PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Sabril (vigabatrin) BILLING CODE Must use valid NDC BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home, Office COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) QUANTITY LIMIT see Dosage Allowed below LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Sabril (vigabatrin) 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. INFANTILE SPASMS (West syndrome, X-linked infantile spasms syndrome) For initial authorization: 1. Member has documented diagnosis of infantile spasms; AND 2. Member is an infant or a child between 1 months and 2 years of age; AND 3. Medication must be prescribed by a pediatric neurologist or an epilepsy physician specialist; AND 4. Sabril must be used as monotherapy; AND 5. Member has documentation of vision testing at baseline and every 3 months, up to 6 months following discontinuation of therapy. 6. Dosage allowed: Initiate therapy at 50 mg/kg/day given in 2 divided doses i ncreasing total daily dose per package insert to a maximum of 150 mg/kg/day given in 2 divided doses . Note: Only use Sabril if potential benefits outweigh the potential risk of vision loss. If member meets all the requirements listed above, the medication will be approved for 6 months. For reauthorization: 1. 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 . REFRACTORY COMPLEX PARTIAL SEIZURES For initial authorization: 1. Member has a d ocumented diagnosis of refractory complex partial seizures ; AND 2. Member is 10 years of age or older ; AND 3. Medication must be prescribed by a pediatric neurologist or an epilepsy physician specialist; AND 4. Sabril must be used as adjunctive therapy; AND 5. Member has documentation of failure of two alternative treatments for control of the complex partial seizures; AND 6. Member has documentation of vision testing at baseline and every 3 months, up to 6 months following discontinuation of therapy. 7. Dosage allowed: Adults >16 years of age: Initiate therapy at 500 mg twice daily, increasing total daily dose in 500 mg increments at weekly intervals depending on response. The recommended dose is 1500 mg twice daily. Pediatrics 10 to 16 years of age: Treatment is based on body weight. Initiate therapy at 250 mg twice dail y, increasing total daily dose per package insert . The recommended maintenance dose is 1000 mg twice daily. Patients weighing more than 60 kg should be dosed according to adult recommendations . If member meets all the requirements listed above, the medication will be approved for 6 months. For reauthorization: 1. 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 . CareSource considers Sabril (vigabatrin) not medically necessary for the treatment of the diseases that are not listed in this document. DATE ACTION/DESCRIPTION 10/08/2018 New policy for Sabril created. Policy placed in the new format. References: 1. Sabril [package insert]. Deerfield, IL: Lundbeck Inc.; October 2013. 2. AAN/CNS evidence-based guideline update on medical treatment of infantile spasms. Neurology 2012: 78 (24): 1974 80. doi: 10.1212/WNL.0b013e318259e2cf. 3. Management and prognosis of infantile spasms. Daniel GGlaze. UpToDate [online database]. Available from: http://www.uptodate.com 4. Go CY, Mackay MT, Weiss SK, Stephens D, Adams-Webber T, Ashwal S, Snead, III OC. Evidence-based guideline update: Medical treatment of infantile spasms. Report of the Guideline Development Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society. Neurology. 2012; 78(24): 1974 1980. 5. Hancock EC, Osborne JP, Edwards SW. Treatment of infantile spasms. Cochrane Database Syst Rev. 2013. 6. French JA, Mosier M, Walker S, et al. A double-blind, placebo-controlled study of vigabatrin (3 g/day) in patients with uncontrolled complex partial seizures. Vigabatrin Protocol 024 Investigative Cohort. Neurology 1996;46(1):54-61. 7. Dean C, Mosier M, Penry K. Dose-response study of vigabatrin as add-on therapy in patients with uncontrolled complex partial seizures. Epilepsia. 1999;40(1):74-82. Effective date: 12/13/2018 Revised date: 10/08/2018
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Orilissa (elagolix) BILLING CODE Must use valid NDC code BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home COVERAGE REQUIREMENTS Prior Authorization Required (Preferred Product) Alternative preferred product includes Lupron QUANTITY LIMIT up to 200 mg twice daily LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Orilissa (elagolix) 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. ENDOMETRIOSIS For initial authorization: 1. Member is a premenopausal women of 18 years of age or older; AND 2. Member is not currently breast feeding, pregnant, or planning to become pregnant while receiving medication (chart notes documentation of members assessment with no intention to become pregnant AND negative pregnancy test or evidence of sterilization (partners sterilization is also acceptable) required with prior authorization request ); AND 3. Member does not have ANY of the following: a) Osteoporosis; b) Severe hepatic impairment; c) Currently using strong OATP1B1 inhibitors (e.g., cyclosporine and gemfibrozil) ; AND 4. Medication must be prescribed by gynecologist or obstetrician; AND 5. Endometriosis symptoms, as indicated by one or more of the following: a) Dysmenorrhea; b) Dyspareunia; c) Pelvic pain; AND 6. Member has failed control of symptoms with ALL of the following: a) NSAIDs; b) Any hormonal contraceptives for at least 30 days or progestin therapy ( Depo-Provera, hormonal IUD, progesterone only pill ) for at least 30 days. 7. Dosage allowed: 150 mg once daily for 24 months or 200 mg twice daily for 6 months. 150 mg once daily for 6 months for member s with moderate hepatic impairment (Child-Pugh Class B). If member meets all the requirements listed above, the medication will be approved for 24 months if dose requested is 150 mg and for 6 months if dose requested is 200 mg. For reauthorization: 1. Orilissa will not be reauthorized for continued therapy. CareSource considers Orilissa (elagolix) not medically necessary for the treatment of the diseases that are not listed in this document. DATE ACTION/DESCRIPTION 11/20/2018 New policy for Orilissa (elagolix) created. References: 1. Orilissa [package insert]. North Chicago, IL: AbbVie Inc.; July 2018. 2. Taylor HS, Giudice LC, Lessey BA, et al. Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist. NEngl JMed 2017;377:28-40. 3. ClinicalTrials.gov Identifier: NCT01620528 . A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain. Available at: https://clinicaltrials.gov/ct2/show/NCT0162 0528. Accessed on July 30, 2018. 4. ClinicalTrials.gov Identifier: NCT01931670. A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain. Available at: https://clinicaltrials.gov/ct2/show/NCT01931670. Accessed on July30, 2018. Effective date: 12/13/2018 Revised date: 11/20/2018
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Qbrexza (glycopyrronium) cloth, 2.4% BILLING CODE Must use valid NDC code BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) Alternative preferred product includes Botox QUANTITY LIMIT carton of 30 pouches for 30 days LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Qbrexza (glycopyrronium) cloth, 2.4% 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. AXILLARY HYPERHIDROSIS For initial authorization: 1. Member has diagnosis of severe primary axillary hyperhidrosis, with resting sweat production of 50 mg per axilla measured over 5 minutes at room temperature documented in chart notes; AND 2. Documentation of Hyperhidrosis Disease Severity Scale (HDSS) rating of 3 or 4 must be submitted with chart notes; A ND 3. Member is 9-17 years of age; OR 4. Member 18 years old AND has tried and failed Botox (prior authorization required) for 30 days unless contraindicated or clinically significant adverse effects are experienced; AND 5. Medication must be p rescribed by or in consultation with a dermatologist AND p rescribing physician has documented the members hyperhidrosis is causing social anxiety, depression, or similar mental health related issues that impact daily life; AND 6. Member has tried and failed to respond to treatment with Drysol for 1 month, unless contraindicated or clinically significant adverse effects are experienced; AND 7. Secondary causes of hyperhidrosis (e.g., hyperthyroidism) have been evaluated and, if necessary, treated; AND 8. Member does not have ANY of the following: a) History of Sjgr en’s syndrome or Sicca syndrome; b) History of glaucoma, inflammatory bowel disease, toxi c megacolon, or febrile illness; c) Men with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive sy mptoms of prostatic hypertrophy; d) History or presence of ventricular arrhythmias, atri al fibrillation, atrial flutter. 9. Dosage allowed: Qbrexza cloth (one cloth per pouch) is used topically once daily to both axillae using a single cloth . If member meets all the requirements listed above, the medication will be approved for 4 weeks. 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 a two level improvement in HDSS score . If member meets all the reauthorization requirements above, the medication will be approved for an additional 6 months. CareSource considers Qbrexza (glycopyrronium) cloth, 2.4% 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: Hyperhidrosis of palms/hands , soles (feet) , forehead and o ther regions DATE ACTION/DESCRIPTION 11/27/2018 New policy for Qbrexza created. References: 1. Obrexza [package insert] . Menlo Park, CA : Dermira, Inc . June, 2018. 2. ClinicalTrials.gov. Identifier: NCT02530281. Study of Glycopyrronium in Axillary Hyperhydrosis . Available at: https://clinicaltrials.gov/ct2/show/NCT02530281?term=NCT02530281&rank=1. 3. ClinicalTrials.gov. Identifier: NCT02530294. Study of Glycopyrronium in Subjects With Axillary Hyperhidrosis . Available at: https://clinicaltrials.gov/ct2/show/NCT02530294?term=NCT02530294&rank=1. 4. Doolittle, J., Walker, P., Mills, T . et al. Arch Dermatol Res (2016) 308: 743. https://doi.org/10.1007/s00403-016-1697-9 Hyperhidrosis: an update on prevalence and severity in the United States 5. Gelbard, Christina M. MD, et al. “Primary pediatric hyperhidrosis: a review of current treatment options”. Pediatric Dermatology 25:6 (2008): 591-598. 6. Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. FDA, 2009. 7. Kowalski et . al., Validity and Reliability of the Hyperhidrosis Disease Severity Scale (HDSS). JAm Acad Dermatol. 50(3): P51, 2004. https://www.jaad.org/article/S0190-9622(03)03534-5/fulltext 8. A Comprehensive Approach to the Recognition, Diagnosis, and Severity-Based Treatment of Focal Hyperhidrosis: Recommendations of the Canadian Hyperhidrosis Advisory Committee, Dermatologic Surgery, August 2007, pages 908-923. 9. IPD Analytics. New Drug Approval. Qbrexza (glycopyrronium) . Available at: http://www.ipdanalytics.com/. 10. Sammons JE, et al. Axillary hyperhidrosis: a focused review. JDermatolog Treat. 2017 Nov;28(7):582-590. 11. Lee KY, et al. Turning the tide: a history and review of hyperhidrosis treatment. JRSM Open. 2014 Jan; 5(1):2042533313505511. Effective date: 12/13/2018 Revised date: 11/27/2018
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Pegasys (peginterferon alfa-2a) BILLING CODE Must use valid NDC code BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home COVERAGE REQUIREMENTS Prior Authorization Required (Preferred Product) QUANTITY LIMIT 4 per 28 days LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Pegasys (peginterferon alfa-2a) is a 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. HEPATITIS BFor initial authorization: 1. Member is an adult with chronic Hepatitis B (CHB) and compensated liver disease (Child-Pugh A score less than or equal to 6 ) or a child (3 years of age or older) with non-cirrhotic CHB ; AND 2. Medication must be prescribed by a board certified hepatologist, gastroenterologist, infectious disease specialist , a physician assistant or a nurse practitioner working with the above specialists; AND 3. Member has t wo elevated ALT lab values within the past 12 months (> 60 IU/L for men, > 38 IU/L for women) and HBV DNA levels > 20,000 IU/ml ; AND 4. Member has tried and failed course of treatment with tenofovir (for 12 years of age) or entecavir (for 2 years of age); AND 5. Member does not have any of the following; a) Acute autoimmune hepatitis; b) HIV; c) Hepatic decompensation . 6. Dosage allowed: Adults: 180 mc g (1.0 mL) once weekly by subcutaneous administration in the abdomen or thigh; pediatrics: BSA x 180 mcg/1.732 m2 subcutaneously once weekly . Note: Serial monitoring of HBV-DNA levels along with ALT level should be used in determining the need for a treatment. 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 app roved for an additional 12 months .HEPATITIS CFor initial authorization: 1. Member is 5-17 years of age previously untreated with interferon alfa ; AND 2. Medication must be prescribed by a board certified hepatologist, gastroenterologist, infectious disease specialist , a physician assistant or a nurse practitioner working with the above specialists. 3. Dosage allowed: Pediatrics: BSA x 180 mcg/1.732 m2 subcutaneously once weekly . 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 . MYELOPROLIFERATIVE NEOPLASMS (MYELOFIBROSIS (MF), POLYCYTHEMIA VERA (PV), AND ESSENTIAL THROMBOCYTHEMIA (ET)) For initial authorization: 1. Member has diagnosis of Myeloproliferative Neoplasms (or one of the following: myelofibrosis (MF), polycythemia vera (PV), or essential thrombocythemia (ET)); AND 2. Medication m ust be prescribed by oncologist or hematologist ; AND 3. Member has tried and failed course of treatment with at least two of the following: a) Low-dose aspirin (81-100 mg ); b) Phlebotomy ( to maintain a hematocrit level of
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Palynziq (pegvaliase-pqpz) BILLING CODE Must use valid NDC code BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) Alternative preferred product includes Kuvan QUANTITY LIMIT up to 40 mg SQ once daily LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Palynziq (pegvaliase-pqpz) 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. PHENYLKETONURIA For initial authorization: 1. Member is 18 years old or older; AND 2. Member has diagnosis of phenylketonuria and have uncontrolled blood phenylalanine concentrations greater than 600 micromol/L on existing management; AND 3. Members baseline blood phenylalanine concentration submitted with chart notes before initiating treatment; AND 4. Member does not have ANY of the following: a) Current use of levodopa; b) A positive test for HIV antibody, hepatitis Bsurface antigen, or hepatitis Cantibody ; c) A history of organ transplantation or on chronic immunosuppressive therapy ; d) A history of substance abuse (as defined by the Diagnostic and Statistical Manual of Mental Disorders [DSM IV]) in the past 12 months or current alcohol or drug abuse; e) Alanine aminotransferase (ALT) concentration > 2 times the upper limit of normal ; f) Creatinine >1.5 times the upper limit of normal. 5. Dosage allowed: The recommended initial dosage is 2.5 mg subcutaneously once weekly for 4 weeks. Titrate the dosage in a step-wise manner over at least 5 weeks based on tolerability to achieve a dosage of 20 mg subcutaneously once daily. Consider increasing the dosage to a maximum of 40 mg subcutaneously once daily in patients who have been on 20 mg once daily continuously for at least 24 weeks and who have not achieved either a 20% reduction in blood phenylalanine concentration from pre-treatment baseline or a blood pheny lalanine concentration less than or equal to 600 micromol/L. If member meets all the requirements listed above, the medication will be approved for 12 months. For reauthorization: 1. Member achieved at least a 20% reduction in blood phenylalanine concentration from pre-treatment baseline or a blood phenylalanine concentration less than or equal to 600 micromol/L after 16 weeks of continuous treatment with the maximum dosage of 40 mg once daily; 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. CareSource considers Palynziq (pegvaliase-pqpz) not medically necessary for the treatment of the diseases that are not listed in this document. DATE ACTION/DESCRIPTION 07/27/2018 New policy for Palynziq (pegvaliase-pqpz) created. References: 1. Palynziq [package insert]. Novato, CA: BioMarin Pharmaceutical Inc. ; May, 2018. 2. U.S. Food and Drug Administration. Media release. FDA approves a new treatment for PKU, a rare and serious genetic disease. Available at: https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm608835.htm. Accessed on July 2 7, 2018. 3. ClinicalTrials.gov Identifier: NCT01819727. An Open-Label Phase 3 Study of BMN 165 for Adults With PKU Not Previously Treated w/ BMN 165 (Prism301) . Available at: https://clinicaltrials.gov/ct2/show/NCT01819727?term=NCT01819727&rank=1. Accessed on July 27, 2018. Effective date: 10/26/2018 Revised date: 07/27/2018
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Lupron Depot and Lupron Depot-PED (leuprolide acetate) BILLING CODE J1950, J9217, J9218 BENEFIT TYPE Medical SITE OF SERVICE ALLOWED Office/Outpatient COVERAGE REQUIREMENTS Prior Authorization Required (Preferred Product) QUANTITY LIMIT see Dosage allowed below LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Lupron Depot and Lupron Depot-PED (leuprolide acetate) 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 st ates and meet their individual criteria as stated. ADVANCED BREAST CANCER For initial authorization: 1. Member is pre-OR p eri-menopausal women with locally adv anced, recurrent, or metastatic hormone receptor-positive breast cancer ; AND 2. Member is not currently breast feeding, pregnant, or planning to become pregnant while receiving medication; AND 3. Medication must be prescribed by oncologist, gynecologist or obstetrician. 4. Dosage allowed: Lupron Depot 3.75 mg for 1-month or 11.25 mg for 3-month administration . If member meets all the requirements listed above, the medication will be approved for 6 months. For reauthorization: 1. 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. CENTRAL PRECOCIOUS PUBERTY (CPP) For initial authorization: 1. Pubertal symptoms appeared before the age of 9 in male member or before the age of 8 in female member; AND 2. Member has confirmed diagnostic evaluation, including assessment of one of the following: a) Bone age advanced one year beyond chronological age; b) Pubertal response to a gonadotropin releasing hormone ( GnRH) stimulation test; AND 3. Members baseline gonadal sex steroid hormone levels , adrenal steroid levels, height and weight are submitted with chart notes; AND 4. Other diagnosis are ruled out (e.g., intracranial tumors, congenital adrenal hyperplasia, chronic gonadotropin-secreting tumor, etc.); AND 5. Female member must meet ALL of the following: a) Breast development Tanner stage 2 or greater ; b) Menstrual bleeding or vaginal discharge; c) No pregnancy currently ; d) No undiagnosed abnormal vaginal bleeding; OR 6. Male member must meet ALL of the following: a) Signs and symptoms as indicated by one or more of the following: i) Acne ; ii) Erections ; iii) Nocturnal emissions ; iv) Oily skin ; AND b) Testicular volume 4 mL or greater . 7. Dosage allowed: Lupron Depot-PED-Single intramuscular injection. The starting dose 7.5 mg, 11.25 mg, or 15 mg for 1-month administration is based on the childs weight . The doses are either 11.25 mg or 30 mg for 3-month administration. Note: Discontinu ation of leuprolide for central precocious puberty should be considered at age 11 for girls and age 12 for boys. If member meets all the requirements listed above, the medication will be approved for 12 months. For reauthorization: 1. 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. ENDOMETRIOSIS For initial authorization: 1. Member is a female of 18 years of age or older ; AND 2. Member is not currently breast feeding, pregnant, or planning to become pregnant while receiving medication; AND 3. Medication must be prescribed by gynecologist or obstetrician; AND 4. Medication must be prescr ibed with daily norethindrone acetate 5 mg (Leuprolide Depot alone is not recommended for retreatment. If norethindrone acetate is contraindicated, then retreatment is not recommended) ; AND 5. Endometriosis s ymptoms, as indicated by one or more of the following: a) Dysmenorrhea; b) Dyspareunia; c) Pelvic pain ; AND 6. Member has failed control of symptoms with ALL of the following: a) NSAIDs ; b) Any contraceptives . 7. Dosage allowed: Lupron Depot 3.75 mg for 1-month or 11.2 5 mg for 3-month administration. If member meets all the requirements listed above, the medication will be approved for 6 months. For reauthorization: 1. Leuprolide Depot alone is not recommended for retreatment. If norethindrone acetate is contraindicated, then retreatment is not recommended. If member meets all the reauthorization requirements above, the medication will be app roved for an additional 12 months. ADVANCED PROSTATE CANCER (Palliative Treatment) For initial authorization: 1. Member has signs and symptoms of symptomatic locally advanced, recurrent, or metastatic disease; AND 2. Member has i ntermediate to high risk of disease recurrence in clinically localized prostate cancer, as indicated by one or more of the following: a) Intermediate risk of recurrence: i) T2a or lower, an aggressive histologic pattern (i .e ., Gleason score of 7) ; ii) T2a or lower, and PSA 10 to 20mg/mL (mcg/L) ; iii) T2b or T2c ; b) High risk of recurrence: i) T2c or lower, and aggressive histologic pattern (i .e ., Gleason score of 8 to 10) ; ii) T2c or lower, and PSA greater than 20 ng/mL (mcg/L) ; iii) T3a; AND 3. Medication must be prescribed by gynecologist or obstetrician. 4. Dosage allowed: Lupron Depot 7.5 mg for 1-month administration, given as a single intramuscular injection every 4 weeks. Lupron Depot 22.5 mg for 3-month administration, given as a single intramuscular injection every 12 weeks. Lupron Depot 30 mg for 4-month administration, given as a single intramuscular injection every 16 weeks. Lupron Depot 45 mg for 6-month administration, given as a single intramuscular injection every 24 weeks. If member meets all the requirements listed above, the medication will be approved for 6 months. For reauthorization: 1. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease or member did not get any worse. If member meets all the reauthorization requirements above, the medication will be app roved for an additional 6 months. UTERINE LEIOMYOMAS (FIBROIDS) For initial authorization: 1. Member is a female of 18 years of age or older; AND 2. Member is not currently breast feeding, pregnant, or planning to become pregnant while receiving medication; AND 3. Medication must be prescribed by gynecologist or obstetrician; AND 4. Proposed date of planned fibroid s urgery submitted with chart notes; AND 5. Leiomyoma symptoms, as indicated by one or more of the following: a) Abnormal uterine bleeding; b) Bulk-related symptoms (e. g., pelvic pain or pressure, dyspareunia, urinary symptoms) ; c) Iron deficiency anemia; d) Other causes of symptoms or bleeding ruled out (e.g., by endometrial biopsy). 6. Dosage allowed: Lupron Depot 3.75 mg for 1-month and 11.25 mg for 3-month administration with iron therapy are prescription medications used before fibroid surgery to improve anemia due to va ginal bleeding from fibroids. Note: Treatment beyond total of 3 months is considered unproven, therefore second reauthorization would not be allowed. If member meets all the requirements listed above, the medication will be approved for 3 months. CareSource considers Lupron Depot and Lupron Depot-PED (leuprolide acetate) 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: Dysfunctional Uterine Bleeding DATE ACTION/DESCRIPTION 10/09/2018 New policy for Lupron created. Age requirement for Central Precocious Puberty and diagnostic evaluation assessment were revised. Coverage for Advanced Breast Cancer is specified for hormone receptor-positive breast cancer. Proposed d ate of planned fibroid surgery criterion was added to diagnosis of Uterine Leiomyomas. Diagnosis of Dysfunctional uterine bleeding was removed. The r equirement for increased uterine volume from the female criteria in CPP was removed. References: 1. Lupron Depot [package i nsert]. North Chicago, IL: AbbVie Inc. ; June, 2016. 2. Lupron Depot PED [package insert]. North Chicago, IL: Abb Vie Inc.; May, 2017. 3. Burstein HJ, Lacchetti C, Anderson H, et al. Adjuvant endocrine therapy for women with hormone receptor-positive breast cancer: American society of clinical oncology clinical practice guideline update on ovarian suppression. JClin Oncol. 2016;34(14):1689-701. 4. Dowsett M, Mehta A, Mansi J, Smith IE. A dose-comparative endocrine-clinical study of leuprorelin in premenopausal breast cancer patients. Br JCancer. 1990;62(5):834-837. 5. Dowsett M, Jacobs S, Aherne J, Smith IE. Clinical and endocrine effects on leuprorelin acetate in pre-and postmenopausal patients with advanced breast cancer. Clin Ther . 1992;14(suppl A):97-103. 6. Gradishar WJ, Anderson BO, Blair SL, et al, and the National Comprehensive Cancer Netw ork Breast Cancer Panel. Breast cancer version 3.2014. JNatl Compr Canc Netw. 2014;12(4):542-590. 7. Kurebayashi J, Toyama T, Sumino S, Miyajima E, Fujimoto T. Efficacy and safety of leuprorelin acetate 6-month depot, TAP-144-SR (6M), in combination with tam oxifen in postoperative, premenopausal patients with hormone receptor-positive breast cancer: A phase III, randomized, open-label, parallel-group comparative study. Breast Cancer . 2017;24(1):161-170. 8. Recchia F, Candeloro G, Necozione S, et al. Premenopausal hormone-responsive breast cancer with extensive axillary nodes involvement: total estrogen blockade and chemotherapy. Anticancer Res. 2011;31:671-676. 9. Schmid P, Untch M, Koss V, et al. Leuprorelin acetate every-3 -months depot vers us cyclophosphamide, methotrexate, and fluorouracil as adjuvant treatment in premenopausal patients with node-positive breast cancer: the TABLE study. JClin Oncol . 2007;25(18):2509-2515. 10. Shiba E, Yamashita H, Kurebayashi J, et al. A randomized controlled study evaluating safety and efficacy of leuprorelin acetate every-3 -months depot for 2 versus 3 or more years with tamoxifen for 5 years as adjuvant treatment in premenopausal patients with endocrine-responsive breast cancer. Breast Cancer. 2016;23(3):499-509. 11. Untch M, Fuchs W, Kreienberg R. Clinical efficacy of leuprorelin acetate monthly depot in premenopausal patients with metastatic breast cancer. Oncol Rep. 1997;4(4):717-721. 12. Watanabe T, Adachi I, Taguchi T, et al; with members of the TAP-144-SR Breast Cancer Study Group. Phase II trial of TAP-144-SR (leuprorelin sustained release formulation) in premenopausal patients with metastatic breast cancer (MBC) [abstract]. Breast Cancer Res Treat. 1996;37(suppl 1):74. Abstract 233. 13. Jasonni VM, DAnna R, Mancus o A, Caruso C, Corrado F, Leonardi I. Randomized double-blind study evaluating the efficacy on uterine fibroids shrinkage and on intra-operative blood loss of different length of leuprolide acetate depot treatment before myomectomy. Acta Obstet Gynecol Scand . 2001;80(10):956-958. 14. Palomba S, Orio Jr. F, Russo T, et al. Long-term effectiveness and safety of GnRH agonist plus raloxifene administration in women with uterine leiomyomas. Human Reproduction. 2004;19(6):1308-1314. 15. Schlaff WD, Zerhouni EA, Huth JAM, Chen J, Damewood MD, Rock JA. A placebo-controlled trial of a depot gonadotropin-releasing hormone analogue (leuprolide) in the treatment of uterine leiomyomata. Obstet Gynecol . 1989;74(6):856-862. 16. Vaval V, Lanzone A, Monaco A, Scribanti A, Guida C, Manc uso S. Postoperative GnRH analog treatment for the prevention of recurrences of uterine myomas after myomectomy. A pilot study. Gynecol Obstet Invest. 1997;43(4):251-254. 17. Stovall TG, Muneyyirci-Delale O, Summitt RL Jr, Scialli AR; Leuprolide Acetate Study Group. GnRH agonist and iron versus placebo and iron in the anemic patient before surgery for leiomyomas: a randomized controlled trial. Obstet Gynecol . 1995;86(1):65-71. 18. Donnez J, Tomaszewski J, Vazquez F, et al; for the PEARL II Study Group. Ulipristal acetate versus leuprolide acetate for uterine fibroids. NEng JMed. 2012;366(5):421-432. 19. Mitwally MFM, Gotlieb L, Casper RF. Prevention of bone loss and hypoestrogenic symptoms by estrogen and interrupted progestogen add-back in long-term GnRH-agonist down-regulated patients with endometriosis and premenstrual syndrome. Menopause. 2002;9(4):236-241. 20. Bedaiwy MA, Casper RF. Treatment with leuprolide acetate and hormonal add-back for up to 10 years in stage IV endometriosis patients with chronic pelvic pain [l etter]. Fertil Steril. 2006;86(1):220-222. 21. Eksioglu AS, et al. Value of pelvic sonography in the diagnosis of various forms of precocious puberty in girls. JClin Ultrasound. 2013 Feb;41(2):84-93. 22. Sathasivam A, et al. Pelvic ultrasonography in the evaluation of central precocious puberty: comparison with leuprolide stimulation test. JPediatr. 2011 Sep;159(3):490-5. Effective date: 10/26/2018 Revised date: 10/09/2018
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Fulphila (pegfilgrastim-jmdb) BILLING CODE Q5108 BENEFIT TYPE Medical SITE OF SERVICE ALLOWED Home/Office/Outpatient COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) Alternative preferred product includes Neulasta QUANTITY LIMIT 12 mg per 28 days LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Fulphila (pegfilgrastim-jmdb) 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. PREVENTION OF FEBRILE NEUTROPENIA For initial authorization: 1. Member has a non-myeloid malignancy; AND 2. Medication will not be administered less than 14 days before OR less than 24 hours after chemotherapy; AND 3. Chart notes with length of chemotherapy cycle, the days of the cycle on which chemotherapy will be administered, and the day of the cycle on which the Fulphila will be administered, are submitted with prior authorization request; AND 4. Member has a documented history of febrile neutropenia (defined as an ANC 38.2C) following a previous course of chemotherapy and is receiving myelosuppressive chemotherapy; OR 5. Member is receiving myelosuppressive anti-cancer drugs associated with a high risk (> 20%, see Appendix for description) for incidence of febrile neutropenia; OR 6. Member is receiving myelosuppressive anti-cancer drugs associated with at intermediate risk (10-20%, see Appendix for description) for incidence of febrile neutropeni a including one of the following: a) Previous chemotherapy or radiation therapy; b) Persistent neutropenia; c) Bone marrow involvement with tumor; d) Recent surgery and/or o pen wounds; e) Liver dysfunction (bilirubin > 2.0); f) Renal dysfunction (creatinine clearance 65 years receiving full chemotherapy dose intensity. 7. Dosage allowed: Up to 6 mg per chemotherapy cycle, beginning at least 24 hours after completion of chemotherapy. Note: Fulphila is not indicated for hematopoietic syndrome of acute radiation syndrome. 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. If member meets all the reauthorization requirements above, the medication will be approved for an additional 12 months. CareSource considers Fulphila (pegfilgrastim-jmdb) 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: Hematopoietic syndrome of acute radiation syndrome Mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplant DATE ACTION/DESCRIPTION 07/25/2018 New policy for Fulphila (pegfilgrastim-jmdb) created. References: 1. Fulphila [package insert]. Rockford, IL: Mylan Institutional LLC.; June 2018. 2. U.S. Food and Drug Administration. Media release. FDA approved first biosimilar to Nulasta to help reduce the risk of infection during cancer treatment. Available at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609805.htm. Accessed on July 25, 2018. 3. National Comprehensive Cancer Network. (2016). NCCN Drugs & Biologics Compendium. Pegfilgrastim. Retrieved November 22, 2016 from the National Comprehensive Cancer Network. Effective date: 10/26/2018 Revised date: 07/25/2018Appendix Chemotherapy Regimens with a High Risk for Febrile Neutropenia (>20%) Cancer Type Regimen Acute Lymphoblastic Leukemia (ALL) ALL induction regimens (see NCCN guidelines) Bladder Cancer MVAC (methotrexate, vinblastine, doxorubicin, cisplatin) (neoadjuvant, adjuvant, metastatic) Breast Cancer Docetaxel + trastuzumab (metastatic or relapsed) Dose-dense AC followed by T (doxorubicin, cyclophosphamide, paclitaxel) (adjuvant) TAC (docetaxel, doxorubicin, cyclophosphamide) (adjuvant) Esophageal and Gastric Cancers Docetaxel/cisplatin/fluorouracil Hodgkin Lymphoma BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone) Kidney Cancer Doxorubicin/gemcitabine Non-Hodgkin's Lymphoma ICE (ifosfamide, carboplatin, etoposide) (diffuse large B-cell lymphoma [DLBCL], peripheral T-cell lymphomas [PTCL], 2nd line) RICE (rituximab, ifosfamide, carboplatin, etoposide) CHOP-14 (cyclophosphamide, doxorubicin, vincristine, prednisone) + rituximab MINE (mesna, ifosfamide, novantrone, etoposide) (DLBCL, 2nd line, refractory) DHAP (dexamethasone, cisplatin, cytarabine) ESHAP (etoposide, methylprednisolone, cisplatin, cytarabine (Ara-C)) (DLBCL, PTCL, 2nd line, recurrent) HyperCVAD + rituximab (cyclophosphamide, vincristine, doxorubicin, dexamethasone + rituximab) Melanoma Dacarbazine-based combination (dacarbazine, cisplatin, vinblastine) (advanced, metastatic, or recurrent) Dacarbazine-based combination with IL-2, interferon alpha (dacarbazine, cisplatin, vinblastine, IL-2, interferon alpha) (advanced, metastatic, or recurrent) Ovarian Cancer Topotecan Paclitaxel Docetaxel Soft Tissue Sarcoma MAID (mesna, doxorubicin, ifosfammide, dacarbazine) Doxorubicin Ifosfamide/doxorubicin Small Cell Lung Cancer topotecan Testicular cancer VelP (vinblastine, ifosfamide, cisplatin) VIP (etoposide, ifosfamide, cisplatin) BEP (bleomycin, etoposide, cisplatin) TIP (paclitaxel, ifosfamide, cisplatin) National Comprehensive Cancer Network (NCCN): Myeloid Growth Factors, 2016. Chemotherapy Regimens with an Intermediate Risk of Febrile Neutropenia ( 10% to 19%) Cancer Histology Regimen Occult primary-adenocarcinoma Gemcitabine/docetaxel Breast cancer Docetaxel every 21 days CMF classic (cyclophosphamide, methotrexate, fluorouracil) (adjuvant) AC (doxorubicin, cyclophosphamide) + sequential docetaxel (adjuvant) (taxane portion only) AC + sequential docetaxel + trastuzumab (adjuvant) FEC (fluorouracil, epirubicin, cyclophosphamide) + sequential docetaxel TC (docetaxel, cyclophosphamide) Cervical Cancer Cisplatin/topotecan (recurrent or metastatic) Paclitaxel/cisplatin Topotecan (recurrent or metastatic) Irinotecan (recurrent or metastatic) Colorectal FOLFOX (fluorouracil, leucovorin, oxaliplatin) Esophageal and Gastric Cancers Irinotecan/cisplatin Epirubicin/cisplatin/5-fluorouracil Epirubicin/cisplatin/capecitabine Multiple myeloma DT-PACE (dexamethasone/thalidomide/cisplatin/doxorubicin/cyclophoaphamide/etoposide) DT-PACE + bortezomib (VTD-PACE) Non-Hodgkin's lymphomas EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin) (AIDS-related NHL, Burkitt lymphoma, recurrent, otherr NHL subtypes) EPOCH-IT chemotherapy (AIDS-related NHL, DLBCL, recurrent) GDP (gemcitabine, dexamethasone, cisplatin) (DLBCL, PTCL, 2nd line) GDP (gemcitabine, dexamethasone, cisplatin) + rituximab (DLBCL, 2nd line, Burkitt lymphoma, other NHL subtypes) FMR (fludarabine, mitoxantrone, rituximab) CHOP + rituximab (cyclophosphamide, doxorubicin, vincristine, prednisone, rituximab) including regimens with pegylated liposomal doxorubicin or mitoxantrone substituted for doxorubicin Non-Small Cell Lung Cancer Cisplatin/paclitaxel (advanced/metastatic) Cisplatin/vinorelbine (adjuvant, advanced/metastatic) Cisplatin/docetaxel (adjuvant, advanced/metastatic) Cisplatin/etoposide (adjuvant, advanced/metastatic) Carboplatin/paclitaxel (adjuvant, advanced/metastatic) Docetaxel (advanced/metastatic) Ovarian Cancer Carboplatin/docetaxel Pancreatic Cancer FOLFIRINOX Prostate Cancer Cabazitaxel Small Cell Lung Cancer Etoposide/carboplatin Testicular Cancer Etoposide/cisplatin Uterine Sarcoma Docetaxel (advanced or metastatic) National Comprehensive Cancer Network (NCCN): Myeloid Growth Factors, 2016.
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Procrit (epoetin alfa) BILLING CODE For Medical-J0885 (Non-ESRD) For Pharmacy-Must use valid NDC code BENEFIT TYPE Medical or Pharmacy SITE OF SERVICE ALLOWED Office, Outpatient COVERAGE REQUIREMENTS Prior Authorization Required (Preferred Product) QUANTITY LIMIT vary per diagnosis LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Procrit (epoetin alfa) 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. ANEMIA For initial authorization: 1. Medication must be prescribed by an oncologist, a nephrologist, an immunologist or infectious disease specialist; AND 2. Member has documented diagnosis of anemia due to one of the following: a) Myelodysplastic syndrome; b) Chronic Kidney Disease ( GFR below 60 mL/min/1.73 m2) ; c) Concomitant Zidovudine treatment in member with HIV-infection; d) The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a min imum of two additional months of planned chemotherapy; AND 3. Members individual iron status reveals both of the following: a) Transfe rrin saturation is at least 20%; b) Fer ritin is at least 100 mc g/L; AND 4. Member is on supplemental iron therapy (unless serum ferritin level > 800 mcg/L); AND 5. Members labs show hemoglobin 10 g/dL for adults (11 g/dL for children) within the last 14 days for initial therapy, OR 1 0.5 g/dL for adults (11.5 g/dL for children) current ly receiving therapy. 6. Dosage allowed: Members with CKD-50 to 100 Units/kg 3 times weekly (adults) as initial dose and 50 Units/kg 3 times weekly (pediatric patients). Individualize maintenance dose. Intravenous route recommended for members on hemodialysis. Members on Zidovudine due to HIV-infection-100 Units/kg 3 times weekly. Members with cancer-40,000 Units weekly or 150 Units/kg 3 times weekly (adults); 600 Units/kg intravenously weekly (pediatric patients 5 years) . If member meets all the requirements listed above, the medication will be approved for 6 months. For reauthorization: 1. Members hemoglobin increased, stayed the same and not decreased further (baseline labs and current labs required); AND 2. Red blood cel ls transfusions are not required or the number of the transfusions has decreased. If member meets all the reauthorization requirements above, the medication will be approved for an additional 6 months. REDUCTION OF ALLOGENEIC RBC TRANSFUSIONS For initial authorization: 1. Medication must be prescribed by an oncologist, a nephrologist, an immunologist or infectious disease specialist; AND 2. Medication is being used for reduction of allogeneic RBC transfusions in member undergoing elective, non-cardiac, nonvascular high-risk surgery at increased risk of or intolerant to transfusions ; AND 3. Me mbers labs show hemoglobin 13 g/dL. 4. Dosage allowed: 300 Units/kg per day daily for 15 days or 600 Units/kg weekly . If member meets all the requirements listed above, the medication will be approved for 3 months. For reauthorization: 1. Medication will not be reauthorized. CareSource considers Procrit (epoetin alfa) 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: In members with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy In members with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure In members with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion In members scheduled for surgery who are willing to donate autologous blood In members undergoing cardiac or vascular surgery As a substitute for RBC transfusions in patients who require immediate correction of anemia DATE ACTION/DESCRIPTION 10/04/2018 New policy for Procrit created. Hemoglobin requirement expanded. Endogenous serum erythropoietin level requirement removed. References: 1. Procrit [package insert]. Thousand Oaks, CA: Amgen; September, 2017 . 2. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology; Cancer-and Chemotherapy-Induced Anemia. V.2.2018. Available at https://www.nccn.org/professionals/physician_gls/pdf/anemia.pdf. Accessed January 30, 2018. 3. Wolters Kluwer. Facts & Comparisons. www.factsandcomparis ons.com, 2011. (May 11, 2011). 4. Young. D. CMS Anemia Drugs Proposal: Bad for Amgen, Good for Patients, 17 May 2007. 5. New risk management program for erythropoiesis-stimulating agents. Aranesp, Procrit, and Epogen Article; Pharmacist’s Letter; April 2010; Vol : 26 Hematology / Oncology. 6. Singh AK, Szczech L, Tang KL, et al. Correction of Anemia with Epoetin Alfa in Chronic Kidney Disease, NEngl j Med. 2006; 355:2085-98. 7. Mueller BU, Jacobsen RN, Jarosinski P, et al. Erythropoietin for zidovudine-associated anemia in children with HIV infection. 8. Pediatr AIDS and HIV Infect: Fetus to Adolesc. 1994;5:169-173. 9. Bohlius J, Wilson J, Seidenfeld J, et al., Recombinant Human Erythropoietins and Cancer Patients: Updated Meta-Analysis of 57 Studies Including 9353 Patients. JNatl Cancer Inst. 2006; 98:708-14. 10. Erythropoiesis-stimulating agents in oncology: a study-level meta-analysis of survival and other safety outcomes. 11. Glaspy J, Crawford J, Vansteenkiste J, Henry D, Rao S, Bowers P, Berlin JA, Tomita D, Bridges K, Ludwig HBr JCancer. 2010;102(2):301. American Society of Clinical Oncology/American Society of Hematology clinical practice guideline update on the use of epoetin and darbepoetin in adult patients with cancer. 12. Rizzo JD, Brouwers M, Hurley P, Seidenfeld J, Arcasoy MO, Spivak JL, Bennett CL, Bohlius J, Evanchuk D, Goode MJ, Jakubowski AA, Regan DH, Somerfield MR, American Society of Clinical Oncology, American Society of Hematology; JClin Oncol. 2010;28(33):4996. National Comprehensive Cancer Network (NCCN) guidelines www.nccn.org. Accessed September 3, 2015. 13. Aliment Pharmacol Ther. 2010 May;31(9):929-37. Epub 2010 Feb 18.Review article: optimizing SVR and management of the haematol ogical side effects of peginterferon/ribavirin antiviral therapy for HCV-the role of epoetin, G-CSF and novel agents . 14. Definition and management of anemia in patients infected with hepatitis Cvirus. McHutchison JG, Manns MP, Longo DL Liver Int. 2006;26(4):389 MCG 20th edition, 2016. Effective date: 10/19/2018 Revised date: 10/04/2018
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME NPlate (romiplostim) BILLING CODE J2796 BENEFIT TYPE Medical SITE OF SERVICE ALLOWED Hospital, Office COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) Alternative preferred products include immune globulins and Promacta QUANTITY LIMIT 10 mcg/kg (actual body weight) LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here NPlate (romiplostim ) 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. IMMUNE THROMBOCYTOPENIC PURPURA (ITP) For initial authorization: 1. Member is 18 years of age or older ; AND 2. Member has a documented diagnosis of chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND 3. Medication must be prescribed by or in consultation with a hematologist; AND 4. Member has ONE of the following conditions: a) Current platelet count is
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