Serostim — Blue Cross Blue Shield of Texas
other FDA labeled indications for growth hormone agents
Preferred products
- Humatrope
- Norditropin FlexPro
- Nutropin AQ NuSpin
Initial criteria
- The patient has a pituitary abnormality and a known deficit of at least one other pituitary hormone OR the patient has another FDA labeled indication for the requested agent and route of administration OR another indication supported in compendia for the requested agent and route of administration
- The patient is a child (open epiphysis)
- If the patient has an FDA labeled indication, then one of: patient age within FDA labeling OR evidence supports requested agent for the patient’s age for the requested indication
- Requested agent is FDA labeled for the requested indication
- Short-acting Growth Hormone step therapy: one of the following— preferred short-acting GH agent(s) not FDA labeled for indication OR patient stable on requested agent ≥ 12 months OR tried/inadequate response OR discontinued due to lack of efficacy/adverse event OR intolerance/contraindication OR expected ineffective/causes barrier/adverse reaction OR not in best interest/medical necessity OR tried another GH class drug and discontinued for efficacy/adverse event
- Long-acting Growth Hormone step therapy: one of the following— requested agent preferred OR preferred long-acting GH agent not FDA labeled OR patient stable on requested agent ≥ 12 months OR tried/inadequate response OR discontinued due to lack of efficacy/adverse event OR intolerance/contraindication OR expected ineffective/causes barrier/adverse reaction OR not in best interest/medical necessity OR tried another GH class drug and discontinued for efficacy/adverse event
- Imaging indicates epiphyses are not closed (female > age 12 or male > age 14)
- Prescriber is a specialist in patient’s diagnosis or has consulted with a specialist
- No FDA labeled contraindications to requested agent
- Requested dose within FDA labeling or supported in compendia
Reauthorization criteria
- Patient previously approved for GH through plan’s prior authorization
- Patient is a child (open epiphysis)
- Requested agent FDA labeled for indication
- Short-acting GH step therapy criteria repeated (as above)
- Long-acting GH step therapy criteria repeated (as above)
- For growth hormone deficiency: imaging confirms epiphyses open and improvement in height or height velocity since last approval OR for other diagnoses: clinical benefit with requested agent
- Patient monitored for adverse effects
- Prescriber is or consulted an appropriate specialist
- No FDA labeled contraindications to requested agent
- Requested dose within FDA labeling or supported in compendia
Approval duration
12 months