Product Details

Somavert

Pegvisomant
25 mg/Vial
Powder for Solution for Subcutaneous Injection
Single-Dose 25-mg Vial Pack

DIN/PIN/NPN

02448831

Manufacturer

Pfizer Canada Inc.

Formulary Listing Date

2023-04-28  

Unit Price

326.0600

Amount MOH Pays

326.0600

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

H01AX01

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Metabolic/Genetic Modifiers

Pegvisomant

  • Brand(s): Somavert
  • Dosage Form/Strength: 10 mg, 15 mg, 20 mg, 25 mg, 30 mg for SC Injection
 

Initiation Criteria:

For the treatment of patients with proven acromegaly who meet the following criteria:

  1. Active disease as indicated by GH concentration following an oral glucose tolerance test of >1 ug/L; AND 

  1. Failed pituitary surgery or pituitary surgery is not possible1; AND 

  1. After a failed 6-month trial of a somatostatin analogue2
    (Failure is defined as IGF-1 levels more than 25 per cent above upper limits of age-adjusted normal range.) 

  1. Treatment should be supervised by an endocrinologist. 

Note: Maximum daily dose of 30mg of Pegvisomant will be approved.

Approval Duration: 1 year 

Renewal Criteria:

Patient has been able to tolerate the medication (i.e., no significant adverse effects) and there is objective evidence of response to therapy demonstrated by:

  1. Normalization of IGF-1 level; AND

  1. Improvement in the patient’s symptoms and/or co-morbid complications; AND

  1. No progression of pituitary tumour

Note: Maximum daily dose of 30mg of Pegvisomant will be approved. The approval letter will include a note to consider once weekly dosing.

Approval Duration: 1 year 

1Surgery may not be appropriate in some patients due to technical reasons or due to unstable co-morbid conditions. The requesting physician should provide documentation (i.e., surgical consultation notes). Patients with acromegaly due to non-pituitary tumours will also be considered for reimbursement using the above criteria. 

2Patient must have documented intolerance to the maximal dose and/or have failed to achieve normalization of age-adjusted IGF-1 levels from treatment with maximal dose.

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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