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The Policy VaultThe Policy Vault

TasignaBlue Cross Blue Shield of Alabama

Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase

Preferred products

  • imatinib (generic)
  • dasatinib (generic)

Initial criteria

  • ONE of the following: • The patient has been treated with the requested agent within the past 180 days OR • The prescriber states the patient is being treated with the requested agent within the past 180 days AND is at risk if therapy is changed OR • ALL of the following: – ONE of the following: • The patient has an FDA labeled indication for the requested agent and route of administration OR • The patient has an indication that is supported in compendia for the requested agent and route of administration – 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 OR • There is support for using the requested agent for the patient’s age for the requested indication – ONE of the following: • The requested indication does NOT require specific genetic/diagnostic testing per FDA labeling or compendia for the requested agent OR • The requested indication requires specific genetic/diagnostic testing per FDA labeling or compendia for the requested agent AND BOTH of the following: ◦ Specific genetic/diagnostic testing has been completed ◦ The results indicate therapy with the requested agent is appropriate – ONE of the following: • The requested agent will be used as monotherapy AND is supported as such within FDA labeling or compendia OR • The requested agent will be used as combination therapy AND is supported as such within FDA labeling or compendia – ONE of the following: • The requested agent will be used as a first-line agent AND is first-line within FDA labeling or compendia OR • The patient has tried and had an inadequate response to the appropriate prerequisite agents OR • The patient has an intolerance or hypersensitivity to prerequisite agents OR • The patient has an FDA labeled contraindication to all required prerequisite agents – ONE of the following: • The requested agent is a preferred agent for the requested indication OR • The requested agent is a non-preferred agent AND ONE of the following: ◦ The patient has used ONE preferred agent for the requested indication ◦ The patient has intolerance/hypersensitivity to ONE preferred agent ◦ The patient has an FDA labeled contraindication to ALL preferred agents ◦ NCCN does not specify the preferred agent as a preferred regimen but specifies the requested agent ◦ There is support for the non-preferred agent over the preferred agent ◦ If the requested agent is Bosulif or Tasigna, patient has been previously treated with Bosulif OR Tasigna ◦ If Bosulif capsules, requested dose < 500 mg OR patient failed or is intolerant to Bosulif tablets OR has contraindication OR there is support for use over tablets (e.g., swallowing difficulty) – If the requested agent is brand with generic equivalent listed, ONE of the following: • Patient has intolerance/hypersensitivity to generic equivalent not expected with brand • Patient has an FDA labeled contraindication to generic equivalent not expected with brand • There is support for use of brand over generic equivalent – 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 PA process AND • If the requested agent is Vitrakvi, then the patient has had clinical benefit (partial response, complete response, or stable disease) AND • If the requested agent is Bosulif capsules, then ONE of the following: – Requested dose < 500 mg – Patient failed Bosulif tablets – Patient has intolerance/hypersensitivity to Bosulif tablets not expected with capsules – Patient has FDA contraindication to tablets not expected with capsules – There is support for use over tablets (e.g., swallowing difficulties) AND • If the requested agent is Imbruvica 140 mg or 280 mg tablets, then ONE of the following: – Patient failed Imbruvica 140 mg capsules – Patient intolerant/hypersensitive to capsules – Patient has FDA contraindication to capsules – There is support for use over capsules AND • If the requested agent is Imkeldi, then ONE of the following: – Patient failed imatinib tablets – Patient intolerant/hypersensitive to imatinib tablets – Patient has FDA contraindication to imatinib tablets not expected with requested agent – There is support for use over imatinib tablets

Approval duration

3 months (titration/Vitrakvi) or 12 months (all others)