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Drug Category: Muscle

Medication Class/Individual Agents: Neuromuscular Blockers

I. Prior-Authorization Requirements

 Botulinum Toxins (Types A and B)

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

abobotulinumtoxinA Dysport PA  
incobotulinumtoxinA Xeomin PA  
onabotulinumtoxinA Botox PA  
rimabotulinumtoxinB Myobloc PA  

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

Additional information:

  • Due to the formation of antibodies, patients may develop resistance to Type A after repeated use. In these cases, Type B may be an alternative because antibodies to Type A and B do not cross-react.
  • Units of biological activity cannot be directly converted between Botulinum Types A and B.
  • There is also a difference in relative potencies between products distributed in North America and elsewhere.

Contraindications:

  • Infection at the proposed injection site

Warnings:

  • Recommended dose and frequency should not be exceeded. Risks with higher doses are unknown.
  • Hypersensitivity reactions
  • Pre-existing neuromuscular disorders
  • Dysphagia
  • Human albumin (both products contain albumin)
 
Table Footnotes

II. Therapeutic Uses

FDA-approved, for example:

  • BlepharospasmBotox, Xeomin
  • Cervical dystoniaBotox, Dysport, Myobloc, Xeomin
  • Lower limb spasticityBotox, Dysport
  • Migraine prophylaxisBotox
  • Overactive bladderBotox
  • Severe primary axillary hyperhidrosisBotox
  • SialorrheaXeomin
  • StrabismusBotox
  • Upper limb spasticity–Botox, Dysport, Xeomin
  • Urinary incontinence associated with neurologic conditionsBotox

Note: The above list may not include all FDA-approved indications.

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III.  Evaluation Criteria for Approval

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

  • All PA requests must include clinical diagnosis, drug name, dose, and frequency.
  • A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
  • Additional criteria may apply, depending upon the member's condition and requested medication (see below).

 

Botox

  • Documentation of all of the following is required for blepharospasm associated with dystonia, cervical dystonia, limb spasticity, and strabismus:
    • an appropriate diagnosis; and
    • dose is appropriate for stated indication (member's weight must be provided).

SmartPA: Claims for Botox ≤ 600 units will usually process at the pharmacy without a PA request if the member has a history of MassHealth medical claims for cerebral palsy and if MassHealth pharmacy claims indicate at least 70 days have passed since the last paid claim for Botox.†

    

  • Documentation of all of the following is required for migraine prophylaxis:
    • an appropriate diagnosis; and
    • prescriber is a neurologist, pain medicine/anesthesiology physician, or physical medicine/rehabilitation physician, or a consult from one is provided; and
    • headache frequency of ≥ 15 days per month; and
    • an inadequate response or adverse reaction to one of the following or contraindication to all of the following:
      • atenolol; or
      • metoprolol; or
      • nadolol; or
      • propranolol; or
      • timolol; and
    • an inadequate response or adverse reaction to two of the following or contraindication to all of the following:
      • amitriptyline; or
      • topiramate; or
      • valproic acid; or
      • venlafaxine; and
    • dose is appropriate for stated indication.

  

  • Documentation of all of the following is required for neurogenic bladder dysfunction:
    • an appropriate diagnosis; and
    • prescriber is a urologist or a urology consult is provided; and
    • an inadequate response or adverse reaction to one of the following or contraindication to all of the following classes:
      • two anticholinergic medications; or
      • one anticholinergic medication and one cholinergic agent; or
      • one anticholinergic medication and one alpha blocker; or
    • dose is appropriate for stated indication.
    •  

  

  • Documentation of all of the following is required for overactive bladder:
    • an appropriate diagnosis; and
    • prescriber is a urologist or a urology consult is provided; and
    • one of the following:
      • an inadequate response or adverse reaction to two anticholinergic medications (e.g., oxybutynin, tolterodine); or
      • an inadequate response or adverse reaction to one anticholinergic medication and one beta-3 adrenergic receptor agonist (mirabegron); or
      • a contraindication to all anticholinergic medications and beta-3 adrenergic receptor agonists; and
    • dose is appropriate for stated indication.

  

  • Documentation of all of the following is required for severe primary axillary hyperhidrosis:
    • an appropriate diagnosis; and
    • prescriber is a dermatologist or neurologist; and
    • an inadequate response, adverse reaction, or contraindication to aluminum chloride solution; and
    • dose is appropriate for stated indication.

  

Dysport

  • Documentation of all of the following is required for cervical dystonia, upper limb spasticity and lower limb spasticity:
    • an appropriate diagnosis; and
    • dose is appropriate for stated indication (member's weight must be provided).

  

Myobloc

  • Documentation of all of the following is required for cervical dystonia:
    • an appropriate diagnosis; and
    • dose is appropriate for stated indication (member's weight must be provided).

  

Xeomin

  • Documentation of all of the following is required for blepharospasm, cervical dystonia, and upper limb spasticity:
    • an appropriate diagnosis; and
    • dose is appropriate for stated indication (member's weight must be provided).

 

  • Documentation of all of the following is required for sialorrhea:
    • an appropriate diagnosis; and
    • an inadequate response or adverse reaction to two of the following or contraindication to all of the following:
      • atropine; or
      • glycopyrrolate; or
      • hyoscyamine; or
      • scopolamine; or
      • TCA agent; and
    • dose is appropriate for stated indication (member's weight must be provided).

 

†  Note: The decision on whether PA is required is based upon information available in the MassHealth medical claim and pharmacy claim databases. The MassHealth database contains member information exclusive to MassHealth, and no other health plans.


Original Effective Date: 04/2001

Last Revised Date: 07/2019


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Last updated 07/15/19