PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Xeljanz/Xeljanz XR (tofacitinib) BILLING CODE Must use valid NDC code BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home COVERAGE REQUIREMENTS Prior Authorization Required (Preferred Product) QUANTITY LIMIT see Dosage allowed below LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Xeljanz/Xeljanz XR (tofacitinib) is a preferred product and will only be considered for coverage under the 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. PSORIATIC ARTHRITIS (PsA) For initial authorization: 1. Member must be 18 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 has predominately non-axial disease (e.g., peripheral synovitis or dactylitis or nail involvement) and has tried and failed to respond to treatment with at least 30-day trial of methotrexate and NSAID taken at the maximum recommended dosages (if unable to tolerate or has contraindication to methotrexate than 30-day trial of sulfasalazine or azathioprine or cyclosporine) . 5. Dosage allowed: Xeljanz is 5 mg twice daily; Xeljanz XR is 11 mg once daily. 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. RHEUMATOID ARTHRITIS (RA) For initial authorization: 1. Member must be 18 years of age or older with moderate to severe active RA; 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; AND 4. Member must have tried and failed treatment with at least two non-biologic DMARDS (i.e., methotrexate, hydroxychloroquine, sulfasalazine, azathioprine, cyclosporine and leflunomide) or must have documented contraindication to all non-biologic DMARDS. Treatment trial duration with each non-biologic DMARD agent must have been at least 30 days. 5. Dosage allowed: Xeljanz is 5 mg twice daily; Xeljanz XR is 11 mg once daily. 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. ULCERATIVE COLITIS (UC) For initial authorization: 1. Member is 18 years of age or older with moderate to severe active UC (e.g., total Mayo score of 6 to 12, with an endoscopy subscore of at least 2, and rectal bleeding subscore of at least 1) ; AND 2. Member have had a documented history of an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker ( e.g., Remicade, Humira, Simponi, etc.); AND 3. 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 4. Member does not have presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease; AND 5. Medication must be prescri bed by a gastroenterologist. 6. Dosage allowed: Induction: 10 mg twice daily for 8 weeks . If needed, continue 10 mg twice daily for a maximum of 16 weeks. Maintenance: 5 mg twice daily. Lowest effective dose must be used to maintain response. See package insert for details on dose adjustments. Discontinue Xeljanz after 16 weeks of treatment w ith 10 mg twice daily, if adequate therapeutic benefit is not achieved. 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. CareSource considers Xeljanz/Xeljanz XR (tofacitinib) 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: Alopecia Dry eye disease Crohns disease Prevention of organ transplant rejection Plaque psoriasis DATE ACTION/DESCRIPTION 05/10/2017 New policy for Xeljanz/Xeljanz XR created. Policy SRx-0042 archived. For diagnosis of RA: trial of Humira and Enbrel required. List of diagnoses considered not medically necessary was added. 02/05/2018 New indication of Psoriatic Arthritis (PsA) was added. 09/14/2018 New indication of Ulcerative Colitis was added. Requirements on axial disease type removed from PsA. 02/26/2019 Humira and Enbrel removed from trials requirement. Initial authorization length increased to 12 months for UC. TB test allowed to be done within 12 months prior to initiation of therapy; chest x-ray option removed. References updated. Other drugs options allowed for PsA if there is an intolerance or contraindication to methotrexate. 08/06/2019 For diagnosis of UC, treatment options of immunomodulators, corticosteroids and salicylates were removed. References: 1. Xeljanz [package insert] . New York, NY: Pfizer; July , 2019. 2. American College of Rheumatology. Guidelines for the management of rheumatoid arthritis: American College of Rheumatology Ad Hoc Committee on Clinical Guidelines. Arthritis Rheuma. 1996;39(5):713-723. 3. Fleischmann R, Kremer J, Cush J, et al. Placebo-controlled trial of tofacitinib monotherapy in rheumatoid arthritis. NEngl JMed. 2012b;367(6):495-507. 4. Singh JA, Furst DE, Beharat A, et al. 2012 Update the 2008 American College of Rheumatology Recommendations for the Use of Disease Modifying Antirheumatic Drugs and Biologic Agents in the Treatment of Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2012;64(5):625-639. 5. Kornbluth A, Sachar DB, Janowitz HD, et al.Ulcerative Colitis in Adults: American College of Gastroenterology. Am JGastroenterol 2010; 105:501 523; doi:10.1038/ajg.2009.727. 6. ClinicalTrials.gov. Identifier: NCT01458951. A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative Colitis (OCTAVE). Available at: https://clinicaltrials.gov/ct2/show/NCT01458951?term=xeljanz&draw=2&rank=55. 7. Pascart Tet al. Comparative efficacy of tocilizumab, abatacept and rituximab after non-TNF inhibitor failure: results from a multicentre study. Int JRheum Dis. 2016 Nov;19(11):1093-1102. 8. Emery P. Optimizing outcomes in patients with rheumatoid arthritis and an inadequate response to anti-TNF treatment. Rheumatology (Oxford). 2012 Jul;51 Suppl 5:v22-30. 9. Remy A, et al. Clinical relevance of switching to a second tumour necrosis factor-alpha inhibitor after discontinuation of a first tumour necrosis factor-alpha inhibitor in rheumatoid arthritis: a systematic literature review and meta-analysis. Clin Exp Rheumatol. 2011 Jan-Feb;29(1):96-103. Effective date: 09/26/2019 Revised date: 08/06/2019
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Sublocade (buprenorphine extended-release) injection, for subcutaneous use BILLING CODE Must use valid NDC code BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Office COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) Alternative preferred product s include transmucosal buprenorphine-containing product s and Vivitrol QUANTITY LIMIT up to 300 mg monthly LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Sublocade ( buprenorphine extended-release) is a non-preferred product and will only be con sidered for coverage under the 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. OPIOID DEPENDENCE For initial authorization: 1. Member must have had at least 7 days treatment with transmucosal buprenorphine-containing product ( equivalent of 8 to 24 mg of buprenorphine daily ) within the last 21 days ; AND 2. Medication must be prescribed and administered by addiction specialist (i.e. , DATA 2000 certified) solely for t he treatment of opioid dependence . 3. Dosage allowed: Initially, t wo monthly doses of 300 mg after treatment has been inducted and adjusted with 8 to 24 mg of a transmucosal buprenorphine-containing product for a minimum of 7 days , followed by 100 mg monthly for maintenance. Increasing the maintenance dose to 300 mg monthly may be considered with submission of detailed chart notes documenting lack of satisfactory clinical response to Sublocade 100 mg, recent clinical opioid withdrawal scale and specific clinical reasons outlined by provider. 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. If member meets all the reauthorization requirements above, the medication will be approved for an additional 12 months. CareSource considers Sublocade (buprenorphine extended-release) not medically necessary for the treatment of the diseases that are not listed in this document. DATE ACTION/DESCRIPTION 07/23/2018 New policy for Sublocade created. References: 1. Sublocade [package insert]. North Chesterfield, VA: Indivior, Inc; March 2018. Effective date: 08/31/2018 Revised date: 07/23/2018
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Zulresso (brexanolone) BILLING CODE J3490 BENEFIT TYPE Medical SITE OF SERVICE ALLOWED TBD COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) QUANTITY LIMIT see Dosage allowed below LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Zulresso (brexanolone) 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. POSTPARTUM DEPRESSION (PPD) For initial authorization: 1. Member is 18 y ears old or older and 6 months postpartum ; AND 2. Member has diagnosis of PPD and has documented onset of symptoms in the third trimester or within 4 weeks of delivery; AND 3. Member must have ceased lactating before drug administration, or if still lactating or actively breastfeeding, agreed to temporarily cease giving breastmilk to their infant(s); AND 4. Medication must be prescribed by or in consultation with psychiatrist, ob/gyn provider; AND 5. Member has documented total baseline score of Hamilton Rating Scale for Depression 20; AND 6. Member does not have ANY of the following: a) Active psychosis, b) Attempted suicide associated with index case of postpartum depression, c) Medical history of bipolar disorders, schizophrenia, and/or schizoaffective disorder. 7. Dosage allowed: Infusion over a total of 60 hours (2.5 days) as follows: 0 to 4 hours: Initiate with a dosage of 30 mcg/kg/hour , 4 to 24 hours: Increase dosage to 60 mcg/kg/hour , 24 to 52 hours: Increase dosage to 90 mcg/kg/hour (a reduction in dosage to 60 mcg/kg/hour may be considered during this time period for patients who do not tolerate 90 mcg/kg/hour) , 52 to 56 hours: Decrease dosage to 60 mcg/kg/hour , 56 to 60 hours: Decrease dos age to 30 mcg/kg/hour. If member meets all the requirements listed above, the medication will be approved for 1 month. For reauthorization: 1. Zulresso will not be authorized for continues administration (it is a single time injection). CareSource considers Zulresso (brexanolone) not medically necessary for the treatment of the diseases that are not listed in this document. DATE ACTION/DESCRIPTION 08/12/2019 New policy for Zulresso created. References: 1. Zulresso [prescribing information]. Cambridge, MA : Sage Therapeutics, Inc.; June 2019. 2. ClinicalTrials.gov Identifier: NCT02942004. A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B) . Available at: https://clinicaltrials.gov/ct2/show/NCT02942004?term=NCT02942004&rank=1. 3. ClinicalTrials.gov Identifier: NCT02942017. A Study to Evaluate Safety and Efficacy of SAGE-547 in Participants With Moder ate Postpartum Depression (547-PPD-202C) . Available at: https://clinicaltrials.gov/ct2/show/NCT02942017?term=NCT02942017&rank=1. 4. Hamilton M. A rating scale for depression. Journal of Neurology, Neurosurgery and Psychiatry, 1960; 23:56-62. Available at: https://www.outcometracker.org/library/HAM-D.pdf. Effective date: 09/26/2019 Revised date: 08/12/2019
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) BILLING CODE Must use valid NDC code BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) QUANTITY LIMIT see Dosage allowed below LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) are non-preferred product and will only be con sidered for coverage under the 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. CARDIOMYOPATHY OF WILD TYPE OR HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM) For initial authorization: 1. Member is 18 years old or older; AND 2. Medication must be prescr ibed by or in consultation with neurologist ; AND 3. Member has diagnosis of ATTR-CM confirmed by ALL of the following: a) The demonstration of amyloid deposits via tissue biopsy or via cardiac pyrophosphate imaging; b) Genetic testing confirming TTR gene mutation for hereditary ATTR-CM or immunohistochemical analysis, scintigraphy, or mass spectrometry confirming presence of transthyretin precursor proteins for wild type ATTR-CM ; c) Documentation of MRI or ECG results confirming cardiac involvement or m edical history of Heart Failure (HF) with at least 1 prior hospitalization for HF or clinical evidence of HF (without hospitalization) manifested by signs or symptoms of volume overload or elevated intracardiac pressures (e.g., elevated jugular venous pres sure, shortness of breath or signs of pulmonary congestion on x-ray or auscultation, peripheral edema) that required/requires treatment with a diuretic for improvement ; AND 4. Documented baseline of 6-minute walk test; AND 5. Member does not have ANY of the foll owing: a) A New York Heart Associat ion (NYHA) classification of IV; b) Presence of pr imary (light chain) amyloidosis; c) Prior liver or heart transplantation or implanted c ardiac mechanical assist device; AND 6. Member is not receiving Vyndagel and/or Vyndamax with Tegsedi or Onpattro. 7. Dosage allowed : Vyndaqel 80 mg orally once daily, or Vyndamax 61 mg orally once daily . 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 (e.g., distance walked on 6-minute walk improved, reduced the decline in functional capacity and quality of life, cardiovascular-related hospitalizations decreased); AND 3. Member is not receiving Vyndagel and/or Vyndamax with Tegsedi or Onpattro. If member meets all the reauthorization requirements above, the medication will be approved for an additional 12 months. CareSource considers Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) 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: Primary amyloidosis DATE ACTION/DESCRIPTION 08/08/2019 New policy for Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) created. References: 1. Vyndaqel and Vydamax [package insert]. New York, NY: Pfizer Labs.; May 2019. 2. ClinicalTrials.gov Identifier: NCT01994889. Safety and Efficacy of Tafamidis in Patients With Transthyretin Cardiomyopathy (ATT R-ACT) . Available at: https://www.clinicaltrials.gov/ct2/show/NCT01994889?term=NCT01994889&rank=1. 3. Maurer MS, Schwartz JH, Gundapaneni B, et al. Tafamidis treatment for patients with transthyretin amyloid cardiomyopathy. NEngl JMed. 2018 Sep 13; 379(11):1007-1016. 4. Shintani Y, et al. Monitoring treatment response to tafamidis by serial native T1 and extracellular volume in transthyretin amyloid cardiomyopathy. ESC Heart Fail. 2019;6(1):232 236. 5. Maurer MS, et al. Tafamidis in Transthyretin Amyloid Cardiomyopathy.Effects on Transthyretin Stabilization and Clinical Outcomes. Heart Failure. 2015;8:519 526. 6. Bokhari S, et al. (99m)Tc-pyrophosphate scintigraphy for differentiating light-chain cardiac amyloidosis from the transthyretin-related familial and senile cardiac amyloidoses. Circ Cardiovasc Imaging. 2013;6(2):195 201. 7. Brown EE, et al. Genetic testing improves identification of transthyretin amyloid (ATTR) subtype in cardiac amyloidosis. Amyloid. 2017 Jun;24(2):92-95. Effective date: 09/26/2019 Revised date: 08/08 /2019
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Tegsedi (inotersen) BILLING CODE Must use valid NDC code BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home/Office COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) QUANTITY LIMIT 4 prefilled syringes per month LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Tegsedi (inotersen) is a non-preferred product and will only be con sidered for coverage under the 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. POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (hATTR) For initial authorization: 1. Member is 18 years old or older; AND 2. Medication must be prescr ibed by or in consultation with neurologist ; AND 3. Member has diagnosis of hATTR confirmed by ALL of the following: a) The demonstration of amyloid deposits via tissue biopsy; b) Genetic testing confirming TTR gene mutation; c) Documentation of f amilial amyloid polyneuropathy (FAP) stage 1 (unimpaired ambulation; mostly mild sensory, motor, and autonomic neuropathy in the lower limbs) or stage 2 (assistance with ambulation required; mostly moderate impairment progression to the lower limbs, upper limbs, and trunk); AND 4. Members platelet count is > 100 x 109/L ; AND 5. Member does not have ANY of the following: a) Prior liver transplant ; b) Known type 1 or type 2 diabetes mellitus ; c) Sensorimotor or autonomic neuropathy ; d) New York Heart Association (NYHA) functional classification of 3 ; e) Acute Coronary Syndrome or major surgery within 3 months ; f) Known Primary or Leptomeningeal Amyloidosis ; g) Anticipated survival less than 2 years ; AND 6. Member is not receiving Tegsedi with Vynd agel, Vyndamax or Onpattro. 7. Dosage allowed: 284 mg SQ injection once weekly. If member meets all the requirements listed above, the medication will be approved for 6 months.For reauthorization: 1. Member continues to have FAP stage 1 or stage 2; AND 2. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease (e.g., quality of life and motor function improved, neuropathic pain decreased, serum TTR levels reduced); AND 3. Members platelet count is no less than 100 x 109/L ; AND 4. Member did not experience acute glomerulonephritis caused by Tegsedi ; AND 5. Member is not receiving Tegsedi with Vyndagel, Vyndamax or Onpattro. If member meets all the reauthorization requirements above, the medication will be approved for an additional 12 months. CareSource considers Tegsedi (inotersen) 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: Autonomic neuropathy Sensorimotor neuropathy DATE ACTION/DESCRIPTION 08/07/2019 New policy for Tegsedi created. References: 1. Tegsedi [prescribing information]. Carlsbad, CA : Ionis Pharmaceuticals, Inc. ; October, 2018. 2. ClinicalTrials.gov Identifier: NCT01737398. Efficacy and Safety of Inotersen in Familial Amyloid Polyneuropathy . Available at: https://www.clinicaltrials.gov/ct2/show/NCT01737398?term=NCT+01737398&rank=1. 3. Ando Y, Coelho T, Berk JL, et al. Guideline of transthyretin-related hereditary amyloidosis for clinicians. Orphanet JRare Dis. 2013;8:31. 4. National Institutes of Health (NIH). Transthyretin amyloidosis. Available at: https://ghr.nlm.nih.gov/condition/transthyretin-amyloidosis. Effective date: 09/26/2019 Revised date: 08/07/2019
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Takhzyro (lanadelumab-flyo) BILLING CODE J3590 BENEFIT TYPE Medical SITE OF SERVICE ALLOWED Home/Office COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) Alternative preferred product includes Haegarda QUANTITY LIMIT 2 vials ( 300 mg/2 ml per vial) per 30 days LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Takhzyro (lanadelumab-flyo) 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. HEREDITARY ANGIOEDEMA (HAE) For initial authorization: 1. Member must be 12 years of age or older, and medication is being used for routine prophylaxis to prevent HAE attacks (NOT for treatment of acquired angioedema) ; AND 2. Medication prescribed by or in consultation with a provider specializing in allergy, immunology, or hematology; AND 3. Member has documented trial and failure of or contraindication to Heagarda (Chart notes required); AND 4. Member must have a confirmed diagnosis of HAE as one of the following: a) Type 1 HAE documented in chart notes with ALL of the following ( Note: tests listed below must be repeated for confirmation of diagnosis): i) Low levels (below the limits of the laboratorys normal reference range) of C4, C1-INH antigenic protein and C1-INH functional level; AND ii) Positive family history of angioedema OR earlier age of onset (before age 30) with normal C1q antigenic protein level; b) Type 2 HAE documented in chart notes with ALL of the following ( Note: tests listed below must be repeated for confirmation of diagnosis): i) Normal or elevated level of C1-INH antigenic protein (as defined by performing lab); AND ii) Low level (below the limits of the laboratorys normal reference range) C4 and C1-INH functional; AND 5. Documentation in medical chart of at least two attacks per month before treatment initiation; AND 6. Medication is not being used in combination with Haegarda; AND 7. Medications known to cause angioedema (i.e. , ACE-Inhibitors, estrogens, angiotensin II receptor blockers) have been evaluated and discontinued when appropriate. 8. Dosage allowed: 300 mg every 2 weeks. A dosing interval of 300 mg every 4 weeks is also effective and may be considered if the patient is well-controlled (e.g., attack free) for more than 6 months. Note: Personal documentation (log book, journal, etc.) of medication use will be necessary for reauthorization. Prescribers should be aware and make their patients aware of this requirement for reauthorization. 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 s signs and symptoms of disease have improved and the number of acute attacks per month has decreased; AND 3. Log of medication use supported by medical chart or by claims data has been provided. If member meets all the reauthorization requirements above, the medication will be approved for an additional 6 months. CareSource considers Takhzyro (lanadelumab-flyo) 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: Acquired angioedema (AAE) Treatment of acute HAE attacks DATE ACTION/DESCRIPTION 08/06/2019 New policy Takhzyro created. References: 1. Takhzyro [package insert]. Lexington, MA : Dyax Corp. ; November, 2018. 2. Bowen T, Cicardi M, Farkas H, et al. 2010 International consensus algorithm for the diagnosis, therapy, and management of hereditary angioedema. Allergy Asthma Clin Immunol. 2010;6(1):24. 3. ClinicalTrials.gov Identifier: NCT02586805. Efficacy and Safety Study of DX-2930 to Prevent Ac ute Angioedema Attacks in Patients With Type I and Type II HAE . Available at: https://clinicaltrials.gov/ct2/show/NCT02586805?term=NCT02586805&rank=1. 4. ClinicalTrials.g ov Identifier: NCT02741596. Long-term Safety and Efficacy Study of DX-2930 (SHP643) to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE . Available at: https://www.clinicaltrials.gov/ct2/show/NCT02741596?term=NCT02741596&rank=1. 5. Craig T, Pursun EA, Bork K, Bowen T, et al. World Allergy Organization Guideline for the Management of Hereditary Angioedema. WAO J. 2012; 5:182-199. 6. Lang DM, Aberer W, Bernstein JA, et al. International consensus on hereditary and acquired angioedema. Ann Allergy Asthma Immunol. 2012;109:395-402. 7. Lumry W. Management and Prevention of Hereditary Angioedema Attacks. Am JManag Care. 2013;19:S111-S118. Effective date: 09/26/2019 Revised date: 08/06/2019
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Synagis (palivizumab) BILLING CODE 90378 (1 unit = 50 mg) BENEFIT TYPE Medical or Pharmacy SITE OF SERVICE ALLOWED Office/Outpatient Hospital/Home COVERAGE REQUIREMENTS Prior Authorization Required (Preferred Product) QUANTITY LIMIT 200 mg per month LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Synagis ( palivizumab ) is a preferred product and will only be con sidered 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. PREVENTION OF RESPIRATORY TRACT DISEASE CAUSED BY RESPIRATORY SYNCYTIAL VIRUS (RSV) For initial authorization: 1. Request must be made during the RSV season ( November 1st through March 31st ) AND initiation of injections should be timed with the onset of laboratory confirmed cases of RSV activity in the community, no earlier than November 1, 2019 ; AND 2. Member is 21% oxygen for at least the first 28 days after birth) ; c) Member h as hemodynamically significant Congenital Heart Disease (CHD) with one or more of the following: i) Acyanotic heart disease (e.g., atrial septal defect (ASD), vent ricular septal defect (VSD), patent ductus arteriosus (PDA) , etc.), AND member is receiving medication to control conges tive heart failure (CHF) AND will require cardiac surgical procedures; ii) Moderate to severe pulmonary hypertension; iii) Cyanotic heart defect ( e.g. , coarctation or complete interruption of the aorta, Ebstein anomaly, h ypoplastic left heart syndrome, Tetralogy of Fallot (TOF) , total a nomalous pulmonary venous connection (TAPVC) , transposition of the great arteries (TGA) , truncus arteriosus , tricuspid atresia, etc.) ; iv) Previous cardiac or cardiopulmonary surgical procedures (e.g. , cardiac bypass, at the conclusion of extracorporeal membrane oxygenation (ECMO), etc.); d) Member has pulmonary abnormalities or neuromuscular disorder that impairs the ability to clear secretions from the upper airways ; e) Member is profoundly immunocompromised during the RSV season (e.g. , concurrent chemotherapy, stem cell transplantation, organ transplantation, etc. ); f) Member undergoes cardiac transplantation during the RSV season; g) Member has Cystic Fibrosis with clinical evidence of CLD and/or nutritional compromise in the first year of life; OR 3. Member is 12 24 months old at the beginning of the RSV season AND meet one of the following criteria (chart notes must be provided to support evidence) : a) Member was born
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Spinraza (nusinersen) BILLING CODE J2326 (1 unit = 0.1 mg) BENEFIT TYPE Medical SITE OF SERVICE ALLOWED Outpatient Hospital COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) QUANTITY LIMIT 12 mg or 5 mL per administration LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Spinraza (nusinersen) is a non-preferred product and will only be considered 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. SPINAL MUSCULAR ATROPHY (SMA) For initial authorization: 1. Medication must be prescribed by or in consultation with a neurologist with expertise in the treatment of SMA; AND 2. Member has documented diagnosis of SMA type I, II or III confirmed by BOTH of the following diagnostic test results (both a and b): a) The mutation or deletion of genes in chromosome 5q resulting in one of the following: i) homozygous gene deletion OR mutation (e.g., homozygous deletion of exon 7 at locus 5q13); ii) compound heterozygous mutation (e.g., deletion of SMN1 exon 7(allele 1) and mutation of SMN1 (allele 2)); b) Genetic testing confirming 2 or 3 copies of SMN2; AND 3. Member has documented laboratory tests at baseline and prior to each dose of Spinraza as listed below: a) Platelet count; AND b) Prothrombin time; activated partial thromboplastin time; AND c) Quantitative spot urine protein testing; AND 4. Member has documentation of baseline of at least one of the following exams (based on patient age and motor ability): a) Hammersmith Infant Neurological Exam (HINE) (infant to early childhood); b) Hammersmith Functional Motor Scale Expanded (HFMSE); c) Upper Limb Module (ULM) Test (Non ambulatory); d) Childrens Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP INTEND); AND 5. Members gestational age is 37 to 42 weeks for singleton births or 34 to 42 weeks for twins; AND 6. Members documented oxygen saturation is 92% (awake or asleep) without any supplemental oxygen or respiratory support; AND 7. Member does not have shunt or central nerv ous system (CNS) catheter; AND 8. Member has no history of bacterial meningitis or viral encephalitis ; AND 9. Medication must not be concomitantly used with Zolgensma (discontinuation of Spinraza prior to Zolgensma therapy is required and Spinraza will not be reauthorized after Zolgensma infusion). 10. Dosage allowed: Initiate Spinraza treatment with 4 loading doses (12 mg (5 mL) per administration). The first three loading doses should be administered at 14-day intervals, the 4th loading dose should b e administered 30 days after the 3rd dose. A maintenance dose should be administered once every 4 months thereafter. If member meets all the requirements listed above, the medication will be approved 6 months. For reauthorization: 1. Member must be in compliance with all other initial criteria; AND 2. Member has documentation of positive clinical improvement from pretreatment baseline status in spinal muscular atrophy-associated symptoms or maintenance (not worsening) of the disease state (e.g. , decreased decline in motor function, increased ability to kick, increased in the motor milestones of head control, rolling, sitting, crawling, standing, or walking, etc.). If member meets all the reauthorization requirements above, the medication will be approved f or an additional 12 months. CareSource considers Spinraza (nusinersen) not medically necessary for the treatment of the diseases that are not listed in this document. DATE ACTION/DESCRIPTION 05/05/2017 New policy for Spinraza created. 06/11/2019 Concomitant used of Spinraza with Zolgensma will not be authorized. Spinraza must be discontinued before Zolgensma infusion. Spinraza will not be reauthorized after Zolgensma infusion. References: 1. Spinraza [package insert]. Cambridge, MA;Biogen Inc.; December, 2016. 2. Markowitz JA, Singh P, Darras BT. Spinal Muscular Atrophy: A Clinical and Research Update. Pediatric Neurology 46 (2012) 1-12. 3. Ionis Pharmaceuticals, Inc. A Study to Assess the Efficacy and Safety of IONIS-SMN Rx in Infants With Spinal Musc ular Atrophy. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000 Available from: https://clinicaltrials.gov/show/NCT02193074. NLM Identifier: NCT02193074. 4. Ionis Pharmaceuticals, Inc. A Study to Assess the Efficacy and Safety of IONIS-SMN Rx in Patients With Later-onset Spinal Muscular Atrophy. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000. Available from: https://clinicaltrials.gov/show/NCT02292537. NLM Identifier: NCT02292537. 5. Finkel RS, Chiriboga CA, Vajsar J, et al. Treatment of infantile-onset spinal muscular atrophy with nusinersen: a phase 2, open-label, dose-escalation study. Lancet. 2017 Dec 17;388(10063):3017-3026. Effective date: 09/26/2019 Revised date: 06/11/2019
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Skyrizi (risankizumab-rzaa) BILLING CODE Must use valid NDC code BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home/Office COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) Alternative preferred products include Cimzia, Cosentyx, Enbrel, Otezla and Siliq QUANTITY LIMIT see Dosage allowed below LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Skyrizi (risankizumab-rzaa) is a non-preferred product and will only be con sidered for coverage under the 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. PLAQUE PSORIASIS (PsO) For initial authorization: 1. Member must be 18 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 has PsO for 6 months or longer; AND 5. Member has PsO involves 10% or more of the members body surface area (BSA); AND 6. Members Psoriasis Area and Severity Index (PASI) score is greater than or equal to 12; AND 7. Member has tried and failed to respond to treatment with at least one of the following: a) At least 30 days of photochemotherapy (i.e., psoralen plus ultraviolet A therapy); b) At least 30 days of phototherapy (i.e., UVB light therapy, Excimer laser treatments) (tanning beds emit mostly UVA light and therefore would not meet this criteria); c) At least a 4 week trial with topical antipsoriatic agents (i.e., anthralin, calcipotriene, coal tar, corticosteroids, tazarotene); AND 8. Member has tried and failed to respond to treatment with traditional first-line oral/systemic therapies (i.e., cyclosporine, methotrexat e, acitretin) for at least 30 days ; AND 9. Member has tried and failed treatment with at least two of the following: Cimzia, Cosentyx, Enbrel, Otezla and Siliq. Treatment failure requires at least 30 days of therapy with each drug. 10. Dosage allowed: 1 50 mg (two 75 mg injections) administered by subcutaneous injection at w eek 0, w eek 4, and every 12 weeks thereafter . 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 (e.g., documented members PASI score improvement, etc.). If member meets all the reauthorization requirements above, the medication will be approved for an additional 12 months. CareSource considers Skyrizi (risankizumab-rzaa) 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 infections Ankylosing spondylitis Asthma Cellulitis Crohns Disease Dissecting scalp cellulitis For use in combination with other TNF-inhibitors (i.e., Humira, Kineret, Enbrel, Remicade) Giant-cell arteritis Infectious uveitis Juvenile idiopathic arthritis Lupus perino Osteoarthritis Psoriatic Arthritis Recurrent pregnancy loss Relapsing polychondritis Rheumatoid arthritis Sarcoidosis Sciatica Spondyloarthritis (other than ankylosing spondylitis) Takayasus arteritis Ulcerative Colitis Vogt-Koyanagi DATE ACTION/DESCRIPTION 07/28/2019 New policy for Skyrizi created. References: 1. Skyrizi [prescribing information]. North Chicago, IL : AbbVie Inc.; April 2019. 2. Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 6. Guidelines of care for the treatment of psoriasis and psoriatic arthritis: Case-based presentations and evidence-based conclusions. Journal of the American Academy of Dermatology, Volume 65, Issue 1, 137 174. 3. Hsu S, Papp KA, Lebwohl MG, et al. Consensus guidelines for the management of plaque psoriasis. Arch Dermatol. 2012 Jan;148(1):95-102. 4. ClinicalTrials.gov. Identifier: NCT02684370. BI 655066 (Risankizumab) Compared to Placebo and Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis . Available at: https://clinicaltrials.gov/ct2/show/NCT02684370?term=ULTIMMA-1&rank=1. 5. ClinicalTrials.gov. Identifier: NCT02684357. BI 655066 Versus Placebo & Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis . Available at: https://clinicaltrials.gov/ct2/show/NCT02684357?term=ULTIMMA-2&rank=1. 6. Gottlieb AB, et al. Safet y observations in 12095 patients with psoriasis enrolled in an international registry (PSOLAR): experience with infliximab and other systemic and biologic therapies. JDrugs Dermatol. 2014 Dec;13 (12):1441-8. 7. Sbidian E, et al. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis. Cochrane Database Syst Rev. 2017;12:CD011535. 8. Nast A, et al. European S3-Guideline on the systemic treatment of psoriasis vulgaris-Update Apremilast and Secukinumab-EDF in cooperation with EADV and IPC. JEur Acad Dermatol Venereol. 2017;31(12):1951. Effective date: 09/26/2019 Revised date: 07/28/2019
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Prolia (denosumab) BILLING CODE J0897 BENEFIT TYPE Medical SITE OF SERVICE ALLOWED Office/Outpatient hospital COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) Alternative preferred products include alendronate, ibandronate and zoledronic acid QUANTITY LIMIT 60 mg every 6 months LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Prolia (denosuab ) is a non-preferred product and will only be considered 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. OSTEOPOROSIS For initial authorization: 1. Medication is intended to be used for one the following (see Appendix for details on risk factors for fracture for all indications) : a) Treatment of postmenopausal women with osteoporosis at high risk for fracture ; b) Treatment to increase bone mass in men with osteoporosis at high risk for fracture; c) Treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture (member has been taking 5 mg of prednisone (or equivalent) daily for 3 months); AND 2. Members osteoporosis evidenced by one of the following: a) Bone mineral density (BMD) T-score 2.5 or below in the lumbar spine, femoral neck, total, and/or 33% (one-third) radius ; b) Low-trauma spine or hip fracture (regardless of BMD) ; c) Osteopenia or low bone mass (T-score between 1 and 2.5) with a fragility fracture of proximal humerus, pelvis, or possibly distal forearm ; d) Osteopenia or low bone mass and high FRAX fracture probability (a 10-year probability for major osteoporotic fracture is 20% or the 10-year probability of hip fracture is 3% ); AND 3. Member does not have ANY of the following: a) Uncorrected hypocalcemia; b) Dental disease; c) History of receiving Xgeva within the past 6 months; AND 4. Member was instructed to take calcium 1,000 mg daily and at least 400 IU of vitamin Ddaily ; AND 5. Member cannot take oral bisphosphonate therapies (i.e., alendronate and /or ibandronate) as evidenced by one or more of the following: a) Esophogeal dysmotility or varices; b) Member is unable to stand or sit upright for 30-60 minutes; c) Presence of anatomic or functional esophageal abnormalities that might delay tablet transit (e.g., achalasia, stricture, or dysmotility); d) Presence of documented or potential GI malabsorption (e.g., gastric bypass procedures, celiac disease, Crohns disease, infiltrative disorders, etc.); e) Member has experienc ed intolerance to or treatment failure of one or more bisphosphonate medications; f) Member has a hi story of non-adherence to oral bisphosphonate medications ; AND 6. Member has had a documented trial and inadequate response to zoledronic acid. 7. Dosage allowed: 60 mg every 6 months . If member meets all the requirements listed above, the medication will be approved for 6 months. For reauthorization: 1. Member meets all initial criteria ; AND 2. Chart notes have been provided that show the member has shown an increase in bone mineral density . If member meets all the reauthorization requirements above, the medication will be approved for an additional 12 months. BONE LOSS (for nonmetastatic prostate cancer or for breast cancer) For initial authorization: 1. Medication is intended to be used for one the following (see Appendix for details on risk factors for fracture for all indications) : a) Treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy (e.g. , goserelin, leuprolide, bicalutamide) for nonmetastatic prostate cancer; b) Treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy (e.g. , anastrozole, letrozole) for breast cancer; 2. Member has a bone mineral density (BMD) T-score at the lumbar spine, total hip, or femoral neck 1 or less ; AND 3. Member does not have ANY of the following: a) Uncorrected hypocalcemia; b) Dental disease; c) History of receiving Xgeva within the past 6 months; AND 4. Member was instructed to take calcium 1,000 mg daily and at least 400 IU of vitamin Ddaily ; AND 5. Member cannot take oral bisphosphonate therapies (i.e., alendronate and/or ibandronate) as evidenced by one or more of the following: a) Esophogeal dysmotility or varices; b) Member is unable to stand or sit upright for 30-60 minutes; c) Presence of anatomic or functional esophageal abnormalities that might delay tablet transit (e.g., achalasia, stricture, or dysmotility); d) Presence of documented or potential GI malabsorption (e.g., gastric bypass procedures, celiac disease, Crohns disease, infiltrative disorders, etc.); e) Member has experienced intolerance to or treatment failure of one or more bisphosphonate medications; f) Member has a history of non-adherence to oral bisphosphonate medications. 6. Dosage allowed: 60 mg every 6 months . If member meets all the requirements listed above, the medication will be approved for 6 months. For reauthorization: 1. Member meets all initial criteria ; AND 2. Chart notes have been provided that show the member has shown an increase in bone mineral density. If member meets all the reauthorization requirements above, the medication will be approved for an additional 12 months. CareSource considers Prolia (denosumab) 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: Bone metastases from solid tumors Giant Cell Tumor of Bone Multiple Myeloma Pagets disease DATE ACTION/DESCRIPTION 07/19/2019 New policy for Prolia created. References: 1. Prolia (denosumab) [prescribing information]. Thousand Oaks, CA: Amgen Inc; June 2018. 2. Camacho PM, Petak SM, Binkley N, et al. American Association of Clinical Endocrinologists and American College of Endocrinology clinical practice guidelines for the diagnosis and treatment of postmenopausal osteoporosis 2016. Endocr Pract . 2016;22(Suppl 4). Doi: 10.4158/ EP161435.GL. 3. Watts NB, Adler RA, Bilezikian JP, et al. Osteoporosis in men: an Endocrine Society clinical practice guideline. JClin Endocrinol Metab. 2012;97(6):1802-1822. Doi: 10.1210/jc.2011-3045. 4. Buckley L, Guyatt G, Fink HA, et al. 2017 American College of Rheumatology guideline for the prevention and treatment of glucocorticoid-induced osteoporosis. Arthritis Rheumatol. 2017;69(8):1521-1537. Doi: 10.1002/art.40137. 5. Bienz M, Saad F. Androgen-deprivation therapy and bone loss in prostate cancer patients: a clinical review. Bonekey Rep. 2015;4:Article 716. Doi: 10.1038/bonekey.2015.85. 6. Hadji P, Aapro MS, Body JJ, et al. Management of aromatase inhibitor-associated bone loss (AIBL) i n postmenopausal women with hormone sensitive breast cancer: Joint position statement of the IOF, CABS, ECTS, IEG, ESCEO, IMS, and SIOG. JBone Oncol . 2017;7:1-12. Doi: 10.1016/j.jbo.2017.03.001. 7. Mohler JL, Lee RJ, Antonarakis ES, et al. Prostate cancer NCCN Guidelines Version 4.2018. National Comprehensive Cancer Network. Updated August 15, 2018. Accessed February 27, 2019. https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf. 8. Gradishar WJ, Anderson BO, Abraham J, et al. Breast Cancer NCCN Guidelines Version 4.2018. National Comprehensive Cancer Network. Updated February 8, 2019. Accessed February 27, 2019. https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Effective date: 09/26/2019 Revised date: 07/19/2019 Appendix. Risk Factors for Fracture: 1. Prior fracture ; 2. Age 65; 3. Low body weight (
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