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Gralise — Blue Cross Blue Shield of Texas

FDA labeled indication for the requested agent

Preferred products

  • generic immediate release gabapentin

Initial criteria

  • The patient has an FDA labeled indication for the requested agent AND
  • ONE of the following:
  • A. 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
  • B. BOTH of the following:
  • 1. ONE of the following:
  • A. The patient has been diagnosed with stage four advanced, metastatic cancer and the requested agent is being used to treat the cancer OR
  • B. The patient has been diagnosed with stage four advanced, metastatic cancer and the requested agent is being used to treat an associated condition related to stage four advanced metastatic cancer [chart notes are required] AND
  • 2. The use of the requested agent is consistent with best practices for the treatment of stage four advanced, metastatic cancer, or an associated condition; supported by peer-reviewed, evidence-based literature; and approved by the United States Food and Drug Administration OR
  • C. The prescriber states the patient is currently being treated with the requested agent AND the patient is currently stable on the requested agent [chart notes are required] OR
  • D. The patient has tried and had an inadequate response to a generic immediate release gabapentin agent [chart notes are required] OR
  • E. A generic immediate release gabapentin agent was discontinued due to lack of efficacy, effectiveness, diminished effect, or an adverse event [chart notes are required] OR
  • F. The patient has an intolerance or hypersensitivity to a generic immediate release gabapentin agent [chart notes are required] OR
  • G. The patient has an FDA labeled contraindication to ALL generic immediate release gabapentin agents [chart notes are required] OR
  • H. A generic immediate release gabapentin agent is expected to be ineffective based on the known clinical characteristics of the patient and the known characteristics of the prescription drug; OR cause a significant barrier to the patient’s adherence of care; OR worsen a comorbid condition; OR decrease the patient’s ability to achieve or maintain reasonable functional ability in performing daily activities; OR cause an adverse reaction or cause physical or mental harm [chart notes are required] OR
  • I. A generic immediate release gabapentin agent is not in the best interest of the patient based on medical necessity [chart notes are required] OR
  • J. The patient has tried another prescription drug in the same pharmacologic class or with the same mechanism of action as a generic immediate release gabapentin agent and that prescription drug was discontinued due to lack of efficacy, effectiveness, diminished effect, or an adverse event [chart notes are required]
  • For BCBS NM Fully Insured or NM HIM members, the requested agent will also be approved when ALL of the following are met:
  • 1. The request is for a BCBS NM Fully Insured or NM HIM member AND
  • 2. The patient does NOT have any FDA labeled contraindications to the requested agent AND
  • 3. The requested indication is a rare disease AND
  • 4. ONE of the following:
  • A. The patient has another FDA labeled indication for the requested agent and route of administration OR
  • B. The patient has another indication supported in compendia for the requested agent and route of administration (DrugDex level 1, 2A, 2B; AHFS-DI; NCCN 1 or 2A; Clinical Pharmacology; Lexi-Drugs evidence level A; peer-reviewed literature)

Approval duration

12 months