FDA-approved, for example:

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

non-FDA-approved, for example:

• Achalasia or esophageal dysphagia–Botox, Dysport
• Anal fissures–Botox, Dysport, Myobloc, Xeomin
• Anal stenosis, chronic constipation, or encopresis–Botox
• Gastroparesis–Botox, Dysport, Myobloc, Xeomin
• Migraine prophylaxis (concomitant therapy with a CGRP inhibitor)–Botox
• Migraine prophylaxis (dosing frequency every ten weeks)–Botox
• Myofascial pain syndrome–Botox
• Myofascial pelvic pain syndrome–Botox
• Severe craniofacial hyperhidrosis–Botox
• Severe primary axillary hyperhidrosis in pediatrics–Botox
• Severe palmar or plantar hyperhidrosis–Botox
• Sialorrhea–Botox
• Raynaud's phenomenon–Botox
• Trigeminal neuralgia–Botox

Note: The above lists may not include all FDA-approved and non-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.
• Dispensing in a 90-day supply of medication may be mandated or allowable for agents in this therapeutic class (designated by M90 or A90, respectively, in the Drug Notes section above). Applicable quantity limits are described below as units per day, per month, per 28 days, or as clinically appropriate, and may be extrapolated for fills of longer day supply. 
• 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 diagnosis and/or requested medication (see below). Other factors, including rebate and FDA-approval status, may change independently of scheduled MassHealth updates, which may result in additional restrictions.

Botox

• Documentation of all of the following is required for achalasia or esophageal dysphagia:
  • appropriate diagnosis; and
  • prescriber is a gastroenterologist or surgeon or consult notes from a gastreoenterologist or surgeon are provided; and
  • one of the following:
    • member has failed a surgical option; or
    • member is not a surgical candidate or is unwilling to undergo surgical procedure; and
  • initial requested dose is ≤ 100 units no more frequently than every six months.

• Documentation of all of the following is required for anal fissures:
  • appropriate diagnosis; and
  • prescriber is a gastroenterologist or surgeon or consult notes from a gastreoenterologist or surgeon are provided; and
  • inadequate response or adverse reaction to one or contraindication to both of the following: topical nifedipine, topical nitroglycerin.

• Documentation of all of the following is required for anal stenosis, chronic constipation, or encopresis:
  • appropriate diagnosis; and
  • prescriber is a gastroenterologist or surgeon or consult notes from a gastreoenterologist or surgeon are provided; and
  • inadequate response or adverse reaction to two or contraindication to all laxatives; and
  • inadequate response to dietary changes (e.g., increased intake of fluids and fiber) and/or behavior modification (e.g., biofeedback training, toilet training); and
  • initial requested dose is ≤ 100 units no more frequently than every three months.

• Documentation of all of the following is required for blepharospasm associated with dystonia, cervical dystonia, limb spasticity, and strabismus:
  • appropriate diagnosis; and
  • appropriate dosing for requested indication (for pediatric members, child's weight must be provided).

• Documentation of all of the following is required for gastroparesis:
  • appropriate diagnosis; and
  • prescriber is a gastroenterologist or surgeon or consult notes from a gastreoenterologist or surgeon are provided; and
  • inadequate response, adverse reaction, or contraindication to metoclopramide; and
  • inadequate response or adverse reaction to one or contraindication to all antiemetics.

• Documentation of all of the following is required for migraine prophylaxis:
  • appropriate diagnosis; and
  • prescriber is a neurologist, pain medicine/anesthesiology physician, or physical medicine/rehabilitation physician, or consult notes from a specialist are provided; and
  • migraine headache frequency of ≥ 15 days/30 days; and
  • inadequate response or adverse reaction to one or contraindication to all of the following: atenolol, metoprolol, nadolol, propranolol, timolol; and 
  • inadequate response or adverse reaction to two or contraindication to all of the following: amitriptyline, topiramate, valproic acid, venlafaxine; and
  • appropriate dosing for requested indication; and
  • for a dosing frequency of every ten weeks, both of the following:
    • member received initial positive response to therapy; and
    • member is experiencing a "wearing-off" or efficacy after a dose increase to 195 units; and
  • for concomitant therapy with a CGRP inhibitor, a partial, but incomplete, response to a CGRP inhibitor.

• Documentation of all of the following is required for myofascial pain syndrome:
  • appropriate diagnosis; and
  • inadequate response or adverse reaction to two or contraindication to all of the following: cyclobenzaprine, gabapentin or pregabalin, local anesthetic, SNRI, TCA agent; and 
  • approriate dosing (up to a total dose of 200 units).

• Documentation of all of the following is required for myofascial pelvic pain syndrome:
  • appropriate diagnosis; and
  • inadequate response or adverse reaction to two or contraindication to all of the following: gabapentin or pregabalin, muscle relaxant, SNRI, TCA agent, vaginal diazepam; and 
  • approriate dosing (up to a total dose of 300 units).

• Documentation of all of the following is required for neurogenic bladder dysfunction or neurogenic detrusor overactivity in adults:
  • appropriate diagnosis; and
  • prescriber is a urologist or consult notes from a urologist are provided; and
  • inadequate response or adverse reaction to one 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
  • appropriate dosing for requested indication.

• Documentation of all of the following is required for neurogenic bladder dysfunction or neurogenic detrusor overactivity in pediatrics:
  • appropriate diagnosis; and
  • prescriber is a urologist or consult notes from a urologist are provided; and
  • inadequate response or adverse reaction to one or contraindication to both of the following classes:
    • one anticholinergic medication; or
    • one beta-3 adrenergic receptor agonist; and
  • appropriate dosing for requested indication.

• Documentation of all of the following is required for overactive bladder (including urinary urgency with or without incontinence, nocturia, or urinary frequency):
  • appropriate diagnosis; and
  • prescriber is a urologist or consult notes from a urologist are provided; and
  • inadequate response or adverse reaction to one or contraindication to both of the following: two anticholinergic medications or one anticholinergic medication and one beta-3 adreneric receptor agonist; and
  • appropriate dosing for requested indication.

• Documentation of all of the following is required for Raynaud's Phenomenon:
  • appropriate diagnosis; and
  • inadequate response or adverse reaction to three or contraindication to all of the following: a calcium channel blocker (amlodipine or nifedipine), fluoxetine, losartan, a PDE type 5 inhibitor, a topical nitrate; and
  • requested dose is ≤ 200 units/90 days.

• Documentation of all of the following is required for severe craniofacial hyperhidrosis:
  • appropriate diagnosis; and
  • prescriber is a dermatologist or neurologist or consult notes from a dermatologist or neurologist are provided; and 
  • inadequate response or adverse reaction to one or contraindication to all of the following: aluminum chloride solution, oral glycopyrrolate, oral oxybutynin; and
  • appropriate dosing (areas to be injected must be provided).

• Documentation of all of the following is required for severe primary axillary hyperhidrosis in adults:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • prescriber is a dermatologist or neurologist or consult notes from a dermatologist or neurologist are provided; and
  • inadequate response, adverse reaction, or contraindication to aluminum chloride solution; and
  • appropriate dosing for requested indication.

• Documentation of all of the following is required for severe primary axillary hyperhidrosis in pediatrics:
  • appropriate diagnosis; and
  • member is 12 to ≤ 18 years of age; and
  • prescriber is a dermatologist or neurologist or consult notes from a dermatologist or neurologist are provided; and
  • inadequate response, adverse reaction, or contraindication to aluminum chloride solution; and
  • appropriate dosing for requested indication.

• Documentation of all of the following is required for escalated dosing in severe axillary hyperhidrosis:
  • appropriate diagnosis; and
  • prescriber is a dermatologist or neurologist or consult notes from a dermatologist or neurologist are provided; and
  • inadequate response to FDA-approved dosing of 50 units per axilla; and
  • requested dose is ≤ 200 units per axilla.

• Documentation of all of the following is required for severe palmar or plantar hyperhidrosis:
  • appropriate diagnosis; and
  • prescriber is a dermatologist or neurologist or consult notes from a dermatologist or neurologist are provided; and
  • inadequate response, adverse reaction, or contraindication to aluminum chloride solution; and
  • appropriate dosing for requested indication.

• Documentation of all of the following is required for sialorrhea:
  • appropriate diagnosis; and
  • inadequate response or adverse reaction to two or contraindication to all of the following: atropine, glycopyrrolate, hyoscyamine, scopolamine, a tricyclic antidepressant; and
  • inadequate response, adverse reaction, or contraindication to both of the following: Myobloc, Xeomin; and
  • appropriate dosing (40 to 100 units every three to six months).

• Documentation of all of the following is required for trigeminal neuralgia:
  • appropriate diagnosis; and
  • prescriber is a neurologist or physical medicine/rehabilitation physician or consult notes from a specialist are provided; and
  • inadequate response or adverse reaction to two or contraindication to all of the following: baclofen, carbamazepine, gabapentin, lamotrigine, oxcarbazepine, tizanidine, topiramate; and
  • appropriate dosing.

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.† 

Daxxify

• Documentation of all of the following is required for cervical dystonia/spasmodic torticollis:
  • appropriate diagnosis; and 
  • member is ≥ 18 years of age; and 
  • appropriate dosing.

Dysport

• Documentation of all of the following is required for achalasia or esophageal dysphagia:
  • appropriate diagnosis; and
  • prescriber is a gastroenterologist or surgeon or consult notes from a gastreoenterologist or surgeon are provided; and
  • one of the following:
    • member has failed a surgical option; or
    • member is not a surgical candidate or is unwilling to undergo surgical procedure; and
  • initial requested dose is ≤ 250 units no more frequently than every six months.

• Documentation of all of the following is required for anal fissures:
  • appropriate diagnosis; and
  • prescriber is a gastroenterologist or surgeon or consult notes from a gastreoenterologist or surgeon are provided; and
  • inadequate response or adverse reaction to one or contraindication to both of the following: topical nifedipine, topical nitroglycerin.

• Documentation of all of the following is required for cervical dystonia:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • appropriate dosing for requested indication.

• Documentation of all of the following is required for gastroparesis:
  • appropriate diagnosis; and
  • prescriber is a gastroenterologist or surgeon or consult notes from a gastreoenterologist or surgeon are provided; and
  • inadequate response, adverse reaction, or contraindication to metoclopramide; and
  • inadequate response or adverse reaction to one or contraindication to all antiemetics.    

• Documentation of all of the following is required for upper limb spasticity and lower limb spasticity:
  • appropriate diagnosis; and
  • member is ≥ two years of age; and
  • appropriate dosing for requested indication (for pediatric members, child's weight must be provided).

Myobloc

• Documentation of all of the following is required for anal fissures:
  • appropriate diagnosis; and
  • prescriber is a gastroenterologist or surgeon or consult notes from a gastreoenterologist or surgeon are provided; and
  • inadequate response or adverse reaction to one or contraindication to both of the following: topical nifedipine, topical nitroglycerin.

• Documentation of all of the following is required for cervical dystonia:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and 
  • appropriate dosing for requested indication.

• Documentation of all of the following is required for gastroparesis:
  • appropriate diagnosis; and
  • prescriber is a gastroenterologist or surgeon or consult notes from a gastreoenterologist or surgeon are provided; and
  • inadequate response, adverse reaction, or contraindication to metoclopramide; and
  • inadequate response or adverse reaction to one or contraindication to all antiemetics.

• Documentation of all of the following is required for sialorrhea:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • inadequate response or adverse reaction to two or contraindication to all of the following: atropine, glycopyrrolate, hyoscyamine, scopolamine, a TCA agent; and
  • appropriate dosing for requested indication.

Xeomin

• Documentation of all of the following is required for anal fissures:
  • appropriate diagnosis; and
  • prescriber is a gastroenterologist or surgeon or consult notes from a gastreoenterologist or surgeon are provided; and
  • inadequate response or adverse reaction to one or contraindication to both of the following: topical nifedipine, topical nitroglycerin.

• Documentation of all of the following is required for blepharospasm and cervical dystonia:
  • an appropriate diagnosis; and
  • member is ≥ 18 years of age; and 
  • appropriate dosing for requested indication.

• Documentation of all of the following is required for gastroparesis:
  • appropriate diagnosis; and
  • prescriber is a gastroenterologist or surgeon or consult notes from a gastreoenterologist or surgeon are provided; and
  • inadequate response, adverse reaction, or contraindication to metoclopramide; and
  • inadequate response or adverse reaction to one or contraindication to all antiemetics.

• Documentation of all of the following is required for sialorrhea:
  • appropriate diagnosis; and
  • member is ≥ two years of age; and
  • inadequate response or adverse reaction to two or contraindication to all of the following: atropine, glycopyrrolate, hyoscyamine, scopolamine, a TCA agent; and
  • appropriate dosing for requested indication (for pediatric members, child's weight must be provided).

• Documentation of all of the following is required for upper limb spasticity:
  • an appropriate diagnosis; and
  • member is ≥ two years of age; and 
  • if member is <18 years of age, spasticity is not caused by cerebral palsy; and
  • appropriate dosing for requested indication (for pediatric members, child'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.