DYSPORT Resource Guide

Transcription

1 DYSPORT Resource Guide Contains helpful information about: Dysport Acquisition Dysport Billing and Coding IPSEN CARES Reimbursement and Support for Healthcare Professionals and Patients Hours: 8:00 AM 8:00 PM ET, Monday Friday Phone: Fax: Website: INDICATIONS Dysport (abobotulinumtoxina) for injection is indicated for the treatment of: Spasticity in adult patients Adults with cervical dystonia Lower limb spasticity in pediatric patients years of age and older IMPORTANT SAFETY INFORMATION Warning: Distant Spread of Toxin Effect Postmarketing reports indicate that the effects of Dysport 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 upper limb spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to or lower than the maximum recommended total dose.

2 Acquisition Options This tip sheet is designed to assist your office in understanding and navigating the options available for providing your patients access to Dysport. Institutions Wholesalers Dysport Acquisition Options Offices Select the Best Option for Your Office If Dysport is Covered Under the Medical Benefit Purchase Dysport Directly (Buy and Bill) Requires upfront financial investment Your office acquires Dysport (abobotulinumtoxina) directly from a select group of Specialty Distributors Your office collects copay/coinsurance directly from the patient Your office seeks reimbursement from payer(s) Specialty Pharmacy Assignment of Benefit (AOB) No upfront financial investment IPSEN CARES can provide helpful information on selecting the appropriate Specialty Pharmacy Provider by calling Patient pays copay/coinsurance directly to Specialty Pharmacy Specialty Pharmacy ships product directly to your office If Dysport is Covered Under the Pharmacy Benefit Specialty Pharmacy No upfront financial investment IPSEN CARES can provide your office with helpful information on selecting the appropriate Specialty Pharmacy Provider Patient pays copay/coinsurance directly to Specialty Pharmacy Specialty Pharmacy ships product directly to your office

3 Authorized Specialty Distributors Specialty Distributor Customer Service/Ordering New Accounts Products Order Times Besse Medical Phone: Phone: Pages/Create Account.aspx Dysport Mon - Thurs: 8:30 am 7:00 pm ET Fri: 8:30 am 5:00 pm ET Sat: Delivery Available by Prior Arrangement Cardinal Specialty Phone: com/specialtyonline Phone: us/en/spd/ordering Dysport Mon - Fri: 7:00 am 6:00 pm CT CuraScript SD Phone: online.com/login.aspx Phone: com/new-accounts Dysport Mon - Fri: 8:30 am 7:00 pm ET McKesson Specialty Health Phone: cialtyhealth.com/ Phone: cialtyhealth.com/ open-an-account Dysport Mon - Fri: 7:00 am 7:00 pm CT The above listed specialty distributors are not associated with Ipsen Biopharmaceuticals, Inc. nor do they represent Ipsen Biopharmaceuticals, Inc. These specialty distributors have been selected by Ipsen to distribute Dysport given their reputation, capabilities, and customer satisfaction ratings. Our goal is to provide you with options to select the specialty distributors that will meet your needs. You are free to engage with any individual specialty distributors or multiple specialty distributors. Feel free to contact your sales representative with any questions. Important Notice This guide was developed to provide physician practices and hospital outpatient office staff with a resource guide to Dysport support offerings and assist in understanding third-party reimbursement for Dysport. The guide is not intended to provide recommendations on clinical practice or legal advice. Laws, regulations, and policies concerning reimbursement are complex and are updated frequently. Although we have made an effort to be current as of the issue date of this document, the information may not be current or comprehensive when you view it. This document represents no statement, promise, or guarantee concerning coverage or levels of reimbursement. Similarly, all International Classification of Diseases, 9th edition; Clinical Modification (-CM); Current Procedural Terminology (CPT ); and Health Care Procedure Coding System (HCPCS) codes for Dysport are supplied for informational purposes. It is always the physician s or facility s responsibility to determine and submit appropriate codes, charges, and modifiers for services that are rendered. It is recommended that you contact your local payers with regard to local reimbursement policies and practices. Please consult your counsel or reimbursement specialist on reimbursement or billing questions specific to your practice. 3

4 Billing and Coding Payers require providers to include standard CPT, HCPCS, and -CM codes on claims for Dysport (abobotulinumtoxina) treatments. Healthcare Common Procedure Coding System (HCPCS) Level II Code: A permanent HCPCS Code has been assigned to report the use of Dysport : Dysport HCPCS Code Description J0586 Injection, abobotulinumtoxina, 5 units Current Procedure Terminology (CPT) Drug Administration Code The following CPT codes may be appropriate to report Dysport administration services: Adults with Cervical Dystonia CPT Code Description Notes 64616* Chemodenervation of muscle(s); neck muscle(s), excluding muscles of the larynx, unilateral (eg, for cervical dystonia, spasmodic torticollis). For bilateral procedure, report with modifier 50. For chemodenervation guided by needle electromyography or muscle electrical stimulation, see 95873, Do not report more than one guidance code for any unit of Ultrasonic guidance for needle placement (eg, biopsy, aspiration, injection, localization device), imaging supervision and interpretation To describe the injection procedure Ultrasound guidance may be used independently or together with electromyography or electrical stimulation based on clinical necessity Electrical stimulation for guidance in conjunction with chemodenervation (list separately in addition to code for primary procedure) Needle electromyography for guidance in conjunction with chemodenervation (list separately in addition to code for primary procedure) To account for guidance using electrical stimulation, use CPT code in addition to the CPT code for the injection To account for the EMG guidance, use CPT code in addition to the CPT code for the injection. Do not report in conjunction with

5 Billing and Coding (continued) Common Diagnostic Codes for Adults with Cervical Dystonia Description G4.3 Spasmodic torticollis *64613 has been deleted. To report, use [Revised as of 013]. For a full list of changes to CMS-1500, please visit IMPORTANT SAFETY INFORMATION (continued) Contraindications Dysport is contraindicated in patients with known hypersensitivity to any botulinum toxin preparation or to any of the components; or in the presence of infection at the proposed injection site(s); or in patients known to be allergic to cow s milk protein. Hypersensitivity reactions including anaphylaxis have been reported. Warnings and Precautions Lack of Interchangeability Between Botulinum Toxin Products The potency Units of Dysport 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 Dysport cannot be compared to or converted into units of any other botulinum toxin products assessed with any other specific assay method. 5

6 Billing and Coding (continued) Healthcare Common Procedure Coding System (HCPCS) Level II Code: A permanent HCPCS Code has been assigned to report the use of Dysport : Dysport HCPCS Code Description J0586 Injection, abobotulinumtoxina, 5 units Current Procedure Terminology (CPT) Drug Administration Code The following CPT codes may be appropriate to report Dysport administration services: Adults with Upper Limb Spasticity CPT Code Description Notes 6464 Chemodenervation of one extremity, 1-4 muscle(s) Each additional extremity, 1-4 muscle(s) Chemodenervation of one extremity; each additional extremity, 1-4 muscle(s) List separately in addition to code for primary procedure Chemodenervation of one extremity, 5 or more muscles Each additional extremity, 5 or more muscle(s) Chemodenervation of one extremity; each additional extremity, 5 or more muscles List separately in addition to code for primary procedure 7694 Ultrasonic guidance for needle placement (eg, biopsy, aspiration, injection, localization device), imaging supervision and interpretation Electrical stimulation for guidance in conjunction with chemodenervation (list separately in addition to code for primary procedure) Needle electromyography for guidance in conjunction with chemodenervation (list separately in addition to code for primary procedure) Ultrasound guidance may be used independently or together with electromyography or electrical stimulation based on clinical necessity To account for guidance using electrical stimulation, use CPT code in addition to the CPT code for the injection To account for the EMG guidance, use CPT code in addition to the CPT code for the injection. Do not report in conjunction with Modifier 50 is not reported with any of the new CPT codes from code range but needle guided EMG or muscle electrical stimulation can additionally be reported with codes or

7 Billing and Coding (continued) Common Diagnostic Codes for Adults with Upper Limb Spasticity Note: This list is not exhaustive. Description Description G81.10 Spastic hemiplegia affecting unspecified side G8.53 Quadriplegia, C5-C7, complete G81.11 Spastic hemiplegia affecting right G8.54 Quadriplegia, C5-C7, incomplete G81.1 Spastic hemiplegia affecting left G83.0 Diplegia of upper limbs, Diplegia (Upper), Paralysis of both upper limbs G81.13 Spastic hemiplegia affecting right non G83.0 Monoplegia of upper limb affecting unspecified side G81.14 Spastic hemiplegia affecting left non G83.1 Monoplegia of upper limb affecting right G80.1 Spastic diplegic cerebral palsy G83. Monoplegia of upper limb affecting left G80. Spastic hemiplegic cerebral palsy G83.3 Monoplegia of upper limb affecting right non G80.0 Spastic quadriplegic cerebral palsy G83.4 Monoplegia of upper limb affecting left non 7

8 Billing and Coding (continued) Common Diagnostic Codes for Adults with Upper Limb Spasticity (continued) Description Description I Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting unspecified side I69.59 Hemiplegia and hemiparesis intracranial hemorrhage affecting unspecified side I Hemiplegia and hemiparesis following cerebral infarction affecting unspecified side I Hemiplegia and hemiparesis following other cerebrovascular disease affecting unspecified side I69.15 Hemiplegia and hemiparesis following nontraumatic intracerebral hemorrhage affecting left I69.51 Hemiplegia and hemiparesis intracranial hemorrhage affecting right I69.5 Hemiplegia and hemiparesis intracranial hemorrhage affecting left I Hemiplegia and hemiparesis following cerebral infarction affecting right I Hemiplegia and hemiparesis following unspecified cerebrovascular disease affecting unspecified side I69.35 Hemiplegia and hemiparesis following cerebral infarction affecting left I Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting right I69.05 Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting left I Hemiplegia and hemiparesis following other cerebrovascular disease affecting right I69.85 Hemiplegia and hemiparesis following other cerebrovascular disease affecting left I Hemiplegia and hemiparesis following nontraumatic intracerebral hemorrhage affecting right I Hemiplegia and hemiparesis following unspecified cerebrovascular disease affecting right 8

9 Billing and Coding (continued) Common Diagnostic Codes for Adults with Upper Limb Spasticity (continued) Description Description I69.95 Hemiplegia and hemiparesis following unspecified cerebrovascular disease affecting left I Hemiplegia and hemiparesis following cerebral infarction affecting left non I Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting right non I Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting left non I Hemiplegia and hemiparesis following nontraumatic intracerebral hemorrhage affecting right non I Hemiplegia and hemiparesis following nontraumatic intracerebral hemorrhage affecting left non I69.53 Hemiplegia and hemiparesis intracranial hemorrhage affecting right non I69.54 Hemiplegia and hemiparesis intracranial hemorrhage affecting left non I Hemiplegia and hemiparesis following cerebral infarction affecting right non I Hemiplegia and hemiparesis following other cerebrovascular disease affecting right non I Hemiplegia and hemiparesis following other cerebrovascular disease affecting left non I Hemiplegia and hemiparesis following unspecified cerebrovascular disease affecting right non I Hemiplegia and hemiparesis following unspecified cerebrovascular disease affecting left non I Monoplegia of upper limb following nontraumatic subarachnoid hemorrhage affecting unspecified side I Monoplegia of upper limb following nontraumatic intracerebral hemorrhage affecting unspecified side I69.39 Monoplegia of upper limb intracranial hemorrhage affecting unspecified side 9

10 Billing and Coding (continued) Common Diagnostic Codes for Adults with Upper Limb Spasticity (continued) Description I Monoplegia of upper limb following cerebral infarction affecting unspecified side I Monoplegia of upper limb following other cerebrovascular disease affecting unspecified side Description I69.3 Monoplegia of upper limb intracranial hemorrhage affecting left I Monoplegia of upper limb following cerebral infarction affecting right I Monoplegia of upper limb following unspecified cerebrovascular disease affecting unspecified side I Monoplegia of upper limb following nontraumatic subarachnoid hemorrhage affecting right I69.03 Monoplegia of upper limb following nontraumatic subarachnoid hemorrhage affecting left I Monoplegia of upper limb following nontraumatic intracerebral hemorrhage affecting right I69.13 Monoplegia of upper limb following nontraumatic intracerebral hemorrhage affecting left I69.31 Monoplegia of upper limb intracranial hemorrhage affecting right I69.33 Monoplegia of upper limb following cerebral infarction affecting left I Monoplegia of upper limb following other cerebrovascular disease affecting right I69.83 Monoplegia of upper limb following other cerebrovascular disease affecting left I Monoplegia of upper limb following unspecified cerebrovascular disease affecting right I69.93 Monoplegia of upper limb following unspecified cerebrovascular disease affecting left I Monoplegia of upper limb following nontraumatic subarachnoid hemorrhage affecting right non 10

11 Billing and Coding (continued) Common Diagnostic Codes for Adults with Upper Limb Spasticity (continued) Description Description I Monoplegia of upper limb following nontraumatic subarachnoid hemorrhage affecting left non I Monoplegia of upper limb following nontraumatic intracerebral hemorrhage affecting right non I Monoplegia of upper limb following nontraumatic intracerebral hemorrhage affecting left non I Monoplegia of upper limb following other cerebrovascular disease affecting left non I Monoplegia of upper limb following unspecified cerebrovascular disease affecting right non I Monoplegia of upper limb following unspecified cerebrovascular disease affecting left non I69.33 Monoplegia of upper limb intracranial hemorrhage affecting right non I69.34 Monoplegia of upper limb intracranial hemorrhage affecting left non I Monoplegia of upper limb following cerebral infarction affecting right non I Monoplegia of upper limb following cerebral infarction affecting left non I Monoplegia of upper limb following other cerebrovascular disease affecting right non 11

12 Billing and Coding (continued) Healthcare Common Procedure Coding System (HCPCS) Level II Code: A permanent HCPCS Code has been assigned to report the use of Dysport : Dysport HCPCS Code Description J0586 Injection, abobotulinumtoxina, 5 units Current Procedure Terminology (CPT) Drug Administration Code The following CPT codes may be appropriate to report Dysport administration services: Adults with Lower Limb Spasticity CPT Code Description 6464 Chemodenervation of one extremity, 1-4 muscle(s) Each additional extremity, 1-4 muscle(s) Chemodenervation of one extremity; each additional extremity, 1-4 muscle(s) List separately in addition to code for primary procedure Chemodenervation of one extremity, 5 or more muscles Each additional extremity, 5 or more muscle(s) Chemodenervation of one extremity; each additional extremity, 5 or more muscles List separately in addition to code for primary procedure 7694 Ultrasonic guidance for needle placement (eg, biopsy, aspiration, injection, localization device), imaging supervision and interpretation Ultrasound guidance may be used independently or together with electromyography or electrical stimulation based on clinical necessity Electrical stimulation for guidance in conjunction with chemodenervation (list separately in addition to code for primary procedure) To account for guidance using electrical stimulation, use CPT code in addition to the CPT code for the injection Needle electromyography for guidance in conjunction with chemodenervation (list separately in addition to code for primary procedure) To account for the EMG guidance, use CPT code in addition to the CPT code for the injection. Do not report in conjunction with

13 Billing and Coding (continued) Common Diagnostic Codes for Adults with Lower Limb Spasticity (continued) Description Description G11.4 Hereditary spastic paraplegia G81.14 Spastic hemiplegic affecting left non G80.0 Spastic quadriplegic cerebral palsy Congenital spastic paralysis (cerebral) G8.0 Paraplegia, unspecified G80.1 Spastic diplegic cerebral palsy Spastic cerebral palsy NOS G8.1 Paraplegia, complete G80. Spastic hemiplegic cerebral palsy G8. Paraplegia, incomplete G80.8 Other cerebral palsy Mixed cerebral palsy syndromes G8.51 Quadriplegia, C1-C4 complete G80.9 Cerebral palsy, unspecified Cerebral palsy NOS G8.5 Quadriplegia, C1-C4 incomplete G81.10 Spastic hemiplegia affecting unspecified side G83.10 Monoplegia of lower limb affecting unspecified side G81.11 Spastic hemiplegic affecting right G83.11 Monoplegia of lower limb affecting right G81.1 Spastic hemiplegic affecting left G83.1 Monoplegia of lower limb affecting left G81.13 Spastic hemiplegic affecting right non G83.13 Monoplegia of lower limb affecting right non 13

14 Billing and Coding (continued) Common Diagnostic Codes for Adults with Lower Limb Spasticity (continued) Description Description G83.14 Monoplegia of lower limb affecting left non G83.31 Monoplegia, unspecified affecting right G83.3 Monoplegia, unspecified affecting left G83.33 Monoplegia, unspecified affecting right non G83.34 Monoplegia, unspecified affecting left non I Monoplegia of lower limb following nontraumatic subarachnoid hemorrhage affecting right I69.04 Monoplegia of lower limb following nontraumatic subarachnoid hemorrhage affecting left I Monoplegia of lower limb following nontraumatic subarachnoid hemorrhage affecting right non I Monoplegia of lower limb following nontraumatic subarachnoid hemorrhage affecting left non I Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting right I69.05 Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting left I Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting right non I Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting left non I Monoplegia of lower limb following nontraumatic intracerebral hemorrhage affecting right I69.14 Monoplegia of lower limb following nontraumatic intracerebral hemorrhage affecting left I Monoplegia of lower limb following nontraumatic intracerebral hemorrhage affecting right non 14

15 Billing and Coding (continued) Common Diagnostic Codes for Adults with Lower Limb Spasticity (continued) Description Description I Monoplegia of lower limb following nontraumatic intracerebral hemorrhage affecting left non I Hemiplegia and hemiparesis following nontraumatic intracerebral hemorrhage affecting right I69.15 Hemiplegia and hemiparesis following nontraumatic intracerebral hemorrhage affecting left I Hemiplegia and hemiparesis following nontraumatic intracerebral hemorrhage affecting right non I Hemiplegia and hemiparesis following nontraumatic intracerebral hemorrhage affecting left non I69.41 Monoplegia of lower limb intracranial hemorrhage affecting right I69.4 Monoplegia of lower limb intracranial hemorrhage affecting left I69.43 Monoplegia of lower limb intracranial hemorrhage affecting right non I69.44 Monoplegia of lower limb intracranial hemorrhage affecting left non I69.51 Hemiplegia and hemiparesis intracranial hemorrhage affecting right I69.5 Hemiplegia and hemiparesis intracranial hemorrhage affecting left I69.53 Hemiplegia and hemiparesis intracranial hemorrhage affecting right non I69.54 Hemiplegia and hemiparesis intracranial hemorrhage affecting left non I Monoplegia of lower limb following cerebral infarction affecting right I69.34 Monoplegia of lower limb following cerebral infarction affecting left I Monoplegia of lower limb following cerebral infarction affecting right non 15

16 Billing and Coding (continued) Common Diagnostic Codes for Adults with Lower Limb Spasticity (continued) Description Description I Monoplegia of lower limb following cerebral infarction affecting left non I Monoplegia of lower limb following other cerebrovascular disease affecting left non I Hemiplegia and hemiparesis following cerebral infarction affecting right I Hemiplegia and hemiparesis following other cerebrovascular disease affecting right I69.35 Hemiplegia and hemiparesis following cerebral infarction affecting left I69.85 Hemiplegia and hemiparesis following other cerebrovascular disease affecting left I Hemiplegia and hemiparesis following cerebral infarction affecting left I Hemiplegia and hemiparesis following other cerebrovascular disease affecting right non I Hemiplegia and hemiparesis following cerebral infarction affecting right non I Hemiplegia and hemiparesis following other cerebrovascular disease affecting left non I Monoplegia of lower limb following other cerebrovascular disease affecting right I Monoplegia of lower limb following unspecified cerebrovascular disease affecting right I69.84 Monoplegia of lower limb following other cerebrovascular disease affecting left I69.94 Monoplegia of lower limb following unspecified cerebrovascular disease affecting left I Monoplegia of lower limb following other cerebrovascular disease affecting right non I Monoplegia of lower limb following unspecified cerebrovascular disease affecting right non 16

17 Billing and Coding (continued) Common Diagnostic Codes for Adults with Lower Limb Spasticity (continued) Description Description I Monoplegia of lower limb following unspecified cerebrovascular disease affecting left non I Hemiplegia and hemiparesis following unspecified cerebrovascular disease affecting right I69.95 Hemiplegia and hemiparesis following unspecified cerebrovascular disease affecting left I Hemiplegia and hemiparesis following unspecified cerebrovascular disease affecting right non I Hemiplegia and hemiparesis following unspecified cerebrovascular disease affecting left non M6.451 Contracture of muscle, right thigh M6.46 Contracture of muscle, left lower leg M6.471 Contracture of muscle, right ankle and foot M6.47 Contracture of muscle, left ankle and foot M6.48 Contracture of muscle, other site M6.49 Contracture of muscle, multiple sites M6.831 Muscle spasm of calf M6.45 Contracture of muscle, left thigh M6.838 Other muscle spasm M6.461 Contracture of muscle, right lower leg R5. Cramp and spasm 17

18 Billing and Coding (continued) Healthcare Common Procedure Coding System (HCPCS) Level II Code: A permanent HCPCS Code has been assigned to report the use of Dysport : Dysport HCPCS Code Description J0586 Injection, abobotulinumtoxina, 5 units Current Procedure Terminology (CPT) Drug Administration Code The following CPT codes may be appropriate to report Dysport administration services: Pediatric Lower Limb Spasticity and Older CPT Code Description 6464 Chemodenervation of one extremity, 1-4 muscle(s) Each additional extremity, 1-4 muscle(s) Chemodenervation of one extremity; each additional extremity, 1-4 muscle(s) List separately in addition to code for primary procedure Chemodenervation of one extremity, 5 or more muscles Each additional extremity, 5 or more muscle(s) Chemodenervation of one extremity; each additional extremity, 5 or more muscles List separately in addition to code for primary procedure 7694 Ultrasonic guidance for needle placement (eg, biopsy, aspiration, injection, localization device), imaging supervision and interpretation Ultrasound guidance may be used independently or together with electromyography or electrical stimulation based on clinical necessity Electrical stimulation for guidance in conjunction with chemodenervation (list separately in addition to code for primary procedure) To account for guidance using electrical stimulation, use CPT code in addition to the CPT code for the injection Needle electromyography for guidance in conjunction with chemodenervation (list separately in addition to code for primary procedure) To account for the EMG guidance, use CPT code in addition to the CPT code for the injection. Do not report in conjunction with

19 Billing and Coding (continued) Common Diagnostic Codes for Pediatric Lower Limb Spasticity and Older Description Description G11.4 Hereditary spastic paraplegia G81.14 Spastic hemiplegic affecting left non G80.0 Spastic quadriplegic cerebral palsy Congenital spastic paralysis (cerebral) G8.0 Paraplegia, unspecified G80.1 Spastic diplegic cerebral palsy Spastic cerebral palsy NOS G8.1 Paraplegia, complete G80. Spastic hemiplegic cerebral palsy G8. Paraplegia, incomplete G80.8 Other cerebral palsy Mixed cerebral palsy syndromes G8.51 Quadriplegia, C1-C4 complete G80.9 Cerebral palsy, unspecified Cerebral palsy NOS G8.5 Quadriplegia, C1-C4 incomplete G81.10 Spastic hemiplegia affecting unspecified side G83.10 Monoplegia of lower limb affecting unspecified side G81.11 Spastic hemiplegic affecting right G83.11 Monoplegia of lower limb affecting right G81.1 Spastic hemiplegic affecting left G83.1 Monoplegia of lower limb affecting left G81.13 Spastic hemiplegic affecting right non G83.13 Monoplegia of lower limb affecting right non 19

20 Billing and Coding (continued) Common Diagnostic Codes for Pediatric Lower Limb Spasticity and Older (continued) Description Description G83.14 Monoplegia of lower limb affecting left non G83.31 Monoplegia, unspecified affecting right G83.3 Monoplegia, unspecified affecting left G83.33 Monoplegia, unspecified affecting right non G83.34 Monoplegia, unspecified affecting left non I Monoplegia of lower limb following nontraumatic subarachnoid hemorrhage affecting right I69.04 Monoplegia of lower limb following nontraumatic subarachnoid hemorrhage affecting left I Monoplegia of lower limb following nontraumatic subarachnoid hemorrhage affecting right non I Monoplegia of lower limb following nontraumatic subarachnoid hemorrhage affecting left non I Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting right I69.05 Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting left I Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting right non I Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting left non I Monoplegia of lower limb following nontraumatic intracerebral hemorrhage affecting right I69.14 Monoplegia of lower limb following nontraumatic intracerebral hemorrhage affecting left I Monoplegia of lower limb following nontraumatic intracerebral hemorrhage affecting right non I Monoplegia of lower limb following nontraumatic intracerebral hemorrhage affecting left non I Hemiplegia and hemiparesis following nontraumatic intracerebral hemorrhage affecting right I69.15 Hemiplegia and hemiparesis following nontraumatic intracerebral hemorrhage affecting left I Hemiplegia and hemiparesis following nontraumatic intracerebral hemorrhage affecting right non I Hemiplegia and hemiparesis following nontraumatic intracerebral hemorrhage affecting left non I69.41 Monoplegia of lower limb following other nontraumatic intracranial hemorrhage affecting right 0

21 Billing and Coding (continued) Common Diagnostic Codes for Pediatric Lower Limb Spasticity and Older (continued) Description Description I69.4 Monoplegia of lower limb intracranial hemorrhage affecting left I69.43 Monoplegia of lower limb intracranial hemorrhage affecting right non I69.44 Monoplegia of lower limb intracranial hemorrhage affecting left non I69.51 Hemiplegia and hemiparesis intracranial hemorrhage affecting right I69.5 Hemiplegia and hemiparesis intracranial hemorrhage affecting left I69.53 Hemiplegia and hemiparesis intracranial hemorrhage affecting right non I69.54 Hemiplegia and hemiparesis intracranial hemorrhage affecting left non I Monoplegia of lower limb following cerebral infarction affecting right I Monoplegia of lower limb following cerebral infarction affecting left non I Hemiplegia and hemiparesis following cerebral infarction affecting right I69.35 Hemiplegia and hemiparesis following cerebral infarction affecting left I Hemiplegia and hemiparesis following cerebral infarction affecting left I Hemiplegia and hemiparesis following cerebral infarction affecting right non I Monoplegia of lower limb following other cerebrovascular disease affecting right I69.84 Monoplegia of lower limb following other cerebrovascular disease affecting left I Monoplegia of lower limb following other cerebrovascular disease affecting right non I69.34 Monoplegia of lower limb following cerebral infarction affecting left I Monoplegia of lower limb following other cerebrovascular disease affecting left non I Monoplegia of lower limb following cerebral infarction affecting right non I Hemiplegia and hemiparesis following other cerebrovascular disease affecting right 1

22 Billing and Coding (continued) Common Diagnostic Codes for Pediatric Lower Limb Spasticity and Older (continued) Description Description I69.85 Hemiplegia and hemiparesis following other cerebrovascular disease affecting left M6.451 Contracture of muscle, right thigh I Hemiplegia and hemiparesis following other cerebrovascular disease affecting right non M6.45 Contracture of muscle, left thigh I Hemiplegia and hemiparesis following other cerebrovascular disease affecting left non M6.461 Contracture of muscle, right lower leg I Monoplegia of lower limb following unspecified cerebrovascular disease affecting right M6.46 Contracture of muscle, left lower leg I69.94 Monoplegia of lower limb following unspecified cerebrovascular disease affecting left M6.471 Contracture of muscle, right ankle and foot I Monoplegia of lower limb following unspecified cerebrovascular disease affecting right non M6.47 Contracture of muscle, left ankle and foot I Monoplegia of lower limb following unspecified cerebrovascular disease affecting left non M6.48 Contracture of muscle, other site I Hemiplegia and hemiparesis following unspecified cerebrovascular disease affecting right M6.49 Contracture of muscle, multiple sites I69.95 Hemiplegia and hemiparesis following unspecified cerebrovascular disease affecting left M6.831 Muscle spasm of calf I Hemiplegia and hemiparesis following unspecified cerebrovascular disease affecting right non M6.838 Other muscle spasm I Hemiplegia and hemiparesis following unspecified cerebrovascular disease affecting left non R5. Cramp and spasm

23 Additional Information: Consult with Individual Payers as Appropriate Evaluation and Management (E&M) Services: E&M or office visit services in addition to injection may be appropriate. Most payers require documentation of a separate and identifiable procedure Use of Modifiers: Document procedure modifier codes on the claim form. Coding advice from the American Academy of Neurology may differ from the payer s requirements Average Sales Price (ASP): ASP is reported by the manufacturer and published by the Centers for Medicare & Medicaid Services (CMS) quarterly Drug Wastage: Some, but not all, payers allow payment for discarded drug from single-use vials. Contact your Ipsen Field Reimbursement Manager for information on local policies For additional medical information about Dysport, please call Always verify the patient s health insurance benefits prior to injecting neurotoxins. Medicare contractor coverage policies for neurotoxins vary and are publicly available on the Centers for Medicare and Medicaid Services (CMS) website at CPT is 017 American Medical Association (AMA). All rights reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. 3

24 Sample CMS-1500 claim form for Dysport (abobotulinumtoxina) - physician office setting * Box 1 Enter the appropriate ICD- 10-CM diagnosis code, eg, G81.11 for Spastic hemiplegia affecting right (upper limb spasticity). Code to the highest level of specificity. -CM diagnosis codes contain 3-7 digits. It is recommended that providers verify each payer s specific coding requirements prior to injecting. Box 3 Input the authorization number if obtained from the insurance provider. Box 4E For each code, insert the number corresponding to the appropriate diagnosis code in field 1. Box 4A Box 4D Box 4G In the shaded area list the N4 qualifier, the 11 digit drug NDC#, the unit of measurement qualifier, and dosage. Example: UN (Note: some payers may request the NDC number be listed in box 19.) In the non-shaded area, list the date of service. Include the appropriate CPT codes to report administration procedures, eg, 6464 (Chemodenervation of one extremity, 1-4 muscle[s], eg, for upper limb spasticity). For Dysport, use the unique HCPCS code required by payer. Also, include appropriate modifiers as instructed by payer. Report the appropriate number of units for the procedure and the appropriate number of HCPCS Units for Dysport J0586 (500-Unit vial = 100 billing units, and 300-Unit vial = 60 billing units). Note: For Dysport obtained through a specialty pharmacy, no charges for the drug should be billed by the provider. However, inclusion of the HCPCS code (J0586) is recommended to designate the drug administered and number of units administered. Consult with the individual payer to determine the appropriate method of documenting and billing for drugs obtained through a specialty pharmacy. 4

25 Sample CMS claim form for Dysport (abobotulinumtoxina) - hospital outpatient setting * Box 4 Box 45 Revenue Code: Enter the appropriate numeric code to identify specific accommodations and/or ancillary service in ascending numeric order by date of service if applicable. For the administration, list the revenue code for the cost center where services, were performed (eg, 0510, clinic, 500, outpatient services, etc). For Dysport, most often revenue code 0636, drugs requiring detailed coding will be used. Use revenue code 050, general pharmacy for payers who do not recognize the 0636 revenue code. Service Date: Enter the date on which the service was performed using MMDDYY format. Box 46 Service Units: Report the appropriate number of units for the procedure and the appropriate number of HCPCS Units for Dysport, J0586 (500-Unit vial = 100 billing units, and 300-Unit vial = 60 billing units). Box 43 Revenue Description: Enter the narrative description of the related room and board and/ or ancillary categories shown in field 4. For payers that require a detailed drug description a drug description can be inputted. The N4 indicator is listed first, followed by the appropriate Dysport 11 digit NDC number, next a code describing the unit of measurement qualifier is listed and followed by the unit quantity. Box 44 Use the appropriate CPT code to report the administration procedure and unique HCPCS code for Dysport (J0586). Note: For Dysport obtained through a specialty pharmacy, no charges for the drug should be billed by the provider. However, inclusion of the HCPCS code (J0586) is recommended to designate the drug administered and number of units administered. Consult with the individual payer to determine the appropriate method of documenting and billing for drugs obtained through a specialty pharmacy. Box 67 Enter the appropriate primary -CM diagnosis code, eg, G81.11 for Spastic hemiplegia affecting right (upper limb spasticity). Code to the highest level of specificity. -CM diagnosis codes contain 3-7 digits. It is recommended that providers verify each payer s specific coding requirements prior to injecting. * The healthcare provider is responsible for determining appropriate codes and is directed to consult with the payer for acceptable codes. The diagnosis and procedure codes listed on these sample claim forms are provided as examples only. Current Procedural Terminology (CPT) codes 016 American Medical Association (AMA). All rights reserved. 5

26 Two strengths available for Dysport 500-Unit vial NDC * Box containing 1 sterile, single-use vial. Each single-use vial contains 500 Units of freeze-dried abobotulinumtoxina, 15 μg human serum albumin, and.5 mg lactose. HCPCS: J0586 Billing units: Unit vial NDC * Box containing 1 sterile, single-use vial. Each single-use vial contains 300 Units of freeze-dried abobotulinumtoxina, 15 μg human serum albumin, and.5 mg lactose. HCPCS: J0586 Billing units: 60 HCPCS Coding for Dysport : J0586 (injection, abobotulinumtoxina, 5 units) *Please note that for billing purposes, the NDC number requires 11 digits. Therefore, a zero must be entered into the 10th position (eg, ). This is consistent with Red Book and First DataBank listings. J0586 effective as of January 1, 010. One billing unit represents 5 Dysport dosing Units. Contact IPSEN CARES or your Ipsen Field Reimbursement Manager for a current list of authorized specialty distributors or how to access product through specialty pharmacies. JW Modifier Effective January 1, 017, Medicare requires providers to use the JW modifier (Drug amount discarded/ not administered to any patient) for all claims with unused drugs or biologicals from single use vials that are appropriately discarded, and to document the discarded drug or biological in the patient s medical record. Wastage-reporting requirements for payers other than Medicare may vary providers should check with their specific plans about policies related to use of the JW modifier. 6

27 Dysport Pack Dimensions Approximate Dimensions - Unit Depth: 1, Height: 1 7/8, Width: 3 Handling and Storage Information Dysport for Injection is supplied in a sterile, single-use, 3 ml glass vial. Dysport must be stored under refrigeration at C 8 C (36 F 46 F). Protect from light. Sales Unit to Trade One dispensing pack Product Expiration The expiration date is printed on each dispensing pack and the vial. Special Shipping Requirement Dysport is labeled with specific transportation and storage requirements. Care should be taken to ensure that temperature control at C 8 C (36 F 46 F) is maintained during these activities. Ipsen will ship Dysport in a manner that maintains this temperature during transport from Ipsen to the product destination. Specialty Distributors and Specialty Pharmacies should also package and ship Dysport in a manner that maintains this same environment. Customers should call if they have any questions pertaining to proper shipping. Product Returns Credit for returns is subject to Ipsen s current Return Goods Policy. Returns and Return Authorizations must meet Ipsen Return Goods Policy requirements. Phone:

28 IMPORTANT SAFETY INFORMATION (continued) Warnings and Precautions (continued) Dysphagia and Breathing Difficulties Treatment with Dysport 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 side 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 weeks, 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. Patients treated with botulinum toxin may require immediate medical attention should they develop problems with swallowing, speech, or respiratory disorders. These reactions can occur within hours to weeks after injection with botulinum toxin. Pre-existing Neuromuscular Disorders Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junction 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 Dysport. Human Albumin and Transmission of Viral Diseases This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vcjd). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD, or vcjd have ever been identified for licensed albumin or albumin contained in other licensed products. Intradermal Immune Reaction The possibility of an immune reaction when injected intradermally is unknown. The safety of Dysport for the treatment of hyperhidrosis has not been established. Dysport is approved only for intramuscular injection. Adverse Reactions Most common adverse reactions ( % and greater than Placebo in either Dysport group) in adults with upper limb spasticity for Dysport 500 Units, Dysport 1000 Units, and Placebo, respectively, were: nasopharyngitis (4%, 1%, 1%), urinary tract infection (3%, 1%, %), muscular weakness (%, 4%, 1%), musculoskeletal pain (3%, %, %), dizziness (3%, 1%, 1%), fall (%, 3%, %), and depression (%, 3%, 1%). Most common adverse reactions ( 5% and greater than placebo in either Dysport group) in adults with lower limb spasticity for Dysport 1000 Units, Dysport 1500 Units, and Placebo, respectively, were: falls (9%, 6%, 3%), muscular weakness (%, 7%, 3%), and pain in extremity (6%, 6%, %). Muscular weakness was reported more frequently in women (10%) treated with 1500 units of Dysport compared to men (5%). Most common adverse reactions ( 5% and greater than Placebo) in adults with cervical dystonia for Dysport 500 Units and Placebo, respectively, were: muscular weakness (16%, 4%), dysphagia (15%, 4%), dry mouth (13%, 7%), injection site discomfort (13%, 8%), fatigue (1%, 10%), headache (11%, 9%), musculoskeletal pain (7%, 3%), dysphonia (6%, %), injection site pain (5%, 4%), and eye disorders (7%, %). Most common adverse reactions ( 10% in any group and greater than Placebo) in pediatric patients with lower limb spasticity for Dysport 10 Units/kg, 15 Units/kg, 0 Units/kg, or 30 Units/kg; and Placebo, respectively, were: upper respiratory tract infection (9%, 0%, 5%, 10%, 13%), nasopharyngitis (9%, 1%, 16%, 10%, 5%), influenza (0%, 10%, 14%, 3%, 8%), pharyngitis (5%, 0%, 11%, 3%, 8%), cough (7%, 6%, 14%, 10%, 6%), and pyrexia (7%, 1%, 8%, 7%, 5%). 8

29 Drug Interactions Co-administration of Dysport and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like agents), or muscle relaxants, should be observed closely because the effect of botulinum toxin may be potentiated. Use of anticholinergic drugs after administration of Dysport may potentiate systemic anticholinergic effects, such as blurred vision. The effect of administering different botulinum neurotoxins at the same time or within several months of each other is unknown. Excessive weakness may be exacerbated by another administration of botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin. Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of Dysport. Use in Pregnancy Based on animal data, Dysport may cause fetal harm. There are no adequate and well-controlled studies in pregnant women. Dysport should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Pediatric Use Based on animal data Dysport may cause atrophy of injected and adjacent muscles; decreased bone growth, length, and mineral content; delayed sexual maturation; and decreased fertility. Geriatric Use In general, elderly patients should be observed to evaluate their tolerability of Dysport, due to the greater frequency of concomitant disease and other drug therapy. Subjects aged 65 years and over who were treated with Dysport for lower limb spasticity reported a greater percentage of fall and asthenia as compared to those younger (10% versus 6%, and 4% versus %, respectively). To report SUSPECTED ADVERSE REACTIONS or product complaints, contact Ipsen at You may also report SUSPECTED ADVERSE REACTIONS to the FDA at FDA-1088 or Please see Dysport Full Prescribing Information including Boxed Warning and Medication Guide. 9

30 Personal Support at Your Patients Fingertips The IPSEN CARES team is fully dedicated to: Facilitating patients access to the Ipsen medications that are important to their care Providing information and support for the interactions between the HCP office, patients, and insurance companies IPSEN CARES provides a single point of contact dedicated to supporting you, your staff, and your patients. Ipsen is proud of our patient support program, IPSEN CARES, which is available for your patients and your practice. Phone: Fax: Hours: 8:00 am 8:00 pm ET, Monday Friday Website: REIMBURSEMENT ASSISTANCE Benefits Verification verifies patients coverage, restrictions (if applicable), and copayment/coinsurance amounts Prior Authorization (PA) provides information on documentation required by payers on PA specifics, and recommendations for next steps based on payer policy Appeals Support provides information on the payer-specific processes required to submit a level I or a level II appeal, as well as provides guidance as needed through the process FINANCIAL SUPPORT Copay Assistance Program covers most out-of-pocket costs related to the use of Dysport for eligible* patients Patient Assistance Program (PAP) determines patients eligibility for PAP and dispenses free product to eligible patients PRODUCT DISTRIBUTION Institutions Dysport can be acquired from wholesaler Private Practices Direct (buy-and-bill) acquisition from a select group of specialty distributors Specialty Pharmacy delivery (IPSEN CARES can provide helpful information on selection of the appropriate specialty provider by calling ) PATIENT SUPPORT 360 Communication conducts calls to both healthcare provider and patient with status updates about patient s IPSEN CARES enrollment, benefits verification results, coverage status, dispense date, etc *Please see page 33 for Patient Eligibility & Terms and Conditions. Patients may be eligible to receive free drug if they are experiencing financial hardship, have no insurance coverage, are US residents, and received a prescription for an on-label use of Dysport, as supported by information provided in the Program application. Eligibility does not guarantee approval for participation in the program. The PAP provides Dysport product only, and does not cover the cost of previously purchased product or medical services. 30

31 Patient Savings on Private Insurance Copay, Deductible, and Coinsurance Costs for Dysport Dysport Copay Assistance Program Savings may be applied for up to four injections per calendar year. Eligible * patients may receive up to a $5,000 savings during the calendar year. Beginning or currently receiving treatment with Dysport Being treated for an approved indication for Dysport Currently have commercial insurance that covers the medication and associated cost of Dysport, or uninsured patients who pay their entire out-of-pocket cost Four Simple Steps for enrolled patients to receive their Dysport savings: 1 Patient receives treatment with Dysport. Physician follows standard procedure for collection of patient copay. Provider submits claim to patient s insurance company and to the program. Provider then submits secondary claim to the IPSEN CARES program. (Instructions to submit claims to the program will be sent to the provider s office.) Provider can also call IPSEN CARES at for processing instructions. 3 IPSEN CARES will process the claim for copay assistance and notify the patient and provider of the claim status. 4 Physician office will receive funds for approved copay assistance claims directly from IPSEN CARES in the manner they receive primary insurance payments (either EFT or check, based on how they were set up). More details regarding enrollment are available by calling IPSEN CARES. If your office does not accept medical claims processing for your patient s out-of-pocket expenses of Dysport through a specialty pharmacy provider, your patient may qualify to receive a copay assistance check by submitting required information, including a valid proof of purchase, via fax to IPSEN CARES at If your office does not want to participate in the program, the patient can submit their Explanation of Benefits (EOB) to IPSEN CARES at For additional information about the Dysport Copay Assistance Program call: Monday Friday 8:00 am 8:00 pm ET For additional information, visit us online at 31

32 Frequently Asked Questions Q: A: Q: A: Q: A: Q: A: Q: A: Q: A: Q: A: Q: A: How do patients receive Dysport Copay Assistance? First, a patient must satisfy the requirements of eligibility and then be enrolled in IPSEN CARES. Once a patient has successfully enrolled in the program, their Doctor s office can then submit a secondary copay assistance claim to IPSEN CARES following treatment. Where can the Dysport Copay Assistance Program be used? The Dysport (abobotulinumtoxina) Copay Assistance Program is meant to be used at the physician s office/practice or hospital when utilizing the patient s medical benefits. A patient does not have commercial insurance. Are they eligible* for the Dysport Copay Assistance Program? Yes, uninsured patients who are not eligible to participate in state or federally funded programs are eligible for the Dysport Copay Assistance Program. What if the patient is unable to use the Dysport Copay Assistance Program at their physician s office/practice or pharmacy? The patient may request copay assistance via a mail-in request when utilizing their Pharmacy Benefit or if their Provider cannot use the Copay Assistance Program at their physician s office. The patient must submit a request for a check and valid Explanation of Benefits (EOB), which includes, but is not limited to, quantity dispensed, days supply, drug name and NDC, and patient s copay. This information can be faxed to or mailed to IPSEN CARES, 50 Perimeter Park Drive, Suite 00, Morrisville, NC Once verified, a check for the patient s savings amount will be mailed to the patient within 7-10 business days. A patient has multiple EOBs that need payment. Can multiple EOB submissions be sent for payment at one time? Yes. Subject to the maximum annual cap and other program restrictions, multiple EOBs can be submitted for consideration at one time, including EOBs 6 months prior to the patient s enrollment date. I have a patient who has two separate documentations (i.e., an EOB and a Specialty Pharmacy receipt) for the same date of service. Will this patient be paid for both documents? This depends on which services were provided to the patient. Subject to the maximum annual benefit and other restrictions, the Dysport Copay Assistance Program will cover the cost of the drug and injections (this also includes the physician s visit the same day of injection) where allowable by the state. Our processors will calculate the associated Dysport costs and reimburse accordingly. Any surgical, physician, and/or laboratory expenses will be excluded from payment. What if the physician has already been reimbursed in full for cost of the drug and the service but later the patient receives an EOB indicating out of pocket expenses are due; can they submit this for reimbursement? Yes, our processors can adjust previous claims if the documentation is valid. The patient should submit this information as ADDITIONAL CORRESPONDENCE FOR [DATE OF SERVICE] for the adjustment changes. How does the Physician receive funds for the program? The Physician s office will receive funds in the same manner as they are paid for the other medical insurance benefit plans. 3

33 The Dysport Copay Assistance Program benefits are available to patients who... Are beginning or are currently receiving treatment with Dysport Currently have commercial insurance that covers the medication and associated cost of Dysport, or uninsured patients who pay their entire out-of-pocket cost Dysport benefits are determined by medication cost, associated infusion administration, and doctor s visit. Other Restrictions... This offer may not be combined with any other coupon, discount, prescription savings card, free trial, or other offer. Patient Eligibility & Terms and Conditions * Patients who are eligible to participate (i.e. prescriptions or coverage could be paid in part or in full) in any state or federally funded programs, including, but not limited to, Medicare or Medicaid, VA, DOD, or TRICARE (collectively, Government Programs ) are not eligible for copay assistance through IPSEN CARES. Patients residing in Massachusetts, Minnesota, Michigan, or Rhode Island can only receive assistance with the cost of Ipsen products but not the cost of related medical services (injection). Patients receiving free starter therapy through the IPSEN CARES program are not eligible for the copay assistance program while they are waiting for insurance prescription coverage to begin. Patients receiving assistance through another assistance program or foundation, free trial, or other similar offer or program, also are not eligible for the copay assistance program during current enrollment year. Patient or guardian is responsible for reporting receipt of copay savings benefit to any insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled through the program, as may be required. Additionally, patients may not submit any benefit provided by this program for reimbursement through Flexible Spending Account, Health Savings Account, or Health Reimbursement Account. Ipsen reserves the right to rescind, revoke, or amend these offers without notice at any time. Ipsen and/or TrialCard, Incorporated are not responsible for any transactions processed under this program where Medicaid, Medicare, or Medigap payment in part or full has been applied. Cash-paying patients are eligible to participate. Cash-pay patients are defined for purposes of this program as patients without insurance coverage or who have commercial insurance that does not cover Dysport. Medicare Part D enrollees who are in the prescription drug coverage gap (the donut hole ) are not considered cash-pay patients, and are not eligible for the copay benefit. Data related to your participation may be collected, analyzed, and shared with Ipsen for market research and other purposes related to assessing the program. Data shared with Ipsen will be de-identified, meaning it will not identify you. Void outside of the United States and its territories or where prohibited by law, taxed, or restricted. This program is not health insurance. No other purchase is necessary. Offer expires December 31, 018. In any calendar year commencing January 1, the maximum copay benefit paid by Ipsen Biopharmaceuticals, Inc. will be $5,000, covering no more than four (4) Dysport treatments. For cash-pay patients, the maximum copay benefit amount per eligible Dysport treatment is $1,50, subject to the annual maximum of $5,000 in total. There could be additional financial responsibility depending on the patient s insurance plan. For additional information, visit us online at 33

34 Field Reimbursement Managers are Available to Support Healthcare Professionals Help minimize non-clinical barriers through reimbursement education Provide information to help solve complex reimbursement obstacles/issues for healthcare professionals Explain IPSEN CARES services and support offerings for patients and healthcare professionals 34

35 Get Started with Dysport Today The Dysport Resource Guide contains the following information to assist you with: Acquiring Dysport in two easy ways Billing and Coding tips Reimbursement and support services for healthcare professionals and patients 35

36 For additional information, visit us online at Dysport (abobotulinumtoxina) for injection, for intramuscular use 300- and 500-Unit vials. DYSPORT is a registered trademark of Ipsen Biopharm Limited. IPSEN CARES is a registered trademark of Ipsen S.A. All other trademarks are property of their respective owners. 017 Ipsen Biopharmaceuticals, Inc. October 017 DYS-US-00356

37 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use DYSPORT safely and effectively. See full prescribing information for DYSPORT. DYSPORT (abobotulinumtoxina) for injection, for intramuscular use Initial U.S. Approval: 009 WARNING: DISTANT SPREAD OF TOXIN EFFECT See full prescribing information for complete boxed warning The effects of DYSPORT and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. 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 occur in adults, particularly in those patients who have underlying conditions that would predispose them to these symptoms RECENT MAJOR CHANGES Indications and Usage, Spasticity in Adults (1.3) 6/017 Indications and Usage, Pediatric Lower Limb Spasticity (1.4) 7/016 Dosage and Administration, Spasticity in Adults (.4) 6/017 Dosage and Administration, Pediatric Lower Limb Spasticity (.5) 7/ INDICATIONS AND USAGE DYSPORT is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for: The treatment of adults with cervical dystonia (1.1) 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 (1.) The treatment of spasticity in adults (1.3) The treatment of lower limb spasticity in pediatric patients years of age and older (1.4) DOSAGE AND ADMINISTRATION Instructions for Safe Use (.1) Once reconstituted, store in original container in a refrigerator at C to 8 C (36 F to 46 F) and use within 4 hours (.1) Do not freeze after reconstitution (.1) Protect from light (16) Reconstitution instructions are specific for the 300 Unit and 500 Unit vials (.1) Reconstituted DYSPORT is intended for intramuscular injection only. After reconstitution, DYSPORT should be used for only one injection session and for only one patient. Cervical Dystonia (.) Initial dose is 500 Units given intramuscularly as a divided dose among the affected muscles Re-treatment every 1 to 16 weeks or longer, as necessary, based on return of clinical symptoms with doses administered between 50 Units and 1000 Units to optimize clinical benefit Re-treatment should not occur in intervals of less than 1 weeks Titrate in 50 Unit steps according to patient s response Glabellar Lines (.3) Administer a total dose of 50 Units, divided in five equal aliquots of 10 Units each, intramuscularly to affected muscles to achieve clinical effect Re-treatment should be administered no more frequently than every 3 months Spasticity in Adults (.4) Select dose based on muscles affected, severity of muscle spasticity, prior response and adverse reaction history following treatment with DYSPORT or other botulinum toxin A Dosing for upper limb spasticity: between 500 Units and 1000 Units Dosing for lower limb spasticity: up to 1500 Units The maximum recommended total dose per treatment session (upper and lower limb combined) in adults is 1500 Units Re-treatment, based on return of clinical symptoms, should not occur in intervals of less than 1 weeks Pediatric Lower Limb Spasticity (.5) Select dose based on the affected muscle, severity of spasticity, and treatment history with botulinum toxins Dosing is based on Units/kg; recommended total DYSPORT dose per treatment session is 10 to 15 Units/kg per limb FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: DISTANT SPREAD OF TOXIN EFFECT 1 INDICATIONS AND USAGE 1.1 Cervical Dystonia 1. Glabellar Lines 1.3 Spasticity in Adults 1.4 Lower Limb Spasticity in Pediatric Patients DOSAGE AND ADMINISTRATION.1 Instructions for Safe Use. Dosing in Cervical Dystonia.3 Dosing in Glabellar Lines.4 Dosing in Spasticity in Adults.5 Dosing in Lower Limb Spasticity in Pediatric Patients 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Lack of Interchangeability Between Botulinum Toxin Products 5. Spread of Toxin Effect 5.3 Dysphagia and Breathing Difficulties 5.4 Facial Anatomy in the Treatment of Glabellar Lines 5.5 Pre-existing Neuromuscular Disorders 5.6 Human Albumin and Transmission of Viral Diseases 5.7 Intradermal Immune Reaction 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6. Postmarketing Experience 6.3 Immunogenicity Total dose per treatment session must not exceed 15 Units/kg for unilateral lower limb injections, 30 Units/kg for bilateral injections, or 1000 units, whichever is lower Re-treatment, based on return of clinical symptoms, should not occur in intervals of less than 1 weeks DOSAGE FORMS AND STRENGTHS For Injection: 300 Units or 500 Units lyophilized powder in a single-use vial for reconstitution with preservative-free 0.9% Sodium Chloride Injection, USP (3) CONTRAINDICATIONS Hypersensitivity to any botulinum toxin product or excipients (4, 6.1, 6.) Allergy to cow s milk protein (4) Infection at the proposed injection site(s) (4) WARNINGS AND PRECAUTIONS The potency Units of DYSPORT are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of DYSPORT cannot be compared to or converted into units of any other botulinum toxin products (5.1) Recommended dose and frequency of administration should not be exceeded (5.4) Immediate medical attention may be required in cases of respiratory, speech or swallowing difficulties (5.3) Concomitant neuromuscular disorder may exacerbate clinical effects of treatment (5.5) DYSPORT contains human albumin. There is a risk for transmission of Creutzfeldt-Jakob disease (CJD) however, no cases of transmission of viral diseases or CJD have ever been identified for albumin (5.6) ADVERSE REACTIONS Cervical Dystonia Most commonly observed adverse reactions ( 5% of patients) are: muscular weakness, dysphagia, dry mouth, injection site discomfort, fatigue, headache, musculoskeletal pain, dysphonia, injection site pain and eye disorders (6.1) Glabellar Lines The most frequently reported adverse reactions ( %) are: nasopharyngitis, headache, injection site pain, injection site reaction, upper respiratory tract infection, eyelid edema, eyelid ptosis, sinusitis, nausea, and blood present in urine (6.1) Spasticity in Adults Upper limb spasticity: The most frequently reported adverse reactions (>%) are: urinary tract infection, nasopharyngitis, muscular weakness, musculoskeletal pain, dizziness, fall and depression (6.1) Lower limb spasticity The most frequently reported adverse reactions ( 5%) are: falls, muscular weakness, and pain in extremity (6.1) Lower Limb Spasticity in Pediatric Patients The most frequently reported adverse reactions ( 10%) are: upper respiratory tract infection, nasopharyngitis, influenza, pharyngitis, cough and pyrexia (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Ipsen Biopharmaceuticals, Inc. at or FDA at FDA-1088 or DRUG INTERACTIONS Concomitant use of DYSPORT and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like agents), or muscle relaxants, should be observed closely because the effect of botulinum toxin may be potentiated (7) Anticholinergic drugs may potentiate systemic anticholinergic effects (7) The effect of administering different botulinum neurotoxins during the course of treatment with DYSPORT is unknown (7) USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm (8.1) Administer DYSPORT with care in elderly patients, reflecting the greater frequency of concomitant disease and other drug therapy (8.5) See 17 for PATIENT COUNSELING INFORMATION and Medication Guide Revised: 9/017 7 DRUG INTERACTIONS 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8. Lactation 8.3 Females and Males of Reproductive Potential 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Ethnic Groups 10 OVERDOSAGE 11 DESCRIPTION 1 CLINICAL PHARMACOLOGY 1.1 Mechanism of Action 1. Pharmacodynamics 1.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 14.1 Cervical Dystonia 14. Glabellar Lines 14.3 Spasticity in Adults 14.4 Pediatric Patients with Lower Limb Spasticity 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed.

38 FULL PRESCRIBING INFORMATION WARNING: DISTANT SPREAD OF TOXIN EFFECT Postmarketing reports indicate that the effects of DYSPORT 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 upper limb spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to or lower than the maximum recommended total dose [see Warnings and Precautions (5.)]. 1 INDICATIONS AND USAGE 1.1 Cervical Dystonia DYSPORT is indicated for the treatment of adults with cervical dystonia. 1. Glabellar Lines DYSPORT is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adult patients less than 65 years of age. 1.3 Spasticity in Adults DYSPORT is indicated for the treatment of spasticity in adult patients. 1.4 Lower Limb Spasticity in Pediatric Patients DYSPORT is indicated for the treatment of lower limb spasticity in pediatric patients years of age and older. DOSAGE AND ADMINISTRATION.1 Instructions for Safe Use The potency Units of DYSPORT 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 DYSPORT cannot be compared to or converted into units of any other botulinum toxin products assessed with any other specific assay method [see Description (11)]. Reconstituted DYSPORT is intended for intramuscular injection only. Reconstitution instructions are specific for each of the 300 Unit vial and the 500 Unit vial. These volumes yield concentrations specific for the use for each indication (Table 1). Table 1: Dilution Instructions for DYSPORT Vials (500 Units and 300 Units) Diluent* per 500 Unit Vial Resulting Dose Units per 0.1 ml Diluent* per 300 Unit Vial Resulting Dose Units per 0.1 ml 1 ml 50 Units 0.6 ml 50 Units ml 5 Units ml 0 Units 1.5 ml 0 Units ml 1 Units 5 ml** 10 Units 3 ml 10 Units *Preservative-free 0.9% Sodium Chloride Injection, USP Only Note: These dilutions are calculated for an injection volume of 0.1 ml. A decrease or increase in the DYSPORT dose is also possible by administering a smaller or larger injection volume (i.e ml (50% decrease in dose), 0.08 ml (0% decrease in dose) or 0.15 ml (50% increase in dose). ** When using 5 ml of diluent for a 500 Unit vial of DYSPORT, complete the following steps (see also.4 Dosing in Upper Limb Spasticity). 1. Reconstitute a 500 Unit vial of DYSPORT with.5 ml of Preservative-free 0.9% Sodium Chloride Injection, USP, gently mix, and set the vial aside.. Withdraw.5 ml of Preservative-free 0.9% Sodium Chloride Injection, USP, into a 5 ml syringe. 3. Take the 5 ml syringe with.5 ml Preservative-free 0.9% Sodium Chloride Injection, USP, and draw up the DYSPORT solution from the reconstituted vial without inverting and mix gently. The resulting concentration will be 10 units/0.1 ml. 4. Use immediately after reconstitution in the syringe. Dispose of any unused saline. After reconstitution, DYSPORT should be used for only one injection session and for only one patient. Once reconstituted, DYSPORT should be stored in the original container, in a refrigerator at C to 8 C (36 F to 46 F), protected from light for up to 4 hours. It must be discarded if not used within 4 hours. Do not freeze reconstituted DYSPORT. Discard the vial and needle in accordance with local regulations.. Dosing in Cervical Dystonia The recommended initial dose of DYSPORT for the treatment of cervical dystonia is 500 Units given intramuscularly as a divided dose among affected muscles in patients with or without a history of prior treatment with botulinum toxin. (A description of the average DYSPORT dose and percentage of total dose injected into specific muscles in the pivotal clinical trials can be found in Table 1 of Section 14.1, Clinical Studies Cervical Dystonia.). Limiting the dose injected into the sternocleidomastoid muscle may reduce the occurrence of dysphagia. Clinical studies with DYSPORT in cervical dystonia suggest that the peak effect occurs between two and four weeks after injection. Simultaneous EMG-guided application of DYSPORT may be helpful in locating active muscles. Dose Modification Where dose modification is necessary for the treatment of cervical dystonia, uncontrolled open-label studies suggest that dose adjustment can be made in 50 Unit steps according to the DYSPORT (abobotulinumtoxina) individual patient s response, with re-treatment every 1 weeks or longer, as necessary, based on return of clinical symptoms. Uncontrolled open-label studies also suggest that the total dose administered in a single treatment should be between 50 Units and 1000 Units. Re-treatment, if needed, should not occur in intervals of less than 1 weeks. Doses above 1000 Units have not been systematically evaluated. Special Populations Adults and elderly The starting dose of 500 Units recommended for cervical dystonia is applicable to adults of all ages [see Use in Specific Populations (8.5)]. Pediatric Patients The safety and effectiveness of DYSPORT in the treatment in pediatric patients less than 18 years of age has not been assessed [see Warnings and Precautions (5.)]. Instructions for Preparation and Administration for the Treatment of Cervical Dystonia DYSPORT is supplied as a single-use vial. Only use sterile preservative-free 0.9% Sodium Chloride Injection, USP for reconstitution of DYSPORT. Each 500 Unit vial of DYSPORT is to be reconstituted with 1 ml of preservative-free 0.9% Sodium Chloride Injection USP to yield a solution of 50 Units per 0.1 ml or reconstituted with ml of preservative-free 0.9% Sodium Chloride Injection USP to yield a solution of 5 Units per 0.1 ml. Each 300 Unit vial of DYSPORT is to be reconstituted with 0.6 ml of preservative-free 0.9% Sodium Chloride Injection USP to yield a solution equivalent to 50 Units per 0.1 ml. Using an appropriately sized sterile syringe, needle and aseptic technique, draw up ml or 1 ml of sterile, preservative-free 0.9% Sodium Chloride Injection USP for the 500 Unit vial or 0.6 ml of sterile, preservative-free 0.9% Sodium Chloride Injection USP for the 300 Unit vial. Insert the needle into the DYSPORT vial. The partial vacuum will begin to pull the saline into the vial. Any remaining required saline should be expressed into the vial manually. Do not use the vial if no vacuum is observed. Swirl gently to dissolve. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Reconstituted DYSPORT should be a clear, colorless solution, free of particulate matter, otherwise it should not be injected. Expel any air bubbles in the syringe barrel. Remove the needle used to reconstitute the product and attach an appropriately sized new sterile needle. Discard the vial and needle in accordance with local regulations..3 Dosing in Glabellar Lines The dose of DYSPORT for the treatment of glabellar lines is a total of 50 Units given intramuscularly in five equal aliquots of 10 Units each to achieve clinical effect (see Figure 1). Special Populations Adults A total dose of 50 Units of DYSPORT, in five equal aliquots, should be administered to achieve clinical effect. The clinical effect of DYSPORT may last up to four months. Repeat dose clinical studies demonstrated continued efficacy with up to four repeated administrations. It should be administered no more frequently than every three months. When used for re-treatment, DYSPORT should be reconstituted and injected using the same techniques as the initial treatment. Pediatric Patients DYSPORT for glabellar lines is not recommended for use in pediatric patients less than 18 years of age [see Warnings and Precautions (5.)]. Instructions for Preparation and Administration for the Treatment of Glabellar Lines DYSPORT is supplied as a single-use vial. Only use sterile preservative-free 0.9% Sodium Chloride Injection, USP for reconstitution of DYSPORT. Each 300 Unit vial of DYSPORT is to be reconstituted with.5 ml of preservative-free 0.9% Sodium Chloride Injection USP prior to injection. The concentration of the resulting solution will be 10 Units per 0.08 ml (1 Units per 0.1 ml) to be delivered in five equally divided aliquots of 0.08 ml each. DYSPORT may also be reconstituted with 1.5 ml of preservative-free 0.9% Sodium Chloride Injection USP for a solution of 10 Units per 0.05 ml (0 Units per 0.1 ml) to be delivered in five equally divided aliquots of 0.05 ml each. Using an appropriately sized sterile syringe, needle and aseptic technique, draw up.5 ml or 1.5 ml of preservative-free 0.9% Sodium Chloride Injection USP Insert the needle into the DYSPORT vial. The partial vacuum will begin to pull the saline into the vial. Any remaining required saline should be expressed into the vial manually. Do not use the vial if no vacuum is observed. Swirl gently to dissolve. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Reconstituted DYSPORT should be a clear, colorless solution, free of particulate matter otherwise it should not be injected. Draw a single patient dose of DYSPORT into a sterile syringe. Expel any air bubbles in the syringe barrel. Remove the needle used to reconstitute the product and attach a 30 gauge needle. Discard the vial and needle in accordance with local regulations. Injection Technique Glabellar facial lines arise from the activity of the lateral corrugator and vertical procerus muscles. These can be readily identified by palpating the tensed muscle mass while having the patient frown. The corrugator depresses the skin creating a furrowed vertical line surrounded by tensed muscle (i.e., frown lines). The location, size, and use of the muscles vary markedly among individuals. Physicians administering DYSPORT must understand the relevant neuromuscular and/or orbital anatomy of the area involved and any alterations to the anatomy due to prior surgical procedures. Risk of ptosis can be mitigated by careful examination of the upper lid for separation or weakness of the levator palpebrae muscle (true ptosis), identification of lash ptosis, and evaluation of the range of lid excursion while manually depressing the frontalis to assess compensation.

39 DYSPORT (abobotulinumtoxina) DYSPORT (abobotulinumtoxina) In order to reduce the complication of ptosis, the following steps should be taken: Avoid injection near the levator palpebrae superioris, particularly in patients with larger brow depressor complexes. Medial corrugator injections should be placed at least 1 centimeter above the bony supraorbital ridge. Ensure the injected volume/dose is accurate and where feasible kept to a minimum. Do not inject toxin closer than 1 centimeter above the central eyebrow. To inject DYSPORT, advance the needle through the skin into the underlying muscle while applying finger pressure on the superior medial orbital rim. Inject patients with a total of 50 Units in five equally divided aliquots. Using a 30 gauge needle, inject 10 Units of DYSPORT into each of five sites, two in each corrugator muscle, and one in the procerus muscle (see Figure 1). Figure 1 Repeat DYSPORT treatment should be administered when the effect of a previous injection has diminished, but no sooner than 1 weeks after the previous injection. A majority of patients in clinical studies were retreated between 1-16 weeks; however some patients had a longer duration of response, i.e. 0 weeks. The degree and pattern of muscle spasticity at the time of re-injection may necessitate alterations in the dose of DYSPORT and muscles to be injected. Clinical improvement may be expected one week after administration of DYSPORT. Lower Limb Spasticity In the clinical trial that assessed the efficacy and safety of DYSPORT for treatment of lower limb spasticity in adults [see Clinical Studies (14.3)], doses of 1000 Units and 1500 Units were divided among selected muscles at a given treatment session (see Table 3 and Figure 3). Table 3: DYSPORT Dosing by Muscle for Lower Limb Spasticity in Adults Muscles Injected Recommended Dysport Dose Recommended Number of Injection Sites per Muscle Distal Muscles Gastrocnemius.4 Dosing in Spasticity in Adults Dosing in initial and subsequent treatment sessions should be tailored to the individual based on the size, number and location of muscles involved, severity of spasticity, the presence of local muscle weakness, the patient s response to previous treatment, and/or adverse event history with botulinum toxins. No more than 1 ml should generally be administered at any single injection site. The maximum recommended total dose (upper and lower limb combined) of DYSPORT for the treatment of spasticity in adults is 1500 Units. Although actual location of the injection sites can be determined by palpation, the use of injection guiding technique e.g., electromyography, electrical stimulation is recommended to target the injection sites. Upper Limb Spasticity In the clinical trial that assessed the efficacy and safety of DYSPORT for treatment of upper limb spasticity in adults [see Clinical studies (14.3)], doses of 500 Units and 1000 Units were divided among selected muscles at a given treatment session (see Table and Figure ). Medial head 100 Units to150 Units 1 Lateral head 100 Units to 150 Units 1 3 Soleus 330 Units to 500 Units Tibialis posterior 00 Units to 300 Units Flexor digitorum longus 130 Units to 00 Units 1 to Flexor hallucis longus 70 Units to 00 Units 1 Figure 3: Muscles for Injection for Lower Limb Spasticity in Adults Table : DYSPORT Dosing by Muscle for Upper Limb Spasticity in Adult Patients Muscles Injected Recommended Dose DYSPORT Recommended Number of Injection(s) per Muscle Flexor carpi radialis (FCR) 100 Units to 00 Units 1 to Flexor carpi ulnaris (FCU) 100 Units to 00 Units 1 to Flexor digitorum profundus (FDP) 100 Units to 00 Units 1 to Flexor digitorum superficialis (FDS) 100 Units to 00 Units 1 to Brachialis 00 Units to 400 Units 1 to Brachioradialis 100 Units to 00 Units 1 to Biceps Brachii (BB) 00 Units to 400 Units 1 to Pronator Teres 100 Units to 00 Units 1 Figure : Muscles for Injection for Upper Limb Spasticity in Adults Repeat DYSPORT treatment should be administered when the effect of a previous injection has diminished, but no sooner than 1 weeks after the previous injection. A majority of patients in clinical studies were retreated between 1-16 weeks. The degree and pattern of muscle spasticity at the time of re-injection may necessitate alterations in the dose of DYSPORT and muscles to be injected. Instructions for Preparation and Administration for the Treatment of Spasticity in Adults DYSPORT is supplied as a single-use vial. Only use sterile preservative-free 0.9% Sodium Chloride Injection, USP for reconstitution of DYSPORT. The recommended concentration is 100 Units/mL or 00 Units/mL with preservative-free 0.9% Sodium Chloride Injection USP) (see Table 1). Using an appropriately sized sterile syringe, needle and aseptic technique, draw up the required volume (Table 1) of preservative-free 0.9% Sodium Chloride Injection USP. Insert the needle into the DYSPORT vial. The partial vacuum will begin to pull the saline into the vial. No more than.5 ml of saline should be introduced into the vial (see footnote in Table 1). Do not use the vial if a vacuum is absent. Gently swirl to dissolve. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Reconstituted DYSPORT should be a clear, colorless solution, free of particulate matter; otherwise it should not be injected. Expel any air bubbles in the syringe barrel. Remove the needle used to reconstitute the product and attach an appropriately sized new sterile needle. Discard the vial and needle in accordance with local regulations.

40 DYSPORT (abobotulinumtoxina).5 Dosing in Lower Limb Spasticity in Pediatric Patients Lower Limb Spasticity in Pediatric Patients years of age and older DYSPORT dosing for pediatric lower limb spasticity is based on Units per kilogram of body weight. Table 4 describes the recommended Units/kg dose of DYSPORT per muscle of the Gastrocnemius-Soleus Complex (GSC). The recommended total DYSPORT dose per treatment session is 10 to 15 Units/kg for unilateral lower limb injections or 0 to 30 Units/kg for bilateral lower limb injections. However, the total dose of DYSPORT administered per treatment session must not exceed 15 Units/kg for unilateral lower limb injections or 30 Units/kg for bilateral lower limb injections or 1000 units, whichever is lower. The total dose administered should be divided between the affected spastic muscles of the lower limb(s). When possible, the dose should be distributed across more than 1 injection site in any single muscle (see Table 4). No more than 0.5 ml of DYSPORT should be administered in any single injection site. Dosing in initial and sequential treatment sessions should be tailored to the individual patient based on the size, number and location of muscles involved, severity of spasticity, the presence of local muscle weakness, the patient s response to previous treatment, and/or adverse event history with botulinum toxins. Table 4: DYSPORT Dosing by Muscle for Lower Limb Spasticity in Pediatric Patients Muscle Injected Recommended DYSPORT Dose Range per muscle per leg (Units/kg Body Weight) Recommended number of injections per muscle Gastrocnemius 6 to 9 Units/kg a Up to 4 Soleus 4 to 6 Units/kg a Up to Total 10 to 15 Units/kg divided across both muscles Up to 6 Note: a the listed individual doses to be injected in the muscles can be used within the range mentioned without exceeding 15 Units/kg total dose for unilateral injection or 30 Units/kg for bilateral injections or 1000 Units whichever is lower. Figure 4: Muscles for Injection for Lower Limb Spasticity in Pediatric Patients Although actual location of the injection sites can be determined by palpation, the use of injection guiding technique, e.g. electromyography or electrical stimulation, is recommended to target the injection sites. Repeat DYSPORT treatment should be administered when the effect of a previous injection has diminished but no sooner than 1 weeks after the previous injection. A majority of patients in the clinical studies were retreated between 16- weeks, however; some had a longer duration of response. The degree and pattern of muscle spasticity and overall clinical benefit at the time of re-injection may necessitate alterations in the dose of DYSPORT and muscles to be injected. The safety and effectiveness of DYSPORT injected into proximal muscles of the lower limb for the treatment of spasticity in pediatric patients has not been established. Lower Limb Spasticity in Pediatric Patients less than years of age The safety and effectiveness of DYSPORT in the treatment of lower limb spasticity in pediatric patients of less than years of age has not been evaluated. Treatment of Upper Limb Spasticity in Pediatric Patients The safety and effectiveness of DYSPORT in the treatment of upper limb spasticity in pediatric patients has not been demonstrated [see Warnings and Precautions (5.)]. Instructions for Preparation and Administration for the Treatment of Lower Limb Spasticity in Pediatric Patients years and older DYSPORT is supplied as single-use 300Unit or 500Unit vials. Only use sterile preservative-free 0.9% Sodium Chloride Injection, USP for reconstitution of DYSPORT. Each 500 Unit vial of DYSPORT is to be reconstituted with.5 ml of preservative-free 0.9% Sodium Chloride Injection, USP prior to injection. Each 300 Unit vial of DYSPORT is to be reconstituted with 1.5 ml of preservative-free 0.9% Sodium Chloride Injection, USP prior to injection. The concentration of the resulting solution will be 0 Units per 0.1 ml. Further dilution with preservative-free 0.9% Sodium DYSPORT (abobotulinumtoxina) Chloride Injection, USP, may be required to achieve the final volume for injection. No more than 0.5 ml of DYSPORT should be administered in any single injection site. To calculate the total units of DYSPORT required for treatment of one leg, select the dose of DYSPORT in Units/kg/leg and the body weight (kg) of the patient (see Table 4). Using an appropriately sized sterile syringe (e.g., 3 ml syringe), needle and aseptic technique, draw up.5 ml of preservative-free 0.9% Sodium Chloride Injection, USP. Insert the needle into the DYSPORT 500 Unit vial. The partial vacuum will begin to pull the saline into the vial. Any remaining required saline should be expressed into the vial manually. Do not use the vial if no vacuum is observed. Swirl gently to dissolve. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Reconstituted DYSPORT should be a clear, colorless solution, free of particulate matter; otherwise it should not be injected. Draw the required patient dose of DYSPORT into a sterile syringe and dilute with additional preservative-free 0.9% Sodium Chloride Injection, USP, if required, to achieve the final volume for injection. Expel any air bubbles in the syringe barrel. Remove the needle used to reconstitute the product and attach an appropriately sized new sterile needle. Use immediately after reconstitution in the syringe. Discard the vial and needle in accordance with local regulations. 3 DOSAGE FORMS AND STRENGTHS For injection: 300 Units or 500 Units of lyophilized powder in a single-use vial for reconstitution with preservative-free 0.9% Sodium Chloride Injection, USP. 4 CONTRAINDICATIONS DYSPORT is contraindicated in patients with: Known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation [see Description (11)]. Hypersensitivity reactions have been reported, including anaphylaxis [see Adverse Reactions (6.)]. This product may contain trace amounts of cow s milk protein. Patients known to be allergic to cow s milk protein should not be treated with DYSPORT. Infection at the proposed injection site(s). 5 WARNINGS AND PRECAUTIONS 5.1 Lack of Interchangeability between Botulinum Toxin Products The potency Units of DYSPORT 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 DYSPORT cannot be compared to or converted into units of any other botulinum toxin products assessed with any other specific assay method [see Description (11)]. 5. Spread of Toxin Effect Post-marketing safety data from DYSPORT and other approved botulinum toxins suggest that botulinum toxin effects may, in some cases, be observed beyond the site of local injection. The symptoms are consistent with the mechanism of action of botulinum toxin and 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 related to spread of toxin effects. 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 upper limb spasticity in children and approved indications, symptoms consistent with spread of toxin effect have been reported at doses comparable to or lower than the maximum recommended total dose [see Use in Specific Populations (8.4)]. 5.3 Dysphagia and Breathing Difficulties Treatment with DYSPORT 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 Warnings and Precautions (5.)]. Deaths as a complication of severe dysphagia have been reported after treatment with botulinum toxin. Dysphagia may persist for several weeks, 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. Treatment of cervical dystonia with botulinum toxins may weaken neck muscles that serve as accessory muscles of ventilation. This may result in a critical loss of breathing capacity in patients with respiratory disorders who may have become dependent upon these accessory muscles. There have been post-marketing reports of serious breathing difficulties, including respiratory failure. Patients treated with botulinum toxin may require immediate medical attention should they develop problems with swallowing, speech or respiratory disorders. These reactions can occur within hours to weeks after injection with botulinum toxin [see Warnings and Precautions (5.), Adverse Reactions (6.1), Clinical Pharmacology (1.)]. 5.4 Facial Anatomy in the Treatment of Glabellar Lines Caution should be exercised when administering DYSPORT to patients with surgical alterations to the facial anatomy, excessive weakness or atrophy in the target muscle(s), marked facial asymmetry, inflammation at the injection site(s), ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin [see Dosage and Administration (.3)] or the inability to substantially lessen glabellar lines by physically spreading them apart [see Clinical Studies (14.)].