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Lumryz starter pack — Blue Cross Blue Shield of New Mexico

Idiopathic hypersomnia

Preferred products

  • Authorized generic Sodium Oxybate

Initial criteria

  • ONE of the following:
  • A. The patient has a diagnosis of narcolepsy with cataplexy OR narcolepsy with excessive daytime sleepiness AND ONE of the following:
  • 1. BOTH of the following:
  • A. ONE of the following:
  • 1. The patient has been diagnosed with stage four advanced, metastatic cancer and the requested agent is being used to treat the cancer OR
  • 2. 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 AND
  • B. 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
  • 2. The patient is currently being treated with the requested agent and the patient is currently stable on the requested agent OR
  • 3. The patient has tried and had an inadequate response to modafinil OR armodafinil OR
  • 4. Modafinil OR armodafinil was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event OR
  • 5. The patient has an intolerance or hypersensitivity to modafinil OR armodafinil OR
  • 6. The patient has an FDA labeled contraindication to BOTH modafinil AND armodafinil OR
  • 7. Modafinil OR armodafinil is expected to be ineffective based on characteristics of the patient and drug OR cause a significant barrier to adherence of care; OR worsen a comorbid condition; OR decrease functional ability; OR cause adverse reaction or harm OR
  • 8. Modafinil OR armodafinil is not in the best interest of the patient based on medical necessity OR
  • 9. The patient has tried another prescription drug in the same pharmacologic class or with the same mechanism of action as modafinil OR armodafinil and discontinued due to lack of efficacy or adverse event OR
  • B. The patient has a diagnosis of idiopathic hypersomnia AND ALL of the following:
  • 1. The requested agent is Xywav AND
  • 2. All other causes of hypersomnia have been ruled out AND
  • 3. ONE of the following:
  • A. The patient has tried and had an inadequate response to modafinil OR
  • B. The patient has intolerance or hypersensitivity to modafinil OR
  • C. The patient has an FDA labeled contraindication to modafinil OR
  • C. The patient has another FDA labeled indication for the requested agent and route of administration AND
  • 2. The patient has been evaluated using polysomnography and/or a Multiple Sleep Latency Test AND
  • 3. If the patient has an FDA labeled indication, ONE of the following:
  • A. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
  • B. There is support for using the requested agent for the patient’s age for the requested indication AND
  • 4. If the request is for brand Xyrem, then ONE of the following:
  • A. BOTH of the following:
  • 1. ONE of the following related to stage four advanced metastatic cancer (same criteria as above) AND
  • 2. The use of the requested agent is consistent with best practices for treatment of stage four advanced metastatic cancer and approved by FDA OR
  • B. The patient is currently being treated with the requested agent and stable OR
  • C. The patient has tried and had inadequate response to authorized generic Sodium Oxybate OR
  • D. Authorized generic Sodium Oxybate was discontinued due to lack of efficacy, diminished effect, or adverse event OR
  • E. The patient has an intolerance or hypersensitivity to authorized generic Sodium Oxybate not expected to occur with the requested agent OR
  • F. The patient has an FDA labeled contraindication to authorized generic Sodium Oxybate not expected to occur with the requested agent OR
  • G. Authorized generic Sodium Oxybate is expected to be ineffective or cause barriers, comorbidity worsening, adverse reaction, or harm OR
  • H. Authorized generic Sodium Oxybate is not in the patient’s best interest based on medical necessity OR
  • I. The patient has tried another prescription drug in the same class as authorized generic Sodium Oxybate and discontinued due to lack of efficacy or adverse event OR
  • J. There is support for the use of the requested agent over authorized generic Sodium Oxybate AND
  • 5. The prescriber is a specialist (e.g., sleep specialist, neurologist, psychiatrist) or has consulted with one AND
  • 6. The patient does NOT have any FDA labeled contraindications to the requested agent
  • Alternate coverage path:
  • 1. The member resides in Ohio AND the plan is Fully Insured or HIM Shop (SG) AND BOTH of the following:
  • A. The patient does NOT have any FDA labeled contraindications to the requested agent AND
  • B. ONE of the following:
  • 1. The patient has another FDA labeled indication for the requested agent and route of administration OR
  • 2. The patient has another indication supported in compendia (DrugDex level 1, 2A, 2B or AHFS-DI supportive text) OR
  • 3. The prescriber has submitted two peer-reviewed journal articles supporting proposed use

Reauthorization criteria

  • 1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process AND
  • 2. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., sleep specialist, neurologist, psychiatrist) or has consulted with one AND
  • 3. The patient has shown clinical benefit with the requested agent AND
  • 4. The patient does not have any FDA labeled contraindications to the requested agent

Approval duration

12 months