Xeomin (incobotulinumtoxinA)
Indications for Prior Authorization
Xeomin (incobotulinumtoxinA)
-
For diagnosis of Blepharospasm
Indicated for the treatment of blepharospasm in adults. -
For diagnosis of Cervical Dystonia
Indicated for the treatment of cervical dystonia in adults. -
For diagnosis of Chronic Sialorrhea
Indicated for the treatment of chronic sialorrhea in patients 2 years of age and older. -
For diagnosis of Adult Upper Limb Spasticity
Indicated for the treatment of upper limb spasticity in adults. -
For diagnosis of Pediatric Upper Limb Spasticity
Indicated for the treatment of upper limb spasticity in pediatric patients 2 to 17 years of age, excluding spasticity caused by cerebral palsy. -
For diagnosis of Cosmetic Uses [Non-approvable Use]
Is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adults.*Note: Use of Xeomin for the improvement in the appearance of glabellar lines is excluded, as this is considered a cosmetic use.
Criteria
Xeomin
Prior Authorization (Initial Authorization)
Length of Approval: 3 months [A]
For diagnosis of Cervical Dystonia (also known as spasmodic torticollis)
- Diagnosis of cervical dystonia (also known as spasmodic torticollis) [1]
Xeomin
Prior Authorization (Reauthorization)
Length of Approval: 3 months [A]
For diagnosis of Cervical Dystonia (also known as spasmodic torticollis)
- Patient demonstrates positive clinical response to therapy AND
- At least 3 months have elapsed or will have elapsed since the last treatment [1]
Xeomin
Prior Authorization (Initial Authorization)
Length of Approval: 3 months [1, B]
For diagnosis of Blepharospasm
- Diagnosis of blepharospasm
Xeomin
Prior Authorization (Reauthorization)
Length of Approval: 3 months [1, 4, C]
For diagnosis of Blepharospasm
- Patient demonstrates positive clinical response to therapy AND
- At least 3 months have elapsed or will have elapsed since the last treatment [C]
Xeomin
Prior Authorization (Initial Authorization)
Length of Approval: 3 months [1, 3]
For diagnosis of Upper Limb Spasticity
- Diagnosis of upper limb spasticity [1] AND
- Patient is 2 years of age or older
Xeomin
Prior Authorization (Reauthorization)
Length of Approval: 3 months [1, 3, D]
For diagnosis of Upper Limb Spasticity
- Patient demonstrates positive clinical response to therapy AND
- At least 3 months have elapsed or will have elapsed since the last treatment [D]
Xeomin
Prior Authorization (Initial Authorization)
Length of Approval: 3 months [1, D]
For diagnosis of Chronic Sialorrhea
- Diagnosis of chronic sialorrhea AND
- Patient is 2 years of age or older
Xeomin
Prior Authorization (Reauthorization)
Length of Approval: 3 months [1, D]
For diagnosis of Chronic Sialorrhea
- Patient demonstrates positive clinical response to therapy AND
- At least 4 months have elapsed or will have elapsed since the last treatment [E]
Xeomin
Prior Authorization
For diagnosis of Cosmetic Use
- Requests for coverage of any Xeomin 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
2024-07-31, 2023-09-06, 2022-09-06, 2021-09-17, 2021-04-07, 2021-02-03, 2020-10-02, 2020-09-10
References
- Xeomin Prescribing Information. Merz Pharmaceuticals, LLC. Raleigh, NC. July 2024.
- Benecke R, Jost WH, Kanovsky P, Ruzicka E, Comes G, Grafe S. A new botulinum toxin type A free of complexing proteins for treatment of cervical dystonia. Neurology. 2005;64:1949-1951.
- Kanovsky P, Slawek J, Denes Z, et al. Efficacy and safety of treatment with incobotulinum toxin A (botulinum neurotoxin type A free from complexing proteins; NT 201) in post-stroke upper limb spasticity. J Rehabil Med 2011; 43(6):486-492.
- Jankovic J, Comella C, Hanschmann A, et al. Efficacy and safety of incobotulinumtoxinA (NT 201, Xeomin) in the treatment of blepharospasm-a randomized trial. Mov Disord 2011; 26(8):1521-1528.
End Notes
- In a randomized, double-blind, active-controlled, parallel group study, 463 patients with a documented stable therapeutic response to Botox as a result of the last two consecutive injection sessions directly prior to trial entry (70 to 300 Units) were included. Patients in the study received IM injections of 70 to 300 Units of Xeomin or Botox, based on the previous two consecutive doses of Botox prior to study entry. [2]
- The total initial dose of Xeomin in both eyes should not exceed 50 Units (25 Units/eye). [1]
- The median onset of treatment effect with incobotulinumtoxinA was 4 days (range, 0 to 30 days), time to waning of treatment effect was 6 weeks (range 1 to 15 weeks), and duration of treatment effect was 10.6 weeks (range, 6.1 to 19.1 weeks). [4]
- The typical duration of effect of each treatment is up to 12-16 weeks; however, the duration of effect may vary in individual patients. [1]
- The timing for repeat treatment of chronic sialorrhea should be determined based on the actual clinical need of the individual patient, and no sooner than every 16 weeks (4 months). [1]
Revision History
- 2024-07-31: 2024 annual review. Formatting changes with no change to clinical intent. Addition of criteria bucket to confirm that cosmetic uses will not be covered.
- 2023-09-06: Annual review: Updated criteria and background.
- 2022-09-06: Annual review - added age criterion to chronic sialorrhea and upper limb spasticity indications to align with prescribing information. Updated references.
- 2021-09-17: 2021 annual review: Background, endnote, and reference updates. No criteria changes.
- 2021-04-07: Removed "single dose" language in approval duration due to feedback from PA team.
- 2021-02-03: Updated background/references sections per expanded indication for chronic sialorrhea in patients 2 years of age and older. No criteria changes.
- 2020-10-02: Updated background/references sections per expanded indication for pediatric upper limb spasticity. No criteria changes.
- 2020-09-10: Annual review - removed drug name from reauthorization criteria.
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