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

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APREMILAST

All products: not a benefit

Other products in the same Health Canada class (L04A) — coverage varies; not interchangeable

  • Adalimumab (Hyrimoz): limited Use 600, 601, 602, 603, 604, 605, 606, 607, 609, 611, Limited Use 600, 602, 603, 604, 605, 606, 607, 609, 633, 634
  • Etanercept (Erelzi): limited Use 498, 499, 514, 563, 591, Limited Use 512, 513, 514, 563, 591
  • Infliximab (Remdantry): limited Use 468, 469, 470, 471, 477, 478, 479, Limited Use 541, 542, 543, 544, 545, 546, 547, Limited Use 592, 593, 594, 595, 596, 597, 598, Limited Use 715, 716, 718
  • Tocilizumab (Tyenne): limited Use 697, 698, 720, Limited Use 697, 698, 720, 721
  • Tofacitinib (Xeljanz): limited Use 480, 589, 743, Limited Use 589
  • Tofacitinib (Xeljanz XR): limited Use 565

1 more in the class list below

Apo-Apremilast · DIN 02538180 · 30mg · 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.
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
Apo-Apremilast · DIN 02538180 Manufacturer: Apotex Inc.; listing date 2023-09-28 Health Canada: Marketed since 2023-09-28 · brand APO-APREMILAST · ATC L04AA32 APREMILAST · form Tablet · route Oral · ingredients APREMILAST 30 MG · company Apotex inc · schedule Prescription
Check this DIN again · Health Canada product record

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=102693 · Verify on the e-Formulary ↗ (DIN 02538180)

Source record
DIN 02538180: Apo-Apremilast Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 923600040; group id 1020; item number 2364; lccId None; manufacturer id APX Source form: Tab; strength: 30mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit Source prices (unrounded): $18.7238; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02538180 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102693
Interchangeable products
Auro-Apremilast · DIN 02524104 · not recorded GLN-Apremilast · DIN 02518910 · not recorded Jamp Apremilast · DIN 02528959 · not recorded Mint-Apremilast · DIN 02525747 · not recorded Otezla · DIN 02434334 · not recorded PMS-Apremilast · DIN 02521733 · not recorded Sandoz Apremilast · DIN 02529084 · not recorded
Shortage status: not checked (no credentials)
Other drugs in the same formulary class (92:36 Disease-Modifying Antirheumatic Agents) and how they are covered

Matched class: 92:36 Disease-Modifying Antirheumatic Agents

Drug-class inventory only. Lists recorded Ontario formulary products, not every Canadian medication; does not recommend treatment. No displayed product is listed as a general benefit in this extract. Check its listing requirements below. 92:36 Disease-Modifying Antirheumatic Agents

ADALIMUMAB

· 30 products · 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) · strengths: 20mg/0.2mL, 40mg/0.4mL, 20mg/0.4mL, 40mg/0.8mL, 80mg/0.8mL · Inj Sol-0.2mL Pref Syr (Preservative-Free), Inj Sol-0.4mL Autoinj (Preservative-Free), Inj Sol-0.4mL Pref Autoinj Pen (Preservative-Free), Inj Sol-0.4mL Pref Autoinj Syr (Preservative-Free), Inj Sol-0.4mL Pref Pen (Preservative-Free), Inj Sol-0.4mL Pref Syr (Preservative-Free), Inj Sol-0.8mL Pref Autoinj (Preservative-Free), Inj Sol-0.8mL Pref Pen (Preservative-Free), Inj Sol-0.8mL Pref Syr (Preservative-Free)

ETANERCEPT

· 7 products · Limited Use, codes 512, 513, 514, 563, 591 (3), Limited Use, codes 498, 499, 514, 563, 591 (4) · strengths: 25mg/0.5mL, 50mg/mL · Inj Sol-0.5mL Pref Syr Pk, Inj Sol-1mL Pref Syr Pk, Inj Sol-1mL Prefilled SensoReady Pen Pk, Inj Sol-Pref Autoinj Pen, Inj Sol-Pref Syr, Sol- Pref AutoInj

INFLIXIMAB

· 6 products · 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) · strengths: 100mg/Vial, 120mg/mL · Inj Pd-Vial Pk, Inj Sol-1mL Pref Pen Pk (Preservative-Free), Inj Sol-1mL Pref Syr Pk (Preservative-Free), Pd for Sol-Vial Pk

TOCILIZUMAB

· 10 products · Limited Use, codes 697, 698, 720 (6), Limited Use, codes 697, 698, 720, 721 (4) · strengths: 200mg/10mL, 400mg/20mL, 80mg/4mL, 162mg/0.9mL · Inj Sol-10mL Vial Pk, Inj Sol-10mL Vial Pk (Preservative-Free), Inj Sol-20mL Vial Pk, Inj Sol-20mL Vial Pk (Preservative-Free), Inj Sol-4mL Vial Pk, Inj Sol-4mL Vial Pk (Preservative-Free), Inj Sol-Pref Autoinj, Inj Sol-Pref Autoinj (Preservative-Free), Inj Sol-Pref Syr, Inj Sol-Pref Syr (Preservative-Free)

TOFACITINIB

· 10 products · Limited Use, codes 480, 589, 743 (6), Limited Use, codes 589 (4) · strengths: 5mg, 10mg · Tab

TOFACITINIB CITRATE

· 2 products · Limited Use, codes 565 · strengths: 11mg · ER Tab

UPADACITINIB

· 3 products · Limited Use, codes 637, 684 (1), Limited Use, codes 684 (2) · strengths: 15mg, 30mg, 45mg · ER Tab Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 92:36
Full class listing Related classes: 92:20 Biologic Response Modifiers, 92:44 Immunosuppressive Agents, 92:92 Other Miscellaneous Therapeutic Agents Same formulary class, not same indication: class membership alone does not establish equivalent uses.
Other drugs whose Health Canada label lists a similar indication: active psoriatic arthritis, psoriasis
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 SECUKINUMAB · Limited Use, codes 476 Indications COSENTYX® (secukinumab injection/secukinumab for injection) is indicated for: Adult patients Plaque psoriasis COSENTYX is indicated for 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/00080972.PDF; date not captured; DIN 02529653; fetched 2026-09-10 Product monograph Psoriatic arthritis COSENTYX is indicated for the treatment of adult patients with active psoriatic arthritis when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate. PM: https://pdf.hres.ca/dpd_pm/00080972.PDF; date not captured; DIN 02529653; fetched 2026-09-10 Product monograph Hidradenitis Suppurativa COSENTYX is indicated for the treatment of adult patients with moderate to severe hidradenitis suppurativa (acne inversa) who have responded inadequately to conventional systemic hidradenitis suppurativa therapy (see 14.1.5 Hidradenitis suppurativa). 1.1 Pediatrics Plaque psoriasis COSENTYX (secukinumab injection/secukinumab for injection) is indicated for the treatment of moderate to severe plaque psoriasis in patients 6 year and older who are candidates for systemic therapy or phototherapy. PM: https://pdf.hres.ca/dpd_pm/00080972.PDF; date not captured; DIN 02529653; fetched 2026-09-10 Product monograph USTEKINUMAB · Limited Use, codes 669, 670, 671, 672 (5), Limited Use, codes 668, 669, 671, 672 (6), Limited Use, codes 669, 671, 672, 733 (3), Limited Use, codes 669, 671, 672, 742 (2), Limited Use, codes 671, 672 (4) Plaque Psoriasis JAMTEKI (ustekinumab) is indicated for: • the treatment of chronic moderate to severe plaque psoriasis in adult patients who are candidates for phototherapy or systemic therapy. PM: https://pdf.hres.ca/dpd_pm/00077781.PDF; date November 9, 2023; DIN 02543036; fetched 2026-09-10 Product monograph Psoriatic Arthritis Jamteki (ustekinumab) is indicated for the treatment of adult patients with active psoriatic arthritis. PM: https://pdf.hres.ca/dpd_pm/00077781.PDF; date November 9, 2023; DIN 02543036; 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 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 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 GUSELKUMAB · Limited Use, codes 658 Psoriatic Arthritis TREMFYA (guselkumab injection) is indicated for: • the treatment of adult patients with active psoriatic arthritis. PM: https://pdf.hres.ca/dpd_pm/00085777.PDF; date 2026-08-14; DIN 02469758; 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 IXEKIZUMAB · Limited Use, codes 526 Psoriatic Arthritis TALTZ is indicated for the treatment of adult patients with active psoriatic arthritis who have responded inadequately to, or are intolerant to one or more disease-modifying antirheumatic drugs (DMARD). PM: https://pdf.hres.ca/dpd_pm/00080067.PDF; date not captured; DIN 02455102; fetched 2026-09-10 Product monograph METHOTREXATE · General benefit (29), Listed, not a benefit (1), Off-Formulary Interchangeable, not an ODB benefit (4) • Severe disabling psoriasis/psoriatic arthritis PM: https://pdf.hres.ca/dpd_pm/00078227.PDF; date JAN 08, 2025; DIN 02170698; fetched 2026-09-10 Product monograph and 1 more Coverage source: ON formulary extract 2026-08-26
What the Health Canada label says it is for
1. 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. Limitations of Use: OTEZLA has not been studied and is therefore not indicated in combination with other systemic (conventional or biologic) therapies or phototherapy for psoriasis. • Psoriatic Arthritis OTEZLA (apremilast), alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response, intolerance, or contraindication to a prior disease-modifying anti-rheumatic drug (DMARD). • Behçet’s Disease OTEZLA is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s disease who are candidates for systemic therapy. See 4.1 Dosing Considerations 1.1. Pediatrics Pediatrics (< 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 geriatric population may be at a higher risk of complic… https://pdf.hres.ca/dpd_pm/00084256.PDF PM date: 2026-04-10 Source product: OTEZLA; DIN 02434318; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.

Other review policies

For Apo-Apremilast: 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