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TETRABENAZINE

All products: not a benefit

Other products in the same Health Canada class (N07XX) — coverage varies; not interchangeable

  • Fampridine (Fampyra): not a benefit
  • Riluzole (Rilutek): not a benefit

PMS-Tetrabenazine · DIN 02402424 · 25mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Coverage criteria
Exceptional Access criteria on record are for Brand(s): Nitoman; DOSAGE FORM/ STRENGTH: 25 mg tablet — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange 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: i) 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 ii) 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 106 Tetrabenazine Brand(s): Nitoman DOSAGE FORM/ STRENGTH: 25 mg tablet 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. 107 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 106, record 66, corpus 2025-01-01; name match only, not an eligibility decision
1 brand, same coverage
PMS-Tetrabenazine · DIN 02402424 Manufacturer: Pharmascience Inc.; listing date 2013-04-30 Health Canada: Marketed since 2013-02-26 · brand PMS-TETRABENAZINE · ATC N07XX06 TETRABENAZINE · form Tablet · route Oral · ingredients TETRABENAZINE 25 MG · company Pharmascience inc · schedule Prescription
Check this DIN again · Health Canada product record

PMS-Tetrabenazine: Formulary list price $4.8551/unit (unit not stated in source; not the patient's cost)

Ministry pays: $4.8551 per source unit.

Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.

Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=88726 · Verify on the e-Formulary ↗ (DIN 02402424)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02402424). DIN 02402424: PMS-Tetrabenazine Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 920000447; group id 968; item number 2298; lccId None; manufacturer id PMS Source form: Tab; strength: 25mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $4.8551; ministry $4.8551 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02402424 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=88726
Interchangeable products
Apo-Tetrabenazine · DIN 02407590 · $4.8551 Nitoman · DIN 02199270 · not recorded Tetrabenazine Tablets · DIN 02410338 · $4.8551
Shortage status: resolved shortage (ended 2019-10-31); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02402424
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Other drugs in the same formulary class (92:00 UNCLASSIFIED THERAPEUTIC AGENTS) and how they are covered

Matched class: 92:00 UNCLASSIFIED THERAPEUTIC AGENTS

Drug-class inventory only. Lists recorded Ontario formulary products, not every Canadian medication; does not recommend treatment. Covered without a code on the Ontario formulary: ALENDRONATE & CHOLECALCIFEROL, AZATHIOPRINE, CYCLOSPORINE, GLUCAGON RDNA ORIGIN, LANREOTIDE ACETATE, LEFLUNOMIDE, LEVODOPA & BENSERAZIDE, MYCOPHENOLATE SODIUM Some products covered without a code (check the product listing): ALENDRONATE, ALLOPURINOL, AMANTADINE HCL, BROMOCRIPTINE, CLOPIDOGREL BISULFATE, LEVODOPA & CARBIDOPA, MYCOPHENOLATE MOFETIL, OCTREOTIDE, RISEDRONATE SODIUM, ROPINIROLE, SELEGILINE HCL, TAMSULOSIN HCL 92:00 UNCLASSIFIED THERAPEUTIC AGENTS

RILUZOLE

· 3 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 50mg · Tab

ALENDRONATE

· 28 products · Off-Formulary Interchangeable, not an ODB benefit (4), Listed, not a benefit (1), General benefit (23) · strengths: 5mg, 10mg, 70mg · Tab

ALENDRONATE & CHOLECALCIFEROL

· 6 products · General benefit · strengths: 70mg & 70mcg, 70mg & 140mcg · Tab

ALLOPURINOL

· 10 products · General benefit (6), Listed, not a benefit (4) · strengths: 100mg, 200mg, 300mg · Tab

AMANTADINE HCL

· 5 products · Listed, not a benefit (2), General benefit (3) · strengths: 100mg, 10mg/mL · Cap, O/L

AZATHIOPRINE

· 3 products · General benefit · strengths: 50mg · Tab

BROMOCRIPTINE

· 4 products · Listed, not a benefit (2), General benefit (2) · strengths: 5mg, 2.5mg · Cap, Tab

CLOPIDOGREL BISULFATE

· 19 products · General benefit (16), Off-Formulary Interchangeable, not an ODB benefit (3) · strengths: 75mg, 300mg · Tab

CYCLOSPORINE

· 8 products · General benefit · strengths: 10mg, 25mg, 50mg, 100mg, 100mg/mL · Cap, O/L

GLUCAGON RDNA ORIGIN

· 2 products · General benefit · strengths: 1mg/Vial · Inj Pd-Syr Pk, Inj Pd-Vial Pk

LANREOTIDE ACETATE

· 6 products · General benefit · strengths: 60mg/Syr, 90mg/Syr, 120mg/Syr · ER Pref Syr Pk

LEFLUNOMIDE

· 16 products · General benefit · strengths: 10mg, 20mg · Tab Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 92:00 and 75 more
Full class listing Related classes: Same formulary class, not same indication: class membership alone does not establish equivalent uses.
What the Health Canada label says it is for
INDICATIONS AND CLINICAL USE NITOMAN (tetrabenazine) has been found useful in the treatment of hyperkinetic movement disorders such as Huntington’s chorea, hemiballismus, senile chorea, tic and Gille’s de la Tourette’s syndrome and tardive dyskinesia. Pr NITOMAN® Product Monograph Page 2 of 20 Tetrabenazine is not indicated for the treatment of levodopa-induced dyskinetic/choreiform movements (see WARNINGS). Tetrabenazine should only be used by (or in consultation with) physicians who are experienced in the treatment of hyperkinetic movement disorders. https://pdf.hres.ca/dpd_pm/00058267.PDF PM date: October 1, 2020 Source product: NITOMAN; DIN 02199270; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.

Prepare an Exceptional Access request

SADIE has its own form for many drugs; this checklist prepares the answers; the ministry decides. Open SADIE

Use this text in SADIE’s free-text fields or read from it on a Telephone Request Service call. Review marks do not indicate eligibility. Evidence stays in this page until you copy it; nothing entered here is sent or saved. Do not enter patient identifiers.

EAP Telephone Request Service: The TRS can be accessed by calling toll-free at 1-866-811-9893 or 416-327-8109 (Toronto area) between 8:30 a.m. and 5:00 p.m. Monday through Friday (except holidays) and selecting the TRS option. Source; updated September 15, 2026

EAP fax: In Ontario: 1-866-811-9908 or 416-327-7526 (Toronto area). Outside Ontario: 1-833-905-4260. Source; updated September 15, 2026

Posted turnaround and Telephone Request Service scope
Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days |
For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day.
Source; updated September 15, 2026

Tetrabenazine (Nitoman)

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

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

Ministry criteria corpus 2025-01-01; page 106

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:
i) 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
ii) 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
106 Tetrabenazine Brand(s): Nitoman DOSAGE FORM/ STRENGTH: 25 mg tablet
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.
107

Prepared from the ministry's published criteria; eligibility is decided by the Exceptional Access Program.

Other review policies

For PMS-Tetrabenazine: no applicable EAP criteria are held and no ODB benefit is established. These policies do not establish coverage.

For rare, immediately life-, limb- or organ-threatening circumstances, the Compassionate Review Policy may consider an unfunded drug or indication, subject to its criteria and without bypassing the drug review process. Compassionate Review Policy

Compassionate Review Policy: source quote
Where there are rare clinical circumstances in immediately life, limb, or organ-threatening conditions, the Executive Officer will also consider requests for drugs or indications in situations where there has not been a decision by the Executive Officer to provide funding of the drug or indication as part of the Ontario Drug Benefit program (and the EAP), and the drug or indication requested would not circumvent the established review process for new drugs or indications as part of the drug submission process for listing within the Ontario Drug Benefit program. Requests must meet the criteria for the Compassionate Review Policy.

Ontario source; updated September 15, 2026

For cancer drugs, Case-by-Case Review considers rare, immediately life-threatening circumstances when no satisfactory funded treatment exists; its criteria and application process apply. Case-by-Case Review (cancer drugs)

Case-by-Case Review (cancer drugs): source quote
Note: Requests for cancer drugs are considered under the Case-by-Case Review Program (CBCRP) which is administered by Ontario Health (Cancer Care Ontario) on behalf of the Ministry of Health. The CBCRP considers funding requests for drugs (both oral therapies and injectable drugs) for the treatment of cancer in patients who have a rare clinical circumstance that is immediately life-threatening (death is likely within a matter of months) and who require treatment with an unfunded drug, because there is no other satisfactory and funded treatment. Please refer to the Ontario Health website for information on the application process, FAQs, eligibility criteria and program policies.

Ontario source; updated September 15, 2026