Somavert (pegvisomant) — Blue Cross Blue Shield of Texas
other FDA labeled indications for the requested agent and route of administration
Preferred products
- lanreotide deep subcutaneous injection (Somatuline Depot generic equivalent)
- octreotide gluteal intramuscular injection
Initial criteria
- 1. ONE of the following:
- A. The requested agent is eligible for continuation of therapy AND the following: the prescriber states the patient has been treated with the requested agent within the past 180 days and is at risk if therapy is changed OR
- B. The patient has a diagnosis of acromegaly AND ALL of the following:
- 1. ONE of the following: (A) The patient had an inadequate response to surgical resection or pituitary radiation therapy as indicated by growth hormone and serum IGF-1 above reference ranges OR (B) The patient is not a candidate for surgical resection OR (C) The requested agent will be used in combination with or following pituitary radiation therapy AND
- 2. ONE of the following:
- A. The patient is currently being treated with the requested agent and is currently stable on it [chart notes required] OR
- B. The patient has tried and had an inadequate response to ONE preferred agent [chart notes required] AND ONE of these: (1) preferred agent at maximally tolerated dose OR (2) preexisting impaired glucose metabolism OR
- C. ONE preferred agent was discontinued due to lack of efficacy, diminished effect, or adverse event [chart notes required] OR
- D. The patient has intolerance or hypersensitivity to ONE preferred agent [chart notes required] OR
- E. The patient has an FDA labeled contraindication to ALL preferred agents [chart notes required] OR
- F. ONE preferred agent is expected to be ineffective or cause major issues (ineffectiveness, barriers to adherence, worsen comorbidity, decrease function, cause adverse reaction or harm) [chart notes required] OR
- G. ONE preferred agent not in patient's best interest by medical necessity [chart notes required] OR
- H. The patient has tried another prescription drug in the same class as ONE preferred agent and discontinued due to lack of efficacy or adverse event [chart notes required] OR
- I. The patient is currently using ONE preferred agent and the requested agent will be used as add-on therapy OR
- J. There is information supporting use of the requested agent over ALL preferred agents AND
- 3. The patient will NOT be using the requested agent in combination with Signifor LAR (pasireotide) OR
- C. The patient has another FDA labeled indication for the requested agent and route of administration OR
- D. The patient has another compendia-supported indication for the requested agent and route of administration AND
- 2. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist, oncologist) or has consulted with a specialist AND
- 3. The patient does NOT have any FDA labeled contraindications to the requested agent.