General Approval Criteria for ALL Growth Hormone agents: (ALL criteria must be met)

Transcription

1 Growth Hormone Agents Prior Authorization Criteria for Louisiana Fee for Service and MCO Medicaid Recipients Page 1 of 7 Preferred Agents Somatropin Pen (Norditropin ) Somatropin Pen (Nutropin AQ ) Non-Preferred agents Somatropin Cartridge; Syringe (Genotropin ) Somatropin Cartridge; Vial (Humatrope ) Somatropin Cartridge; Vial (Omnitrope ) Somatropin Vial (Serostim ) Somatropin Cartridge; Vial (Saizen ) Somatropin Vial (Zomacton TM ) Somatropin Vial (Zorbtive ) The Growth Hormone Prior Authorization Request Form should be utilized to request prior authorization. ADULTS AND CHILDREN Medications Required ICD-10 Codes Diagnosis Description E23.0 Hypopituitarism E23.1, E89.3 Drug-induced Hypopituitarism, Post Procedural Hypopituitarism Genotropin,Humatrope, Norditropin, Nutropin AQ, Omnitrope, Saizen, Zomacton TM N25.0 Q96* Turner Syndrome Q87.1 P05.1* R62.52 ADULTS ONLY Growth failure in children associated with renal insufficiency or chronic kidney disease Prader-Willi Syndrome Noonan Syndrome Small for gestational age at birth (fetal growth retardation) who fail to manifest catch-up growth or with no catch-up growth Short stature in children associated with SHOX gene mutation/deficiency Serostim R64 HIV-associated cachexia or wasting Zorbtive K90.2, K91.2 Blind Loop Syndrome, Post-Surgical Malabsorption NEC (Alternative name: Short Bowel Syndrome) *Any number or letter or combination of up to four numbers and letters of an assigned ICD-10-CM diagnosis code General Approval Criteria for ALL Growth Hormone agents: (ALL criteria must be met) INITIAL APPROVAL: Diagnosis: Must have a diagnosis of a covered condition, along with supporting documentation. Prescriber: Growth hormone agent must be prescribed by or in consultation with the required specialist for the diagnosis indicated. If prescribed in consultation with a required specialist, the consultation must be submitted. Criteria: All requests must meet criteria in order to be considered for approval with the sole exception of established therapy. Established therapy with evidence of a positive response as defined in the criteria is justification for approval. Requests for non-preferred agents require clinical justification as to why a preferred agent cannot be used. Justification may include but is not limited to any of the following: o Recipient must have had a treatment failure with an adequate trial (3 months) of at least one preferred product ; o Recipient must have had an intolerable side effect to at least one preferred product; o Recipient must have a documented contraindication to all of the preferred products which are appropriate for the condition being treated; o There is no preferred product appropriate to use for the condition being treated. Quantity Limits apply to all Somatropin products. See Table 1.

2 Table 1. Quantity limits for preferred and non-preferred Somatropin products. Page 2 of 7 Medication Genotropin 12 mg Genotropin 5 mg Genotropin Miniquick Humatrope 12 mg Humatrope 24 mg Humatrope 5 mg Humatrope 6 mg Norditropin Flex Pro 10 mg Norditropin Flex Pro 15 mg Norditropin Flex Pro 5 mg Norditropin NordiFlex & Flex Pro 30 mg Nutropin 10 mg Nutropin AQ 10 mg/2 ml Nutropin AQ 20 mg/2 ml Nutropin AQ NuSpin 10 mg/2 ml Nutropin AQ NuSpin 20 mg/2 ml Nutropin AQ NuSpin 5 mg/2 ml Omnitrope 10 mg/1.5ml cartridge Omnitrope 5 mg/1.5 ml cartridge Omnitrope- 5.8 mg Saizen 5 mg Saizen 8.8 mg Serostim 4, 5 & 6 mg/vial Zomacton 10 mg Zomacton 5 mg Zorbtive 8.8 mg/vial Quantity Limit Per Month 8 cartridges 18 cartridges 28 cartridges 8 cartridges 4 cartridges 18 vials 15 cartridges 9 pens 6 pens 18 pens 3 pens 11 vials 9 cartridges 5 cartridges 9 pens 5 pens 18 pens 9 cartridges 18 cartridges 16 vials 18 vials 11 vials/cartridges 28 vials 9 vials 18 vials 28 vials Approval criteria for override of quantity limits: The Growth Hormone Prior Authorization Request Form must be completed in full and submitted to the appropriate plan; AND ONE of the following is required (1, 2, or 3): 1. The recipient has been treated in the past or is currently receiving treatment with the same dosage and quantity of the requested medication; 2. The recipient had an inadequate response to the same medication at a lower dosage/quantity available under the plan, AND ALL of the following (i, ii, and iii): i. Medication non-adherence was ruled out as a reason for the inadequate response; AND ii. The recipient tolerated the medication at the lower dosage; AND iii. The requested dose is considered medically necessary; 3. The recipient has not previously used this medication; however, the prescriber is submitting evidence supporting quantity limit exception with this request (for example, a peer-reviewed journal article demonstrating the safety and efficacy of the requested dose for the indication); AND ALL of the following (i and ii): i. The requested quantity and dosing is supported in the accepted medical compendia; AND ii. The requested dose is considered medically necessary.

3 GROWTH HMONE INITIAL APPROVAL CRITERIA F CHILDREN Diagnosis Description ICD-10: E23.0 Growth Hormone Deficiency (Alternative names: Hypopituitarism, Panhypopituitarism, Pituitary Dwarfism) ICD-10: E23.1, E89.3 Iatrogenic Growth Hormone Deficiency (Alternative names: Iatrogenic Hypopituitarism, Drug- Induced Hypopituarism, Post Procedural Hypopituarism) ICD-10: P05.1* Small For Gestational Age At Birth (fetal growth retardation) who fail to manifest catch-up growth or with no catch-up growth ICD-10: N25.0 Growth Failure In Children Associated With Renal Insufficiency Or Chronic Kidney Disease (up to the time of renal transplantation) Page 3 of 7 Criteria (Documentation required) ONE OF THE FOLLOWING (1, 2, 3, 4, 5, or 6): 1. Infant: Infant is < 4months old and has growth deficiency; 2. Neonatal hypoglycemia: History of neonatal hypoglycemia associated with pituitary disease; 3. Diagnosis: Diagnosis of Panhypopituitarism; 4. History: History of surgery or irradiation in the hypothalamic-pituitary region; 5. CNS Pathology: Defined central nervous system pathology documented by MRI or CT; 6. Confirmation of diagnosis WITH laboratory results (both are required): Diagnosis of Pediatric Growth Hormone Deficiency confirmed by ONE of the following: i. Growth velocity: 2 standard deviations (SD) below the mean for age and gender; ii. Current height: 2 standard deviations (SD) below population mean utilizing age and gender growth carts related to height; iii. Projected height: 1.5 standard deviations (SD) below the midparental height; iv. Skeletal maturity: Delayed bone age as documented on x-ray: Bone age should be assessed through radiological examination of the left hand and wrist. Comparison of bone age to chronological age should be documented as abnormal by greater than or equal to two standard deviations (SD) below the mean for chronological age, which is generally greater than or equal to 2 years delayed growth; AND Laboratory results (ONE of the following is required): i. GH Stimulation tests: Patient has undergone 2 provocative GH stimulatory tests with GH response values of <10mcg/L (laboratory documentation required); ii. IGF-1/IGFBP-3: Patient is under one year of age and ONE of the following is below the age and gender adjusted normal range as provided by the physician s lab: a. IGF-1; b. IGFBP-3. AND NOTE: Other pituitary hormone deficiencies (e.g., hypothyroidism, chronic ischemic disease) must have previously been ruled out. Age: Greater than 2 years of age; AND Growth velocity: Failure to manifest catch-up growth, defined as 2 standard deviations (SD) below the mean for age and gender for height; AND Birth weight length: 2 standard deviations (SD) below the mean for gestational age; AND ONE OF THE FOLLOWING (1 or 2): 1. Growth velocity: 2 standard deviations (SD) below the mean for age and gender ; 2. Skeletal maturity: Delayed bone age as documented on x-ray: Bone age should be assessed through radiological examination of the left hand and wrist. Comparison of bone age to chronological age should be documented as abnormal by greater than or equal to two standard deviations (SD) below the mean for chronological age, which is generally greater than or equal to 2 years delayed growth. AND Diagnosis: Chart documentation supporting diagnosis must be submitted; AND Renal function: Documentation of chronic renal insufficiency AND patient has no functioning renal allograft; AND Epiphyses: Confirmation of open growth plates in patients >12 years of age; AND NOTE: Prior to initiation of GH treatment, existing metabolic derangements such as malnutrition, zinc deficiency, and secondary hyperparathyroidism should be corrected.

4 Page 4 of 7 ICD-10: Q96* Turner Syndrome Age/Gender: Females > 2 years old; AND Growth velocity: 2 standard deviations (SD) below the mean for age; AND Bone age: < 14.5 years; AND ICD-10: Q87.1 Prader-Willi Syndrome Growth velocity: 2 standard deviations (SD) below the mean for age and gender; AND ICD-10: Q87.1 ONE OF THE FOLLOWING (1 or 2): Noonan Syndrome 1. Growth velocity: 2 standard deviations (SD) below the mean for age and gender; 2. Skeletal maturity: Delayed bone age as documented on x-ray: Bone age should be assessed through radiological examination of the left hand and wrist. Comparison of bone age to chronological age should be documented as abnormal by greater than or equal to two standard deviations (SD) below the mean for chronological age, which is generally greater than or equal to 2 years delayed growth. AND ICD-10: R62.52 ONE OF THE FOLLOWING (1 or2): Short Stature Associated 1. Growth velocity: 2 standard deviations (SD) below the mean for age and gender; With SHOX Gene 2. Skeletal maturity: Delayed bone age as documented on x-ray: Bone age should be assessed Mutation/Deficiency through radiological examination of the left hand and wrist. Comparison of bone age to chronological age should be documented as abnormal by greater than or equal to two standard deviations (SD) below the mean for chronological age, which is generally greater than or equal to 2 years delayed growth. AND *Any number or letter or combination of up to four numbers and letters of an assigned ICD-10-CM diagnosis code Documentation required for consideration of initial approval of growth hormone therapy in children: GROWTH HMONE RE-AUTHIZATION CRITERIA F CHILDREN (Documentation required) Clinical records supporting a covered diagnosis; AND Growth hormone agent is prescribed by or in consultation with an endocrinologist or nephrologist; AND Evidence of a positive response to therapy as demonstrated by ALL of the following (1 and 2): 1. Height increase of at least 2cm/year over the previous year documented by both of the following (i and ii): i. Previous height and date obtained; AND ii. Current height and date obtained; AND 2. Expected adult height not yet attained with documentation of expected adult height goal. NOTE: For children with Prader-Willi Syndrome, evidence of a positive response to therapy may also be submitted as proof of an increase of total lean body mass, decrease in fat mass. AND Bone age is less than 16.5 years in males; 14.5 years in females (indicated in x-ray of fingers, hands, or wrists); AND Growth (epiphyseal) plates must be open (evidenced by x-ray) linear growth can no longer occur in patients with epiphyseal closure. Documentation required for consideration of re-authorization of growth hormone therapy in children:

5 Page 5 of 7 GROWTH HMONE DISCONTINUATION CRITERIA F CHILDREN ONE OF THE FOLLOWING (1, 2, 3, 4, or 5): 1. Expected final adult height has been reached; 2. There is a poor response to treatment (generally defined as an increase in growth velocity of less than 50 % from baseline in the 1st year of therapy); 3. Increase in height velocity of < cm total growth in 1 year of therapy; 4. Epiphyseal fusion has occurred; 5. There are persistent and uncorrectable problems with adherence to treatment. GROWTH HMONE INITIAL APPROVAL CRITERIA F TRANSITION PHASE* ADOLESCENT** PATIENTS WITH CHILDHOOD ONSET GHD (COGHD) (Documentation required) *Transition phase has been defined as the period of life starting in late puberty and ending with full adult maturation (as in, from mid to late teenage years until 6-7 years after achievement of final height). ** Adolescent is any person between ages 10 and 19, as defined by The World Health Organization (WHO). BOTH OF THE FOLLOWING: Diagnosis: Must have diagnosis of COGHD with clinical records supporting diagnosis; AND Prescriber: ALL REQUESTS for growth hormone agents for the treatment of COGHD must be prescribed by or in consultation with an endocrinologist or nephrologist (consultation required, if applicable). AND ONE OF THE FOLLOWING (1or 2): 1. Patient has completed linear growth (as defined by growth velocity of <1.5-2cm per year); 2. Evidence of closed epiphyses on bone radiograph. AND ONE OF THE FOLLOWING (1 or 2): 1. GH treatment has been stopped for at least one month and the diagnosis of GHD has been reconfirmed by ONE of the following (i or ii): i. Two GH stimulation tests with GH response values of <10mcg/L; ii. One low IGF-1/IGFBP-3 AND one GH stimulation test with GH response values of <10mcg/L; 2. Documented presence of any of the following conditions (i, ii, or iii): i. Hypothalamic-pituitary structural defect or tumor; ii. Evidence of 3 pituitary hormone deficiencies; iii. Documented genetic cause of GH. Documentation required for consideration of re-authorization of growth hormone therapy in children: GROWTH HMONE RE-AUTHIZATION CRITERIA F TRANSITION PHASE* ADOLESCENT** PATIENTS WITH CHILDHOOD ONSET GHD (COGHD) Diagnosis: Must have diagnosis of COGHD with clinical records supporting diagnosis; AND Prescriber: ALL REQUESTS for growth hormone agents for the treatment of COGHD must be prescribed by or in consultation with an endocrinologist or nephrologist (consultation required, if applicable); AND Evidence of positive response to therapy (such as increase in total lean body mass, exercise capacity or IGF-1 and IGFBP-3 levels). Documentation required for consideration of re-authorization of growth hormone therapy for transition phase adolescent * members with childhood onset GHD (COGHD): Positive response to therapy indicated by ONE OF THE FOLLOWING (1, 2, or 3): 1. Documentation of increase in total lean body mass consisting of both the previous measurement of lean body mass (from 12 months ago) and date obtained, and the current measurement and date obtained; 2. Chart documentation of increased exercise capacity; 3. Documentation of increase in IGF-1 AND IGFBP-3 levels consisting of both the previous measurements (from 12 months ago) and date obtained, and the current measurements and date obtained.

6 GROWTH HMONE INITIAL APPROVAL CRITERIA F ADULTS Page 6 of 7 Diagnosis Description ICD-10: E23.0 Growth Hormone Deficiency (Alternative names: Hypopituitarism, Panhypopituitarism, Pituitary Dwarfism) ICD-10: E23.1, E89.3 **Iatrogenic Growth Hormone Deficiency (Alternative names: Iatrogenic Hypopituitarism, Drug- Induced Hypopituarism, Post Procedural Hypopituarism) ICD-10: K90.2, K91.2 Blind Loop Syndrome NEC, Post-Surgical Malabsorption NEC (Alternative name: Short Bowel Syndrome) ICD-10: R64 HIV-Associated Cachexia Or Wasting Criteria (Documentation required) Diagnosis of GHD as a result of ONE of the following (1 or 2): 1. Child-onset GHD with clinical records supporting diagnosis; 2. Adult-onset GHD with clinical records documenting that hormone deficiency is a result of hypothalamic-pituitary disease from organic or known causes (such as pituitary tumor, damage from surgery, cranial irradiation, head trauma, or subarachnoid hemorrhage); AND Confirmation of GH deficiency: Member has undergone ONE of the following GH stimulation tests to confirm adult GH deficiency (1, 2, 3, or 4): 1. Insulin Tolerance Test (ITT) with peak GH value of 5μ/L; 2. Arginine & GHRH (GHRH+ARG) with peak GH value of ( 11μ/L if BMI < 25 kg/m²; 8μ/L if BMI 25 and 30kg/m²; 4μ/L if BMI 30kg.m²); 3. Glucagon with peak GH value of 3μ/L; 4. Arginine (ARG) with peak GH value of 0.4μ/L; AND endocrinologist. Diagnosis: Chart documentation supporting diagnosis must be submitted; AND Age: 18 yrs; AND Nutritional support: Patient is currently receiving specialized nutritional support, such as a high carbohydrate, low fat diet, enteral feedings, parenteral nutrition, fluid, and micronutrient supplements; AND Prescriber: Growth hormone agent must be prescribed by or in consultation with a gastroenterologist; AND Duration of therapy: Because administration for more than four weeks has not been adequately studied, authorization will only be granted for 4 weeks. ONE OF THE FOLLOWING (1, 2, 3, or 4): 1. Patient has unintentionally lost more than 10% of his/her baseline body weight; 2. Patient weighs less than 90% of the lower limit of ideal body weight; 3. Patient has a body mass index (BMI) less than 20kg/m 2 ; 4. Patient has lost more than 5% body weight in the past 6 months. AND ONE OF THE FOLLOWING (1 or 2): 1. Patient has chronic diarrhea (defined as 2 or more loose stools daily for at least 30 days); 2. Patient has intermittent or constantly occurring chronic weakness and fever for at least 30 days. Diagnosis: Chart documentation confirming diagnosis must be submitted; AND Age: 18 yrs; AND Anti-retroviral therapy: Patient is currently receiving anti-retroviral therapy; AND Appetite stimulant therapy: Patient has tried and failed, or has a contraindication to, either dronabinol (Marinol ) or megestrol acetate (Megace ); AND Prescriber: Growth hormone agent must be prescribed by or in consultation with a physician specializing in diagnosis and management of HIV. NOTE: Causes other than HIV for the member s weight loss must have been previously ruled out. Duration of therapy: 12 weeks Documentation required for consideration of initial approval: (except as noted above)

7 GROWTH HMONE RE-AUTHIZATION CRITERIA F ADULTS WITH GROWTH HMONE DEFICIENCY Diagnosis of GHD (child or adult onset) with clinical records supporting diagnosis; AND endocrinologist; AND Evidence of ongoing monitoring as demonstrated by documentation within the past 12 months of an IGF-1; AND Evidence of positive response to therapy (such as increased total lean body mass, increased exercise capacity or increased IGF-1 and IGFBP-3 levels). Page 7 of 7 Documentation required for consideration of re-authorization criteria for adults with growth hormone deficiency: BOTH OF THE FOLLOWING: Documentation of ongoing monitoring consisting of both the previous measurements (from 12 months ago) of IGF-1 level and date obtained, and the current measurement and date obtained; AND Positive response to therapy indicated by ONE OF THE FOLLOWING (1, 2, or 3): 1. Documentation of increase in total lean body mass consisting of both the previous measurement of lean body mass (from 12 months ago) and date obtained, and the current measurement and date obtained; 2. Chart documentation of increased exercise capacity; 3. Documentation of increase in IGF-1 AND IGFBP-3 levels consisting of both the previous measurements (from 12 months ago) and date obtained, and the current measurements and date obtained. GROWTH HMONE RE-AUTHIZATION CRITERIA F ADULTS WITH HIV-ASSOCIATED CACHEXIA WASTING Diagnosis: Chart documentation confirming diagnosis must be submitted; AND Age: 18 yrs; AND Anti-retroviral therapy: Patient is currently receiving anti-retroviral therapy; AND Prescriber: Growth hormone agent must be prescribed by or in consultation with a physician specializing in diagnosis and management of HIV; AND A positive response to therapy (defined as a 2% or greater increase in body weight); AND One of the following targets or goals has not been achieved (1, 2, or 3) with documentation of expected target or goal: 1. Weight 2. BCM 3. BMI Documentation required for consideration of re-authorization of growth hormone therapy in adults with HIV-associated cachexia or wasting: BOTH OF THE FOLLOWING: Documentation of increase in body weight of at least 2% or greater over the past 12 weeks consisting of both the previous weight (from 12 weeks ago) and date obtained, and the current weight and date obtained; AND Documentation that ONE of the following goals has not been achieved (1, 2, or 3), with documentation of expected goal: 1. Weight 2. BCM 3. BMI Duration of approval: 12 weeks