Pharmacy Prior Authorization Criteria

Increlex (mecasermin [rDNA origin])

Indications for Prior Authorization

Increlex (mecasermin [rDNA origin]) injection

• For diagnosis of Severe Primary IGF-1 deficiency (Primary IGFD)
  Indicated for the treatment of growth failure in pediatric patients 2 years of age and older with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. Severe Primary IGFD is defined by: height standard deviation score less than or equal to -3.0, basal IGF-1 standard deviation score less than or equal to -3.0, and normal or elevated GH.

  Limitations of use: Increlex is not a substitute to GH for approved GH indications. Increlex is not indicated for use in patients with secondary forms of IGF-1 deficiency, such as GH deficiency, malnutrition, hypothyroidism, or chronic treatment with pharmacological doses of anti-inflammatory corticosteroids.

Criteria

Increlex

NOTE: Documentation of previous height, current height and goal expected adult height will be required for renewal. Increlex is not a substitute for GH for approved GH indications.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• One of the following: [A]
• All of the following:
• Diagnosis of severe primary IGF-1 deficiency [3]
AND
• Height standard deviation score less than or equal to -3.0
AND
• Basal IGF-1 standard deviation score less than or equal to -3.0
AND
• Normal or elevated growth hormone
AND
• Prescribed by or in consultation with a pediatric endocrinologist
OR
• Both of the following:
• Diagnosis of growth hormone (GH) gene deletion in patients who have developed neutralizing antibodies to GH
AND
• Prescribed by or in consultation with a pediatric endocrinologist

Increlex

NOTE: Increlex is not a substitute for GH for approved GH indications.

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Growth increase of at least 2 cm/year over the previous year of treatment as documented by both of the following: [2, B]
• Previous height and date obtained
• Current height and date obtained
AND
• Both of the following:
• Expected adult height is not obtained
• Documentation of expected adult height goal

P & T Revisions

2024-11-06, 2023-11-01, 2022-11-02, 2021-10-01, 2021-09-27, 2021-05-19, 2020-10-23, 2019-10-29

References

1. Increlex Prescribing Information. Ipsen Biopharmaceuticals, Inc. Cambridge, MA. March 2024.
2. Mauras N, Attie KM, Reiter EO, Saenger P, Baptista J. High dose recombinant human growth hormone (GH) treatment of GH-deficient patients in puberty increases near-final height: a randomized, multicenter trial. Genentech, Inc., Cooperative Study Group. J Clin Endocrinol Metab. 2000;85(10):3653-60.
3. Grimberg A, DiVall SA, Polychronakos C, et al. Guidelines for growth hormone and insulin-like growth factor-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. Available at: https://www.karger.com/Article/Pdf/452150. Accessed November 1, 2024.

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End Notes

1. Growth Hormone Deficiency (GHD) and severe Primary IGF-1 Deficiency (IGFD) are two distinct hormone disorders. Patients with severe Primary IGFD are not GH deficient, and therefore, exogenous GH treatment cannot be expected to resolve the patient's growth deficiency. [1]
2. Typically near-adult height is defined as bone age of 16 years or more for males and 14 years or more for females and a growth rate less than 2 cm/year for 1 year. [2]

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Revision History

• 2024-11-06: 2024 Annual Review. No criteria changes. Updated references.
• 2023-11-01: Annual Review, no changes.
• 2022-11-02: 2022 Annual Review
• 2021-10-01: 2021 UM Annual Review.
• 2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-19: Addition of EHB formulary to guideline, no changes to criteria
• 2020-10-23: UM Annual Review.
• 2019-10-29: 2019 Annual Review - SL - 10.29.19

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