PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Botox (onabotulinumtoxinA) BILLING CODE J0585 BENEFIT TYPE Medical SITE OF SERVICE ALLOWED Office, Outpatient COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) QUANTITY LIMIT vary per diagnosis LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Botox (onabotulinumtoxinA) is a non-preferred product and will only be con sidered for coverage under the medical benefit when the following criteria are met: Members must be clinically diagnosed with one of the following disease states and meet their individual criteria as stated. AXILLARY HYPERHIDROSIS For initial authorization: 1. Member must be 18 years of age or older ; AND 2. Member has diagnosis of axillary hyperhidrosis, with resting sweat production of 50 mg per axilla measured over 5 minutes at room temperature documented in chart notes; AND 3. Member has f ailed conservative treatment using topical agents ; AND 4. Secondary causes of hyperhidrosis (e. g., hyperthyroidism) have been evaluated and, if necessary, treated; AND 5. Condition is causing a s ignificant effect on daily activities . 6. Dosage allowed: 50 Units per axilla . Note: Medication will not be covered for t reatment of hyperhidrosis in body areas other than axillary . If member meets all the requirements listed above, the medication will be approved for 6 months. For reauthorization: 1. Member must be in compliance with all other initial criteria; AND 2. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If member meets all the reauthorization requirements above, the medication will be app roved for an additional 6 months. BLEPHAROSPASM For initial authorization: 1. Member is 12 years of age or older with diagnosis of bl epharospasm, as indicated by one or more of the following: a) Benign essential blepharospasm ; b) Blepharospasm associated with dystonia; c) Blepharospasm associated with facial nerve (cranial nerve VII) disorders such as Bell palsy ; AND 2. Member does not have neuromuscular disease (e.g., myasthenia gravis). 3. Dosage allowed: The initial recommended dose is 1.25 Units-2.5 Units injected into the medial and lateral pre-tarsal orbicularis oculi of the upper lid and into the lateral pre-tarsal orbicularis oculi of the lower lid . At repeat treatment sessions, the dose may be increased up to two-fold if the response from the initial treat ment is considered insufficient. The cumulative dose of Botox treatment for blepharospasm in a 30-day period should not exceed 200 Units. If member meets all the requirements listed above, the medication will be approved for 6 months. For reauthorization: 1. Member must be in compliance with all other initial criteria; AND 2. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If member meets all the reauthorization requirements above, the medication will be app roved for an additional 6 months. CERVICAL DYSTONIA (SPASMODIC TORTICOLLIS) For initial authorization: 1. Member has a pain or abnormal head position with documented turning of the head (torticollis), lateral tilt of the neck (laterocollis), flexion of the head (anterocollis), or extension of the head (retrocollis) causing adverse effect on daily functioning; AND 2. Member has tried and fail ed one oral medication such as trihexyphenidyl (Artane), clonazepam (Klon opin), or baclofen; AND 3. Member does not have any of the following: a) Fixed contractures causing decreased neck range of motion; b) Neuromuscular disease (e. g., myasthenia gravis) ; c) Prior surgical treatment . 4. Dosage allowed: 50-300 Units. If member meets all the requirements listed above, the medication will be approved for 6 months. For reauthorization: 1. Member must be in compliance with all other initial criteria; AND 2. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If member meets all the reauthorization requirements above, the medication will be app roved for an additional 6 months. ESOPHAGEAL ACHALASIA For initial authorization: 1. Achalasia c onfirmed by esophageal manometry; AND 2. Member has no response to pharmacologic treatment (e .g ., long-acting nitrates, calcium channel antagonists) ; AND 3. Member is not candidate for pneumatic dilation or surgical myotomy ; AND 4. Member has p rogressive dysphagia for liquids and solids ; AND 5. Other causes of dysphagia (e. g., peptic stricture, carcinoma, lower esophageal ring or extrinsic compression) ruled out by upper gastrointestinal endoscopy . 6. Dosage allowed: 40-100 Units. If member meets all the requirements listed above, the medication will be approved for 12 months. For reauthorization: 1. Member must be in compliance with all other initial criteria; AND 2. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If member meets all the reauthorization requirements above, the medication will be approved for an additional 12 months. MIGRAINE HEADACHE PROPHYLAXIS For initial authorization: 1. Member is 18 years of age or older ; AND 2. Member has documented history of 15 headache days per month for more than 3 months, of which 8 days were migraine days characterized as 5 attacks lasting 4-72 hours with both of the following: a) Tw o or more of the following: i) Aggravation by or causing avoidance of routine physical activity; ii) Moderate or severe pain intensity; iii) Pulsating quality; iv) Unilateral location; b) One or more of the following: i) Nausea or vomiting; ii) Photophobia and phonophobia; AND 3. Medication must be prescribed by neurologis t or a headache specialist; AND 4. Member does not have ANY of the following: a) No medication-overuse headaches ; b) No neuromuscular disease (e.g., myasthenia gravis) ; AND 5. Other prophylactic therapeutic options have been ineffective or not tolerated for trial of at lea st 3 months, as indicated by two or more of the following: a) Beta-blockers; b) Calcium channel blockers; c) Antidepressants such as amitriptyline, nortriptyline, doxepin, or protriptyline; d) Anticonvulsant medications such as topiramate or valproic acid; AND 6. Abortive therapeutic options (i.e., ergotamine, triptans, combination analgesics, or simple analgesics) have been ineffective or not tolerated for at least 30 days (for a minimum o f 8 or more days per month). 7. Dosage allowed: 155 Units . Note: Medication will not be covered for prophylaxis of episodic migraine (14 headache days or fewer per month) . Medication will not be covered if used concomitantly with CGRP inhibitors (e.g., Aimovig, Ajovy, Emgality). If member meets all the requirements listed above, the medication will be approved for 6 months. For reauthorization: 1. Member must be in compliance with all other initial criteria; AND 2. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If member meets all the reauthorization requirements above, the medication will be app roved for an additional 12 months. OVERACTIVE BLADDER For initial authorization: 1. Member is 18 years of age or older ; AND 2. Member has tried and failed or has intolerance at least three adequately titrated prescription overactive bladder medications (e.g., oxybutynin, trospium, tolterodine, darifenacin, fesoterodine, mirabegron, solifenacin, duloxetine) OR two adequately titrated prescription ov eractive bladder medications AND an OTC bladder medication (oxybutynin transdermal patch (Oxytrol for Women) ; AND 3. Member does not have ANY of the following: a) Acute urinary retention; b) Acute urinary tract infection. 4. Dosage allowed: 100 Units . If member meets all the requirements listed above, the medication will be approved for 3 months. For reauthorization: 1. Member must be in compliance with all other initial criteria; AND 2. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If member meets all the reauthorization requirements above, the medication will be app roved for an additional 12 months. SPASTICITY For initial authorization: 1. Chart notes submitted with documentation of abnormal muscle tone that is interfering with functional ability (or that is expected to affect joint cont racture in future growth); AND 2. Medication is being requested to improve function or allow additional therapeutic modality to be employed; AND 3. One of the following: a) Member is a c hild with cerebral palsy ; b) Member has hereditary spastic paraplegia; c) Member has l imb spasticity due to multiple sclerosis or other demyelinating diseases of the central nervous system ; d) Member is adult and has upper extremity spasticity due to stroke or brain injury. 4. Dosage allowed: No more than 50 Units per site. If member meets all the requirements listed above, the medication will be approved for 3 months. For reauthorization: 1. Member must be in compliance with all other initial criteria; AND 2. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If member meets all the reauthorization requirements above, the medication will be app roved for an additional 12 months. STRABISMUS For initial authorization: 1. Member is 1 2 years of age or older ; AND 2. Member has one of the following: a) Esotropia; b) Horizontal strabismus with deviations of less than 50 prism diopters; c) Vertical strabismus; d) Persistent cranial nerve VI palsies of 1 month duration or longer (including gaze palsies accompanying diseases, such as neuromyelitis optica and Schilder's disease); AND 3. Members strabismus is not due primarily to: a) Duane syndrome with lateral rectus weakness ; b) Restrictive strabismus ; c) Secondary strabismus caused by prior surgical over-recession of antagonist muscle. 4. Dosage allowed: 1.25-5 Units in any one muscle. If member meets all the requirements listed above, the medication will be approved for 6 months. For reauthorization: 1. Member must be in compliance with all other initial criteria; AND 2. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If member meets all the reauthorization requirements above, the medication will be app roved for an additional 6 months. UPPER EXTREMITY FOCAL DYSTONIA (e.g., Writer's Cramp) For initial authorization: 1. Member is 16 years of age or older ; AND 2. Member has extremity pain or abnormal hand or forearm position causing adverse effect on daily functioning; AND 3. Member did not have prior surgical treatment . 4. Dosage allowed: Depends on intensity of spasm, the size of the muscle and number of muscles affected. If member meets all the requirements listed above, the medication will be approved for 3 months. For reauthorization: 1. Member must be in compliance with all other initial criteria; AND 2. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If member meets all the reauthorization requirements above, the medication will be approved for an additional 6 months. URINARY INCONTINENCE For initial authorization: 1. Member is 18 years of age or older and has diagnosis of neurogenic urinary incontinence, or neurogenic detrusor over activity, or detrusor sphincter dyssynergia; AND 2. Condition secondary to spinal cord injury or neurologic disease, including but not limited to multiple sclerosis; AND 3. Member does not have ANY of the following: a) Acute urinary tract infection; b) Acute urinary retention unless patient receiving regular clean intermittent catheterization; AND 4. Member is u nresponsive or intolerant to pharmacologic therapy including anticholinergic medication (e.g., oxybutynin, tolterodine, trospium, darifenacin, fesoterodine, solifenacin). 5. Dosage allowed: 200 Units. If member meets all the requirements listed above, the medication will be approved for 12 months. For reauthorization: 1. Member must be in compliance with all other initial criteria; AND 2. Chart notes have been provided that show the member has shown improvem ent of signs and symptoms of disease. If member meets all the reauthorization requirements above, the medication will be app roved for an additional 12 months. CareSource considers Botox (onabotulinumtoxinA) not medically necessary for the treatment of the following disease states based on a lack of robust clinical controlled trials showing superior efficacy compared to currently available treatments: Tension headache, cervicogenic headache Myofascial pain syndrome Tremors such as benign essential tremor, chronic motor tic disorder and tics associated with Tourette Syndrome Parkinson's disease Sialorrhea due to Parkinson's disease DATE ACTION/DESCRIPTION 08/03/2018 Criterion no infection at proposed injection site removed from Blepharospasm and Cervical Dystonia diagnosis. Age limitation removed from Cervical Dystonia; pain and abnormal head position requirements clarified and medications trial added. On diagnosis of Urinary Incontinence criterion Surgical treatment or balloon sphincter dilatation is not indicated, has been refused, or has failed was removed. On diagnosis of Spasticity rehabilitation program is not required anymore. Strabismus diagnosis got criteria expanded. Lower Limb Spasticity i s combined into Spasticity diagnosis. For diagnosis of Migraine Headache Prophylaxis trial length for abortive therapeutic options decreased. References: 1. Botox [package insert]. Irv ine, CA: Allergan, Inc.; April, 2017. 2. MCG 20th Edition, 2016. 3. U.S. Drug and Food Administration Safety Data. http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125036s044lbl.pdf (March 6, 2011) . 4. Wolters Kluwer. Facts &Comparisons. www.factsandcomparisons.com, 2011. (March 6, 2011) . 5. Brashear A, Lew MF, Dykstra DD, et al. Safety and Efficacy of NeuroBloc (Botulinum Toxin Type B) in Type A-Responsive Cervical Dystonia, Neurology, 1999, 53(7):1439-46. 6. Clinical Use of Botulinum Toxin, Arch Neurol, 1991, 48(12):1294-8. 7. Beneck e R, Jost WH, Kanovsky P, et al. A New Botu linum Toxin Type A Free of Complexing Proteins for Treatment of Dystonia, Neurology, 2005, 64(11):1949-51.8. Borodic GE and Pearce LB, New Concepts in Botulinum Toxin Therapy, Drug Saf, 1994, 11(3):145-52. Jankovic Jand Brin MF, Therapeutic Uses of Botulinum Toxin, NEngl JMed, 1991, 324(17):1186-94. 9. Naumann Mand Jankovic J, "Safety of Botulinum Toxin Type A: A Systematic Review and Meta-Analysis," Curr Med Res Opin, 2004, 20(7):981-90. 10. Russman, BS, Tilton, A, Gormley ME. Jr. Cerebral palsy; a rational approach to a treatment protocol, and the role of botulinum toxin in treatment, Muscle Nerve Suppl 1997; 6:S181 . 11. Fishman LM, Anderson C, Rosner B. Botox and physical therapy in the treatment of Piriformis syndrome Am JPhys Me d Rehabil. 2002 Dec;81(12):936-42. 12. 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. http://www.guide line.gov/content.aspx?id=12947(March11, 2011) . 13. Simpson DM, et al. Assessment: Botulinum neurotoxin for the treatment of movement disorders (an evidence-based review). Report of the Therapeutics and Technology Subcommittee of the American Academy of Neurology. Neurology. 2008;70(19):1699-706. 14. Neumann M, et al. Assessment: Botulinum neurotoxin in the treatment of autonomic disorders and pain. Report of the Therapeutics and Technology Subcommittee of the American Academy of Neurology. Neurology. 2008; 7 0:1707-14. 15. Keam SJ, Muir VJ, Deeks ED. Botulinum toxin A (Dysport): in dystonias and focal spasticity. Drugs 2011;71(8):1043-58. 16. Ondo WG, Hunter C, Moore W. A double-blind placebo-controlled trial of botulinum toxin Bfor sialorrhea in Parkinsons disease. Neurology. 2004;62(1):37-40. 17. Koivusalo A. I., Pakarinen M.P., Rintala R.J. Botox injection treatment for anal outlet obstruction in patients with internal anal sphincter achalasia and Hirschsprungs disease. Pediatr Surg Int (2009) 25: 873. https://doi.org/10.1007/s00383-009-2438-3. 18. Pasricha, P.J. , Ravich, W.J. , Hendrix, T.R. , et al. M.D. Intrasphincteric Botulinum Toxin for the Treatment of Achalasia . NEngl JMed (1995) ; 332:774-778. March 23, 1995. DOI: 10.1056/NEJM199503233321203 19. Storr M, Born P, Frimberger E, et al. Treatment of achalasia: the short-term response to botulinum toxin injection seems to be independent of any kind of pretreatment. BMC Gastroenterology. 2002;2:19. doi:10.1186/1471-230X-2 -19. 20. Staskin D., Martin M.C. Understanding Dose Titration: Overactive Bladder Treatment With Fesoterodine as an Example.European Association of Urology . 10 (2011): 8-13. DOI:10.1016/j.eursup.2011.01.004. 21. Fock J, Galea MP, Stillman BC, et al. Functional outcome following Botulinum toxin A injection to reduce spastic equinus in adults with traumatic brain injury. Brain Inj. 2004;18(1):57-63. 22. Biglan AW, Burnstine RA, Rogers GL, Saunders RA. Management of strabismus with botulinum A toxin. Ophthalmology. 1989;96(7):935-943. 23. Rowe FJ, Noonan CP. Botulinum toxin for the treatment of strabismus. Cochrane Database Syst Rev. 2012;2:CD006499. 24. Tremor, myoclonus, focal dystonias, and tics. In: Adams and Victor's Principles of Neurology. 7th ed. MVictor, AH Ropper, eds., New York, NY: McGraw-Hill; 2001; Ch. 6: 99-120. 25. Munksgaard SB, et al. Medication overuse headache. Headache. 2014 Jul-Aug;54(7):1251-7. 26. Gmez-Caravaca MT, et al. The use of botulinum toxin in the treatment of sialorrhea in parkinsonian disorders. Neurol Sci. 2015 Feb;36(2):275-9. 27. International Headache Society. Available at: www.ichd-3.org. Effective date: 08/20/2018 Revised date: 08/03/2018
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Durolane (sodium hyaluronate) BILLING CODE J7318 BENEFIT TYPE Medical SITE OF SERVICE ALLOWED Office/Outpatient Hospital COVERAGE REQUIREMENTS Prior Authorization Required (Preferred Product) Alternative pr eferred products include Gelsyn-3, Supartz FX QUANTITY LIMIT 1 injection (60 mg) = 1 unit LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Durolane (sodium hyaluronate) is a preferred product and will only be con sidered for coverage under the medical benefit when the following criteria are met: Members must be clinically diagnosed with one of the following disease states and meet their individual criteria as stated. OSTEOARTHRITIS OF THE KNEE For initial authorization: 1. Member must be 40 years old or older; AND 2. Member must have a diagnosis of osteoarthritis confirmed by radiological evidence (e.g. Kellgren-Lawrence Scale score of grade 2 or greater); AND 3. Medication must be prescribed by an orthopedic surgeon, interventional pain physicians, rheumatologists, physiatrists (PM&R) and all sports medicine subspecialties; AND 4. Member tried and failed an intra-articular corticosteroid injection(s) in which efficacy was
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Fasenra (benralizumab) BILLING CODE J0517 BENEFIT TYPE Medical SITE OF SERVICE ALLOWED Office/Outpatient Hospital COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) QUANTITY LIMIT 30 mg/mL LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Fasenra (benralizumab) is a non-preferred product and will only be con sidered for coverage under the medical benefit when the following criteria are met: Members must be clinically diagnosed with one of the following disease states and meet their individual criteria as stated. SEVERE ASTHMA For initial authorization: 1. Member must be 12 years of age or older; AND 2. Medication must be prescribed by or under the recommendation of a pulmonologist, immunologist or allergist; AND 3. Member has eosinophilic phenotype as defined by a baseline (pre-benraliz umab treatment) peri pheral blood eosinophil level 150 cells/ Lwithin the past 6 weeks; AND 4. Members asthma has been inadequately controlled after 3 month of conventional treatment of medium to high doses of inhaled corticosteroids (ICS) and long acting beta 2-agonists (LABA); AND 5. Member has at least two documented severe asthma exacerbation within last year; AND 6. Medication is being used as the add-on maintenance treatment to conventional therapies for asthma (i.e. , ICS, LABA, etc.); AND 7. Medication is not used in combination with Nucala (mepolizumab) or Cinqair (reslizumab). 8. Dosage allowed: Recommended dose is 30 mg every 4 weeks for the first 3 doses, followed by once every 8 weeks thereafter. If member meets all the requirements listed above, the medication will be approved for 16 weeks. For reauthorization: 1. Medication not being used as monotherapy for asthma; AND 2. Member must be in compliance with all other initial criteria; AND 3. Chart notes have been provided that show the member has demonstrated improvement during 16 weeks of medication therapy: a) Decreased frequency of emergency department visits; OR b) Decreased frequency of hospitalizations due to asthma symptoms; OR c) Increase in percent predicted FEV1 from pretreatment baseline; OR d) Impr oved functional ability (i.e. decreased effect of asthma on ability to exercise, function in school or at work, or quality of sleep); OR e) Decreased utilization of rescue medications. If member meets all the reauthorization requirements above, the medication will be approved for an additional 12 months. CareSource considers Fasenra (benralizumab) not medically necessary for the treatment of the following disease states based on a lack of robust clinical controlled trials showing superior efficacy compared to currently available treatments: Active lung infection Acute bronchospasm Allergic bronchopulmonary aspergillosis/mycosis Alpha 1 anti-trypsin deficiency Atopic dermatitis Atopic eczema Bronchiectasis Chronic obstructive pulmonary disease Chronic rhinosinusitis Churg-Strauss syndrome Cystic fibrosis Eosinophil gastroenteritis Eosinophilic esophagitis Eosinophilic granulomatosis with polyangiitis Hyper-eosinophilic syndrome Hypoventilation syndrome associated with obesity Lung cancer Nasal polyposis Primary ciliary dyskinesia Pulmonary fibrosis Status asthmaticus DATE ACTION/DESCRIPTION 12/01/2017 New policy for Fasenra created. 05/12/2018 Baseline (pre-benralizumab treatment) peripheral blood eosinophil level was changed from 300 to 150 cells/L within the past 6 weeks. References: 1. Fasenra [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals; November 2017. 2. ClinicalTrials.gov web site. U.S. National Library of Medicine. Identifier NCT01914757 Efficacy and Safety Study of Benralizumab in Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting 2 Agonist . Available at: https://clinicaltrials.gov/ct2/show/NCT01914757?term=benralizumab&recrs=e&draw=1&rank=6. 3. Walford HH, Doherty TA. Diagnosis and management of eosinophilic asthma: a US perspective. JAsthma Allergy. 2014;7:53 65. 4. ClinicalTrials.gov web site. U.S. National Library of Medicine. IdentifierNCT02075255. Efficacy and Safety Study of Benralizumab to Reduce OCS Use in Patients With Uncontrolled Asthma on High Dose Inhaled Corticosteroid Plus LABA and Chronic OCS Therapy. Available at: https://clinicaltrials .gov/ct2/show/NCT02075255?term=benralizumab&recrs=e&draw=1&rank=7. 5. Goldman M, Hirsch I, Zangrilli JG, et al. The association between blood eosinophil count and benralizumab efficacy for patients with severe, uncontrolled asthma: subanalyses of the Phase II I SIROCCO and CALIMA studies. Curr Med Res Opin. 2017 Sep;33(9):1605-1613. Effective date: 09/07/2018 Revised date: 05/12/2018
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Promacta (eltrombopag) BILLING CODE Must use valid NDC code BENEF IT TYPE Pharmacy SIT EOF SERVICE ALLOWED Home COVERAGE REQUIREMENTS Prior Authorization Required (Preferred Product) Alternative preferred products include immune globulins QUANTITY LIMIT up to 75 mg per day LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click He re Promacta (eltrombopag) is a pre fe rred product and will only be considered for coverage under the pharm acy benefit when the following criteria are met: Members mus t be c linically diagnosed with one of the following dis eas e states and meet their individual c riteria as s tated. IMMUNE THROMBOCYTOPENIC PURPURA (ITP) For initial authorization: 1. Member is 1 year of age or older ; AND 2. Member has a documented diagnosis of chronic immune (idiopathic) thrombocytopenic purpura (ITP) ; AND 3. Documented clinical reason required if request is for suspension for adult member; AND 4. Medication must be prescribed by or in consultation with a hematologist; AND 5. Member has ONE of the following conditions: a) Current platelet count is 6, class Band C); b) History of ascites; c) Hepatic encephalopathy . 7. Dosage allowed: Initiate at a dose of 25 mg by mouth once daily, then adjust in 25 mg increment every week to achieve target platelet count. Max dose of 100 mg daily. If member meets all the requirements listed above, the medication will be approved for 12 weeks. For r e a ut ho riza tion: 1. Member must be in compliance with all other initial criteria; AND 2. Chart notes have been provided that show the member has shown improvement in platelet count from baseline; AND 3. Members platelet count is below 400 x 109/L; AND 4. Member is taking ribavirin or peginterferon concurrently as documented in chart notes and/or pharmacy claims. If member meets all the reauthorization requirements above, the medication will be approved for a n a ddit ion a l 3 months. SEV ERE APLASTIC ANEMIA For initial authorization: 1. Member is 17 years of age or older; AND 2. Documented clinical reason required if request is for suspension for adult member ; AND 3. Member has a documented diagnosis of severe aplastic anemia defined as a marrow cellularity
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Orkambi (lumacaftor/ivacaftor) BILLING CODE Must use valid NDC code BENEF IT TYPE Pharmacy SIT EOF SERVICE ALLOWED Home COVERAGE REQUIREMENT SPrior Authorization Required (Preferred Product) QUANTITY LIMIT 112 tablets per 28 days or 56 unit-dose packets per 28 days LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click He re Orkambi (lumacaftor/ivacaftor) is a pre fe rred product and will only be con sidered for coverage under the pharm acy benefit when the following criteria are met: Members mus t be c linically diagnosed with one of the following dis eas e states and meet their individual c riteria as s tated. CY STIC FIBROSIS For initial authorization: 1. Member must be 2 years of age or older; AND 2. Medication must be prescribed by a pulmonologist or an infectious disease specialist; AND 3. Member has had genetic testing documented in chart notes with two copies (homozygous) of the F508del mutation (F508del/F508del) in their CFTR gene. 4. Dosage allowed: Adults and pediatric member s age 12 years and older : two tablets (each containing lumacaftor 200 mg/ivacaftor 125 mg) taken orally ev e r y 12 hours. Pediatric members age 6 through 11 years : two tablets (each containing lumacaftor 100 mg/ivacaftor 125 mg) taken orally every 12 hours. Pediatric members age 2 through 5 years
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Stelara (ustekinumab) BILLING CODE J3357 (1 unit = 1 mg) Must have valid NDC for self-administered product BENEFIT TYPE Medical or Pharmacy SITE OF SERVICE ALLOWED Office/Outpatient/Home COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) Alternative preferred products include Enbrel, Cimzia, Cosentyx, Xeljanz , Otezla and Siliq QUANTITY LIMIT 90 units per 56 days (after loading dose) LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Stelara (ustekinum ab) is a non-preferred product and will only be considered for coverage under the medical or pharmacy benefit when the following criteria are met: Members must be clinically diagnosed with one of the following disease states and meet their individual criteria as stated. CROHNS DISEASE (CD) For initial authorization: 1. Member is 18 years of age or older with moderate to severe, active CD with demonstrated corticosteroid dependence; AND 2. Must have a documented negative TB test (i.e. , tuberculosis skin test (PPD), an interferon-release assay (IGRA)) within 12 months prior t o starting therapy; AND 3. Medication must be prescribed by a gastroenterologist; AND 4. Member has had a documented trial and inadequate response to a 30-day trail at least one of the following: 6-mercaptopurine, azathioprine, methotrexate or corticosteroids; OR 5. Member has severe disease, as indicated by at least one of the following: a) Esophageal or gastroduodenal disease; b) Extensive small-bowel disease involving more than 100 cm; c) History of colonic resection; d) History of two or more small-bowel resections; e) Perianal or rectal disease; AND 6. Member has tried and failed treatment with Cimzia or Humira. Treatment failur e requires at least 30 days of therapy. 7. Dosage allowed: Induction: 260 mg-520 mg (depending on weight) intravenously as a single dose then 8 weeks afte r induction dose, 90 mg subcutaneously every eight weeks. If member meets all the requirements listed above, the medication will be approved for 12 months. For reauthorization: 1. Must have been retested for TB with a negative result within the past 12 months; AND 2. Member must be in compliance with all other initial criteria; AND 3. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If member meets all the reauthorization requirements above, the medication will be approved for an additional 12 months. PLAQUE PSORIASIS (PsO) For initial authorization: 1. Member must be 12 years of age or older; AND 2. Must have a documented negative TB test (i.e. , tuberculosis skin test (PPD), an interferon-release assay (IGRA)) within 12 months prior to starting therapy; AND 3. Medication must be prescribed by a rheumatologist or dermatologist; AND 4. Member ha s PsO involves 10% or more of the members body surface area; AND 5. Member has tried and failed treatment with at least two of the following: Cimzia, Cosentyx, Enbrel, Otezla and Siliq (Only applicable to members who 18 years old; if member is
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Zubsolv (buprenorphine and naloxone) sublingual tablets for sublingual administration BILLING CODE Must use valid NDC code BENEF IT TYPE Pharmacy SIT EOF SERVICE ALLOWED Home COVERAGE REQUIREMENT SPrior Authorization Required (Non-Preferred Product) Alternative preferred product s include generic buprenorphine/naloxone sublingual tablets QUANTITY LIMIT 30-day supply at a time only Strength Quantity Limit 0.7 mg-0.18 mg 2.9 mg-0.7 mg 11.4 mg-2.9 mg 1.4 mg-0.36 mg 5.7 mg-1.4 mg 8.6 mg-2.1 mg 1 tab per day 1 tab per day 1 tab per day 1 tab per day 1 tab per day 2 tabs per day LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click He re Zubsolv (buprenorphine and naloxone) is a non-pre ferred product and will only be considered for coverage under the pharmacy benefit when the following criteria are met: Members mus t be c linically diagnosed with one of the following dis eas e states and meet their individual c riteria as s tated. OPIOID DEPENDENCE For initial authorization: 1. All of the following: a) The individual has failed an adequate trial of the preferred generic buprenorphine/naloxone sublingual tablets within the previous 120 days ( Note: Adequate trial is defined as at least 28 days of treatment); AND b) One of the following: i) The member experienced therapeutic failure with the preferred generic buprenorphine/naloxone sublingual tablets ( Note: Brand and non-preferred buprenorphine agents will not be approved for member s who report lesser efficacy as compared to the preferred generic bupreno r ph in e sublingual tablets unless it would be clinically inappropriate to addres s efficacy with dose adjustment ); OR ii) Generic sublingual tablets caused adverse outcome; AND c) The prescriber has provided a copy and confirmation of a MedWatch form submission to the FDA documenting the therapeutic failure or adverse outcome experienced by the member ( Note : Th e MedWatch form is available at https://www.fda.gov/download s/AboutFDA/ReportsManualsForms/Forms/UCM163919.pdf) OR 2. Both of the following:a) The individual has a hypersensitivity reaction to an inactive ingredient in the preferred generic buprenorphine sublingual tablets ; AND b) The hypersensitivity reaction(s) is clearly documented in the member 's medical record. 3. Dosage allowed: The maintenance dose of Zubsolv sublingual tablet is generally in the range of 2.9 mg/0.71 mg buprenorphine/naloxone to 17.2 mg/4.2 mg buprenorphine/nal oxone per day. The recommended target dose is 11.4 mg/2.9 mg as a single daily dose. Dosages higher than 17.2 mg/4.2 mg buprenorphine/naloxone have not been demonstrated to provide any clinical advantage . Addit ion a l Not e s: GI upset or irritation is not generally considered an allergy or failed treatment. Members should be referred to their physician or pharmacist for advice on dose adjustment, and/or other options to reduce GI upset/irritation. Common documented side effect s attributed to the drug (i.e. headache, nausea, blurred vision, fatigue, muscle aches) are not considered an allergy and would be expected to occur at the same level in both the generic and brand agent. Drug hypersensitivity symptoms may include skin rash, hives, itching, fever, swelling, shortness of breath, wheezing, runny nose, itchy and/or watery eyes, and in severe cases, anaphylaxis. If member meets all the requirements listed above, the medication will b e a ppr ov e d f or lifetime. Care Source conside rs Zubsolv (bupre norphine and nalox one) not m e dically ne ce ssary for the tre atment of the dise ases that are not liste d in this document. DATE ACTION/DESCRIPTION 03/04/2019 New policy for Zubsolv created. Referenc es : 1. MedWatc h: The FDA Safety Information and Adverse Event Reporting Program. Available at http://www.fda.gov/s afety /medwatch/default.htm. 2. Zubs olv [pac kage insert]. Morristown, NJ : Orex o US, Inc . ; September , 2017. Effec tive date: TBD Rev is ed date: 03/04/2019
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Subutex (buprenorphine) BILLING CODE Must use valid NDC code BENEF IT TYPE Pharmacy SIT EOF SERVICE ALLOWED Home COVERAGE REQUIREMENTS Prior Authorization Required (Preferred Product) with some exceptions QUANTITY LIMIT up to 16 mg/day LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click He re Subutex (buprenorphine) is a pre ferred product and will only be considered for coverage under the pharm acy benefit when the following criteria are met: Members mus t be c linically diagnosed with one of the following dis eas e states and meet their individual c riteria as s tated. OPIOID DEPENDENCE For initial authorization: 1. Medication will not be authorized if one of the following criteria met: a) Member is 15 years of age or younger; OR b) Members who are 16 to 44 years old and not pregnant receiving short acting buprenorphine without naloxone for longer than 9 months; OR c) Dosages requested are greater than 16 mg/day; OR d) Member has claims for concurrent use of opioids (including Medication Assisted Treatments) and benzodiazepines; OR e) Member s who are male or female 45 years of age or older receiving short acting buprenorphine without naloxone. *Exception: if member requests buprenorphine without naloxone than must meets all of the following criteria with Prior Authorization request: i) Member has documented trial of buprenorphine/naloxone combination product supported by claims history (at least one claim in the last 120 days); AND ii) Member has documented allergic hypersensitivity reaction to buprenorphine/naloxone combination product, supported by chart notes; OR iii) Member has documented clinically significant adverse drug reaction in response to buprenorphine/naloxone combination product, and the prescriber has provided a copy and confirmation of a MedWatch form submission to the FDA . If memb er meets all the requirements listed above a n d: Member is pregnant , t h e me dic a t ion will b e a ppr ov e d f or 12 months, OR Member is male or non-pr e gn a n t, t h e me dic a t ion will b e a ppr ov e d f or lifetime. Care Source considers Subutex (buprenorphine) not medically ne cessary for the tre atment of the dise ases that are not liste d in this docum ent. D ATE ACTION/DESCRIPTION 03/04/2019 New policy for Subutex created. Referenc es : 1. MedWatc h: The FDA Safety Information and Adverse Event Reporting Program. Available at http://www.fda.gov/s afety /medwatch/default.htm. 2. Subutex [pres cribing information]. Ric hmond, VA: Indivior Inc; September 2017. Effec tive date: TBD Rev is ed date: 03/04/2019
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Suboxone (buprenorphine and naloxone) sublingual film, for sublingual or buccal use BILLING CODE Must use valid NDC code BENEF IT TYPE Pharmacy SIT EOF SERVICE ALLOWED Home COVERAGE REQUIREMENT SPrior Authorization Required (Non-Preferred Product) Alternative preferred product s include generic buprenorphine/naloxone sublingual tablets QUANTITY LIMIT 30-day supply at a time only Strength Quantity Limit 2 mg 0.5 mg 4 mg 1 mg 8 mg 2 mg 12 mg 3 mg 1 film per day 1 film per day 2 films per day 2 films per day LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click He re Suboxone (buprenorphine and naloxone) is a non-pre ferred product and will only be considered for coverage under the pharmacy benefit when the following criteria are met: Members mus t be c linically diagnosed with one of the following dis eas e states and meet their individual c riteria as s tated. OPIOID DEPENDENCE For initial authorization: 1. All of the following: a) The individual has failed an adequate trial of the preferred generic buprenorphine/naloxone sublingual tablets within the previous 120 days ( Note: Adequate trial is defined as at least 28 days of treatment); AND b) One of the following: i) The member experienced therapeutic failure with the preferred generic buprenorphine/naloxone sublingual tablets ( Note: Brand and non-preferred buprenorphine agents will not be approved for member s who report lesser efficacy as compared to the preferred generic buprenorphine sublingual tablets unless it would be clinically inappropriate to addres s efficacy with dose adjustment ); OR ii) Generic sublin gual tablets caused adverse outcome; AND c) The prescriber has provided a copy and confirmation of a MedWatch form submission to the FDA documenting the therapeutic failure or adverse outcome experienced by the member ( Note : Th e MedWatch form is available at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM163919.pdf) OR 2. Both of the following: a) The individual has a hypersensitivity reaction to an i nactive ingredient in the preferred generic buprenorphine sublingual tablets; ANDb) The hypersensitivity reaction(s) is clearly documented in the member's medical record. 3. Dosage allowed: The maintenance dose of Suboxone is generally in the range of 4 mg/1 mg buprenorphine/naloxone to 24 mg/6 mg buprenorphine/naloxone per day. The recommended target dosage during maintenance is 16 mg/4 mg buprenorphine/naloxone/day as a single daily dose. Dosages higher than 24 mg/6 mg daily have not been demonstrated to provide a clinical advantage. Addit ion a l Not e s: GI upset or irritation is not generally considered an allergy or failed treatment. Members should be referred to their physician or pharmacist for advice on dose adjustment, and/or other options to reduce GI upset/irritation. Common documented side effect s attributed to the drug (i.e., headache, nausea, blurred vision, fatigue, muscle aches) are not considered an allergy and would be expected to occur at the same level in both the generic and brand agent. Drug hypersensitivity symptoms may include skin rash, hives, itching, fever, swelling, shortness of breath, wheezing, runny nose, itchy and/or watery eyes, and in severe cases, anaphylaxis. If member meets all the requirements listed above, the medication will be approved for lifetime. Care Source considers Subox one (buprenorphine and nalox one) not m e dically ne ce ssary for the tre atment of the dise ases that are not liste d in this document. DATE ACTION/DESCRIPTION 03/04/2019 New policy for Suboxone created. Referenc es : 1. MedWatc h: The FDA Safety Information and Adverse Event Reporting Program. Available at http://www.fda.gov/s afety /medwatch/default.htm. 2. Subox one [pac k age insert]. Ric hmond, VA: Indivior Inc.; February , 2017. Effec tive date: TBD Rev is ed date: 03/04/2019
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Probuphine (buprenorphine subdermal implant) BILLING CODE J0570 BENEF IT TYPE Medical SIT EOF SERVICE ALLOWED Office COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) QUANTITY LIMIT 1 implant in each arm for 6 months each LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click He re Probuphine (buprenorphine subdermal implant) is a non-pre ferred product and will only be con sidered for coverage under the m e dical benefit when the following criteria are met: Members mus t be c linically diagnosed with one of the following dis eas e states and meet their individual c riteria as s tated. OPIOID DEPENDENCE For initial authorization: 1. Member is 18 to 65 years of age; AND 2. Member has a documented diagnosis of opioid use disorder and/ or other dependency in char notes; AND 3. Medication must be prescribed by a DATA 2000 waivered physician with an appropriate DEA number associated with an Xprefix or SAMHSA certified ; AND 4. Member must participate in a comprehensive rehabilitation program that includes psychosocial treatment (Documentation of treatment plan and taper strat egy not required, but verification upon request must be provided) ; AND 5. Member must have achieved and sustained prolonged clinical stability on 8 mg/day or less of transmucosal buprenorphine equivalent for at least 3 months without any need for supplemental doses or adjustments. The dose should not have been tapered down to a lower dose for the sole purpose of transitioning to the subdermal implant ; AND 6. A documented reason as to why oral therapy should not be continued; AND 7. All REMS Program criteria must be met (see www.probuphinerems.com) . 8. Dosage allowed: 1 implant in one arm for 6 months, 1 implant in the opposite arm for a total of 12 months of therapy . Implants should not be used for additional treatment cycles after one insertion in each upper arm . Note : Use of buprenorphine subdermal implant (Probuphine ) is limited to a total duration of 12 months (1 implant in each arm for 6 months each). If member meets all the requirements listed above, the medication will be approved for 12 months. For r e a ut ho riza tion: Probuphine will not be reauthorized.Care Source conside rs Probuphine (buprenorphine subde rmal im plant) not m e dically ne cessary for the tre atment of the dise ases that are not liste d in this docum ent. DATE ACTION/DESCRIPTION 03/04/2019 Policy for Probuphine modified into a new format. Referenc es : 1. MedWatc h: The FDA Safety Information and Adverse Event Reporting Program. Available at http://www.fda.gov/s afety /medwatch/default.htm. 2. Probuphine [pac k age ins ert]. Princeton, NJ : Braeburn Pharmaceutic als, Inc.; May 2016. 3. Subs tanc e Abuse and Mental Health Services Administration, Offic e of Applied Studies (2008). US Dept of Health and Human Serv ic es . Results from the 2007 National Surv ey on Drug Us e and Health: National Findings. (NS DUH Series H-34, DHHS Public ation No. SMA 08-4343). Rockv ille, MD. 4. Kak k o J , Heilig M, Sarman I. Buprenorphine and methadone treatment of opiate dependenc e during pregnancy : Comparis on of fetal growth and neonatal outcomes in two c onsecutive c ase s eries. Drug Alcohol Depend. 2008 Jul 1; 96(1-2):69-78. 5. Maremmani I and Gerra G. Buprenorphine-bas ed regimens and methadone for the medical management of opioid dependenc e: s elec ting the appropriate drug for treatment. Am JAddict 2010;19: 668-568. 6. Nic holls L, Bragaw L, and Ruets ch C. Opioid dependence treatment and guidelines. JManag Care Pharm. 2010 Feb;16(1 Suppl B):S14-21. 7. Jones HE, Martin PR, Heil SM, et al. Treatment of opioid dependent pregnant women: c linic al and res earc h is s ues . JSubs t Abuse Treat 2008; 35(3): 245-259. 8. Orman JS, Keating GM. Buprenorphine/nalox one: a rev iew of its use in the treatment of opioid dependenc e. Drugs . 2009; 69(5):577-607. 9. Drug Enforc ement Administration Office of Div ersion Control. DEA requirements for DATA waiv ed phys ic ians (DWPs ). http://www.deadivers ion.usdoj.gov/pubs/doc s/dwp_buprenorphine.htm. 10. Subs tanc e Abuse and Mental Health Services Administration. Buprenorphine Waiver Management. Updated 8/17/16. http://www.s amhsa.gov/medic ation-assistedtreatment/buprenorphine-waiver-management. 11. Ohio. 5122-29-35. Lic ens ure to c onduct an opioid agonist program. 12. Diagnos tic and Statistical Manual of Mental Dis orders , Fifth Edition (DSM-5) 13. Ohio Adminis trative Code 4731-11. 14. Kampman K, Jarvis M. American Society of Addiction Medicine (ASAM) National Practice Guideline for the Use of Medic ations in the Treatment of Addiction Involving Opioid Us e. JAddict Med. 2015; 9: 1-10. Effec tive date: TBD Rev is ed date: 03/04/2019
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