J2170 — Injection, mecasermin, 1 mg
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
Documentation Required
- Documentation that secondary causes of low IGF-1 have been evaluated and corrected prior to initiation (e.g., thyroid status, nutritional status, correction of malnutrition or hypothyroidism if present).
- Baseline and periodic funduscopic exam documentation (recommended at initiation and periodically during therapy) to monitor for intracranial hypertension.
- Pretreatment height (height SD score) demonstrating height ≥ 3 SD below mean for age and gender (documented growth charts and SD calculation/reference).
- Pretreatment basal serum IGF-1 level with SD score demonstrating IGF-1 ≥ 3 SD below the mean for age and gender (use laboratory reference ranges; 'The reference range for the laboratory performing the test should be used').
Key Coverage Criteria
- Mecasermin (Increlex) medically necessary for members with severe primary insulin-like growth factor-1 (IGF-1) deficiency when ALL of the following criteria are met: pretreatment height is greater than or equal to 3 standard deviations (SD) below the mean for age and gender; pretreatment basal insulin-like growth factor-1 (IGF-1) level is greater than or equal to 3 SD below the mean for age and gender; pediatric GH deficiency has been ruled out with a provocative GH test (i.e., peak GH level gre [...]
- Mecasermin (Increlex) medically necessary for members with growth hormone (GH) gene deletion with neutralizing antibodies to growth hormone (GH) when the same ALL criteria above are met (height ≤ ~-3 SD, IGF-1 ≤ ~-3 SD, GH deficiency ruled out by provocative test with peak GH ≥10 ng/ml, and open epiphyses).
- Continuation of mecasermin therapy is medically necessary for severe primary IGF-1 deficiency or GH gene deletion with neutralizing antibodies to GH when ALL of the following are met: the member's growth rate is greater than 2 cm per year OR 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); and the epiphyses are open (confirmed by X-ray or X-ray is not available).
- FDA-approved indication: long-term treatment of growth failure in children with severe primary IGF-1 deficiency (primary IGFD) or with GH gene deletion who have developed neutralizing antibodies to GH.
- Dosing guidance indication: growth failure in pediatrics 2 years of age and older with severe primary IGF-1 deficiency or with GH gene deletion who have developed neutralizing antibodies to GH (recommended starting dose 0.04 to 0.08 mg/kg twice daily; may be increased to maximum 0.12 mg/kg twice daily if tolerated).
- ICD-10 codes listed as covered if selection criteria are met: E34.30 - E34.39 (Short stature due to endocrine disorder) and R62.52 (Short stature (child) [severe primary insulin-like growth factor-1 deficiency (IGFD) or growth hormone gene deletion with neutralizing antibodies]).
1 Active Policy
AETNA-CPB-0711 — Mecasermin (Increlex)
Related Codes
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