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SEVELAMER CARBONATE

All strengths: Off-Formulary Interchangeable, not an ODB benefit; same patient cost rules

Shared coverage and patient cost rules
StatusOff-Formulary Interchangeable, not an ODB benefit
Patient paysPatient pays: program not supplied; amount cannot be determined.

Other products in the same Health Canada class (V03AE) — coverage varies; not interchangeable

  • Polystyrene sulfonate (Solystat): general benefit, Not a benefit
  • Lanthanum (Fosrenol): not a benefit

Accel-Sevelamer · DIN 02461501 · 800mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗)
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

Coverage criteria
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 Lanthanum Brand(s): Fosrenol and Generics DOSAGE FORM/ STRENGTH: 250 mg, 500 mg, 750 mg, 1000 mg Chewable tablet Sevelamer Hydrochloride Brand(s): Renagel DOSAGE FORM/ STRENGTH: 800 mg tablet Sevelamer Carbonate Brand(s): Accel-Sevelamer DOSAGE FORM/ STRENGTH: 800 mg tablet Sevelamer Carbonate Brand(s): Renvela DOSAGE FORM/ STRENGTH: 800 mg tablet, 0.8 g powder sachet, 2.4 g powder sachet Updated: June 7, 2021 i) For the treatment of hyperphosphatemia associated with end-stage renal disease (ESRD) where patients are on dialysis and have a sustained serum phosphate > 1.8 mmol/L AND adjusted serum calcium > 2.65 mmol/L; OR ii) For dialysis patients experiencing hyperphosphatemia (sustained serum phosphate levels >1.8 mmol/L) who have calciphylaxis and/or evidence of coronary artery calcification. 466 Notes: 1. Calcium and phosphate levels provided to demonstrate sustained elevations should be at least 4 weeks apart. 2. Patients who demonstrate reduction of phosphate levels while on a calcium binder but who experience adjusted serum calcium > 2.65 mmol/L must provide supporting laboratory levels before treatment and while on treatment and should include the dose(s) of calcium-based binder used. Exclusion Criteria: Sevelamer will not be reimbursed in the following cases: Use in combination therapy with another funded non-calcium-based phosphate binder (e.g. lanthanum carbonate hydrate, sucroferric oxyhydroxide, other sevelamer formulations) Duration of approval: lifetime On a case-by-case basis, requests may be considered for sevelamer under the EAP for a patient with serum phosphate less than 1.8mmol/L and calcium values less than 2.65 mmol/L. EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 466, record 305, 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 ↗)
1 brand, same coverage
Accel-Sevelamer · DIN 02461501 Manufacturer: Accel Pharma Inc.; listing date 2021-06-07 Health Canada: Marketed since 2017-11-08 · brand ACCEL-SEVELAMER · ATC V03AE02 SEVELAMER · form Tablet · route Oral · ingredients SEVELAMER CARBONATE 800 MG · company Accel pharma inc · schedule Prescription
Check this DIN again · Health Canada product record

Accel-Sevelamer: Formulary list price $1.2634/unit (unit not stated in source; not the patient's cost)

Ministry pays: $1.2634 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=94913 · Verify on the e-Formulary ↗ (DIN 02461501)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02461501). DIN 02461501: Accel-Sevelamer Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 401800009; group id 552; item number 1488; lccId None; manufacturer id ACC Source form: Tab; strength: 800mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $1.2634; ministry $1.2634 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02461501 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=94913
Interchangeable products
Renvela · DIN 02354586 · $1.2634
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=02461501
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Renvela · DIN 02354586 · 800mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
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

Coverage criteria
Exceptional Access criteria on record are for Brand(s): Accel-Sevelamer; DOSAGE FORM/ STRENGTH: 800 mg tablet — not this product; no criteria on record for this product in this block. 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 Lanthanum Brand(s): Fosrenol and Generics DOSAGE FORM/ STRENGTH: 250 mg, 500 mg, 750 mg, 1000 mg Chewable tablet Sevelamer Hydrochloride Brand(s): Renagel DOSAGE FORM/ STRENGTH: 800 mg tablet Sevelamer Carbonate Brand(s): Accel-Sevelamer DOSAGE FORM/ STRENGTH: 800 mg tablet Sevelamer Carbonate Brand(s): Renvela DOSAGE FORM/ STRENGTH: 800 mg tablet, 0.8 g powder sachet, 2.4 g powder sachet Updated: June 7, 2021 i) For the treatment of hyperphosphatemia associated with end-stage renal disease (ESRD) where patients are on dialysis and have a sustained serum phosphate > 1.8 mmol/L AND adjusted serum calcium > 2.65 mmol/L; OR ii) For dialysis patients experiencing hyperphosphatemia (sustained serum phosphate levels >1.8 mmol/L) who have calciphylaxis and/or evidence of coronary artery calcification. 466 Notes: 1. Calcium and phosphate levels provided to demonstrate sustained elevations should be at least 4 weeks apart. 2. Patients who demonstrate reduction of phosphate levels while on a calcium binder but who experience adjusted serum calcium > 2.65 mmol/L must provide supporting laboratory levels before treatment and while on treatment and should include the dose(s) of calcium-based binder used. Exclusion Criteria: Sevelamer will not be reimbursed in the following cases: Use in combination therapy with another funded non-calcium-based phosphate binder (e.g. lanthanum carbonate hydrate, sucroferric oxyhydroxide, other sevelamer formulations) Duration of approval: lifetime On a case-by-case basis, requests may be considered for sevelamer under the EAP for a patient with serum phosphate less than 1.8mmol/L and calcium values less than 2.65 mmol/L. EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 466, record 305, corpus 2025-01-01; name match only, not an eligibility decision
1 brand, same coverage
Renvela · DIN 02354586 Manufacturer: Sanofi Aventis Pharma; listing date 2019-01-31 Health Canada: Marketed since 2014-07-24 · brand RENVELA · ATC V03AE02 SEVELAMER · form Tablet · route Oral · ingredients SEVELAMER CARBONATE 800 MG · company Sanofi-aventis canada inc · schedule Prescription
Check this DIN again · Health Canada product record

Ministry pays: $1.2634 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=83974 · Verify on the e-Formulary ↗ (DIN 02354586)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02354586). DIN 02354586: Renvela Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 401800009; group id 552; item number 1488; lccId None; manufacturer id SAV Source form: Tab; strength: 800mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $1.3125; ministry $1.2634 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02354586 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=83974
Interchangeable products
Accel-Sevelamer · DIN 02461501 · $1.2634
Shortage status: Reversed (report reversed by the reporter); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02354586
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Other drugs in the same formulary class (40:18 Potassium-Removing Resins) and how they are covered

Matched class: 40:18 Potassium-Removing Resins

Drug-class inventory only. Lists recorded Ontario formulary products, not every Canadian medication; does not recommend treatment. Some products covered without a code (check the product listing): POLYSTYRENE SODIUM SULFONATE 40:18 Potassium-Removing Resins

POLYSTYRENE SODIUM SULFONATE

· 6 products · Off-Formulary Interchangeable, not an ODB benefit (2), General benefit (4) · strengths: 250mg/mL, 1mEq/g · O/L, Oral Pd-454g Pk

LANTHANUM

· 8 products · Listed, not a benefit (4), Off-Formulary Interchangeable, not an ODB benefit (4) · strengths: 250mg, 500mg, 750mg, 1000mg · Chew Tab Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 40:18
Full class listing Related classes: 40:12 Replacement Agents, 40:28 Diuretics, 40:40 Uricosuric Drugs 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 RENVELA (sevelamer carbonate) is indicated for: • the control of hyperphosphatemia in adult and pediatric patients (≥6 years of age and a Body Surface Area (BSA) of ≥0.75 m2) with end-stage renal disease (ESRD) undergoing dialysis 1.1. Pediatrics (6 - <18 years of age) Based on the data submitted and reviewed by Health Canada, the safety and efficacy of RENVELA has been established in children ≥6 years of age with a BSA ≥0.75 m2 who have ESRD and are undergoing dialysis; therefore, Health Canada has authorized an indication for pediatric use in this population. RENVELA is not recommended for use in children that are below 6 years of age, have a BSA below 0.75 m2, or that have mild hyperphosphatemia (see 7 Warnings and Precautions, Special Populations; 14 Clinical Trials). 1.2. Geriatrics (≥ 65 years of age) Evidence from clinical studies suggests that lower doses of sevelamer carbonate could be sufficient to normalize serum phosphate levels in elderly patients (≥65 years of age). Cautious monitoring and titration practices are recommended (see 7 Warnings and Precautions, Special Populations; 14 Clinical Trials). https://pdf.hres.ca/dpd_pm/00084338.PDF PM date: 2026-04-17 Source product: RENVELA; DIN 02354586; 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

Sevelamer Carbonate (Accel-Sevelamer)

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 466

Lanthanum Brand(s): Fosrenol and Generics DOSAGE FORM/ STRENGTH: 250 mg, 500 mg, 750 mg, 1000 mg Chewable tablet
Sevelamer Hydrochloride Brand(s): Renagel DOSAGE FORM/ STRENGTH: 800 mg tablet
Sevelamer Carbonate Brand(s): Accel-Sevelamer DOSAGE FORM/ STRENGTH: 800 mg tablet
Sevelamer Carbonate Brand(s): Renvela DOSAGE FORM/ STRENGTH: 800 mg tablet, 0.8 g powder sachet, 2.4 g powder sachet Updated: June 7, 2021
i) For the treatment of hyperphosphatemia associated with end-stage renal disease (ESRD) where patients are on dialysis and have a sustained serum phosphate > 1.8 mmol/L AND adjusted serum calcium > 2.65 mmol/L; OR
ii) For dialysis patients experiencing hyperphosphatemia (sustained serum phosphate levels >1.8 mmol/L) who have calciphylaxis and/or evidence of coronary artery calcification.
466 Notes:
1. Calcium and phosphate levels provided to demonstrate sustained elevations should be at least 4 weeks apart.
2. Patients who demonstrate reduction of phosphate levels while on a calcium binder but who experience adjusted serum calcium > 2.65 mmol/L must provide supporting laboratory levels before treatment and while on treatment and should include the dose(s) of calcium-based binder used.
Exclusion Criteria: Sevelamer will not be reimbursed in the following cases: Use in combination therapy with another funded non-calcium-based phosphate binder (e.g. lanthanum carbonate hydrate, sucroferric oxyhydroxide, other sevelamer formulations)
Duration of approval: lifetime
On a case-by-case basis, requests may be considered for sevelamer under the EAP for a patient with serum phosphate less than 1.8mmol/L and calcium values less than 2.65 mmol/L.

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

Other review policies

For Renvela: 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