FDA-approved, for example:

• Blepharospasm–Botox, Xeomin
• Cervical dystonia–Botox, Dysport, Myobloc, Xeomin
• Lower limb spasticity–Botox, Dysport
• Migraine prophylaxis–Botox
• Neurogenic detrusor overactivity–Botox
• Overactive bladder–Botox
• Severe primary axillary hyperhidrosis–Botox
• Sialorrhea–Myobloc, Xeomin
• Strabismus–Botox
• Upper limb spasticity–Botox, Dysport, Xeomin
• Urinary incontinence associated with neurologic conditions–Botox

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

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.
• For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.
• 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 consult notes are 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 or neurogenic detrusor overactivity in adults:
  • an appropriate diagnosis; and
  • prescriber is a urologist or consult notes from a urologist are 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 neurogenic bladder dysfunction or neurogenic detrusor overactivity in pediatrics:
  • an appropriate diagnosis; and
  • prescriber is a urologist or consult notes from a urologist are provided; and
  • an inadequate response or adverse reaction to one of the following or contraindication to both of the following classes:
    • one anticholinergic medication; or
    • one beta-3 adrenergic receptor agonist; and
  • 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 consult notes from a urologist are 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).

• 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).

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.