WHA

OZOBAX, FLEQSUVY, LYVISPAH (baclofen)

Self-Administration – oral

Diagnosis considered for coverage:

  • Indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.  May also be of some value in patients with spinal cord injuries and other spinal cord diseases

Limitations of Use:

  • Is not indicated in the treatment of skeletal muscle spasms resulting from rheumatic disorders.

Coverage Criteria:

For diagnosis of spasticity:

  • Dose does not exceed the maximum approved by the FDA

    • Fleqsuvy – up to 80 mg (16 mL) per day

    • Ozobax - up to 80 mg (80 mL) per day

    • Lyvispah – up to 80 mg per day (20 mg four times per day); AND

  • Diagnosis of spasticity; AND

  • One of the following:

    • Trial and failure, contraindication, or intolerance to generic baclofen tablets

    • Documentation supporting a medically appropriate reason why the patient cannot try generic baclofen tablets (e.g., unable to swallow tablets)

Reauthorization Criteria:

For diagnosis of spasticity:

  • Dose does not exceed the maximum approved by the FDA

    • Fleqsuvy – up to 80 mg (16 mL) per day

    • Ozobax - up to 80 mg (80 mL) per day

    • Lyvispah – up to 80 mg per day (20 mg four times per day); AND

  • Patient has experienced a positive clinical response to therapy

Coverage Duration:


•    Initial: 1 year
•    Reauthorization: 1 year

Authorization is not covered for the following:


The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 
  • Dosing and administration
    • Fleqsuvy
      • Initiate Fleqsuvy with a low dosage, preferably in divided doses, administered orally
      • The following gradually increasing dosage regimen is suggested, but should be adjusted based on clinical response and tolerability:
        • 1 mL (5 mg) three times a day for three days
        • 2 mL (10 mg) three times a day for three days
        • 3 mL (15 mg) three times a day for three days
        • 4 mL (20 mg) three times a day for three days
      • Maximum recommended dosage of 80 mg daily [4 mL (20 mg) four times daily]
      • Administration:
        • Shake well Fleqsuvy oral suspension before administration
        • Discard unused portion 2 months after first opening
    • Lyvispah
      • Initiate Lyvispah with a low dosage, preferably in divided doses administered orally
      • The following gradually increasing dosage regimen is suggested, but should be adjusted based on clinical response and tolerability:
        • 5 mg three times a day for three days
        • 10 mg three times a day for three days
        • 15 mg three times a day for three days
        • 20 mg three times a day for three days
      • Maximum recommended dosage of 80 mg daily (20 mg four times daily)
      • Administration: entire contents of the packet should be emptied into the mouth
    • Ozobax
      • Initiate Ozobax with a low dosage, preferably in divided doses, administered orally
      • The following gradually increasing dosage regimen is suggested, but should be adjusted based on clinical response and tolerability:
        • 5 mL (5 mg) three times a day for three days
        • 10 mL (10 mg) three times a day for three days
        • 15 mL (15 mg) three times a day for three days
        • 20 mL (20 mg) three times a day for three days
      • Maximum recommended dosage of 80 mg daily (20 mg four times daily)
Policy Updates:


•    11/15/2022 – New policy approved by P&T.

References:
  1. Fleqsuvy prescribing information, Wilmington, DE: Azurity Pharmaceuticals, Inc.; February 2022.
  2. Lyvispah prescribing information, Roswell, GA: Saol Therapeutics, Inc.; November 2021.
  3. Ozobax prescribing information, Athens, GA: Metacel pharmaceuticals, LLC; September 2019

Last review date: December 1, 2022