Product Details

Botox

Botulinum Toxin Type A
200 U/Vial
Powder for Injection
200-U Vial (Preservative-Free)

DIN/PIN/NPN

09857387

Manufacturer

AbbVie Corporation

Formulary Listing Date

2011-08-04  

Unit Price

749.7000

Amount MOH Pays

749.7000

Coverage Status

Discontinued Drug Limited Use Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

M03AX01

Interchangeable Products

NO  

LU 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

  • Brand(s): Botox
  • Dosage Form/Strength: 50 U/Vial, 100 U/Vial, 200 U/vial

For the prophylaxis of headaches in adults meeting the following criteria for funding:

  1. Patient with chronic migraine (defined as ≥15 days per month with continuous headache lasting ≥4 hours AND at least 4 distinct headache episodes each lasting ≥4 hours); AND

  2. Patient has failed1 three or more prior oral prophylactic medications2; AND

  3. Request for Botox to treat migraine must be provided by a physician with specialty training in the management of headache. Administration should only be given by physicians with the appropriate qualifications and experience in the treatment, use, and proper administration of Botox for headaches. 

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: 

  • Beta blockers 

  • Tricyclic antidepressants 

  • Verapamil or flunarizine 

  • Sodium valproate (or divalproex sodium) 

  • Topiramate 

  • Gabapentin 

Requests should contain the following information: 

  • Objective measure of baseline headache days and response to other prophylactic medications (i.e., headache diary) 

  • List of previously tried prophylactic medications, including doses and duration as well as why they were discontinued 

  • Confirmation of specialty training in the management of headache.

Dosing: As per product monograph 

Notes regarding continued therapy with “Botox”: 

  1. Patients who have not obtained an adequate treatment response after 2 treatment cycles should be discontinued from further therapy. 

  1. Patients who obtain an adequate response and who transition from chronic migraine to episodic migraine should be discontinued from therapy within 3 months of that transition. 

An adequate treatment response is defined as a ≥ 50% reduction in frequency of headache days per month 

Duration of Approval: 1 year 

Renewal criteria: 

  • Objective evidence (i.e., headache diary) that the patient has obtained an adequate treatment response defined as a ≥ 50% reduction in frequency of headache days per month; AND 

  • Confirmation that the patient has not transitioned from chronic migraine to episodic migraine. Therapy will be reimbursed for a maximum of 3 months after transition from chronic migraine to episodic migraine. 

  • Consideration will be given for renewals in patients who had an initial adequate response to Botox, discontinued therapy and subsequently transitioned back to chronic migraine status. 

Duration of Approval: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

View Monograph