000 IncobotulinumtoxinA (Xeomin) Upper limb spasticity Lower limb spasticity muscles units IM divided among selected muscles Adults: Up to 1500 units IM divided among selected muscles Pediatric: units/kg/limb IM divided among selected muscles CD The usual starting dose is 120 units per treatment session, doses up to 300 units may be used in treatment-experienced patients. Dose, number, and location of injection sites should be based on the number and location of muscles involved, severity of dystonia, and response to any previous botulinum toxin injections. Blepharospasm When initiating Xeomin therapy, the dose, number, and location of injections should be based on the previous dosing of Botox. If the previous dose of Botox is not known, the recommended starting dose is units per injection site. 1,000 Adults: 1,500 Pediatric: 1, units/treatme nt session 35 units/eye/trea tment session Page 6 of 9

7 Medication Indication Dosing Regimen Upper limb spasticity Dosing varies based on location of muscles to be treated (refer to dosing chart in the prescribing information). RimabotulinumtoxinB Cervical dystonia The initial dose of Myobloc (Myobloc) for patients with a history of tolerating botulinum toxin injections is 2,500 to 5,000 U divided among affected muscles. Give patients without a history of tolerating botulinum toxin injections a lower initial dose. Maximum Dose 400 units/ treatment session 10,000 Optimize subsequent dosing according to the patient's individual response. The duration of effect has been observed in studies to be between 12 and 16 at doses of 5000 U or 10,000 U. *off-label uses III.Product Availability Medication OnabotulinumtoxinA (Botox) AbobotulinumtoxinA (Dysport) IncobotulinumtoxinA (Xeomin) RimabotulinumtoxinB (Myobloc) Vials: 100 units, 200 units Vials: 300 units, 500 units Vials: 50 units, 100 units, 200 units Vials: 2,500 units, 5,000 units, 10,000 units IV. References 1. Botulinum Toxins. Oregon Health Plan Current Drug Use Criteria. Available at: Accessed March 23, Micromedex Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed March 23, Albanese A, Bhatia K, Bressman SB, et al. Phenomenology and classification of dystonia: a consensus update. Mov Disord. June 15, 2013; 28(7): doi: /mds Page 7 of 9

8 Reviews, Revisions, and Approvals Date P&T Approval Date Policy created. Replaces the following Trillium Criteria: TCHP.PHAR.232 OnabotulinumtoxinA (Botox) Supersedes the following Centene Policies: CP.PHAR.230 AbobotulinumtoxinA (Dysport) CP.PHAR.231 IncobotulinumtoxinA (Xeomin) CP.PHAR.232 OnabotulinumtoxinA (Botox) CP.PHAR.233 RimabotulinumtoxinB (Myobloc) Approved by Trillium Oregon Health Plan P&T Important Reminder This clinical policy has been developed by appropriately experienced and licensed health care professionals based on a review and consideration of currently available generally accepted standards of medical practice; peer-reviewed medical literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and other available clinical information. The Health Plan makes no representations and accepts no liability with respect to the content of any external information used or relied upon in developing this clinical policy. This clinical policy is consistent with standards of medical practice current at the time that this clinical policy was approved. Health Plan means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan s affiliates, as applicable. The purpose of this clinical policy is to provide a guide to medical necessity, which is a component of the guidelines used to assist in making coverage decisions and administering benefits. It does not constitute a contract or guarantee regarding payment or results. Coverage decisions and the administration of benefits are subject to all terms, conditions, exclusions and limitations of the coverage documents (e.g., evidence of coverage, certificate of coverage, policy, contract of insurance, etc.), as well as to state and federal requirements and applicable Health Plan-level administrative policies and procedures. This clinical policy is effective as of the date determined by the Health Plan. The date of posting may not be the effective date of this clinical policy. This clinical policy may be subject to applicable legal and regulatory requirements relating to provider notification. If there is a discrepancy between the effective date of this clinical policy and any applicable legal or regulatory requirement, the requirements of law and regulation shall govern. The Health Plan retains the right to change, amend or withdraw this clinical policy, and additional clinical policies may be developed and adopted as needed, at any time. This clinical policy does not constitute medical advice, medical treatment or medical care. It is not intended to dictate to providers how to practice medicine. Providers are expected to exercise professional medical judgment in providing the most appropriate care, and are solely responsible Page 8 of 9

9 for the medical advice and treatment of members. This clinical policy is not intended to recommend treatment for members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. Providers referred to in this clinical policy are independent contractors who exercise independent judgment and over whom the Health Plan has no control or right of control. Providers are not agents or employees of the Health Plan. This clinical policy is the property of the Health Plan. Unauthorized copying, use, and distribution of this clinical policy or any information contained herein are strictly prohibited. Providers, members and their representatives are bound to the terms and conditions expressed herein through the terms of their contracts. Where no such contract exists, providers, members and their representatives agree to be bound by such terms and conditions by providing services to members and/or submitting claims for payment for such services. Note: For Medicaid members, when state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence. Please refer to the state Medicaid manual for any coverage provisions pertaining to this clinical policy. For Health Insurance Marketplace members, when applicable, this policy applies only when the prescribed agent is on your health plan approved formulary. Request for non-formulary drugs must be reviewed using the formulary exception policy Centene Corporation. All rights reserved. All materials are exclusively owned by Centene Corporation and are protected by United States copyright law and international copyright law. No part of this publication may be reproduced, copied, modified, distributed, displayed, stored in a retrieval system, transmitted in any form or by any means, or otherwise published without the prior written permission of Centene Corporation. You may not alter or remove any trademark, copyright or other notice contained herein. Centene and Centene Corporation are registered trademarks exclusively owned by Centene Corporation. Page 9 of 9