WHA

Myobloc (rimabotulinumtoxin B)

Indications for Prior Authorization

Myobloc (rimabotulinumtoxin B)
  • For diagnosis of Cervical Dystonia (CD)
    Indicated for the treatment of adults with cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia.

  • For diagnosis of Chronic Sialorrhea
    Indicated for the treatment of chronic sialorrhea in adults.

Criteria

Myobloc

Prior Authorization (Initial Authorization)

Length of Approval: 3 Month(s)
For diagnosis of Cervical Dystonia (also known as spasmodic torticollis)

  • Diagnosis of cervical dystonia (also known as spasmodic torticollis) [2]
Myobloc

Prior Authorization (Initial Authorization)

Length of Approval: 3 Month(s)
For diagnosis of Chronic Sialorrhea

  • Diagnosis of chronic sialorrhea
Myobloc

Prior Authorization (Reauthorization)

Length of Approval: 3 Month(s)
For diagnosis of All indications listed above

  • Patient demonstrates positive clinical response to therapy.
    • AND
  • At least 3 months have elapsed since the last treatment [B]

  • Guideline ID
    GL-147776

  • Formulary
    premium

  • Effective date
    Oct 1, 2024

  • P&T approval date
    Apr 20, 2001

P & T Revisions

2024-08-20, 2023-10-26, 2023-06-15, 2022-07-21, 2021-06-15, 2021-04-07, 2020-06-30, 2019-10-02

  1. Myobloc Prescribing Information. Solstice Neurosciences, LLC. Louisville, KY. March 2021.
  2. Simpson DM, Hallett M, Ashman EJ, et al. Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache: Report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2016 May;86(19):1818-26.
  1. The duration of effect in patients responding to Myobloc treatment has been observed in studies to be between 12 and 16 weeks at doses of 5,000 Units or 10,000 Units. [1]
  2. The typical duration of effect of each treatment is up to 3 months with the repeat of treatments should be determined by clinical response but should generally be no frequent than every 12 weeks.
  • 2024-08-20: 2024 annual review. Background updates, consolidated reauth criteria. No change to approval length at this time.
  • 2023-10-26: Program update to standard reauthorization language. No changes to clinical intent.
  • 2023-06-15: Annual review - no changes.
  • 2022-07-21: Annual review - no changes.
  • 2021-06-15: Annual review - updated references.
  • 2021-04-07: Removed "single dose" language in approval duration due to feedback from PA team.
  • 2020-06-30: Remove unit amounts from approval duration due to feedback from PA team. Removed drug name from reauth criteria for consistency.
  • 2019-10-02: New indication