Pharmacy Prior Authorization Criteria

Dysport (abobotulinumtoxinA)

Indications for Prior Authorization

Dysport (abobotulinumtoxinA)

• For diagnosis of Cervical Dystonia
  Indicated for the treatment of cervical dystonia in adults.

• For diagnosis of Spasticity
  Indicated for the treatment of spasticity in patients 2 years of age and older.

• For diagnosis of Cosmetic Uses [Non-approvable Use]
  Indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adult patients less than 65 years of age.

  Note: This indication is generally a plan exclusion. Drugs prescribed to primarily improve or otherwise modify the member’s external appearance are excluded from coverage, as this is considered a cosmetic use.

Criteria

Dysport

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, 3]

Dysport

Prior Authorization (Initial Authorization)

Length of Approval: 3 Month(s)
For diagnosis of Spasticity

• Diagnosis of spasticity [3]
AND
• Patient is 2 years of age or older

Dysport

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 [A]

Dysport

Prior Authorization

For diagnosis of Cosmetic Uses

• Requests for coverage of any Dysport product for treating the appearance of facial lines are not authorized and will not be approved. These uses are considered cosmetic only.

P & T Revisions

2024-08-20, 2023-12-12, 2023-08-24, 2022-09-06, 2021-08-17, 2021-04-07, 2020-09-09, 2020-06-30, 2019-11-06

References

1. Dysport Prescribing Information. Ipsen Biopharmaceuticals, Inc. Cambridge, MA. January 2023.
2. Truong D, Duane DD, Jankovic J, et al. Efficacy and safety of botulinum type A toxin (Dysport) in cervical dystonia: results of the first US randomized, double-blind, placebo-controlled study. Mov Disord. 2005;20(7):783-791.
3. Simpson D, Hallett M, Ashman E et al. Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache. Neurology. 2016;86(19):1818-1826.

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End Notes

1. In the pivotal clinical trial, doses of 500 Units and 1000 Units were divided among selected muscles. Repeat treatment should be administered when the effect of a previous injection has diminished, but no sooner than 12 weeks after the previous injection. A majority of patients in clinical studies were retreated between 12-16 weeks; however some patients had a longer duration of response, i.e., 20 weeks. [1]

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Revision History

• 2024-08-20: 2024 annual review. Formatting changes with no change to clinical intent. Addition of criteria bucket to confirm that cosmetic uses will not be covered.
• 2023-12-12: Reauth verbiage update
• 2023-08-24: 2023 Annual Review
• 2022-09-06: Annual review - added age criterion for spasticity indication to align with prescribing information.
• 2021-08-17: 2021 UM Annual Review.
• 2021-04-07: Removed "single dose" language in approval duration due to feedback from PA team.
• 2020-09-09: 2020 UM Annual Review. Updated spasticity criteria to align with PI.
• 2020-06-30: Remove unit amounts from approval duration due to feedback from PA team. Removed drug name from reauth criteria for consistency.
• 2019-11-06: Updated criteria to include expanded indication of upper limb spasticity in pediatric patients. Pending Dec 2019 P&T decision. SL 11.05.19

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