Product Details

Ngenla

Somatrogon
60 mg/1.2 mL (50 mg/mL)
Solution for Subcutaneous Injection
Single-Use 1.2-mL Pre-Filled Pen (With Preservative)

DIN/PIN/NPN

02521687

Manufacturer

Pfizer Canada Inc.

Formulary Listing Date

2023-05-15  

Unit Price

864.6000

Amount MOH Pays

864.6000

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

H01AC08

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Metabolic/Genetic Modifiers

Somatrogon

  • Brand(s): Ngenla
  • Dosage Form/Strength: 24 mg/1.2mL, 60 mg/1.2 mL (Prefilled Pens)
  • Effective date: May 15, 2023

Initiation Criteria: 

For the treatment of pediatric patients with growth failure due to an inadequate secretion of endogenous growth hormone (i.e., growth hormone deficiency (GHD)) who meet all the following criteria:

  1. Patient is pre-pubertal and aged 3 years or older; AND 

  1. Epiphyseal growth plates have not closed/fused; AND 

  1. Bone age is less than 16 years for a male and 14 years for a female; AND 

  1. Diagnosed with isolated growth hormone deficiency OR growth hormone insufficiency as part of multiple pituitary hormone deficiency; AND 

  1. Patient is under the care of a pediatric endocrinologist.

Notes:

  1. Bone age assessments may be based on the Greulich Pyle Atlas, Tanner-Whitehouse, or other appropriate methods of assessments. A copy of the bone age report and other supporting documentation must be provided. 

  1. Case-by-case consideration will be provided for patients who are on another recombinant growth hormone therapy (i.e., somatropin) and wish to switch to somatrogon if initiation criteria are met, and discontinuation and exclusion criteria are not met. Please include the reason(s) for the switch in treatment. 

  1. Treatment response should be assessed every 3 to 4 months in younger children, every 6 months in elementary school-aged children, and every 4 to 6 months in pubertal aged children. 

  1. An inadequate response after the initiation of somatrogon in patients with GHD is often defined by one or more of the following criteria: a change in height velocity of less than 2 cm per year, a height velocity standard deviation score (SDS) of less than 0, or a change in height SDS of less than 0.3 per year during the first 6 months to 12 months of therapy. 

  1. Patients who are not adherent to therapy should be discontinued.

Discontinuation criteria: 

Somatrogon must be discontinued upon the occurrence of any of the following:

  • The change in height velocity is less than 2 cm per year on treatment and bone age is more than 16 years in males and 14 years in females 

  • Closure of the epiphyseal growth plates

Renewal criteria: 

Renewals will be considered in patients who continue to respond to therapy, and who do not meet any of the discontinuation criteria or the exclusion criteria. 

Exclusion criteria:

  1. Patients with closed/fused epiphyseal growth plates. 

  1. Patients with active malignancy 

  1. Patients who do not have isolated growth hormone deficiency or growth hormone insufficiency as part of multiple pituitary hormone deficiency but have other medical or genetic conditions in which recombinant growth hormone therapies are used (e.g., chronic renal failure, Turner syndrome, idiopathic short stature, Prader-Willi syndrome, or adult-onset growth hormone deficiency). 

Approved dosage:
0.66 mg per kg administered subcutaneously once weekly adjusted based on growth velocity, body weight, and serum insulin-like growth factor 1 (IGF-1) concentrations.

Approval duration for initial and renewal requests: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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