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Duvyzat (givinostat) — Blue Cross Blue Shield of Alabama

Duchenne muscular dystrophy (DMD)

Initial criteria

  • ONE of the following:
  • • The requested agent is eligible for continuation of therapy AND ONE of the following:
  • – The patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR
  • – The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed
  • OR BOTH of the following:
  • • ONE of the following:
  • – The patient has a diagnosis of Duchenne Muscular Dystrophy confirmed by genetic analysis (i.e., dystrophin deletion or duplication mutation) (genetic test required)
  • AND ONE of the following:
  • – The patient has tried and had an inadequate response after a 6 month duration of therapy with a glucocorticoid used to treat DMD AND the patient will continue to be on a glucocorticoid while taking the requested agent
  • – The patient has an intolerance or hypersensitivity to a glucocorticoid used to treat DMD
  • – The patient has an FDA labeled contraindication to all glucocorticoids used to treat DMD
  • – The patient has another FDA labeled indication for the requested agent and route of administration
  • AND If the patient has an FDA labeled indication, then ONE of the following:
  • – The patient’s age is within FDA labeling for the requested indication for the requested agent
  • – There is support for the use of the requested agent for the patient’s age for the requested indication
  • AND If the patient is initiating therapy, then ALL of the following:
  • – The patient’s baseline platelet level has been obtained and is ≥ 150 x 10^9/L
  • – The patient’s baseline triglyceride levels have been evaluated
  • – If the patient has underlying cardiac disease or is taking concomitant medications that cause QT prolongation, ECGs have been obtained
  • – The patient's platelet levels will continue to be monitored during treatment
  • – The patient's triglyceride levels will continue to be monitored during treatment
  • – If the patient has underlying cardiac disease or is taking concomitant medications that cause QT prolongation, ECGs will continue to be monitored as clinically indicated
  • – The prescriber is a specialist in the area of the patient’s diagnosis (e.g., pediatric neurologist) or the prescriber has consulted with such a specialist
  • – The patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

  • • The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
  • • The patient has had improvements or stabilization with the requested agent (e.g., slowed disease progression, improved strength, timed motor function, pulmonary function; reduced need for scoliosis surgery)
  • • The patient’s platelet level will continue to be monitored during treatment
  • • The patient’s triglyceride levels will continue to be monitored during treatment
  • • If the patient has underlying cardiac disease or is taking concomitant medications that cause QT prolongation, ECGs will continue to be monitored as clinically indicated
  • • The prescriber is a specialist in the area of the patient’s diagnosis (e.g., pediatric neurologist) or has consulted with such a specialist
  • • The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months