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

Patient plan: look up a medication list

SIROLIMUS

All products: Limited Use (codes 392)

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

  • Azathioprine (Imuran): general benefit
  • Cyclosporine (Neoral): general benefit
  • Leflunomide (Arava): general benefit
  • Mycophenolate mofetil (CellCept): general benefit, Limited Use 556
  • Mycophenolate (Myfortic): general benefit
  • 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

15 more in the class list below

Rapamune · DIN 02243237 · 1mg/mL · oral liquid

Limited Use — Reason for Use code 392 requiredMarketed · checked 2026-09-19
StatusLimited Use — Reason for Use code 392 required
Write on scriptLU code 392 (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.

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

Ontario Limited Use criteria — code 392
Reason for Use code 392 For the prophylaxis of organ rejection in patients receiving allogeneic renal transplants. Coverage limit: LU Authorization Period: Indefinite 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 Sirolimus Brand(s): Rapamune DOSAGE FORM/ STRENGTH: 1 mg tablet, 1 mg/mL oral liquid For liver transplant recipients who require regimens that mandate calcineurin inhibitor avoidance. The physician must be able to explain clearly why the patient cannot use a calcineurin inhibitor. NOTE: Rapamune is currently listed on the ODB Formulary as a Limited Use (LU) benefit for the prophylaxis of organ rejection in patients receiving allogeneic renal transplants. 475 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 475, record 317, corpus 2025-01-01; name match only, not an eligibility decision
How long EAP takes
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 | (ontario.ca, Updated September 15, 2026 ↗) 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. (ontario.ca, Updated September 15, 2026 ↗)
No interchangeable product listed in the Ontario extract
Rapamune · DIN 02243237 Manufacturer: Wyeth Pharmaceuticals; listing date 2005-02-22 Health Canada: Marketed since 2013-06-10 · brand RAPAMUNE · ATC L04AH01 SIROLIMUS · form Solution · route Oral · ingredients SIROLIMUS 1 MG/ML · company Pfizer canada ulc · schedule Prescription
Check this DIN again · Health Canada product record

Rapamune: Formulary list price $9.8695/unit (unit not stated in source; not the patient's cost)

Ministry pays: $9.8695 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=67127 · Verify on the e-Formulary ↗ (DIN 02243237)

Source record
DIN 02243237: Rapamune Raw flags: sec12=Y, sec3=Y Item: 920000403; group id 959; item number 2277; lccId 00163; manufacturer id WAY Source form: O/L; strength: 1mg/mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $9.8695; ministry $9.8695 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02243237 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=67127
Shortage status: not checked (no credentials)
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

AZATHIOPRINE

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

CYCLOSPORINE

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

LEFLUNOMIDE

· 16 products · General benefit · strengths: 10mg, 20mg · Tab

MYCOPHENOLATE MOFETIL

· 16 products · General benefit (14), Limited Use, codes 556 (2) · strengths: 250mg, 200mg/mL, 500mg · Cap, Pd for Oral Susp-175mL Pk, Tab

MYCOPHENOLATE SODIUM

· 8 products · General benefit · strengths: 180mg, 360mg · Ent Tab

LENALIDOMIDE

· 42 products · Limited Use, codes 630, 631, 632, 659, 741 · strengths: 2.5mg, 15mg, 20mg, 25mg, 5mg, 10mg · Cap

TACROLIMUS

· 20 products · Limited Use, codes 173 (10), Limited Use, codes 410 (8), Limited Use, codes 383 (2) · strengths: 5mg/mL, 0.5mg, 1mg, 5mg, 3mg, 0.03%, 0.1% · Amp, Cap, ER Cap, Oint

TERIFLUNOMIDE

· 10 products · Listed, not a benefit (1), Limited Use, codes 647 (9) · strengths: 14mg · Tab

USTEKINUMAB

· 14 products · Limited Use, codes 669, 670, 671, 672 (5), Limited Use, codes 668, 669, 671, 672 (2), Limited Use, codes 669, 671, 672, 733 (3), Limited Use, codes 669, 671, 672, 742 (2), Limited Use, codes 671, 672 (2) · strengths: 45mg/0.5mL, 90mg/1.0mL, 90mg/mL, 130mg/26mL, 5mg/mL · Inj Sol-0.5mL Pref Autoinj (Preservative-Free), Inj Sol-0.5mL Pref Syr Pk, Inj Sol-0.5mL Pref Syr Pk (Preservative-Free), Inj Sol-0.5mL Vial Pk, Inj Sol-1.0mL Pref Syr Pk (Preservative-Free), Inj Sol-1mL Pref Autoinj (Preservative-Free), Inj Sol-1mL Pref Syr Pk, Inj Sol-26mL Vial Pk, Inj Sol-26mL Vial Pk (Preservative-Free), Inj Sol-Vial Pk (Preservative-Free)

FINGOLIMOD

· 10 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 0.5mg · Cap

PIRFENIDONE

· 3 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 267mg · Cap

ALENDRONATE

· 28 products · Off-Formulary Interchangeable, not an ODB benefit (4), Listed, not a benefit (1), General benefit (23) · strengths: 5mg, 10mg, 70mg · 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.
Other drugs whose Health Canada label lists a similar indication: the prophylaxis of organ rejection
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: MYCOPHENOLATE SODIUM MYCOPHENOLATE SODIUM · General benefit • the prophylaxis of organ rejection in patients receiving allogeneic renal transplants, administered in combination with cyclosporine, and corticosteroids. PM: https://pdf.hres.ca/dpd_pm/00083085.PDF; date Feb 11, 2005; DIN 02264560; fetched 2026-09-10 Product monograph Coverage source: ON formulary extract 2026-08-26
What the Health Canada label says it is for
1 INDICATIONS Rapamune (sirolimus oral solution and tablets) is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal transplants: • In patients at low to moderate immunological risk, it is recommended that Rapamune be used initially in a regimen with cyclosporine and corticosteroids. Cyclosporine should be withdrawn 2 to 4 months after transplantation and the Rapamune dose should be increased to reach recommended blood concentrations (See 4 DOSAGE AND ADMINISTRATION). • In patients at high immunologic risk (defined as Black transplant recipients and/or repeat renal transplant recipients who lost a previous allograft for immunologic reason and/or patients with high-panel reactive antibodies (PRA; peak PRA level > 80%), it is recommended that Rapamune be used in combination with cyclosporine and corticosteroids for the first year following transplantation (See 4 DOSAGE AND ADMINISTRATION and 14 CLINICAL TRIALS). Thereafter, any adjustments to the immunosuppressive regimen should be considered on the basis of the clinical status of the patient. 1.1 Pedi… https://pdf.hres.ca/dpd_pm/00081192.PDF PM date: JUL 25, 2025 Source product: RAPAMUNE; DIN 02243237; 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

Sirolimus (Rapamune)

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 475

Sirolimus Brand(s): Rapamune DOSAGE FORM/ STRENGTH: 1 mg tablet, 1 mg/mL oral liquid For liver transplant recipients who require regimens that mandate calcineurin inhibitor avoidance. The physician must be able to explain clearly why the patient cannot use a calcineurin inhibitor.
NOTE: Rapamune is currently listed on the ODB Formulary as a Limited Use (LU) benefit for the prophylaxis of organ rejection in patients receiving allogeneic renal transplants.
475

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