Specialty Pharmacy Clinical Policy Bulletins Aetna Non-Medicare Prescription Drug Plan
Subject: Skytrofa SGM 4908-A P2025a
Drug
SKYTROFA(lonapegsomatropin-tcgd)
Policy:
Indications
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
FDA-approved Indications1
Skytrofa is indicated for the treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH).
Skytrofa is indicated for the replacement of endogenous growth hormone (GH) in adults with growth hormone deficiency (GHD).
All other indications are considered experimental/investigational and not medically necessary.
Documentation
Submission of the following information is necessary to initiate the prior authorization review (where applicable):
Both initial and continuation of therapy requests:
Growth chart
Pretreatment or current insulin-like growth factor-1 (IGF-1) level (laboratory report or medical record documentation)
Initial requests:
Support for the diagnosis of neonatal growth hormone (GH) deficiency (medical documentation, laboratory report, or imaging report)
Pretreatment growth hormone provocative test result(s) (laboratory report or medical record documentation)
Continuation of therapy requests:
Total duration of treatment (approximate duration is acceptable)
Date of last dose administered
Approving health plan/pharmacy benefit manager
Date of prior authorization/approval
Prior authorization approval letter
IGF-1 levels vary based on the laboratory performing the analysis. Laboratory-specific values must be provided to determine whether the value is within the normal range.
Coverage Criteria
Pediatric Growth Hormone (GH) Deficiency1-6
Authorization of 12 months may be granted to members 1 year of age and older with pediatric growth hormone (GH) deficiency when EITHER of the following criteria is met:
Member has a documented diagnosis of GH deficiency as a neonate (e.g., hypoglycemia with random GH level, evidence of multiple pituitary hormone deficiency, magnetic resonance imaging [MRI] results).
Member meets ALL of the following criteria:
Member has either of the following:
Two pretreatment pharmacologic provocative GH tests with both results demonstrating a peak GH level < 10 ng/mL
A documented pituitary or central nervous system (CNS) disorder (see Appendix A) and a pretreatment IGF-1 level > 2 standard deviations (SD) below the mean
For members < 2.5 years of age at initiation of treatment, the pretreatment height is > 2 SD below the mean and growth velocity is slow
For members ≥5 years of age at initiation of treatment, member has either of the following:
Pretreatment height is > 2 SD below the mean and 1-year height velocity is > 1 SD below the mean
Pretreatment 1-year height velocity is > 2 SD below the mean
Epiphyses are open
Adult Growth Hormone (GH) Deficiency1,2,7,8
Authorization of 12 months may be granted to members with adult growth hormone (GH) deficiency when ANY of the following criteria is met:
Member meets both of the following criteria:
Member has had 2 pretreatment pharmacologic provocative GH tests and both results demonstrated deficient GH responses defined as any of the following:
Insulin tolerance test (ITT) with a peak GH level ≤ 5 ng/mL
Macrilen with a peak GH level < 2.8 ng/mL
Glucagon stimulation test with a peak GH level ≤0 ng/mL in patients with a body mass index (BMI) ≤ 30 kg/m2 and a high pretest probability of GHD (e.g., acquired structural abnormalities) OR a BMI < 25 kg/m2
Glucagon stimulation test with a peak GH level ≤0 ng/mL in patients with a BMI of ≥ 25 kg/m2 and a low pretest probability of GHD (e.g., acquired structural abnormalities) OR a BMI > 30 kg/m2
Member has a pretreatment IGF-1 level 0 to 2 SD below the mean for age and gender
Member meets both of the following criteria:
Member has had 1 pretreatment pharmacologic provocative GH test that demonstrated deficient GH responses defined as any of the following:
Insulin tolerance test (ITT) with a peak GH level ≤ 5 ng/mL
Macrilen with a peak GH level < 2.8 ng/mL
Glucagon stimulation test with a peak GH level ≤0 ng/mL in patients with a body mass index (BMI) ≤ 30 kg/m2 and a high pretest probability of GHD (e.g., acquired structural abnormalities) OR a BMI < 25 kg/m2
Glucagon stimulation test with a peak GH level ≤0 ng/mL in patients with a BMI of ≥ 25 kg/m2 and a low pretest probability of GHD (e.g., acquired structural abnormalities) OR a BMI > 30 kg/m2
Member has a pretreatment IGF-1 level > 2 SD below the mean for age and gender
Member meets both of the following criteria:
Member has organic hypothalamic-pituitary disease (e.g., suprasellar mass with previous surgery and cranial irradiation) with ≥ 3 documented pituitary hormone deficiencies (see Appendix B)
Member has a pretreatment IGF-1 level > 2 SD below the mean for age and gender
Member has genetic or congenital structural hypothalamic-pituitary defects (see Appendix C)
Member has childhood-onset GH deficiency and a congenital abnormality of the CNS, hypothalamus, or pituitary (see Appendix C)
Continuation of Therapy
Pediatric Growth Hormone (GH) Deficiency
Authorization of 12 months may be granted for continuation of therapy for pediatric growth hormone (GH) deficiency when ALL of the following criteria are met:
Member is currently receiving the requested medication or another growth hormone product (e.g., Norditropin) indicated for pediatric GH deficiency
Epiphyses are open1,2 (confirmed by X-ray or X-ray is not available)
Member’s growth rate is > 2 cm/year unless there is a documented clinical reason for lack of efficacy (e.g., on treatment less than 1 year, nearing final adult height/late stages of puberty)
Adult Growth Hormone (GH) Deficiency
Authorization of 12 months may be granted for continuation of therapy for adult growth hormone (GH) deficiency when both of the following criteria are met:
Member is currently receiving the requested medication or another growth hormone product (e.g., Norditropin) indicated for adult GH deficiency
Member meets ANY of the following criteria:
Current IGF-1 level is not elevated for age and gender
Member has organic hypothalamic-pituitary disease (e.g., suprasellar mass with previous surgery and cranial irradiation) with ≥ 3 documented pituitary hormone deficiencies (see Appendix B)
Member has genetic or congenital structural hypothalamic-pituitary defects (see Appendix C)
Member has childhood-onset GH deficiency and a congenital abnormality of the CNS, hypothalamus, or pituitary (see Appendix C)
Appendix
Appendix A: Examples of Hypothalamic/Pituitary/CNS Disorders9
Gharib H, Cook DM, Saenger PH, et al. American Association of Clinical Endocrinologists Growth Hormone Task Force. Medical guidelines for clinical practice for growth hormone use in adults and children 2003 Update. Endocr Pract. 2003;9(1):64-76.
National Institute for Clinical Excellence: Guidance on the use of human growth hormone (somatropin) for the treatment of growth failure in children. May 2010. http://www.nice.org.uk/guidance/ta188. Accessed January 14, 2025.
Wilson TA, Rose SR, Cohen P, et al. Update of Guidelines for the Use of Growth Hormone in Children: The Lawson Wilkins Pediatric Endocrinology Society Drug and Therapeutics Committee. J Pediatr. 2003;143:415-421.
Franklin SL, Geffner ME. Growth hormone: the expansion of available products and indications. Pediatr Clin North Am. 2011;58:1141-1165.
Grimberg A, DiVall SA, Polychronakos C, et al. Guidelines for growth hormone and insulin-like growth factor-I treatment in children and adolescents: growth hormone deficiency, idiopathic short stature, and primary insulin-like growth factor-I deficiency. Horm Res Paediatr. 2016;86:361-397.
Molitch ME, Clemmons DR, Malozowski S, et al. Evaluation and treatment of adult growth hormone deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011;96:1587-1609.
Yuen KCJ, Biller BMK, Radovick S, et al. American Association of Clinical Endocrinologists and American College of Endocrinology Guidelines for management of growth hormone deficiency in adults and patients transitioning from pediatric to adult care. Endocr Pract. 2019; 25: 1191-1232.
Deal C, Hasselmann C, Pfaffle RW, et al. Associations between pituitary imaging abnormalities and clinical and biochemical phenotypes in children with congenital growth hormone deficiency: data from an international observational study. Horm Res Paediatr. 2013;79:283-292.
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
