PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Actemra (tocilizumab) BILLING CODE For medical-J3262 (1 unit = 1 mg) For Rx-must use valid NDC BENEF IT TYPE Medical or Pharmacy SIT EOF SERVICE ALLOWED Outpatient/Office/ Ho me COVERAGE REQUIREMENT SPrior Authorization Required (Preferred Product) QUANTITY LIMIT 3200 units per 28 days LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click He re Actemra (tocilizumab) is a pre fe rred product and will only be con sidered for coverage under the m e dical or pharm acy benefit when the following criteria are met: Members mus t be c linically diagnosed with one of the following dis eas e states and meet their individual c riteria as s tated. GIANT CELL ARTERITIS (GCA) For initial authorization: 1. Member must be 50 years of age or older; AND 2. Medication must be prescribed by a rheumatologist; AND 3. Must have a documented negative TB test (i.e. , tuberculosis skin test (PPD), an interferon-r ele a s e assay (I GRA)) within 12 months prior to starting therapy; AND 4. Member has a history of erythrocyte sedimentation rate ( ESR) 50 mm/h or history of C-reactive protein (CRP) 2.45 mg/dL documented in chart notes OR if member received glucocorticoid (prednisone) therapy ESR 30 mm/h and CRP 1 mg/dL; AND 5. At least one of the following: a) Unequivocal cranial symptoms of GCA (new onset localized headache, scalp or temporal artery tenderness, ischemia-related vision loss, or otherwise unexplained mouth or jaw pain upon mastication) ; b) Unequivocal symptoms of polymyalgia rheumatica (PMR), defined as shoulder and/or hip girdle pain associated with inflammatory stiffness; AND 6. At least one of the following: a) Temporal artery biopsy revealing features of GCA; b) Evidence of large-vessel vasculitis by angiography; c) Cross-sectional imaging (such as MRI, CT A or PET-CT) ; AND 7. Medi cation must be used in combination with a tapering course of glucoco rticoids; AND 8. Member does not have ANY of the following: a) Significant cardiac disease (NYHA Class III and IV), or severe chronic obstructive pulmonary disease (COPD) (FEV1 Grade 3 on the MRC Dyspnea Scale) or other significant pulmonary disease ; b) Active infection of any kind, or any major episode of infection requiring hospit alization or treatment with intravenous anti-infectives within the past 4 weeks , or completion of oral anti-in f ec t iv es within th e past 2 weeks; c) History of deep space/tissue infection (e.g., fasciitis, abscess, osteomyelitis) within 52 weeks; d) Any surgical procedure, including bone/joint surgery, within the past 8 weeks (exception temporal artery biopsy or other biopsy related to diagnosing this condition); e) Body weight > 150 kg or BMI > 35. 9. Dosage allowed: 162 mg given once every week as a subcutaneous injection in combination with a tapering course of glucocorticoids. A dose of 162 mg given once every other week as a subcutaneous injection, in combination with a tapering course of glucocorticoids, can be also prescribed based on clinical considerations. If member meets all the requirements listed above, the medication will be approved for 12 months. For r e a ut ho riza tion: 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., ESR and CRP normalized due to treatment response, etc.) If member meets all the reauthorization requirements above, the medication will be approved for a n a ddit ion a l 12 months. JUV ENILE IDIOPATHIC ARTHRITIS (JIA) sy stemic (SJIA) and poly articular (PJIA) For initial authorization: 1. Member must be 2 years of age or older with moderate to severe active PJIA or SJIA; AND 2. Must have a documented negative TB test (i.e. , tuberculosis skin test (PPD), an interferon-r ele a s e assay (I GRA)) within 12 months prior to starting therapy; AND 3. Medication must be prescribed by a rheumatologist; AND 4. Member must have an inadequate response to methotrexate or inability to tolerate methotrexate; AND 5. Member must have least 6 months of active disease AND at least one of the following signs or symptoms: a) Four or fewer joints involved wi th an inadequate response to glucocorticoid injection and methotrexate or leflunomide and NSAID treatment for at least 30 days ; b) Five or more joints involved and an inadequate response to methotrexate or leflunomide for at least 30 days. 6. Dosage allowed: For PJIA intravenously every 4 weeks : body weight
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Zomacton (somatropin) 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 products include Omnitrope (somatropin) vials 5.8 mg QUANTITY LIMIT per diagnosis, see Dosage allowed LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Zomacton (somatropin ) is a non-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. Adult GROWTH HORMONE DEFICIENCY (GHD) – Adult or Childhood Onset For initial authorization: 1. Member must have a documented 3 0-day trial and failure of Omnitrope 5.8 mg vial; AND 2. Member is 18 years of age or older; AND 3. Medication must be prescribed by an endocrinologist; AND 4. Member must have a diagnosis of GHD confirmed by one of the following: a) Chart notes documentation of acquired structural abnormality ( see Appendix ) of the hypothalamus or pituitary and 3 documented pituitary hormone deficiencies ( see Appendix ) with included lab results and reference ranges ; b) Documented childhood-onset of GHD with a documented congenital abnormality (see Appendix ) of the hypothalamus or pituitary; c) Two pre-treatment peak serum growth hormone (GH) concentration 2 Standard Deviations (SD) below the mean ( must include chart notes and documentation to confirm diagnosis and lab results with reference ranges ); AND 5. Member must have a pretreatment height ( must include growth charts) of > 2 SD below the mean for age and gender; AND 6. If member is age 12 or older, radiographic evidence the members epiphyses are open ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal b y > 2 SD below the mean for chronological age. 7. Dosage allowed: 0.18-0.30 mg/kg/week. 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 of the initial criteria; AND 2. If member is age 12 or older, radiographic evidence the members epiphyses are open ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronologi cal age; AND 3. Member has a growth rate > 2.5 cm/year unless there is a documented reason for lack of efficacy (on treatment 2 SD below the mean and 1 year height velocity is > 1 SD below the mean for age ( must include growth charts and documentation ); AND 4. If member is age 12 or older, the members epiphyses are open, confirmed by radiograph of the wrist and hand ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronological age. 5. Dosage allowed: 0.35 mg/kg/week. 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 of the initial criteria; AND 2. If member is age 12 or older, the members epiphyses are open, confirmed by radiograph of the wrist and hand ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronological age; AND 3. Member has a growth rate > 2.5 cm/year unless there is a documented reason for lack of efficacy (on treatment 2 SD below the mean for gestational age ( must include growth charts and documentation); AND 6. Members height remains > 2 SD below population for age and gender ( must include growth charts and documentation); AND 7. If member is age 12 or older, radiographic evidence the members epiphyses are open ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronological age. 8. Dosage allowed: Up to 0.47 mg/kg/week. 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 of the initial criteria; AND 2. If member is age 12 or older, radiographic evidence the members epiphyses are open ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronological age; AND 3. Member has a growth rate > 2.5 cm/year unless there is a documented reason for lack of efficacy (on treatment 2 SD below the mean and 1 year height velocity is > 1 SD below the mean for age ( must include growth charts and documentation ); AND 6. If member is age 12 or older, radiographic evidence the members epiphyses are open ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronological age. 7. Do sage allowed: Up to 0.375 mg/kg/week. 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 of the initial criteria; AND 2. If member is age 12 or older, radiographic evidence the members epiphyses are open ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronological age; AND 3. Member has a growth rate > 2.5 cm/year unless there is a documented reason for lack of efficacy (on treatment
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Serostim (somatropin) BILLING CODE Must use valid NDC code BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Serostim (somatropin ) is a non-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. HIV-ASSOCIATED WASTING, CACHEXIA For initial authorization: 1. Member is age 18 years or older ; AND 2. Medication must be prescribed by an infectious disease specialist ; AND 3. Member is currently on antiretroviral therapy; AND 4. Member has tried and had a suboptimal response to at least one alternative therapy ( e.g., cyproheptadine, dronabinol, megestrol acetate) unless member has a contraindication or intolerance to all alternative therapies listed; AND 5. Member has a pre-treatment BMI 10% body weight in the previous 6 months before initiating therapy. 7. Dosage allowed: 0. 1 mg/kg up to 6 mg. If member meets all the requirements listed above, the medication will be approved for 12 weeks. For reauthorization: 1. Member must be in compliance with all of the initial criteria; AND 2. BMI has improved in response to therapy with Serostim; AND 3. Current BMI is
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Saizen (somatropin) 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 per diagnosis, see Dosage allowed LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Saizen (somatropin ) is a non-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. Adult GROWTH HORMONE DEFICIENCY (GHD) – Adult or Childhood Onset For initial authorization: 1. Member must have a documented 30-day trial and failure of Omnitrope 5.8 mg vial; AND 2. Member is 18 years of age or older; AND 3. Medication must be prescribed by an endocrinologist; AND 4. Member must have a diagnosis of GHD confirmed by one of the following: a) Chart notes documentation of acquired structural abnormality ( see Appendix ) of the hypothalamus or pituitary and 3 documented pituitary hormone deficiencies ( see Appendix ) with included lab results and reference ranges ; b) Documented childhood-onset of GHD with a documented congenital abnormality (see Appendix ) of the hypothalamus or pituitary; c) Two pre-treatment peak serum growth hormone (GH) concentration 2 Standard Deviations (SD) below the mean ( must include chart notes and documentation to confirm diagnosis and lab results with reference ranges ); AND 5. Member must have a pretreatment height ( must include growth charts) of > 2 SD below the mean for age and gender; AND 6. If member is age 12 or older, radiographic evidence the members epiphyses are open ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the me an for chronological age. 7. Dosage allowed: 0.18 mg/kg/week. 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 of the initial criteria; AND 2. If member is age 12 or older, radiographic evidence the members epiphyses are open ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronological age; AND 3. Member has a growt h rate > 2.5 cm/year unless there is a documented reason for lack of efficacy (on treatment
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Omnitrope (somatropin) cartridge 5 mg/1.5 mL and 10 mg/1.5 mL Omnitrope (somatropin) for injection 5.8 mg/vial BILLING CODE Must use valid NDC code BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home COVERAGE REQUIREMENTS Prior Authorization Required QUANTITY LIMIT per diagnosis, see Dosage allowed LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Omnitrope (somatropin) cartridge (5 mg/1.5 mL and 10 mg/1.5 mL) is a non-preferred product and Omnitrope (somatropin ) 5.8 mg/vial is a preferred product and both 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. Adult GROWTH HORMONE DEFICIENCY (GHD) – Adult or Childhood Onset For initial authorization: 1. If request is for Omnitrope cartridge member must have a documented 30-day trial and failure of Omnitrope 5.8 mg vial; AND 2. Member is 18 years of age or older; AND 3. Medication must be prescribed by an endocrinologist; AND 4. Member must have a diagnosis of GHD confirmed by one of the following: a) Chart notes documentation of acquired structural abnormality ( see Appendix ) of the hypothalamus or pituitary and 3 documented pituitary hormone deficiencies ( see Appendix ) with included lab results and reference ranges ; b) Documented childhood-onset of GHD with a documented congenital abnormality (see Appendix ) of the hypothalamus or pituitary; c) Two pre-treatment peak serum growth hormone (GH) concentration 2 Standard Deviations (SD) below the mean ( must include chart notes and documentation to confirm diagnosis and lab results with reference ranges ); AND 5. Member must have a pretreatment height ( must include growth charts) of > 2 SD below the mean for age and gender; AND 6. If member is age 12 or older, radiographic evidence the members epiphyses are open ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below t he mean for chronological age. 7. Dosage allowed: 0.16-0.24 mg/kg/week. 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 of the initial criteria; AND 2. If member is age 12 or older, radiographic evidence the members epiphyses are open ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronological age; AND 3. Member h as a growth rate > 2.5 cm/year unless there is a documented reason for lack of efficacy (on treatment 2 SD below the mean and 1 year height velocity is > 1 SD below the mean for age ( must include growth charts and documentation ); AND 6. If member is age 12 or older, radiographic evidence the members epiphyses are open ( x-ray results must be included). Compariso n of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronological age. 7. Dosage allowed: 0.24 mg/kg/week. 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 of the initial criteria; AND 2. If member is age 12 or older, radiographic evidence the members epiphyses are open ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronological age; AND 3. Member has a growth rate > 2.5 cm/year unless there is a documented reason for lack of efficacy (on treatment 2 SD below the mean for gestational age ( must include growth charts and documentation); AND 6. Members height remains > 2 SD below population for age and gender ( must include growth charts and documentation); AND 7. If member is age 12 or older, radiographic evidence the members epiphyses are open ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronological age. 8. Dosage allowed: Up to 0.48 mg/kg/week. 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 of the initial criteria; AND 2. If member is age 12 or older, radiographic evidence the members epiphyses are open ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronological age; AND 3. Member has a growth rate > 2.5 cm/year unless there is a documented reason for lack of efficacy (on treatment 2 SD below the mean and 1 year height velocity is > 1 SD below the mean for age ( must include growth charts and documentation ); AND 6. If member is age 12 or older, radiographic evidence the members epiphyses are open ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronological age. 7. Dosage allowed: 0.33 mg/kg/week. 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 of the initial criteria; AND 2. If member is age 12 or older, radiographic evidence the members epiphyses are open ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronological age; AND 3. Member has a growth rate > 2.5 cm/year unless there is a documented reason for lack of efficacy (on treatment
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Norditropin (somatropin) 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 products include Omnitrope (somatropin) vials 5.8 mg QUANTITY LIMIT per diagnosis, see Dosage allowed LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Norditropin (somatropin ) is a non-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. Adult GROWTH HORMONE DEFICIENCY (GHD) – Adult or Childhood Onset For initial authorization: 1. Member must have a documented 30-day trial and failure of Omnitrope 5.8 mg vial; AND 2. Member is 18 years of age or older; AND 3. Medication must be prescribed by an endocrinologist; AND 4. Member must have a diagnosis of GHD confirmed by one of the following: a) Chart notes documentation of acquired structural abnormality ( see Appendix ) of the hypothalamus or pituitary and 3 documented pituitary hormone deficiencies ( see Appendix ) with included lab results and reference ranges ; b) Documented childhood-onset of GHD with a documented congenital abnormality (see Appendix ) of the hypothalamus or pituitary; c) Two pre-treatment peak serum growth hormone (GH) concentration 2 SD below the mean and 1 year height velocity is > 1 SD below the mean for age ( must include growth charts and documentation ); AND 5. If member is age 12 or older, the members epiphyses are open, confirmed by radiograph of the wrist and hand ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronological age. 6. Dosage allowed: 0.46 mg/kg/week. 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 of the initial criteria; AND 2. If member is age 12 or older, the members epiphyses are open, confirmed by radiograph of the wrist and hand ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronological age; AND 3. Member has a growth rate > 2.5 cm/year unless there is a documented reason for lack of efficacy (on treatment 2 Standard Deviations (SD) below the mean ( must include chart notes and documentation to confirm diagnosis and lab results with reference ranges ); AND 5. Member must have a pretreatment height ( must include growth charts) of > 2 SD below the mean for age and gender; AND 6. If member is age 12 or older, radiographic evidence the members epiphyses are open (x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronological age. 7. Dosage allowed: 0.17-0.24 mg/kg/week. 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 of the initial criteria; AND 2. If member is age 12 or older, radiographic evidence the members epiphyses are open ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronological age; AND 3. Member has a growth rate > 2.5 cm/year unless there is a documented reason for lack of efficacy (on treatment 2 SD below the mean and 1 year height velocit y is > 1 SD below the mean for age ( must include growth charts and documentation ); AND 6. If member is age 12 or older, radiographic evidence the members epiphyses are open ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronological age. 7. Dosage allowed: 0.24 mg/kg/week. 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 of the initial criteria; AND 2. If member is age 12 or older, radiographic evidence the members epiphyses are open ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the me an for chronological age; AND 3. Member has a growth rate > 2.5 cm/year unless there is a documented reason for lack of efficacy (on treatment 2 SD below the mean for gestational age ( must include growth charts and documentation); AND 6. Members height remains > 2 SD below population for age and gender ( must include growth charts and documentation); A ND 7. If member is age 12 or older, radiographic evidence the members epiphyses are open ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronological age. 8. Dosage all owed: 0.47 mg/kg/week. 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 of the initial criteria; AND 2. If member is age 12 or older, radiographic evidence the members epiphyses are open ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronological age; AND 3. Member has a growth rate > 2.5 cm/year unless there is a documented reason for lack of efficacy (on treatment 2 SD below the mean and 1 year height velocity is > 1 SD below the mean for age ( must include growth charts and documentation ); AND 6. If member is age 12 or older, radiographic evidence the members epiphyses are open ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronological age. 7. Dosage allowed: 0.47 mg/kg/week. 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 of the initial criteria; AND 2. If member is age 12 or older, radiographic evidence the members epiphyses are open ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronological age; AND 3. Member has a growth rate > 2.5 cm/year unless there is a documented reason for lack of efficacy (on treatment
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Macrilen (macimorelin) 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 for weight 120 kg-1 pouch >120 kg J 2 pouches LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Macrilen (macimorelin ) is a non-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. DIAGNOSTIC USE FOR GROWTH HORMONE DEFICIENCY For initial authorization: 1. Member is age 18 years or older; AND 2. Medication must be prescribed by an endocrinologist; AND 3. Member s weight is documented on chart notes and m ember s BMI is 40 kg/m2; AND 4. Member must have a contraindication to ALL other diagnostic tests (insulin tolerance test, glucagon stimulation test, arginine, clonidine, levodopa, or arginine combined with levodopa) for growth hormone deficiency. 5. Dosage allowed: 0.5 mg/kg as single dose . If member meets all the requirements listed above, the medication will be approved for a one-time fill and will not be reauthorized. CareSource considers Macrilen (macimorelin) not medically necessary for the diagnosis or treatment of the diseases that are not listed in this document. DATE ACTION/DESCRIPTION 10/20/2018 New policy for Macrilen created. References: 1. Macrilen [prescribing information]. Trevose, PA: Strongbridge US Inc. ; Revised January 2018. 2. Garcia JM et al., JClin Endocrinol Metab. 2018 May 31. 3. Diagnosis of growth hormone deficiency in childhood. Curr Opin Endocrinol Diabetes Obes . 2012;19(1):47-52. Effective date: 02/01/2019 Revised date: 10/20/2018
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Humatrope (somatropin) 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 products include Omnitrope (somatropin) vials 5.8 mg QUANTITY LIMIT per diagnosis, see Dosage allowed LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Humatrope (somatropin ) is a non-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. Adult GROWTH HORMONE DEFICIENCY (GHD) – Adult or Childhood Onset For initial authorization: 1. Member must have a documented 30-day trial and failure of Omnitrope 5.8 mg vial; AND 2. Member is 18 years of age or older; AND 3. Medication must be prescribed by an endocrinologist; AND 4. Member must have a diagnosis of GHD confirmed by one of the following: a) Chart notes documentation of acquired structural abnormality ( see Appendix ) of the hypothalamus or pituitary and 3 documented pituitary hormone deficiencies ( see Appendix ) with included lab results and reference ranges ; b) Documented childhood-onset of GHD with a documented congenital abnormality ( see Appendix ) of the hypothalamus or pituitary; c) Two pre-treatment peak serum growth hormone (GH) concentration 2 Standard Deviations (SD) below the mean ( must include chart notes and documentation to confirm diagnosis and lab results with reference ranges ); AND 5. Member must have a pretreatment height ( must include growth charts) of > 2 SD below the mean for age and gender; AND 6. If member is age 12 or older, radiographic evidence the members epiphyses are open ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal b y > 2 SD below the mean for chronological age. 7. Dosage allowed: 0.18-0.30 mg/kg/week . 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 of the initial criteria; AND 2. If member is age 12 or older, radiographic evidence the members epiphyses are open ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronologi cal age; AND 3. Member has a growth rate > 2.5 cm/year unless there is a documented reason for lack of efficacy (on treatment 2 SD below the mean and 1 year height velocity is > 1 SD below the mean for age ( must include growth charts and documentation ); AND 4. If member is age 12 or older, the members epiphyses are open, confirmed by radiograph of the wrist and hand ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronological age. 5. Dosage allowed: 0.35 mg/kg/week. 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 of the initial criteria; AND 2. If member is age 12 or older, the members epiphyses are open, confirmed by radiograph of the wrist and hand ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronological age; AND 3. Member has a growt h rate > 2.5 cm/year unless there is a documented reason for lack of efficacy (on treatment 2 SD below the mean for gestational age ( must include growth charts and documentation); AND 6. Members height remains > 2 SD below population for age and gender ( must include growth charts and documentation); AND 7. If member is age 12 or older, radiographic evidence the members epiphyses are open (x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronological age. 8. Dosage allowed: Up to 0.47 mg/kg/week. 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 of the initial criteria; AND 2. If member is age 12 or older, radiographic evidence the members epiphyses are open ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronological age; AND 3. Member has a growth rate > 2.5 cm/year unless there is a documented reason for lack of efficacy (on treatment 2 SD below the mean and 1 year height velocity is > 1 SD below the mean for age ( must include growth charts and documentation ); AND 6. If member is age 12 or older, radiographic evidence the members epiphyses are open ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronological age. 7. Dosage allowed: Up to 0.375 mg/kg/week. 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 of the initial criteria; AND 2. If member is age 12 or older, radiographic evidence the members epiphyses are open ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronological age; AND 3. Member has a growth rate > 2.5 cm/year unless there is a document ed reason for lack of efficacy (on treatment
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Genotropin (somatropin) 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 products include Omnitrope (somatropin) vials 5.8 mg QUANTITY LIMIT per diagnosis, see Dosage allowed LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Genotropin (somatropin ) is a non-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. Adult GROWTH HORMONE DEFICIENCY (GHD) – Adult or Childhood Onset For initial authorization: 1. Member must have a documented 30-day trial and failure of Omnitrope 5.8 mg vial; AND 2. Member is 18 years of age or older; AND 3. Medication must be prescribed by an endocrinologist; AND 4. Member must have a diagnosis of GHD confirmed by one of the following: a) Chart notes documentation of acquired structural abnormality ( see Appendix ) of the hypothalamus or pituitary and 3 documented pituitary hormone deficiencies ( see A ppendix ) with included lab results and reference ranges; b) Documented childhood-onset of GHD with a documented congenital abnormality (see A ppendix ) of the hypothalamus or pituitary; c) Two pre-treatment peak serum growth hormone (GH) concentration 2 Standard Deviations (SD) below the mean ( must include chart notes and documentation to confirm diagnosis and lab results with reference ranges ); AND 5. Member must have a pretreatment height ( must include growth charts) of > 2 SD below the mean for age and gender; AND 6. If member is age 12 or older, radiographic evidence the members epiphyses are open ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronologic al age. 7. Dosage allowed: 0.16-0.24 mg/kg/week. 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 of the initial criteria; AND 2. If member is age 12 or older, radiographic evidence the members epiphyses are open ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronological age; AND 3. Member has a growth rate > 2.5 cm/year unless there is a documented reason for lack of efficacy (on treatment 2 SD below the mean and 1 year height velocity is > 1 SD below the mean for age (must include growth charts and documentation); AND 6. If member is age 12 or older, radiographic evidence the members epiphyses are open (x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronological age. 7. Dosage allowed: 0.24 mg/kg/week. 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 of the initial criteria; AND 2. If member is age 12 or older, radiographic evidence the members epiphyses are open ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronologi cal age; AND 3. Member has a growth rate > 2.5 cm/year unless there is a documented reason for lack of efficacy (on treatment 2 SD below the mean for gestational age ( must include growth charts and documentation); AND 6. Members height remains > 2 SD below population for age and gender ( must include growth charts and documentation); AND 7. If member is age 12 or older, radiographic evidence the members epiphyses are open ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronological age. 8. Dosage allowed: Up to 0.48 mg/ kg/week. 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 of the initial criteria; AND 2. If member is age 12 or older, radiographic evidence the members epiphyses are open ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronological age; AND 3. Member has a growth rate > 2.5 cm/year unless there is a document ed reason for lack of efficacy (on treatment 2 SD below the mean and 1 year height velocity is > 1 SD below the mean for age ( must include growth charts and documentation ); AND 6. If member is age 12 or older, radiographic evidence the members epiphyses are open ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronological age. 7. Dosage allowed: 0.33 mg/kg/week. 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 of the initial criteria; AND 2. If member is age 12 or older, radiographic evidence the members epiphyses are open ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronological age; AND 3. Member has a growth rate > 2.5 c m/year unless there is a documented reason for lack of efficacy (on treatment
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME H.P. Acthar Gel (repository corticotropin injection) BILLING CODE Medical-J0800 Pharmacy-Must use valid NDC BENEFIT TYPE Pharmacy or Medical SITE OF SERVICE ALLOWED Home, Office COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) QUANTITY LIMIT Two-5mL vials per 26 days LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here H.P. Acthar Gel (repository corticotropin injection) is a non-preferred product and will only be considered for coverage under the pharmacy or 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. 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 under 2 years of age; AND 3. Medication must be prescribed by a pediatric neurologist or an epilepsy physician specialist. 4. Dosage allowed: The recommended regimen is a daily dose of 150 U/m2 (divided into twice daily intramuscular injections of 75 U/m2) administered over a 2-week period. If member meets all the requirements listed above, the medication will be approved for 1 month. 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 1 month. CareSource considers H.P. Acthar Gel (repository corticotropin injection) 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: Corticosteroid-responsive conditions (e.g., systemic lupus erythematosus, multiple sclerosis, Stevens-Johnsons syndrome, ophthalmic diseases, rheumatic disorders, serum sickness, and symptomatic sarcoidosis) as it has not been proven to be any more effective than corticosteroids for these indicationsAll other uses of H.P. Acthar Gel (e.g., acute gout, childhood epilepsy, and use in tobacco cessation) are considered experimental/investigational DATE ACTION/DESCRIPTION 10/08/2018 New policy for H.P.Acthar created. Policy placed in the new format. References: 1. H.P. Acthar Gel [package insert]. Hazelwood, MO: Mal linckrodt ARD Inc.; July, 2017. 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. Gold Standard, Inc. Corticotropin ACTH. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc; 2012. Available from: http://www.clinicalpharmacology.com. 4. Management and prognosis of infantile spasms. Daniel GGlaze. UpToDate [online database]. Available from: http://www.uptodate.com 5. Milanese C, La Mantia L, Salmaggi A, et al. Double-blind randomized trial of ACTH versus dexamethasone versus methylprednisolone in multiple sclerosis bouts. Clinical, cerebrospinal fluid and neurophysiological results. Eur Neurol. 1989; 29 (1): 10 14. 6. Thompson AJ, Kennard C, Swash M, e t al. Relative efficacy of intravenous methylprednisolone and ACTH in the treatment of acute relapse in MS. Neurology. 1989; 39 (7): 969 971. 7. Simsarian JP, Saunders C, Smith DM. Five-day regimen of intramuscular or subcutaneous self-prospective, randomiz ed, open-label pilot trial. Drug Des Devel Ther. 2011; 5:381 389. 8. Bomback AS, Tumlin JA, Baranski J, et al. Treatment of nephrotic syndrome with adrenocorticotropic hormone (ACTH) gel. Drug Des Devel Ther. 2011; 5:147 153. 9. 1Go 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. 10. Hancock EC, Osborne JP, Edwards SW. Treatment of infantile spasms. Cochrane Database Syst Rev. 2013. 11. 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. 12. Dean C, Mosier M, Penry K. Dose-response study of vigabatrin as add-on therapy in patients with uncontrolled complex partial s eizures. Epilepsia. 1999;40(1):74-82. Effective date: 12/13/2018 Revised date: 10/08/2018
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