Botulinum toxins: abobotulinumtoxina (Dysport ), incobotulinumtoxina (Xeomin ), onabotulinumtoxina (Botox ), & rimabotulinumtoxinb (Myobloc )

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1 Botulinum toxins: abobotulinumtoxina (Dysport ), incobotulinumtoxina (Xeomin ), onabotulinumtoxina (Botox ), & rimabotulinumtoxinb (Myobloc ) These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan will be used to determine your coverage. Administrative Process Use for migraines, hyperhidrosis and off-label indications will not be covered without prior authorization from HealthPartners Pharmacy Administration. Coverage Coverage for botulinum toxin preparations is subject to the indications listed below, and per your plan documents. Coverage for Medicare products will be provided according to the Local Coverage Determination for Botulinum Toxins. Please see the link in the Related content section to the right for a link to the Coverage Determination. Botulinum toxin preparations are covered as follows based on indication: Prevention of chronic migraine Botox requires a prior authorization but will generally be approved when the following criteria are met: 1. Prescribing by a headache specialist who has received training in the injection technique. 2. Chronic migraine (defined as 15 headache days/month lasting 4 hours a day) despite standard treatment including three or more preventive treatments. Three preventive treatments means trial and failure, or medical contraindications to one agent in three or more of these drug categories. Drug Category Beta-blockers Calcium channel blockers Anticonvulsants Antidepressants Example Agents Metoprolol, propranolol, timolol Verapamil, nifedipine Topiramate, valproate, gabapentin Amitriptyline, nortriptyline, doxepin, venlafaxine The suggested maximum dose is 155 units. Severe axillary hyperhidrosis Botulinum toxin use for hyperhidrosis requires prior authorization. Botox is FDA approved for use in severe axillary hyperhidrosis. Coverage for all other preparations and all other forms of hyperhidrosis is off label, requires a prior authorization and will be reviewed on a case by case Cervical dystonia All preparations are covered and do not require a prior authorization. Upper limb spasticity in adults Botox and Dysport do not require a prior authorization for this use. Lower limb spasticity in adults Botox does not require a prior authorization for this use.

2 Lower limb spasticity in pediatric patients Dysport does not require a prior authorization for this use. Strabismus Botox does not require a prior authorization for this use. Blepharospasm Botox and Xeomin do not require a prior authorization for this use. Urinary incontinence and overactive bladder Botox does not require a prior authorization for this use. Indications that are not covered Cosmetic use (the treatment of glabellar lines or wrinkles) is not considered medically necessary. Other conditions not listed in this policy will be reviewed on a case by case basis for coverage. Botox Quantity Limits Claims for greater than 600 Units will not be covered without prior authorization. Claims for greater amounts will be reviewed for billing accuracy and an inadequate response to standard dosing. A quantity limit for Botox used in the treatment of headaches will be applied to Botox claims submitted for this indication (including migraine-type headaches, tension-type headaches, and chronic daily headaches). Claims for greater than 300 Units will not be covered without prior authorization. Claims for greater amounts will be reviewed for billing accuracy and an inadequate response to standard dosing. Definitions Botulinum toxin is an acetylcholine release inhibitor and a neuromuscular blocking agent. It is a purified neurotoxin that acts at the neuromuscular junction to produce flaccid paralysis. Each preparation has the following indications and dosing: Botox (OnabotulinumtoxinA) Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication. Treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (e.g., spinal cord injury (SCI), multiple sclerosis (MS) in adults who have an inadequate response to or are intolerant of an anticholinergic medication. Prophylaxis of headaches in adult patients with chronic migraine ( 15 days per month with headache lasting 4 hours a day or longer) 155 units, as 5 unit injections per each site divided across 7 head/neck muscles Treatment of spasticity in adult patients Treatment of cervical dystonia in adult patients, to reduce the severity of abnormal head position and neck pain Treatment of severe axillary hyperhidrosis that is inadequately managed by topical agents in adult patients 50 units per axilla

3 Treatment of blepharospasm associated with dystonia in patients 12 years of age 1.25 units 2.5 units into each of three sites per affected eye Treatment of strabismus in patients 12 years of age. The dose is based on prism diopter correction or previous response to treatment with BOTOX The temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients 65 years of age 20 units divided across five sites Temporary improvement in the appearance of moderate to severe lateral canthal lines associated with orbicularis oculi activity in adult patients - 24 units into each of 3 sites per side (6 total injection points) Safety and effectiveness have not been established for the prophylaxis of episodic migraine (14 headache days or fewer per month), treatment of upper or lower limb spasticity in pediatric patients or for treatment of hyperhidrosis in body areas other than axillary. Do not exceed a total dose of 360 units administered every 12 to 16 weeks or at longer intervals. Dysport (AbobotulinumtoxinA) The treatment of adults with cervical dystonia patients 500 units IM as a divided dose among the affected muscles and retreatment every 12 to 16 weeks or longer, as necessary, based on return of clinical symptoms with doses between 250 and 1000 units, not less than every 12 weeks and titration should occur in 250 unit increments 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 50 units divided in five equal aliquots of 10 units each, retreat no more frequently than every 3 months The treatment of upper limb spasticity in adults The treatment of lower limb spasticity in pediatric patients 2 years of age and older Repeat treatments should be determined by clinical response but should generally be no more frequent than every 12 weeks. MyoBloc (RimabotulinumtoxinB) Treatment of adults with cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia initial doses of 2500 units to 5000 units divided among affected muscles with patients without a prior history of tolerating botulinum toxin injections receiving a lower initial dose The duration of effect in patients responding to treatment has been observed in studies to be between 12 and 16 weeks at doses of 5,000-10,000 units. Xeomin (IncobotulinumtoxinA) Treatment of upper limb spasticity in adult patients recommended total dose is up to 400 units no sooner than every 12 weeks Treatment of adults with cervical dystonia 120 units total dose initially with repeat dosing based on initial response Treatment of blepharospasm in adults previously treated with onabotulinumtoxina (Botox) starting dose should be based on previous dosing of Botox. If the previous dose is unknown, the recommended starting dose is units / injection site. In clinical trials the mean dose per injection site was 5.6 units, the mean number of injections per eye was 6, and the mean dose per eye was 33.5 units. Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients 20 units per treatment session divided into five equal intramuscular injections of 4 units each. The frequency of repeat treatments should be determined by clinical response but should generally be no more frequent than every 12 weeks. Codes If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive. The services associated with these codes require prior authorization:

4 HCPCS Codes Codes J0585 J0586 J0587 J0588 Description Injection, onabotulinumtoxina, 1 unit (Botox) Injection, abobotulinumtoxina, 5 units (Dysport) Injection, rimabotulinumtoxinb, 100 units (Myobloc) Injection, incobotulinumtoxina, 1 unit (Xeomin) NDC Codes Codes Description unit single-use vial (Botox) unit single-use vial (Botox) unit single-use vial (Botox Cosmetic) unit single-use vial (Botox Cosmetic) unit single-use vial (Dysport) unit single-use vial (Dysport) ,000 unit/2 ml single-use vial (Myobloc) ,500 unit/0.5 ml single-use vial (Myobloc) ,000 unit/ml single-use vial (Myobloc) unit single-use vial (Xeomin) units single-use vial (Xeomin) unit single-use vial (Xeomin) ICD-10-CM Codes ICD10 Description G24.01 Drug induced subacute dyskinesia G24.02 Drug induced acute dyskinesia G24.09 Other drug induced dystonia G24.1 Genetic torsion dystonia G24.2 Idiopathic nonfamilial dystonia G24.4 Idiopathic orofacial dystonia G24.8 Other dystonia G24.9 Dystonia, unspecified G25.0 G25.2 Other extrapyramidal and movement disorders G25.3 Myoclonus G25.89 Other specified extrapyramidal and movement disorders G35 Multiple sclerosis (limb spasticity due to) G36.0-G37.9 Other acute disseminated and demyelinating diseases of CNS (limb spasticity due to) G04.1 Tropical spastic paraplegia G11.4 Hereditary spastic paraplegia G24.3 Spasmodic torticollis G51.0 Bell s palsy G51.1 Geniculate ganglionitis G51.2 Melkersson s syndrome G51.3 Clonic hemifacial spasm G51.4 Facial myokymia G51.8 Other disorders of facial nerve G51.9 Disorder of facial nerve, unspecified G80.0-G80.9 Cerebral palsy G81.10-G81.14 Spastic hemiplegia G82.20-G83.34 Paraplegia (paraparesis) and quadriplegia (quadriparesis) G83.4 Cauda equine syndrome I69 Sequelae of cerebrovascular disease J38.5 Laryngeal spasm K59.4 Anal spasm K60.1 Chronic anal fissure K60.2 Anal fissure, unspecified R25.0 Abnormal head movements R25.1 Tremor, unspecified R25.2 Cramp and spasm R25.3 Fasciculation

5 R25.8 Other abnormal involuntary movements R25.9 Unspecified abnormal involuntary movements R Ocular torticollis R49.0 Dysphonia R49.8 Other voice and resonance disorders S04.011S Injury of cranial nerve, sequela S06.0x0S Intracranial injury, sequela S06.9x9S S14.0xxS Injury of nerves and spinal cord, sequela S14.9xxS, S24.0xxS- S24.9xxS, S34.01xS- S34.9xxS G24.5 Blepharospasm H50.89 Other specified stabismus H51.0 Palsy (spasm) of conjugate gaze K22.0 Achalasia of cardia N31.0 Uninhibited neuropathic bladder, not elsewhere classified N31.1 Reflex neuropathic bladder, not elsewhere classified N31.9 Neuromuscular dysfunction of bladder, unspecified N32.81 Overactive bladder N36.44 Muscular disorders of urethra N39.41 Urge incontinence N39.46 Mixed incontinence G Chronic migraine without aura, not intractable, with status migrainosus G Chronic migraine without aura, not intractable, without status migrainosus G Chronic migraine without aura, intractable, with status migrainosus G Chronic migraine without aura, intractable, without status migrainosus L L Primary focal hyperhidrosis L74.52 Secondary focal hyperhidrosis CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. Products This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at or Approved: Medical Director Committee; Approved 10/01/96; Revised 11/11/03, 12/19/08, 5/25/11, 9/1/11, 1/1/14; 11/7/16, 8/14/17. Annual Review 11/11/03, 2004, 6/1/05, 7/1/06, 8/1/07, 12/19/08, 6/1/09, 5/20/10, 5/25/11, 9/2011, 9/2012, 7/2013, 1/2014, 10/2015, 5/2016, 4/2017. References Botox and Botox Cosmetic prescribing information. Allergan, Inc. 4/2017. MyoBloc prescribing information. Solstice Neurosciences, Inc. 1/2012. Dysport prescribing information. Ipsen Biopharm Ltd. 12/2016. Xeomin prescribing information. Merz Pharmaceuticals, LLC. 12/2015. Elkind AH, O'Carroll P, Blumenfeld A, DeGryse R, Dimitrova R; BoNTA Study Group. A series of three sequential, randomized, controlled studies of repeated treatments with botulinum toxin type A for migraine prophylaxis. J Pain Oct;7(10): Silberstein SD, Stark SR, Lucas SM, Christie SN, Degryse RE, Turkel CC; BoNTA-039 Study Group. Botulinum toxin type A for the prophylactic treatment of chronic daily headache: a randomized, double-blind, placebo- controlled trial. Mayo Clin Proc Sep;80(9): Evers S, Vollmer-Haase J, Schwaag S, Rahmann A, Husstedt IW, Frese A. Botulinum toxin A in the prophylactic treatment of migraine--a randomized, double-blind, placebo-controlled study. Cephalalgia Oct;24(10): Silberstein S, Mathew N, Saper J, Jenkins S. Botulinum toxin type A as a migraine preventive treatment. For the BOTOX Migraine Clinical Research Group. Headache Jun;40(6): Naumann M, So Y, Argoff CE, Childers MK, Dykstra DD, Gronseth GS, Jabbari B, Kaufmann HC, Schurch B, Silberstein SD, Simpson DM; Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Assessment: Botulinum neurotoxin in the treatment of autonomic disorders and pain (an evidence-based review): report of

6 the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology May 6;70(19):