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

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FERRIC DERISOMALTOSE

All injection strengths: Limited Use (codes 610)

Other products in the same Health Canada class (B03AC) — coverage varies; not interchangeable

  • Iron ferric carboxymaltose (Ferinject): limited Use 735, 736
  • Iron sucrose (Venofer): not a benefit

Monoferric · DIN 02477777 · 100mg elemental iron/mL · injection solution (Preservative-Free)

Limited Use — Reason for Use code 610 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 610 required
Write on scriptLU code 610 (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 610
Reason for Use code 610 For the treatment of patients with Iron Deficiency Anemia (IDA) who meet ALL the following criteria: - Patient has documented diagnosis of IDA confirmed by laboratory testing results (e.g. hemoglobin, ferritin); AND - Patient's IDA has experienced a failure to respond, documented intolerance, or contraindication to an adequate trial (i.e. at least 4 weeks) of at least one oral iron therapy; AND - Patient does not have hemochromatosis or other iron storage disorders; AND - Monoferric is administered in a setting where appropriate monitoring and management of hypersensitivity reactions can be provided to the Patient. Coverage limit: LU Authorization Period: 1 year 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 Ferric derisomaltose (also known as iron isomaltoside 1000) Brand(s): Monoferric DOSAGE FORM/ STRENGTH: 100 mg elemental iron/mL Injectable Requests for iron derisomaltose (formerly iron isomaltoside 1000) (Monoferric) 100 mg/mL that do not meet the Limited Use Criteria on the Ontario Drug Benefit formulary may be considered for funding on a case-by-case basis by the EAP. EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 23, record 4, 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
Monoferric · DIN 02477777 Manufacturer: Pharmacosmos A/S; listing date 2021-02-26 Health Canada: Marketed since 2022-01-14 · brand MONOFERRIC · ATC B03AC IRON, PARENTERAL PREPARATIONS · form Solution · route Intravenous · ingredients IRON (FERRIC DERISOMALTOSE) 100 MG/ML · company Pharmacosmos a/s · schedule Prescription
Check this DIN again · Health Canada product record

Monoferric: Formulary list price $45.0000/unit (unit not stated in source; not the patient's cost)

Ministry pays: $45.0000 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=96866 · Verify on the e-Formulary ↗ (DIN 02477777)

Source record
DIN 02477777: Monoferric Raw flags: sec12=Y, sec3=Y Item: 200400027; group id 246; item number 0437; lccId 00357; manufacturer id PHC Source form: Inj Sol (Preservative-Free); strength: 100mg elemental iron/mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $45.0000; ministry $45.0000 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02477777 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=96866
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=02477777
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Other drugs in the same formulary class (20:04 Antianemia Drugs) and how they are covered

Matched class: 20:04 Antianemia Drugs

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: FERROUS SULFATE Some products covered without a code (check the product listing): FERROUS FUMARATE, FERROUS GLUCONATE 20:04 Antianemia Drugs

(IRON) FERRIC CARBOXYMALTOSE

· 1 products · Limited Use, codes 735, 736 · strengths: 50mg/mL · Inj Sol

IRON SUCROSE

· 2 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 20mg/mL · Inj Sol-5mL Pk (Preservative-Free)

FERROUS FUMARATE

· 3 products · Listed, not a benefit (1), General benefit (2) · strengths: 300mg, 60mg/mL · Cap, O/L

FERROUS GLUCONATE

· 2 products · Listed, not a benefit (1), General benefit (1) · strengths: 300mg · Tab

FERROUS SULFATE

· 1 products · General benefit · strengths: 75mg/mL · O/L Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 20:04
Full class listing Related classes: 20:12 Coagulants and Anti-Coagulants, 20:16 Hematopoietic Agents, 20:24 Hemorrheologic Agents 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 MONOFERRIC® (ferric derisomaltose for injection) is indicated for: • the treatment of iron deficiency anemia in adult patients who have intolerance or unresponsiveness to oral iron therapy. The diagnosis must be based on laboratory tests. 1.1 Pediatrics Pediatrics (< 18 years of age): Limited data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use (see 7.1.3 Pediatrics). 1.2 Geriatrics A careful risk benefit assessment is required before MONOFERRIC is used in patients aged ≥ 65 years and close monitoring for adverse events is required (see 7.1.4 Geriatrics). https://pdf.hres.ca/dpd_pm/00078460.PDF PM date: JAN 29, 2025 Source product: MONOFERRIC; DIN 02477777; 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

Ferric derisomaltose (also known as iron isomaltoside 1000) (Monoferric)

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 23

Ferric derisomaltose (also known as iron isomaltoside 1000) Brand(s): Monoferric DOSAGE FORM/ STRENGTH: 100 mg elemental iron/mL Injectable
Requests for iron derisomaltose (formerly iron isomaltoside 1000) (Monoferric) 100 mg/mL that do not meet the Limited Use Criteria on the Ontario Drug Benefit formulary may be considered for funding on a case-by-case basis by the EAP.

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