Medication Prior Authorization Form

Transcription

1 (OnabotulinumtoxinA) Dysport (abobotulinumtoxina) Myobloc (rimabotulinumtoxinb) Xeomin (incobotulinumtoxina) Policy Number: 1042 Policy History Approve Date: 12/11/2015 Revise Dates: 07/07/2017 Next Review: 12/11/2017 Review Dates: 08/07/2017 Preauthorization All Plans Benefit plans vary in coverage and some plans may not provide coverage for certain service(s) listed in this policy. Decisions for authorization are subject to all terms and conditions of the applicable benefit plan, including specific exclusions and limitations as well as applicable state and/or federal laws. Please review the benefit plan descriptions for details. We utilize a combination of MCG and internally developed evidence-based clinical guidelines to support our prior authorization work. All internally developed prior authorization guidelines follow a rigorous process including, but not limited to, review by clinical pharmacist, clinical nurse manager, Chief Medical Officer, independent 3 rd party physician review agency and WEA Trust s Medical Advisory Committee. Prior authorization guidelines are reviewed at least annually, or when there are significant labeling changes made by FDA or peer-reviewed clinical outcomes (via Cochrane or Hayes). INSTRUCTIONS: Please review section I and complete sections II, III, and IV (type or print clearly). Prescribers are asked to submit this form along with supporting clinical documentation to the WEA Trust for review. Submission of form does not guarantee approval. Submit preauthorization (PA) by fax to the WEA Trust at (608) or by mail to WEA Trust, Pharmacy Services Prior Authorization, P.O. Box 7338, Madison, WI Section I Approval Criteria I. Approval Duration A. Migraine indication - initial six month approval of two treatments B. All other indications - one year II. The use of botulinum toxin is medically necessary when one of the following criteria is met: A. Strabismus

2 Page 2 B. Achalasia C. Anal fissures III. The use of botulinum toxin is medically necessary for spasticity or dystonia when at least one of the following criteria are met: A. Blepharospasm B. Cerebral palsy C. Facial nerve (VII) dystonia D. Hereditary spastic paraparesis E. Hemifacial spasm F. Idiopathic torsion dystonia G. Neuromyelitis optica H. Orofacial dyskinesia (i.e., jaw closure dystonia) I. Schilder s disease J. Spasmodic dysphonia or laryngeal dystonia (a disorder of speech due to abnormal control of the laryngeal muscles present only during the specific task of speaking) K. Spastic hemiplegia L. Spasticity related to stroke, spinal cord injury, or traumatic brain injury M. Symptomatic torsion dystonia N. Other forms of upper motor neuron spasticity IV. The use of botulinum toxin is medically necessary for the treatment of significant drooling in individuals who are unable to tolerate scopolamine V. The use of botulinum toxin is medically necessary in the initial treatment of cervical dystonia (spasmodic torticollis) of moderate or greater severity when ALL of the following criteria are met: A. History of recurrent clonic and/or tonic involuntary contractions of one or more of the following muscles (sternocleidomastoid, splenius, trapezius and/or posterior cervical muscles) AND B. Sustained head tilt and/or abnormal posturing with limited range of motion in the neck AND C. The duration of the condition is greater than six months VI. Subsequent injections of botulinum toxin for the treatment of cervical dystonia (spasmodic torticollis) of moderate or greater severity is medically necessary when both of the following criteria are met: A. There is a response to the initial treatment documented in the medical records AND B. The individual still meets the medical criteria above VII. The use of botulinum toxin may be effective for urge incontinence/overactive bladder (OAB) in women who have failed at least three anticholinergic agents over a continuous six month period with at least 80% adherence. Patient assessment for risk of urinary retention is documented and clearly does not pose a risk for complications. A complete pelvic exam and non-drug therapies, drug therapies and complete bladder training history must be submitted before consideration for coverage. Documentation of shared decision making with the patient to include the risks of urinary retention and risk for urinary tract infections and associated impact on the health and quality of life of the patient. VIII. An initial six month trial of botulinum toxin for prevention of chronic migraine headaches may be approved when all of the following criteria are met: A. Adult individual diagnosed with chronic migraine AND B. Fifteen or more days per month with headache lasting four hours per day or longer AND C. First episode at least six months ago AND D. Medication overuse headache (MOH) has been ruled out. i. Medication overuse headache (MOH) is defined as: 1. Headache occurring at least 15 days per month in a patient with a pre-existing primary headache disorder AND

3 Page 3 2. Regularuse (for >3 months) of one or more drugs that can be taken for acute and/or symptomatic treatment of headache a) These drugs include, but are not limited to, ergotamines, triptans, acetaminophen, aspirin, NSAIDs, opioids, or combination analgesics ii. Not better accounted for by another ICHD-III diagnosis iii. An attempted medication detoxification must have occurredconsistent with commonly accepted practice E. Symptoms persist despite trials (trial defined as adherence to drug therapy of at least by 80% over 180 previous days) of at least two agents in any two of the following classes of medications used to prevent migraines or reduce migraine frequency: i. Antidepressants (e.g., amitriptyline, nortriptyline, doxepin) ii. Antihypertensives (e.g., propranolol, timolol) iii. Antiepileptics (e.g., valproate, topiramate, gabapentin) IX. Continuing treatment with botulinum toxin injection for ongoing prevention of chronic migraine headaches is medically necessary for an initial trial when at least one of the criteria are met: A. Migraine headache frequency was reduced by at least seven days per month (when compared to pretreatment average) by the end of the initial trial OR B. Migraine headache duration was reduced by at least 100 total hours per month (when compared to the pre-treatment average) by the end of the initial trial X. Botulinum toxin is considered cosmetic as a treatment of skin wrinkles or other cosmetic indications and is NOT approvable XI. Botulinum toxin is considered investigational and is not medically necessary for the treatment of any other conditions including, but not limited to, the following: A. For the treatment of headache other than chronic migraine meeting the criteria above, including but not limited to tension, episodic, migraine (14 days per month or less), or chronic daily headaches B. The use of botulinum toxin, whether the same or a different product, following failure of an initial trial for the treatment of an approvable condition (as listed above) is considered investigational and may not be approved. Note: when the initial product was stopped due to a product specific intolerance or allergic reaction (rather than clinical failure), this investigational and non-approvable statement does not apply C. Anismus (pelvic floor dyssynergia) D. Behcet s syndrome E. Chronic motor tic disorder F. Fibromyalgia/fibromyositis G. Gastroparesis H. Hirschsprung's disease I. Low back pain J. Myofascial pain syndrome K. Neck pain not related to conditions mentioned above L. Parkinson s disease M. Post-mastectomy reconstruction syndrome N. Raynaud's syndrome O. Tics associated with Tourette s Syndrome P. Tinnitus Q. Tourette s Syndrome R. Tremors S. Urinary and anal sphincter dysfunction (except as listed above) T. Stuttering U. Carpal tunnel syndrome V. Benign Prostatic Hypertrophy

4 Page 4 W. Disorders of the esophagus (except as listed above) X. Epicondylitis Y. Nystagmus Z. Sphincter of Oddi dysfunction AA. Vaginismus BB. Whiplash related disorders CC. Zygomatic Fractures DD. Temporal mandibular disorders e.g. TMJ, TMD XII. OnabotulinumtoxinA may be indicated for one or more of the following: A. Achalasia B. Anal fissure C. Blepharospasm D. Cervical dystonia (spasmodic torticollis) E. Hyperhidrosis (axillary), as indicated by ALL of the following: I. Age 18 years or older II. Axillary hyperhidrosis, with resting sweat production of 50 mg per axilla measured over five minutes at room temperature III. Failed conservative treatment using topical agents IV. No infection at proposed injection site V. Secondary causes of hyperhidrosis (e.g., hyperthyroidism) have been evaluated and, if necessary, treated VI. Significant effect of hyperhidrosis upon daily activities F. Laryngeal dystonia (i.e., hoarseness) G. Migraine headache prophylaxis needed, as indicated by ALL of the following: I. Age 18 years or older II. Migraine headache lasting four hours a day or longer, as indicated by five or more attacks with ALL of the following: 1. Headache symptoms, as indicated by two or more of the following: a) Aggravation by or causing avoidance of routine physical activity b) Moderate or severe pain intensity c) Pulsating quality d) Unilateral location 2. Migraine-associated symptoms, as indicated by ALL of the following: a) Nausea or vomiting b) Photophobia and phonophobia 3. Other potential causes of headaches have been excluded III. Migraine headache frequency occurring 15 or more days per month for three or more months IV. No neuromuscular disease (e.g., myasthenia gravis) V. Diagnosis of chronic migraines Renewal Criteria I. All renewals will be for six months II. Renewals may be considered appropriate for migraine prevention dependent upon established efficacy and for other conditions there is established initial response with continued benefit over entire treatment period A. Efficacy is defined as headache frequency reduced by at least seven days per month or by at least 100 hours per month References

5 Page 5 1. Hepp, Z et al Cephalalgia May 2015; 35(6), Adherence to Oral Migraine Medications with Chronic Migraine 2. Bajwa, ZH and Smith, JH UpToDate August Preventive Treatment for Migraine Lexicomp Drug Labeling FDA approved product labeling 4. D Amico, D et al Neuropsychiatric Dis Treat. 2008; 4(6), Prophylaxis of Migraine: General Principles and Patient Acceptance 5. MCG Guidelines, 19th Edition, OnabotulinumtoxinA, ACG: A-0296 (AC) 6. Jackson JL, Kuriyama A, Hayashino Y. Botulinum toxin A for prophylactic treatment of migraine and tension headaches in adults: a meta-analysis. Journal of the American Medical Association 2012; 307(16): Herzig DO, Lu KC. Anal fissure. Surgical Clinics of North America 2010; 90(1):33-44, Simpson DM, et al Assessment: Botulinum neurotoxin for the treatment of movement disorders (an evidence-based review): report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology 2008; 70(19): Diamond, Seymour et al. Headache and Migraine Biology and Management, Academic Press, Elsevier.

6 Page 6 Section II Member Information Name (Last, First, Middle Initial) Date of Birth WEA Trust Subscriber Number Diagnosis 1. MEDICATION 2. STRENGTH 3. DIRECTIONS 4. QUANTITY PER 30 DAYS (onabotulinumtoxina) Specify: 5. DIAGNOSIS:

7 Page 7 6. APPROVAL CRITERIA: CHECK ALL BOXES THAT APPLY NOTE: Any areas not filled out are considered not applicable to your patient and MAY AFFECT THE OUTCOME of this request. Yes No Individual has a diagnosis of Strabismus Yes No Individual has a diagnosis of Achalasia Yes No Individual has a diagnosis of Anal Fissures Yes No Individual has significant drooling Blepharospasm Hereditary Spastic Paraparesis Multiple Sclerosis Schilder s Disease Spasticity from Stroke Spinal Cord Injury or Traumatic Brain Injury Idiopathic Torsion Dystonia Orofacial Dyskinesia (i.e., jaw closure dystonia) Symptomatic Torsion Dystonia Cervical Dystonia Cerebral Palsy Neuromyelitis Optica Spastic Hemiplegia Spasmodic Torticollis Organic Writer s Cramp Spasmodic Dysphonia Laryngeal Dystonia Facial Nerve (VII) Dystonia Hemifacial spasm Forms of Upper Motor Neuron Spasticity

8 Page 8 Yes No This is the individual s initial treatment of Cervical Dystonia (spasmodic torticollis) Yes No Individual has moderate to severe Cervical Dystonia Yes No Individual has a history of recurrent clonic and/or tonic involuntary contractions of one or more of the following muscles: stemocleidomastoid splenius trapezius posterior cervical muscles Yes No Individual has sustained head tilt and/or abnormal posturing with limited range of motion in the neck Please indicate the duration of the patient s condition: Yes No This request is for subsequent injections of botulinum toxin for the treatment of cervical dystonia (spasmodic toricollis) Yes No If yes, there is a response to the initial treatment documented in the medical records Yes No Individual is diagnosed with chronic migraine headaches Yes No Request is for initial treatment Yes No Individual is an adult with fifteen or more days per month with headache lasting four hours per day or longer Yes No The first episode was at least six months ago Yes No Symptoms have persisted despite trials (trial defined as adherence to drug therapy by at least by 80% over three consecutive months) of at least two agents in any two of the following classes of medications used to prevent migraines or reduce migraine frequency: Antidepressants (e.g., amitriptyline, nortriptyline, doxepin), Antihypertensives (e.g., propranolol, timolol, clonidine), Antiepileptics (e.g., valproate, topiramate, carbamazepine) Yes No Medication overuse headache (MOH) has been ruled out by absence of the following criteria being met: a. Headache occurring on 15 days per month in a patient with a pre-existing headache disorder AND b. Regular overuse for >3months of one or more drugs that can be taken for acute and/or symptomatic treatment of headache AND c. Not better accounted for by another ICHD-III diagnosis Yes No Request is for continued treatment Yes No Migraine headache frequency was reduced by at least seven days per month (when compared to pretreatment average) by the end of the initial trial Yes No Migraine headache duration was reduced by at least 100 total hours per month (when compared to the pretreatment average) by the end of the initial trial

9 Page 9 Section III Physician Information Physician Name National Provider Identification (NPI) Number Clinic Name Address (Street, City, State, Zip Code) Physician Telephone Number Physician Fax Number Physician Signature Date Section IV For WEA Trust Use Only Plan: Copay Tiers: Date of Receipt: Remarks: Approve Deny More information is needed Incomplete form Submission and review of this form does not guarantee approval of this request. Unless approved, payment of the brand-name medication will be limited to the amount the Trust would have paid for the generic equivalent. Insureds and providers will be informed of the decision in writing within approximately 30 days. Fax to: Pharmacy Services (608) Mail to: WEA Trust Pharmacy Services Prior Authorization P.O. Box 7338 Madison, WI