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Ontario coverage, price, criteria word for word, Health Canada status and shortages for one product

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METHOTREXATE

All injection strengths: not a benefit

Other products in the same Health Canada class (L01B) — coverage varies; not interchangeable

  • Capecitabine (Xeloda): general benefit
  • Fluorouracil + salicylic acid (Actikerall): general benefit
  • Mercaptopurine (Purinethol): general benefit
  • Thioguanine (Lanvis): general benefit
  • Fludarabine (Fludara): limited Use 424, 379

Methotrexate · DIN 02170671 · 50mg/2mL · injection solution-2mL Pk

Listed, not a benefit; Health Canada lists this DIN as Cancelled post market since 2011-05-03 — choose a marketed DIN from the same-category list.Discontinued 2011-05-03 · checked 2026-09-02
StatusListed, not a benefit; Health Canada lists this DIN as Cancelled post market since 2011-05-03 — choose a marketed DIN from the same-category list.
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives; Health Canada lists this DIN as Cancelled post market since 2011-05-03 — choose a marketed DIN from the same-category list.
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.
Brand vs generic price
Lowest DBP recovery rule under medically necessary no-substitution claims: 6.2 Medically Necessary "No Substitution" Claims The Side Effect Reporting Form will not have to be renewed. However, the pharmacy must maintain a copy of the prescription that contains a direction that there be no substitution and the required Health Canada Side Effect Reporting Form (completed and signed by the prescriber). The prescriber must write “No Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will be reimbursed the DBP plus a mark-up and the lesser of the posted usual and customary fee or the ODB dispensing fee minus the applicable ODB co-payment amount. Where a completed Side Effect Reporting Form is not available at the pharmacy during an inspection, the difference between the cost of the higher-cost product and the lowest DBP listed for the interchangeable category will be recovered. (ontario.ca, Revision #17; 2026-08-03 ↗) 6.2 Medically Necessary "No Substitution" Claims The Ministry will provide reimbursement of a higher-cost interchangeable product in medically necessary circumstances where a patient has experienced a significant adverse reaction with two (2) lower-cost interchangeable drug products, where available. When a prescriber identifies a patient for which it is medically necessary that a higher cost interchangeable product be provided, the prescriber must: • Complete, sign and forward to the pharmacist a copy of the Health Canada side effect reporting form for each lower-cost interchangeable drug product trialed (Side Effect Reporting Form[s]); and • Write “No Substitution” or “No Sub” on a written prescription or indicate “No Substitution” to the pharmacist in the case of a verbal prescription. The prescriber should keep a copy of the completed form in the patient’s record for future use and reference. In the case of a written prescription, when the pharmacist or dispensing physician receives a prescription with the written notation “No Substitution” or “No Sub”, reimbursement will be provided for the higher-cost interchangeable product only if the prescription is accompanied by a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed. This form must be completely filled out noting the details of the adverse reaction and signed by the prescriber. In the case of a verbal prescription, the prescriber must satisfy the operator of the pharmacy or dispensing physician that a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed has been completed and signed by the prescriber. A written record of this verbal prescription and the completed Health Canada Side Effect Reporting Form must be received by the pharmacy prior to claim submission. Upon receipt, the pharmacist must: • Fax, submit online or mail the completed and signed form to Health Canada’s Canada Vigilance Program; and • Retain his or her copy of the completed and signed Side Effect Reporting Form. (ontario.ca, Revision #17; 2026-08-03 ↗)
1 brand, same coverage
Methotrexate · DIN 02170671 Manufacturer: Wyeth Pharmaceuticals; listing date 1998-03-17 Health Canada: Cancelled post market since 2011-05-03 · brand METHOTREXATE · ATC L01BA01 METHOTREXATE · form Solution · route Intra-arterial, Intravenous, Intramuscular · ingredients METHOTREXATE 25 MG/ML · company Pfizer canada ulc · schedule Prescription
Check this DIN again · Health Canada product record

Methotrexate: Formulary list price not recorded/unit (unit not stated in source; not the patient's cost)

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=44160 · Verify on the e-Formulary ↗ (DIN 02170671)

Source record
DIN 02170671: Methotrexate Raw flags: notABenefit=Y, sec3=Y Item: 100000032; group id 175; item number 0308; lccId None; manufacturer id WAY Source form: Inj Sol-2mL Pk; strength: 50mg/2mL Recorded listing: Listed, not a benefit; ODB pays only for the benefit products in this interchangeable category Source prices (unrounded): not recorded; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02170671 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=44160
Interchangeable products
Methotrexate · DIN 02182777 · $8.9200 Methotrexate Injection BP · DIN 02464365 · $8.9200
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02170671
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Health Canada lists this DIN as Cancelled post market since 2011-05-03 — choose a marketed DIN from the same-category list.
Other drugs in the same formulary class (10:00 ANTINEOPLASTIC AGENTS) and how they are covered

Matched class: 10:00 ANTINEOPLASTIC 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: ABIRATERONE ACETATE, ALTRETAMINE, ANASTROZOLE, BUSERELIN ACETATE, BUSULFAN, CAPECITABINE, CHLORAMBUCIL, CYPROTERONE ACETATE, DAUNORUBICIN, DEGARELIX ACETATE, ETOPOSIDE, EXEMESTANE, FLUOROURACIL & SALICYLIC ACID, FULVESTRANT, GOSERELIN ACETATE, HYDROXYUREA, IMATINIB MESYLATE, LETROZOLE, LEUPROLIDE ACETATE, MELPHALAN, MERCAPTOPURINE, MITOTANE, PROCARBAZINE HCL, TEMOZOLOMIDE, THIOGUANINE, TRIPTORELIN PAMOATE Some products covered without a code (check the product listing): BICALUTAMIDE, CYCLOPHOSPHAMIDE, FLUTAMIDE, LOMUSTINE (CCNU), MEGESTROL ACETATE, TAMOXIFEN CITRATE, VINCRISTINE SULFATE 10:00 ANTINEOPLASTIC AGENTS

CAPECITABINE

· 15 products · General benefit · strengths: 150mg, 500mg · Tab

FLUOROURACIL & SALICYLIC ACID

· 1 products · General benefit · strengths: 0.5% w/w & 10% w/w · Top Sol

MERCAPTOPURINE

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

THIOGUANINE

· 1 products · General benefit · strengths: 40mg · Tab

FLUDARABINE PHOSPHATE

· 1 products · Limited Use, codes 424, 379 · strengths: 10mg · Tab

ABIRATERONE ACETATE

· 18 products · General benefit · strengths: 250mg, 500mg · Tab

ALTRETAMINE

· 1 products · General benefit · strengths: 50mg · Cap

ANASTROZOLE

· 17 products · General benefit · strengths: 1mg · Tab

BICALUTAMIDE

· 9 products · Listed, not a benefit (1), General benefit (8) · strengths: 50mg · Tab

BUSERELIN ACETATE

· 4 products · General benefit · strengths: 6.3mg, 9.45mg, 1mg/mL · Implant Kit, Inj Sol-5.5mL Pk, Nas Sp-10mL Pk

BUSULFAN

· 1 products · General benefit · strengths: 2mg · Tab

CHLORAMBUCIL

· 1 products · General benefit · strengths: 2mg · Tab Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 10:00 and 34 more
Full class listing Related classes: Same formulary class, not same indication: class membership alone does not establish equivalent uses.
Other drugs whose Health Canada label lists a similar indication: neoplastic diseases, psoriasis, psoriatic arthritis, rheumatoid arthritis
From Health Canada product monographs; label wording only, not a treatment recommendation. Matching is lexical and uses one held product label per generic; formulations and qualifying criteria may differ. Covered without a code on the Ontario formulary: ACITRETIN BIMEKIZUMAB · Limited Use, codes 641 Indications Bimzelx (bimekizumab injection) is indicated for: • Psoriasis (PsO) The treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. PM: https://pdf.hres.ca/dpd_pm/00082779.PDF; date 2025-12-12; DIN 02525267; fetched 2026-09-10 Product monograph • Psoriasis (PsO) The treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. PM: https://pdf.hres.ca/dpd_pm/00082779.PDF; date 2025-12-12; DIN 02525267; fetched 2026-09-10 Product monograph • Psoriatic arthritis (PsA) The treatment of adult patients with active psoriatic arthritis. Bimzelx can be used alone or in combination with a conventional non-biologic disease-modifying antirheumatic drug (cDMARD) (e.g., methotrexate). PM: https://pdf.hres.ca/dpd_pm/00082779.PDF; date 2025-12-12; DIN 02525267; fetched 2026-09-10 Product monograph ACITRETIN · General benefit 1 INDICATIONS SORIATANE (acitretin) is indicated for: • Severe psoriasis (includes erythrodermic and pustular types) • Other disorders of keratinization Severe psoriasis is a condition that involves more than 10% of body surface area or is physically, occupationally or psychologically disabling. PM: https://pdf.hres.ca/dpd_pm/00080165.PDF; date APR 04, 2025; DIN 02070847; fetched 2026-09-10 Product monograph ADALIMUMAB · Limited Use, codes 600, 601, 602, 603, 604, 605, 606, 607, 609, 611 (23), Limited Use, codes 600, 602, 603, 604, 605, 606, 607, 609, 633, 634 (7) Indications AMGEVITA is indicated for: Rheumatoid Arthritis • reducing the signs and symptoms, inducing major clinical response and clinical remission, inhibiting the progression of structural damage and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA). PM: https://pdf.hres.ca/dpd_pm/00085868.PDF; date not captured; DIN 02459299; fetched 2026-09-10 Product monograph APREMILAST · Off-Formulary Interchangeable, not an ODB benefit Indications • Plaque Psoriasis OTEZLA (apremilast) is indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. PM: https://pdf.hres.ca/dpd_pm/00084256.PDF; date 2026-04-10; DIN 02434318; fetched 2026-09-10 Product monograph BARICITINIB · Limited Use, codes 615, 734 (1), Limited Use, codes 734 (1) 1 INDICATIONS OLUMIANT (baricitinib tablets) is indicated for: Rheumatoid Arthritis (RA) • In combination with methotrexate (MTX), for reducing the signs and symptoms of moderate to severe rheumatoid arthritis (RA) in adult patients who have responded inadequately to one or more disease-modifying anti-rheumatic drugs (DMARDs). PM: https://pdf.hres.ca/dpd_pm/00074394.PDF; date not captured; DIN 02480018; fetched 2026-09-10 Product monograph CYCLOSPORINE · Off-Formulary Interchangeable, not an ODB benefit (2), General benefit (8) Psoriasis NEORAL capsules and oral solution (cyclosporine) are indicated for the treatment of severe psoriasis in patients for whom conventional therapy is ineffective or inappropriate. PM: https://pdf.hres.ca/dpd_pm/00085584.PDF; date 2026-07-30; DIN 02150662; fetched 2026-09-10 Product monograph ETANERCEPT · Limited Use, codes 512, 513, 514, 563, 591 (3), Limited Use, codes 498, 499, 514, 563, 591 (4) • treatment of adult patients with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy. PM: https://pdf.hres.ca/dpd_pm/00083562.PDF; date August 31, 2016; DIN 02455323; fetched 2026-09-10 Product monograph HYDROCORTISONE · General benefit (6), Temporary benefit (1), Listed, not a benefit (2) • Neoplastic Diseases: For palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood. PM: https://pdf.hres.ca/dpd_pm/00082414.PDF; date OCT 20, 2025; DIN 00030910; fetched 2026-09-10 Product monograph INFLIXIMAB · Limited Use, codes 468, 469, 470, 471, 477, 478, 479 (2), Limited Use, codes 541, 542, 543, 544, 545, 546, 547 (1), Limited Use, codes 715, 716, 718 (2), Limited Use, codes 592, 593, 594, 595, 596, 597, 598 (1) • treatment of adult patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy. For patients with chronic moderate plaque psoriasis, RemdantryTM should be used after phototherapy has been shown to be ineffective or inappropriate. When assessing the severity of psoriasis, the health professional should consider the extent of involvement, location of lesions, response to previous treatments, and impact of disease on the patient’s PM: https://pdf.hres.ca/dpd_pm/00081840.PDF; date September 2, 2025; DIN 02419475; fetched 2026-09-10 Product monograph RISANKIZUMAB · Limited Use, codes 574 Indications SKYRIZI (risankizumab injection) is indicated for: • the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. PM: https://pdf.hres.ca/dpd_pm/00085642.PDF; date 2026-07-08; DIN 02519283; fetched 2026-09-10 Product monograph and 2 more Coverage source: ON formulary extract 2026-08-26
What the Health Canada label says it is for
1 INDICATIONS pms-METHOTREXATE is indicated for Neoplastic diseases: • Choriocarcinoma: Methotrexate – as single chemotherapy or in combination with other drugs. • Acute Lymphoblastic Leukemia – as maintenance therapy. • Head and Neck Cancer – in combination with other chemotherapies. • Metastasis of unknown primary – as palliative combination chemotherapy. • Burkitt's lymphoma. • Advanced stages of childhood lymphoma (III and IV, St. Jude's Childrens’d Research Hospital Staging System). • Advanced cases of mycosis fungoides (cutaneous T-cell lymphoma). pms-METHOTREXATE is indicated as a Disease Modifying Antirheumatic Drug (DMARD) in the following diseases where standard therapeutic interventions fail: • Severe disabling psoriasis/psoriatic arthritis • Severe disabling rheumatoid arthritis (RA) • Severe disabling seronegative arthritides. In the treatment of psoriasis, pms-METHOTREXATE should be restricted to severe recalcitrant, disabling psoriasis, which is not adequately responsive to other forms of therapy, but only when the diagnosis has been established after dermatologic consultation. 1.1 Pediatrics Pediatrics (<18 y… https://pdf.hres.ca/dpd_pm/00078227.PDF PM date: JAN 08, 2025 Source product: PMS-METHOTREXATE; DIN 02170698; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.

Other review policies

For Methotrexate: 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