Subject: Sogroya 4210-A SGM P2024

Drug

SOGROYA  (somapacitan-beco)

Policy:

      I.  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 Indications
          A.  Sogroya is indicated for the replacement of endogenous growth hormone (GH) in adults
               with growth hormone deficiency (GHD).
          B.  Sogroya is indicated for the treatment of pediatric patients aged 2.5 years and older who
               have growth failure due to inadequate secretion of endogenous growth hormone (GH).

          All other indications are considered experimental/investigational and not medically necessary.


    II.  DOCUMENTATION

          Submission of the following information is necessary to initiate the prior authorization review for
          both initial and continuation or therapy requests (where applicable):
          A.  Medical records supporting the diagnosis of neonatal GH deficiency
          B.  Pretreatment growth hormone provocative test result(s) (laboratory report or medical record
               documentation)
          C.  Growth chart
          D.  Pretreatment and/or current IGF-1 level (laboratory report or medical record
               documentation)*
          E.  The following information must be provided for all continuation of therapy requests:
               1.  Total duration of treatment (approximate duration is acceptable)
               2.  Date of last dose administered
               3.  Approving health plan/pharmacy benefit manager
               4.  Date of prior authorization/approval
               5.  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.


   III.  CRITERIA FOR INITIAL APPROVAL

          A.  Pediatric Growth Hormone (GH) Deficiency
               Authorization of 12 months may be granted to members with pediatric growth hormone (GH)
               deficiency 2.5 years of age or older when EITHER criteria 1. or 2. below is met:
               1.  Member was diagnosed with GH deficiency as a neonate. Medical records must be
                    available to support the diagnosis of neonatal GH deficiency (e.g., hypoglycemia with
                    random GH level, evidence of multiple pituitary hormone deficiency, chart notes, or
                    magnetic resonance imaging [MRI] results).
               2.  Member meets ALL of the following:
                    i.     Member has EITHER:
                           a.  Two pretreatment pharmacologic provocative GH tests with both results
                                demonstrating a peak GH level < 10 ng/mL, OR
                           b.  A documented pituitary or CNS disorder (refer to Appendix A) and a pretreatment
                                IGF-1 level > 2 standard deviations (SD) below the mean
                    ii.    Member meets one of the following:
                           a.  Pretreatment height is > 2 SD below the mean and 1-year height velocity is > 1
                           SD below the mean, OR
                           b.  Pretreatment 1-year height velocity is > 2 SD below the mean
                    iii.   Epiphyses are open

          B.  Adult Growth Hormone (GH) Deficiency
               Authorization of 12 months may be granted to members with adult growth hormone (GH)
               deficiency when ANY of the following criteria is met:
               1.  Member meets both of the following:
                    i.     Member has had 2 pretreatment pharmacologic provocative GH tests and both
                           results demonstrated deficient GH responses defined as the following:
                           a.  Insulin tolerance test (ITT) with a peak GH level ≤ 5 ng/mL
                           b.  Macrilen with a peak GH level of less than 2.8 ng/mL
                           c.  Glucagon stimulation test with a peak GH level ≤ 3.0 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
                           d.  Glucagon stimulation test with a peak GH level ≤ 1.0 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
                    ii.    Member has a low pretreatment IGF-1 (between 0 to 2 SD below the mean for age
                           and gender)
               2.  Member meets both of the following:
                    i.     Member has had 1 pretreatment pharmacologic provocative GH test that
                           demonstrated deficient GH responses defined as one of the following:
                           a.  Insulin tolerance test (ITT) with a peak GH level ≤ 5 ng/mL
                           b.  Macrilen with a peak GH level of less than 2.8 ng/mL
                           c.  Glucagon stimulation test with a peak GH level ≤ 3.0 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
                           d.  Glucagon stimulation test with a peak GH level ≤ 1.0 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
                         ii.    Member has a pretreatment IGF-1 level that is more than 2 SD below the mean
                                for age and gender
                    3.  Member has organic hypothalamic-pituitary disease (e.g., suprasellar mass with
                         previous surgery and cranial irradiation) with ≥ 3 documented pituitary hormone
                         deficiencies (refer to Appendix B) and a low pretreatment IGF-1 more than 2 standard
                         deviations below the mean for age and gender
                    4.  Member has genetic or structural hypothalamic-pituitary defects (refer to Appendix C)
                    5.  Member has childhood-onset GH deficiency and a congenital abnormality of the CNS,
                         hypothalamus or pituitary (refer to Appendix C)


   IV.  CONTINUATION OF THERAPY

          A.  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:
               1.  Member is currently receiving the requested medication or another growth hormone
                    product (e.g., Norditropin) indicated for pediatric GH deficiency
               2.  Epiphyses are open (confirmed by X-ray or X-ray is not available¹⁴)
               3.  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)

          B.  Adult Growth Hormone (GH) Deficiency
               Authorization of 12 months may be granted for continuation of therapy for adult growth
               hormone (GH) deficiency when ANY of the following criteria is met:
               1.  Member meets ALL of the following:
                    i.     Member is currently receiving the requested medication or another growth hormone
                           product (e.g., Norditropin) indicated for adult GH deficiency
                    ii.    Member has had 2 pretreatment pharmacologic provocative GH tests and both
                           results demonstrated deficient GH responses defined as any of the following:
                           a.  Insulin tolerance test (ITT) or another provocative GH test with a peak GH level ≤
                                5 ng/mL
                           b.  Macrilen with a peak GH level of less than 2.8 ng/ml
                           c.  Glucagon stimulation test with a peak GH level ≤ 3.0 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
                           d.  Glucagon stimulation test with a peak GH level ≤ 1.0 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
                    iii.   Member has a low pretreatment IGF-1 (between 0 to 2 SD below the mean for age
                           and gender)
                    iv.   Current IGF-1 level is not elevated for age and gender
               2.  Member meets ALL of the following:
                    i.     Member is currently receiving the requested medication or another growth hormone
                           product (e.g., Norditropin) indicated for adult GH deficiency
                    ii.    Member has had 1 pretreatment pharmacologic provocative GH test that
                           demonstrated deficient GH responses defined as one of the following:
                           a.  Insulin tolerance test (ITT) or another provocative GH test with a peak GH level ≤
                                5 ng/mL
                           b.  Macrilen with a peak GH level of less than 2.8 ng/mL
                           c.  Glucagon stimulation test with a peak GH level ≤ 3.0 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
                           d.  Glucagon stimulation test with a peak GH level ≤ 1.0 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
                    iii.   Member has a pretreatment IGF-1 level that is more than 2 SD below the mean for
                           age and gender
                    iv.   Current IGF-1 level is not elevated for age and gender
               3.  Member meets ALL of the following:
                    i.     Member is currently receiving the requested medication or another growth hormone
                           product (e.g., Norditropin) indicated for adult GH deficiency
                    ii.    Member has organic hypothalamic-pituitary disease (e.g., suprasellar mass with
                           previous surgery and cranial irradiation) with ≥ 3 documented pituitary hormone
                           deficiencies (refer to Appendix B) and a low pretreatment IGF-1 more than 2
                           standard deviations below the mean for age and gender
                    iii.   Current IGF-1 level is not elevated for age and gender
               4.  Member meets both of the following:
                    i.     Member is currently receiving the requested medication or another growth hormone
                           product (e.g., Norditropin) indicated for adult GH deficiency
                    ii.    Member has genetic or structural hypothalamic-pituitary defects (refer to Appendix
                           C) and current IGF-1 level is not elevated for age and gender
               5.  Member meets both of the following:
                    i.     Member is currently receiving the requested medication or another growth hormone
                           product (e.g., Norditropin) indicated for adult GH deficiency
                    ii.    Member has childhood-onset GH deficiency and a congenital abnormality of the
                           CNS, hypothalamus or pituitary (refer to Appendix C) and current IGF-1 level is not
                           elevated for age and gender


    V.  APPENDICES

          A.  Appendix A: Examples of Hypothalamic/Pituitary/CNS Disorders
               1.  Congenital genetic abnormalities
                    a.  Transcription factor defects (PIT-1, PROP-1, LHX3/4, HESX-1, PITX-2)
                    b.  Growth hormone releasing hormone (GHRH) receptor gene defects
                    c.  GH secretagogue receptor gene defects
                    d.  GH gene defects
               2.  Congenital structural abnormalities
                    a.  Optic nerve hypoplasia/septo-optic dysplasia
                    b.  Agenesis of corpus callosum
                    c.  Empty sella syndrome
                    d.  Ectopic posterior pituitary
                    e.  Pituitary aplasia/hypoplasia
                     f.  Pituitary stalk defect
                    g.  Holoprosencephaly
                    h.  Encephalocele
                     i.  Hydrocephalus
                     j.  Anencephaly or prosencephaly
                    k.  Arachnoid cyst
                     l.  Other mid-line facial defects (e.g., single central incisor, cleft lip/palate)
                   m.  Vascular malformations
               3.  Acquired structural abnormalities (or causes of hypothalamic/pituitary damage)
                    a.  CNS tumors/neoplasms (e.g., craniopharyngioma, glioma/astrocytoma, pituitary
                         adenoma, germinoma)
                    b.  Cysts (Rathke cleft cyst or arachnoid cleft cyst)
                    c.  Surgery
                    d.  Radiation
                    e.  Chemotherapy
                     f.  CNS infections
                    g.  CNS infarction
                    h.  Inflammatory processes (e.g., autoimmune hypophysitis)
                     i.  Infiltrative processes (e.g., sarcoidosis, histiocytosis, hemochromatosis)
                     j.  Head trauma/traumatic brain injury
                    k.  Aneurysmal subarachnoid hemorrhage
                     l.  Perinatal or postnatal trauma
                   m.  Surgery of the pituitary or hypothalamus

          B.  Appendix B: Pituitary Hormones (Other than Growth Hormone)
               1.  Adrenocorticotropic hormone (ACTH)
               2.  Antidiuretic hormone (ADH)
               3.  Follicle stimulating hormone (FSH)
               4.  Luteinizing hormone (LH)
               5.  Thyroid stimulating hormone (TSH)
               6.  Prolactin

          C.  Appendix C: Requirements for GH-Stimulation Testing in Adults
               1.  Testing for adult GHD is not required
                    a.  Three or more pituitary hormone deficiencies and low IGF-1
                    b.  Congenital structural abnormalities
                         i.     Transcription factor defects (PIT-1, PROP-1, LHX3/4, HESX-1, PITX-2)
                         ii.    GHRH receptor-gene defects
                         iii.   GH-gene defects associated with brain structural defects
                         iv.   Single central incisor
                         v.    Cleft lip/palate
                    c.  Acquired causes (i.e., perinatal insults)
               2.  Testing for adult GHD is required
                    a.  Acquired
                         i.      Skull-base lesions
                         ii.     Pituitary adenoma
                         iii.    Craniopharyngioma
                         iv.    Rathke’s cleft cyst
                         v.     Meningioma
                         vi.    Glioma/astrocytoma
                         vii.   Neoplastic sellar and parasellar lesions
                         viii.  Chordoma
                         xi.    Hamartoma
                         x.     Lymphoma
                         xi.    Metastases
                         xii.   Other brain injury
                         xiii.  Traumatic brain injury
                         xiv.  Sports-related head trauma
                         xv.   Blast injury
                         xvi.  Infiltrative/granulomatous disease
                         xvii. Langerhans cell histiocytosis
                         xviii. Autoimmune hypophysitis (primary or secondary)
                         xix.  Sarcoidosis
                         xx.   Tuberculosis
                         xxi.  Amyloidosis
                    b.  Surgery to the sella, suprasellar, and parasellar region
                    c.  Cranial irradiation
                    d.  Central nervous system infections (bacteria, viruses, fungi, parasites)
                    e.  Infarction/hemorrhage (e.g., apoplexy, subarachnoid hemorrhage, ischemic stroke,
                         snake bite)
                     f.  Empty sella
                    g.  Hydrocephalus
                    h.  Idiopathic

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Sogroya [package insert]. Plainsboro, NJ: Novo Nordisk, Inc; April 2023.
2. S. National Library of Medicine. ClinicalTrials.gov. Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin FlexPro (Somatropin) in Adults With Growth Hormone Deficiency (REAL 1). https://clinicaltrials.gov/ct2/show/study/NCT02229851. Accessed January 2, 2023.
3. 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.
4. 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.
5. Cook DM, Yuen KCJ, Biller BMK, Kemp SF, Lee Vance M. 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 Pract. 2009;15(2):1-28.
6. National Institute for Clinical Excellence: Human growth hormone (somatropin) in adults with growth hormone deficiency. August 2003.
7. 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.
8. 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/nicemedia/live/12992/48715/48715.pdf. Accessed January 9, 2023.
9. 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.
10. Franklin SL, Geffner ME. Growth hormone: the expansion of available products and indications. Pediatr Clin North Am. 2011;58:1141-1165.
11. 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.
12. 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.

June 09, 2024