Request for Prior Authorization Growth Hormone (Norditropin

Transcription

1 Request for Prior Authorization Growth Hormone (Norditropin, Nutropin/AQ ) Website Form Submit request via: Fax All requests for Growth Hormone require a prior authorization and will be screened for medical necessity and appropriateness using the criteria listed below. Approval of a non-preferred agent requires a documented failure, intolerance or contraindication to the preferred agents. Growth Hormone Prior Authorization Criteria: Coverage may be provided when all of the following criteria is met AND all of the diagnosis specific criteria is met. The indication for the product requested must correspond to an appropriate FDA-approved indication found in the product s labeling. The following criteria applies for all indications: The medication is prescribed by a specialist such as an endocrinologist or neonatologist; AND There are no contraindications to receiving recombinant growth hormone; AND Up to date chart documentation that includes an assessment is provided with each authorization request; AND The requested dose and frequency is within FDA-approved dosing recommendations The following indication-specific criteria must also be satisfied for coverage to be provided: Coverage is provided for pediatric growth hormone deficiency when the following criteria is met: Member s height must be below the third percentile for their age and gender related height > 2 standard deviations below the mid-parental height percentile for gender and age; AND Diagnosis confirmed by 2 provocative stimulation tests producing peak growth hormone concentrations <10 ng/ml; Member has a significant structural abnormality affecting the pituitary and 1 provocative stimulation test producing peak growth hormone concentrations < 10ng/ml; o Note: Only one stimulation test is needed in the presence of a pituitary abnormality Member has panhypopituitarism (defined as at least 3 pituitary hormone deficiencies); o Note: No stimulation tests are needed in the setting of panhypopituitarism Insulin growth factor-1 (IGF-1) a.k.a. somatomedin C, or IGF binding protein-3 (IGFBP-3) levels below normal range; Radiographic documentation that bone age is > 2 standard deviations below the mean for chronological age; Member produces two normal stimulation tests but has a height > 2.25 standard deviations below the age related mean and a growth velocity below the 25 th percentile for bone age; o Note: When growth deficiency is significant (meeting the definition stated) results of stimulation tests may not be as clinically significant. AND Epiphyses confirmed as open in female patients > 12 years of age and in male patients > 14 years of age and in patients in Tanner stage 3 or higher through X-ray of the wrist; AND The member s growth failure is not due to idiopathic short stature, familial short stature or constitutional growth delay.

2 Coverage is provided for pediatric growth failure, (defined as a height > 2 standard deviations below the age and gender related mean), due to chronic renal failure (in situations where the member has not undergone a renal transplant) and when adequate height has not been achieved after management of nutritional and metabolic abnormalities over at least 3 months. Coverage is provided for growth failure in children born small for gestational age (SGA), (defined as a height > 2 standard deviations below the mean for age and gender, and a birth weight < 2500 g at a gestational age > 37 weeks, or weight or length at birth > 2 standard deviations below the mean for gestational age) who fail to manifest catch up growth by age 2. Note: Failure to reach catch up growth is defined as a height > 2 standard deviations below the age/gender related mean. Coverage is provided for a diagnosis of pediatric growth failure, (defined as a height > 2 standard deviations below the age and gender related mean) due to Turner s syndrome when the following criteria is met: Member is female; AND Diagnosis was confirmed by karyotyping; AND Epiphyses are open Coverage is provided for a diagnosis of pediatric growth failure (defined as a height 2 standard deviations below the age and gender related mean) due to Noonan s syndrome when the following criteria is met: Member has clinical features consistent with the typical presentation of this condition diagnosis has been confirmed by genetic testing; AND Epiphyses are open Coverage is provided for a diagnosis of Prader-Willi syndrome when the following criteria is met: A sleep study is required at initial request to rule out sleep apnea; active, untreated sleep apnea is a contraindication to growth hormone therapy; AND If sleep apnea is found, must be treated prior to initiation of growth hormone; active, untreated sleep apnea is a contraindication to growth hormone therapy; AND The member s weight must be documented and is not considered severely obese (a BMI over the 95 th percentile with complications of obesity); severe complicated obesity is a contraindication to growth hormone therapy. Coverage is provided for adult growth hormone deficiency, defined as recipients age 18 and older or any age with closed epiphyses and who have a growth hormone stimulation test with peak growth hormone concentrations < 5ng/ml as a result of: Childhood onset growth hormone deficiency Pituitary or hypothalamic disease Surgery or radiation therapy Trauma - A GH stimulation test is not needed when the patient has panhypopituitarism (> 3 pituitary hormone deficiencies) or a structural abnormality affecting the pituitary and an IGF-1 level below the reference range as indicated on the assay. - An adult transitioning from pediatric growth hormone deficiency must have been off growth hormone for at least one month. Coverage Duration and Reauthorization Criteria Pediatric human growth hormone deficiency, growth failure in children SGA, Turner s Syndrome, Noonan s Syndrome, Chronic renal failure o Benefit approved for up to 12 months and is renewable in members with open epiphyses, a growth velocity of 2 cm/yr, attestation of ongoing monitoring of IGF-1 level, and the member has not reached their expected final adult height.

3 Prader-Willi Syndrome o Benefit approved for up to 12 months and is renewable in the presence of an improvement in linear growth or body composition (e.g., increase in lean body mass, lean/fat ratio, body weight, etc.). Adult growth hormone deficiency syndrome o Benefit approved for up to 6 months and is renewable in the presence of clinical benefit (e.g., increase in total lean body mass, increase in IGF-1, or increase in exercise capacity) and attestation of ongoing monitoring of IGF-1 level. Coverage may be provided for any non-fda labeled indication if it is determined that the use is a medically accepted indication supported by nationally recognized pharmacy compendia or peer-reviewed medical literature for treatment of the diagnosis(es) for which it is prescribed. These requests will be reviewed on a case by case basis to determine medical necessity. References: 1) Norditropin [package insert]. Plainsboro, NJ: Novo Nordisk; April ) Wilson TA, et al. Update of Guidelines for the Use of Growth Hormone in Children: The Lawson Wilkens Pediatric Endocrinology Society Drug and Therapeutics Committee; J Peds. October 2003: ) Hardin DS. Treatment of Short Stature and Growth Hormone Deficiency in Children with Somatotropin (rdna origin). Biologics: Targets & Therapy. 2008:2(4); ) American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for Growth Hormone Use in Growth Hormone-Deficient Adults and Transition Patients 2009 Update. Endocr Practice. 2009;15 (suppl 2) 5) American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for Growth Hormone Use in Adults and Children 2003 Update. Endocr Practice. 2003;9(1) 6) Molitch ME, et al. Evaluation and Treatment of Adult Growth Hormone Deficiency: an Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab Jun;96(6): ) Mahesh S, Kaskel F. Growth Hormone Axis in Chronic Kidney Disease. Pediatr Nephrol. January 2008; 23(1): ) KDIGO Clinical Practice Guideline for the Diagnosis, Evaluation, Prevention and Treatment of Chronic Kidney Disease Mineral and Bone Disorder (CKD-MBD). Kidney International. August 2009; 76 (113) 9) Bondy CA. Care of girls and women with Turner Syndrome: A Guideline of the Turner Syndrome Study Group. J Clin Endocrinol Metab. 2007;92(1): ) Snyder PJ. Growth hormone deficiency in adults. UpTo. Updated June Accessed July ) Scheimann AO. Clinical features, diagnosis, and treatment of Prader-Willi Syndrome. Updated July Accessed September 2017.

4 Growth Hormone Pediatric Growth Hormone Deficiency and Growth Failure Secondary to Chronic Renal Failure/Insufficiency in Children who have not received a Renal Transplant Medication Initiated: Pediatric Growth Hormone Deficiency Growth Failure Secondary to Chronic Renal Failure/Insufficiency in children who have not received a renal transplant Other: Was a wrist film evaluation completed to determine if epiphyses are confirmed as open? Yes No Was an X-ray of left wrist or hand completed to determine skeletal maturation? Yes No Please provide the standard deviations from the mean for age and gender: Please provide the following and attach growth chart: Current Height: : Previous Height: : Height Percentile on growth chart: Standard Deviation Score: Growth Velocity and associated standard deviations from the mean: Member s Growth over the last year: centimeters Provide results of two stimulation tests Two Stimulation Test Results: 1. Result: Agent Used: : 2. Result: Agent Used: : Does the member have panhypopituitarism or a structural abnormality affecting the pituitary? Yes No Provide results of IGF-1 and/or IGFBP-3 and list the reference range: IGF-1: Normal range: : IGFBP-3: Normal range: : Please provide the member s growth in centimeters over the last year: cm Include most recent growth chart, labs, and progress notes Has the member entered puberty? Yes No Has the member reached their expected final adult height? Yes No

5 Growth Hormone Growth Failure in Children Small for Gestational Age (SGA) Medication Initiated: Growth Failure in Children Small for Gestational Age (SGA) Other, please specify: Current Height: : Previous Height: : At birth, did the member have: Weight < 2500 gm at gestational age > 37 weeks Weight or length at birth > 2 standard deviations below the mean for gestational age Did the member achieve catch up growth in length by age 2? Yes No If Yes, has the catch up growth stopped? Yes No SUPPTING INFMATION AND CLINICAL RATIONALE Please provide the member s growth in centimeters over the last year: cm Include most recent growth chart, labs, and progress notes Has the member entered puberty? Yes No Has the member reached their expected final adult height? Yes No

6 Growth Hormone Turner Syndrome Medication Initiated: Turner Syndrome Other, please specify: Was Turner s Syndrome confirmed by karyotyping? Yes No Current Height: Taken: Previous Height: Taken: Does the member s height remain at least 2 standard deviations below the mean for age and gender? Yes No Standard Deviation Score: Was a wrist film evaluation completed to determine if epiphyses are confirmed as open? Yes No Epiphyses: Open Closed SUPPTING INFMATION or CLINICAL RATIONALE Please provide the member s growth in centimeters over the last year: cm Include most recent growth chart, labs, and progress notes Has the member entered puberty? Yes No Has the member reached their expected final adult height? Yes No

7 Growth Hormone Prader-Willi Syndrome Medication Initiated: Prader-Willi Syndrome Other: Was a sleep study conducted? Yes No Do the sleep study results show an obstructive sleep apnea diagnosis? Yes No If yes, has the member been fully evaluated and treated for sleep apnea? Yes No Current Height: : Previous Height: : Member Weight: BMI: SUPPTING INFMATION or CLINICAL RATIONALE Does the member have active, untreated sleep apnea? Yes No Has treatment with growth hormone resulted in clinical benefit? Yes No Please describe:

8 Growth Hormone Adult Growth Hormone Deficiency Medication Initiated: Adult Growth Hormone Deficiency Transition of treatment with growth hormone from a child to an adult Other: Is the adult growth hormone deficiency a result of any of the following? Please indicate. Pituitary or hypothalamic disease Trauma Surgery Radiation therapy Childhood onset growth hormone deficiency Provide results of a growth hormone stimulation test: Stimulation Test Result: Agent Used: Taken: Does the member have panhypopituitarism or a structural abnormality affecting the pituitary? Yes No If yes, provide an IGF-1 level and list the reference range: IGF-1: Normal range: : If the member is transitioning with treatment from a child to an adult, has the member had a washout period of one month of growth hormone? Yes No SUPPTING INFMATION or CLINICAL RATIONALE Has treatment with growth hormone resulted in clinical benefit (e.g., increase in total lean body mass, exercise capacity, IGF-1)? Yes No Please describe:

9 Growth Hormone Noonan s Syndrome Medication Initiated: Noonan s Syndrome Other, please specify: Does the member have either of the following? Clinical features consistent with typical presentation of this condition Diagnosis confirmed by genetic testing Current Height: : Previous Height: : Does the member s height remain at least 2 standard deviations below the mean for age and gender? Yes No Standard Deviation Score: Was a wrist film evaluation completed to determine if epiphyses are confirmed as open? Yes No Epiphyses: Open Closed SUPPTING INFMATION or CLINICAL RATIONALE Please provide the member s growth in centimeters over the last year: cm Include most recent growth chart, labs, and progress notes Has the member entered puberty? Yes No Has the member reached their expected final adult height? Yes No