Product Details
Botox
Botulinum Toxin Type A50 U/Vial
Powder for Injection
50-U Vial (Preservative-Free)
DIN/PIN/NPN
02531577
Manufacturer
AbbVie Corporation
Formulary Listing Date
2023-06-30
Unit Price
187.4300
Amount MOH Pays
187.4300
Coverage Status
Limited Use Product
ODB Formulary Therapeutic Classification
Therapeutic Note
NO
ATC Code
M03AX01
Interchangeable Products
NOLU Clinical Criteria
LU Code | Auth. Period | Clinical Criteria |
---|---|---|
Note: CAUTION: Botox should be administered personally by a urologist, pediatrician, neurologist, physical medicine specialist or a physician with equivalent post-graduate training and experience with neuromuscular or urological disorders as appropriate. | ||
10 | 1 year | For the treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in patients 12 years of age or older |
130 | 1 year | To reduce the subjective symptoms and objective signs of cervical dystonia (spasmodic torticollis) in adults |
412 | 1 year | For the management of focal spasticity, due to stroke or spinal cord injury in adults |
413 | 1 year | For the treatment of focal spasticity secondary to cerebral palsy in patients two years of age or older |
440 | 1 year | For adult patients with urinary incontinence due to neurogenic detrusor overactivity resulting from neurogenic bladder associated with multiple sclerosis or subcervical spinal cord injury who fail to respond to behavioural medication and anticholinergics and/or are intolerant to anticholinergics. The recommended dose is 200U injected into the detrusor muscle. Subsequent injections should be provided at intervals of no less than every 36 weeks and patients who fail to respond to initial treatment with Botulinum Toxin Type A should not be retreated |
460 | 1 year | For adult patients with urinary frequency, urgency or urge incontinence due to overactive bladder who have: Failed to respond to behavioral techniques AND had an inadequate response or intolerance to adequate trials (i.e., at least 2 weeks at the maximum tolerated dose) of at least two medications for overactive bladder (e.g., anticholinergics, mirabegron). The recommended dose is 100U injected into the detrusor muscle. Notes: -Patients who fail to achieve a reduction of greater than 50 percent in the frequency of urinary incontinence episodes with 1 dose should not be retreated. -Maximum 3 doses per year in responders, at a frequency of no more than once every 12 weeks. -Patients must have a post-void residual (PVR) urine volume of less than 150mL |
EAP Criteria
Therapeutic Class | Reimbursement Criteria |
---|---|
Migraine Drugs | Onabotulinum Toxin A
For the prophylaxis of headaches in adults meeting the following criteria for funding:
1Failure is defined as no therapeutic or unsatisfactory effect (Less than a 30% reduction in frequency of headache days) to an adequate dose and duration of 3 prophylactic therapies2 where two treatments must be of different types/classes. Contraindication or intolerable side effects necessitating discontinuation will be considered for 1 of the 3 drugs only. 2Prophylactic therapies to be considered include:
Requests should contain the following information:
Dosing: As per product monograph Notes regarding continued therapy with “Botox”:
An adequate treatment response is defined as a ≥ 50% reduction in frequency of headache days per month Duration of Approval: 1 year Renewal criteria:
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