Product Details

Nitoman

Tetrabenazine
25 mg
Tablet


DIN/PIN/NPN

02199270

Manufacturer

Valeant Canada Ltd.

Formulary Listing Date

2013-04-30  

Unit Price

NA

Amount MOH Pays

NA

Coverage Status

Off-Formulary Interchangeable Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

N07XX06

Interchangeable Products

DIN/ PIN/ NPN Brand name Unit Price Amount MOH pays
02410338 Tetrabenazine Tablets 4.8551 4.8551
02402424 PMS-Tetrabenazine 4.8551 4.8551
02199270 Nitoman NA NA
02407590 Apo-Tetrabenazine 4.8551 4.8551
 

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Central Nervous System Drugs

Tetrabenazine

  • Brand(s): Nitoman
  • Dosage Form/Strength: 25 mg tablet

For the treatment of Hungtington’s chorea, tic and Gille’s de la Toureet syndrome and tardive dyskinesia in patients meeting the following criteria: 

  1. is prescribed by (or in consultation with) physicians who are experienced in the treatment of hyperkinetic movement disorders (e.g., specialists practicing in a Movement Disorder Clinic, neurologists, psychiatrists, physiatrists, geriatricians, pediatricians); AND 

  1. have disabling Huntington’s chorea OR tic and Gille’s de la Tourette syndrome and have documented evidence of failure to respond, intolerable side effects or contraindication to at least one agent presently available on the Formulary. 

**Note that for patients with disabling tardive dyskinesia, a trial of a Formulary agent is NOT required (i.e., tetrabenazine can be considered for use as a first-line agent) 

Duration of Approval: 1 year 

Renewals will be considered for patients whose request is prescribed by (or in consultation with) physicians who are experienced in the treatment of hyperkinetic movement disorders (e.g., specialists practicing in a Movement Disorder Clinic, neurologists, psychiatrists, physiatrists, geriatricians, pediatricians); AND who provide written confirmation that movements and functional status are stabilized on tetrabenazine therapy. 

Duration of Approval: 5 years

For the treatment of Hemiballismus, senile chorea, or other disabling hyperkinetic movement disorders (HKMD) will be considered on a case-by-case basis in patients meeting the following criteria: 

  • is prescribed by (or in consultation with) physicians who are experienced in the treatment of hyperkinetic movement disorders (e.g., specialists practicing in a Movement Disorder Clinic, neurologists, psychiatrists, physiatrists, geriatricians, pediatricians); AND 

  • have documented evidence of failure to respond, intolerable side effects or contraindication to at least one agent presently available on the Formulary. 

Duration of Approval: 1 year 

Renewals will be considered for patients whose request is prescribed by (or in consultation with) physicians who are experienced in the treatment of hyperkinetic movement disorders (e.g., specialists practicing in a Movement Disorder Clinic, neurologists, psychiatrists, physiatrists, geriatricians, pediatricians); AND who provide written confirmation that movements and functional status are stabilized on tetrabenazine therapy. 

Duration of Approval: 5 years 

Please note that information MUST BE provided about why a patient has not tried or cannot try a formulary alternative. 

Requests not meeting the above criteria for HKMD will be considered through a case-by-case review and the physician must provide adequate clinical information to enable this assessment.

EAP Drug Request Form:
Standard Form for EAP Drug Requests

Product Monograph

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