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

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TILDRAKIZUMAB

All injection strengths: Limited Use (codes 629)

Other products in the same Health Canada class (L04AC) — coverage varies; not interchangeable

  • Bimekizumab (Bimzelx): limited Use 641
  • Brodalumab (Siliq): limited Use 553
  • Guselkumab (Tremfya One-Press): limited Use 658
  • Ixekizumab (Taltz): limited Use 526
  • Risankizumab (Skyrizi): limited Use 574
  • Secukinumab (Cosentyx): limited Use 476

Ilumya · DIN 02516098 · 100mg/mL · injection, 1 mL pre-filled syringe (preservative-free)

Limited Use — Reason for Use code 629 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 629 required
Write on scriptLU code 629 (patient must meet the criteria below)
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.
Ontario Limited Use criteria — code 629
Reason for Use code 629 For the treatment of severe plaque psoriasis (see Note 1 below) in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies (see Note 2 below). Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. Approvals will only allow for standard dosing for Ilumya 100mg subcutaneously at weeks 0 and 4, and then every 12 weeks. Ilumya should not be used in combination with other systemic or biologic treatments for severe plaque psoriasis. If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved dose, higher doses are not recommended, and the physician should consider switching to an alternative biologic agent. Note 1: Definition of severe plaque psoriasis: - Body Surface Area (BSA) involvement of at least 10%, or involvement of the face, hands, feet or genital regions, AND - Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND - Dermatology Life Quality Index (DLQI) score of at least 10. Note 2: Definition of failure, intolerance or contraindication to adequate trials of standard therapies: - 6 month trial of at least 3 topical agents including vitamin D analogues and steroids, AND - 12 week trial of phototherapy (unless not accessible), AND - 6 month trial of at least 2 systemic, oral agents used alone or in combination - Methotrexate 15-30mg per week - Acitretin (could have been used with phototherapy) - Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: - at least 75% reduction in PASI, AND - at least 50% reduction in BSA involvement, AND - at least a 5 point reduction in DLQI score. Coverage limit: LU Authorization Period: 1 year
No interchangeable product listed in the Ontario extract
Ilumya · DIN 02516098 Manufacturer: Sun Pharma; listing date 2022-02-28 Health Canada: Marketed since 2022-10-24 · brand ILUMYA · ATC L04AC17 TILDRAKIZUMAB · form Solution · route Subcutaneous · ingredients TILDRAKIZUMAB 100 MG/ML · company Sun pharmaceutical industries limited · schedule Prescription, Schedule d
Check this DIN again · Health Canada product record

Ilumya: Formulary list price $4935.0000/unit (unit not stated in source; not the patient's cost)

Ministry pays: $4935.0000 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=100544 · Verify on the e-Formulary ↗ (DIN 02516098)

Source record
DIN 02516098: Ilumya Raw flags: sec12=Y, sec3=Y Item: 849200007; group id 874; item number 2112; lccId 00356; manufacturer id SPC Source form: Inj Sol-1mL Pref Syr (Preservative-Free); strength: 100mg/mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $4935.0000; ministry $4935.0000 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02516098 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=100544
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=02516098
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Other drugs in the same formulary class (84:00 SKIN AND MUCOUS MEMBRANE PREPARATIONS) and how they are covered

Matched class: 84:00 SKIN AND MUCOUS MEMBRANE PREPARATIONS

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: ACITRETIN, AZELAIC ACID, BECLOMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE IN A BASE CONTAINING PROPYLENE GLYCOL, BETAMETHASONE DIPROPIONATE IN PROPYLENE GLYCOL BASE, CALCIPOTRIOL & BETAMETHASONE DIPROPIONATE, CLINDAMYCIN PHOSPHATE & BENZOYL PEROXIDE, DIMETHICONE., FLUOROURACIL, FUSIDIC ACID, HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE & TAZAROTENE, ISOPROPYL MYRISTATE, ISOTRETINOIN, METRONIDAZOLE & NYSTATIN, MICONAZOLE NITRATE, MOMETASONE FUROATE, MUPIROCIN CALCIUM, PERMETHRIN, PYRETHRINS & PIPERONYL BUTOXIDE, SILVER SULFADIAZINE, SODIUM FUSIDATE, TERBINAFINE HCL, ZINC SULFATE Some products covered without a code (check the product listing): AMCINONIDE, BETAMETHASONE DIPROPIONATE, BETAMETHASONE VALERATE, CLOBETASOL PROPIONATE, CLOTRIMAZOLE, COLLAGENASE, DESONIDE, FLUOCINONIDE, HYDROCORTISONE, HYDROCORTISONE ACETATE, HYDROCORTISONE VALERATE, KETOCONAZOLE, METRONIDAZOLE, MUPIROCIN, NYSTATIN, TERCONAZOLE, TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE 0.1% IN ORABASE 84:00 SKIN AND MUCOUS MEMBRANE PREPARATIONS

BIMEKIZUMAB

· 4 products · Limited Use, codes 641 · strengths: 160mg/mL, 320mg/2mL · Inj Sol-1mL Pref Autoinj (Preservative-Free), Inj Sol-1mL Pref Syr (Preservative-Free), Inj Sol-2mL Pref Autoinj (Preservative-Free), Inj Sol-2mL Pref Syr (Preservative-Free)

GUSELKUMAB

· 2 products · Limited Use, codes 658 · strengths: 100mg/mL · Inj Sol-1mL Autoinj (Preservative-Free), Inj Sol-1mL Pref Syr (Preservative-Free)

HALOBETASOL PROPIONATE & TAZAROTENE

· 1 products · General benefit · strengths: 0.01% & 0.045% · Lot

TAZAROTENE

· 1 products · Limited Use, codes 636 · strengths: 0.045% w/w · Lot

ACYCLOVIR

· 3 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 5% · Top Oint Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 84:00 84:04:04 Antibiotics

CLINDAMYCIN PHOSPHATE & BENZOYL PEROXIDE

· 4 products · General benefit · strengths: 1% & 5% · Gel, Top Gel

FUSIDIC ACID

· 2 products · General benefit · strengths: 2% · Cr

MUPIROCIN

· 2 products · Listed, not a benefit (1), General benefit (1) · strengths: 2% · Oint

MUPIROCIN CALCIUM

· 1 products · General benefit · strengths: 2% w/w · Cr

SODIUM FUSIDATE

· 2 products · General benefit · strengths: 2% · Oint

CLINDAMYCIN PHOSPHATE & ADAPALENE & BENZOYL PEROXIDE

· 1 products · Limited Use, codes 724 · strengths: 1.2% w/w & 0.15% w/w & 3.1% w/w · Top Gel Pump

CLINDAMYCIN

· 2 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 1% · Top Sol Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 84:04:04 and 53 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
1 INDICATIONS Ilumya® (tildrakizumab injection) is indicated for the treatment of adult patients with moderate- to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. 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): Limited data did not indicate differences in safety or efficacy in elderly patients compared to younger patients (see 7.1.4 Geriatrics). https://pdf.hres.ca/dpd_pm/00080963.PDF PM date: July 10, 2025 Source product: ILUMYA; DIN 02516098; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.