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METHADONE HCL

All products: not a benefit

Apo-Methadone · DIN 02533650 · 5mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-19
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): Metadol; DOSAGE FORM/ STRENGTH: 1 mg, 5 mg, 10 mg, 25 mg tablets, 1 mg/mL oral — 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 Methadone Brand(s): Metadol DOSAGE FORM/ STRENGTH: 1 mg, 5 mg, 10 mg, 25 mg tablets, 1 mg/mL oral solution, 10 mg/mL oral concentrate solution For the treatment of cancer and non-cancer pain in patients who cannot tolerate, or have failed treatment with a listed long-acting opioid. The CED noted that there is a potential for drug interactions with the use of methadone resulting from inhibition of drug metabolism (via CYP 3A4 inhibition; e.g. QT prolongation with certain antibiotics). The requesting physician is asked to ensure that this issue is addressed with the patient. Duration of Approval 1 Year Renewals will be considered on a case-by-case basis. For renewals, the requesting physician is asked to provide details of the patient’s clinical response to therapy and additional information pertaining to the current medications and addition or stoppage of other pain medications in the prior year of methadone use. Please specify the dosages and dosing frequency of current medications and provide reasons for any changes in the medication regimen. EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 403, record 232, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Metadol; DOSAGE FORM/ STRENGTH: 1 mg/mL oral liquid, 10 mg/mL oral liquid, 1 mg, 5 mg, — 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 Methadone Brand(s): Metadol DOSAGE FORM/ STRENGTH: 1 mg/mL oral liquid, 10 mg/mL oral liquid, 1 mg, 5 mg, 10 mg 25 mg If traditional narcotic analgesics fail to control pain or lead to side effects. Standard Approval Duration: 12 months EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 474, record 312, corpus 2025-01-01; name match only, not an eligibility decision
1 brand, same coverage
Apo-Methadone · DIN 02533650 Manufacturer: Apotex Inc.; listing date 2024-04-30 Health Canada: Marketed since 2024-03-08 · brand APO-METHADONE · ATC N07BC02 METHADONE · form Tablet · route Oral · ingredients METHADONE HYDROCHLORIDE 5 MG · company Apotex inc · schedule Narcotics (cdsa i)
Check this DIN again · Health Canada product record

Apo-Methadone: Formulary list price $0.3417/unit (unit not stated in source; not the patient's cost)

Ministry pays: $0.3417 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=102262 · Verify on the e-Formulary ↗ (DIN 02533650)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02533650). DIN 02533650: Apo-Methadone Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 280808143; group id 407; item number 0984; lccId None; manufacturer id APX Source form: Tab; strength: 5mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $0.3417; ministry $0.3417 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02533650 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102262
Interchangeable products
Metadol · DIN 02247699 · $0.3417
Shortage status: not checked (no credentials)
Other drugs in the same formulary class (28:08:08 Opiate Agonists) and how they are covered

Matched class: 28:08:08 Opiate Agonists

Drug-class inventory only. Lists recorded Ontario formulary products, not every Canadian medication; does not recommend treatment. Some products covered without a code (check the product listing): ACETAMINOPHEN & CAFFEINE & CODEINE PHOSPHATE, ACETAMINOPHEN & CODEINE PHOSPHATE, CODEINE PHOSPHATE, HYDROMORPHONE HCL, MORPHINE SULFATE, OXYCODONE HCL & ACETAMINOPHEN, OXYCODONE HCL & ACETYLSALICYLIC ACID 28:08:08 Opiate Agonists

ACETAMINOPHEN & CAFFEINE & CODEINE PHOSPHATE

· 4 products · General benefit (2), Listed, not a benefit (2) · strengths: 300mg & 15mg & 15mg, 300mg & 15mg & 30mg · Tab

ACETAMINOPHEN & CODEINE PHOSPHATE

· 6 products · General benefit (3), Listed, not a benefit (3) · strengths: 160mg & 8mg/5mL, 300mg & 30mg, 300mg & 60mg · O/L, Tab

CODEINE PHOSPHATE

· 3 products · General benefit (2), Listed, not a benefit (1) · strengths: 15mg, 30mg · Tab

HYDROMORPHONE HCL

· 28 products · General benefit (21), Listed, not a benefit (3), General benefit; DIN status E (meaning unconfirmed); confirm discontinuation/availability with Health Canada (4) · strengths: 4.5mg, 9mg, 3mg, 6mg, 12mg, 18mg, 2mg/mL, 10mg/mL, 1mg/mL, 1mg, 2mg, 4mg, 8mg · CR Cap, Inj Sol-1mL Pk, Oral Sol, Tab

MORPHINE SULFATE

· 35 products · General benefit (31), Listed, not a benefit (1), Off-Formulary Interchangeable, not an ODB benefit (3) · strengths: 10mg, 15mg, 30mg, 60mg, 100mg, 2mg/mL, 10mg/mL, 15mg/mL, 50mg/mL, 20mg, 50mg, 200mg, 5mg · ER Cap, Inj Sol Amp, Inj Sol-1mL Pk, SR Cap, SR Tab, Tab

OXYCODONE HCL & ACETAMINOPHEN

· 5 products · General benefit (4), Listed, not a benefit (1) · strengths: 5mg & 325mg · Tab

OXYCODONE HCL & ACETYLSALICYLIC ACID

· 2 products · General benefit (1), Listed, not a benefit (1) · strengths: 5mg & 325mg · Tab

CODEINE SULFATE TRIHYDRATE & MONOHYDRATE

· 4 products · Limited Use, codes 201 · strengths: 50mg, 100mg, 150mg, 200mg · CR Tab

FENTANYL TRANSDERMAL SYSTEM

· 22 products · Listed, not a benefit (6), Limited Use, codes 511 (6), Limited Use, codes 689 (2), Off-Formulary Interchangeable, not an ODB benefit (8) · strengths: 12mcg/hr, 25mcg/hr, 50mcg/hr, 75mcg/hr, 100mcg/hr · Trans Patch

ACETYLSALICYLIC ACID & BUTALBITAL & CAFFEINE

· 3 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 330mg & 50mg & 40mg · Cap

ACETYLSALICYLIC ACID & BUTALBITAL & CAFFEINE & CODEINE PHOSPHATE

· 6 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 330mg & 50mg & 40mg & 15mg, 330mg & 50mg & 40mg & 30mg · Cap

OXYCODONE HCL

· 9 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 5mg, 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 28:08:08 and 2 more
Full class listing Related classes: 28:08:04 Nonsteroidal Anti-Inflammatory Agents, 28:08:12 Opiate Partial Agonists, 28:08:92 Miscellaneous Analgesics and Antipyretics, 28:16:04 Antidepressants, 28:16:08 Tranquilizers, 28:16:12 Other Psychotropics, 28:36:08 Anticholinergic Agents, 28:36:20 Dopamine Receptor Agonists Same formulary class, not same indication: class membership alone does not establish equivalent uses.
What the Health Canada label says it is for
1 INDICATIONS METADOL-D (methadone hydrochloride oral solution and oral concentrate) is indicated in adult patients for: • the detoxification treatment of opioid addiction (heroin or other morphine-like drugs); as well as the maintenance treatment of opioid addiction (heroin or other morphine-like drugs). Patients prescribed METADOL-D should be carefully monitored within a framework of medical, social and psychological support as part of a comprehensive opioid dependence treatment program. METADOL-D is not indicated as an as-needed (prn) analgesic. NOTE: If methadone is administered for treatment of heroin dependence for more than 180 days, the procedure passes from treatment of the acute withdrawal syndrome (detoxification) to maintenance therapy. 1.1 Pediatrics Pediatric (< 18 years of age): No data are available to Health Canada. Therefore, Health Canada has not authorized an indication for pediatric use. 1.2 Geriatrics Geriatrics (> 65 years of age): The safety and efficacy of METADOL-D in patients 65 years and older have not been established. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the … https://pdf.hres.ca/dpd_pm/00083767.PDF PM date: MAR 5, 2026 Source product: METADOL-D; DIN 02244290; 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

Methadone (Metadol)

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 cancer and non-cancer pain in patients who cannot tolerate, or have failed treatment with a listed long-acting opioid.

Ministry criteria corpus 2025-01-01; page 403

Methadone Brand(s): Metadol DOSAGE FORM/ STRENGTH: 1 mg, 5 mg, 10 mg, 25 mg tablets, 1 mg/mL oral solution, 10 mg/mL oral concentrate solution
For the treatment of cancer and non-cancer pain in patients who cannot tolerate, or have failed treatment with a listed long-acting opioid.
The CED noted that there is a potential for drug interactions with the use of methadone resulting from inhibition of drug metabolism (via CYP 3A4 inhibition; e.g. QT prolongation with certain antibiotics). The requesting physician is asked to ensure that this issue is addressed with the patient.
Duration of Approval 1 Year
Renewals will be considered on a case-by-case basis.
For renewals, the requesting physician is asked to provide details of the patient’s clinical response to therapy and additional information pertaining to the current medications and addition or stoppage of other pain medications in the prior year of methadone use. Please specify the dosages and dosing frequency of current medications and provide reasons for any changes in the medication regimen.

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

Methadone (Metadol)

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: See the ministry wording below; no separate indication heading is held.

Ministry criteria corpus 2025-01-01; page 474

Methadone Brand(s): Metadol DOSAGE FORM/ STRENGTH: 1 mg/mL oral liquid, 10 mg/mL oral liquid, 1 mg, 5 mg, 10 mg 25 mg
If traditional narcotic analgesics fail to control pain or lead to side effects.
Standard Approval Duration: 12 months

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

Other review policies

For Apo-Methadone: 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