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Limited coverage drugs – botulinum neurotoxin type A, with complexing proteins, also known as onabotulinumtoxinA (Botox®)

Last updated on August 7, 2024

Generic name

clostridium botulinum neurotoxin type A, with complexing proteins, also known as onabotulinumtoxinA

Strength

50 units/vial, 100 units/vial, 200 units/vial

Form

concentrate powder for solution for injection

Special Authority criteria

Approval period
  1. For the treatment of spasmodic torticollis

Initial: 1 year

Renewali: 3 years

  1. For the treatment of blepharospasm

Initial: 1 year

Renewali: 3 years
  1. For the treatment of strabismus

Initial: 1 year

Renewali: 3 years
  1. For the treatment of equinus foot deformity due to spasticity in pediatric cerebral palsy patients 2 years of age or older

Initial: 1 year

Renewali: 3 years
  1. For the treatment of focal spasticity, including the treatment of upper limb spasticity associated with stroke in adults

Initial: 1 year

Renewali: 3 years
  1. For the treatment of urinary incontinence due to neurogenic detrusor overactivity (NDO) associated with multiple sclerosis or subcervical spinal cord injury, when the patient has experienced treatment failureiii or intoleranceiv to at least 1 anticholinergic drug

Initial: 1 course (maximum 200 units)

Renewalii: 1 year (coverage is provided for treatment with up to 200 units per course at minimum intervals of 36 weeks)
  1. For the treatment of overactive bladder (OAB) in adult patients who have experienced treatment failureiii or intoleranceiv to at least 2 appropriate medications (i.e., anticholinergics, mirabegron), and when prescribed by a urologist

Initial: 1 course (maximum 100 units)

Renewalii:  1 course (coverage is provided for treatment with up to 100 units per course at minimum intervals of 12 weeks, to a maximum of 3 courses per year)

Practitioner exemptions

  • Physical medicine and rehabilitation specialists may be eligible to enter into a Collaborative Prescribing Agreement (CPA). CPAs are provided by invitation only. Special Authority will identify eligible practitioners who treat a high volume of patients that meet PharmaCare criteria for coverage

Special notes

  1. For renewal requests, physicians must provide documentation of the patient’s functional and/or symptomatic improvement, as well as the dosage and injection schedule
  2. For renewal requests for urinary indications, physicians must provide documentation indicating a ≥50% reduction in the frequency of urinary incontinence episodes from the baseline
  3. Treatment failure is defined as using optimal doses of the indicated number of anticholinergic drug(s) for NDO or anticholinergic drugs and/or mirabegron for OAB, for a minimum of 4 weeks on each drug without a reduction of symptoms
  4. For cases of intolerance to anticholinergics or mirabegron, specific details about the nature and severity of the intolerance must be provided
  5. PharmaCare covers clostridium botulinum neurotoxin type A/onabotulinumtoxinA only for the indications stated above. Coverage cannot be provided for other indications such as migraines or hyperhidrosis

Special Authority request form(s)