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CLADRIBINE

All products: not a benefit

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

  • Baricitinib (Olumiant): limited Use 615, 734, Limited Use 734
  • Tacrolimus (Envarsus PA): limited Use 590

Mavenclad · DIN 02470179 · 10mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-20
StatusOff-Formulary Interchangeable, not an ODB benefit
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 ↗)
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

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 Cladribine Brand(s): Mavenclad DOSAGE FORM/ STRENGTH: 10 mg tablet Initiation Criteria For the treatment of Relapsing Remitting Multiple Sclerosis (RRMS) in adult patients with active disease meeting ALL the following criteria: 1. 18 years of age or older 2. Diagnosis of RRMS is in accordance with the McDonald 2017 criteria demonstrating dissemination of lesions in the central nervous system in space and time meeting the following; i) 2 or more attacks1 and clinical evidence of 2 or more lesions2; OR ii) 2 or more attacks1 and clinical evidence of 1 lesion with clear historical evidence of prior attack involving lesion in different location; 1If the patient has experienced only one attack, the patient must meet ONE of the additional criteria of dissemination in time in the list below: • Additional clinical attack • Simultaneous presence of both enhancing and non-enhancing, symptomatic or asymptomatic MS-typical MRI lesions; OR new T2 or enhancing MRI lesion compared to baseline scan (without regard to timing of baseline scan) • Presence of cerebrospinal fluid (CSF)-specific oligoclonal bands 2 If the patient has evidence of only one lesion the patient must meet ONE of the additional criteria of dissemination in space in the list below: • Additional clinical attack implicating different CNS site • 1 or more MS-typical T2 lesions in 2 or more areas of the Central Nervous System (CNS): periventricular, cortical, juxtacortical, infratentorial or spinal cord AND 3. Failure or documented intolerance to at least one of an interferon OR glatiramer acetate OR dimethyl fumarate OR teriflunomide OR ocrelizumab; AND 4. Patient has experienced a clinical relapse and/or new MS lesions in the last 2 years; AND 5. Patient has an EDSS score less than 6.0 before start of therapy; AND 6. Cladribine is used as monotherapy for the treatment of RRMS; AND 221 Cladribine Brand(s): Mavenclad DOSAGE FORM/ STRENGTH: 10 mg tablet 7. The drug request is from a neurologist experienced in the management of RRMS or includes a consult note from a neurologist from an MS clinical recognized by the MS Society of Canada supporting the diagnosis. Requests from community neurologists not working with an MS Clinic will be considered case-by-case. (Please include MRI reports or labwork to support the diagnosis pf RRMS aligned with McDonald 2017 criteria.) *Note: Requests for patients who is under the care of a community neurologist working outside of one of the MS Society recognized Ontario MS clinics can be considered on a case-by-case basis. Submit MRI and relevant history with your request. Exclusion criteria: 1. Combination therapy with another disease modifying therapy for RRMS will not be reimbursed. 2. Patients with an EDSS score equal to or greater than 7.0 Dosage: Refer to the Mavenclad product monograph for dosing regimen based on body weight. Taken as two treatment courses over 2 years. Each treatment course consists of 2 treatment weeks, which are one month apart at the beginning of each treatment year. 1.75 mg/kg per year administered as a treatment course in year 1 and a second treatment course starting 12 months after the first course in the respective year upon monitoring for recovery of lymphocytes before the second course of treatment is administered in accordance with prescribing information. The recommended cumulative dose of is 3.5 mg/kg body weight over 2 years (1.75 mg/kg per year). Approval Duration: Two treatment courses over 2 years are funded 222 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 221, record 130, 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
Mavenclad · DIN 02470179 Manufacturer: EMD Serono Canada Inc.; listing date 2026-01-30 Health Canada: Marketed since 2017-11-30 · brand MAVENCLAD · ATC L04AA40* CLADRIBINE · form Tablet · route Oral · ingredients CLADRIBINE 10 MG · company Emd serono, a division of emd inc., canada · schedule Prescription
Check this DIN again · Health Canada product record

Ministry pays: $1606.0000 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=95915 · Verify on the e-Formulary ↗ (DIN 02470179)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02470179). DIN 02470179: Mavenclad Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 924400007; group id 1045; item number 2397; lccId None; manufacturer id EMS Source form: Tab; strength: 10mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $3212.0000; ministry $1606.0000 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02470179 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=95915
Interchangeable products
Apo-Cladribine · DIN 02553295 · $1606.0000 Auro-Cladribine · DIN 02566443 · $1606.0000
Shortage status: not checked (no credentials)
Other drugs in the same formulary class (92:44 Immunosuppressive Agents) and how they are covered

Matched class: 92:44 Immunosuppressive 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. 92:44 Immunosuppressive Agents

BARICITINIB

· 2 products · Limited Use, codes 615, 734 (1), Limited Use, codes 734 (1) · strengths: 2mg, 4mg · Tab

TACROLIMUS

· 3 products · Limited Use, codes 590 · strengths: 0.75mg, 1mg, 4mg · 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 92:44
Full class listing Related classes: 92:20 Biologic Response Modifiers, 92:36 Disease-Modifying Antirheumatic Agents, 92:92 Other Miscellaneous Therapeutic 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 MAVENCLAD (cladribine) is indicated as monotherapy for the treatment of adult patients with relapsing- remitting multiple sclerosis (RRMS) to reduce the frequency of clinical exacerbations and delay the progression of disability. MAVENCLAD is generally recommended in MS patients who have had an inadequate response to, or are unable to tolerate, one or more therapies for multiple sclerosis. MAVENCLAD treatment should be initiated and supervised by neurologists experienced in the treatment of MS and who have fully familiarized themselves with the efficacy and safety profile of MAVENCLAD and are able to discuss benefits/risks with patients. The efficacy of taking MAVENCLAD for treatment duration beyond 2 years has not been established. 1.1 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 (> 65 years of age) Clinical studies of MAVENCLAD in MS did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients (see 7.1.4, Geriatrics). https://pdf.hres.ca/dpd_pm/00076576.PDF PM date: November 29, 2017 Source product: MAVENCLAD; DIN 02470179; 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

Cladribine (Mavenclad)

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: For the treatment of Relapsing Remitting Multiple Sclerosis (RRMS) in adult patients with active disease meeting ALL the following criteria:

Ministry criteria corpus 2025-01-01; page 221

Cladribine Brand(s): Mavenclad DOSAGE FORM/ STRENGTH: 10 mg tablet
Initiation Criteria
For the treatment of Relapsing Remitting Multiple Sclerosis (RRMS) in adult patients with active disease meeting ALL the following criteria:
1. 18 years of age or older
2. Diagnosis of RRMS is in accordance with the McDonald 2017 criteria demonstrating dissemination of lesions in the central nervous system in space and time meeting the following; i) 2 or more attacks1 and clinical evidence of 2 or more lesions2; OR ii) 2 or more attacks1 and clinical evidence of 1 lesion with clear historical evidence of prior attack involving lesion in different location; 1If the patient has experienced only one attack, the patient must meet ONE of the
additional criteria of dissemination in time in the list below:
• Additional clinical attack
• Simultaneous presence of both enhancing and non-enhancing, symptomatic or asymptomatic MS-typical MRI lesions; OR new T2 or enhancing MRI lesion compared to baseline scan (without regard to timing of baseline scan)
• Presence of cerebrospinal fluid (CSF)-specific oligoclonal bands
2 If the patient has evidence of only one lesion the patient must meet ONE of the
additional criteria of dissemination in space in the list below:
• Additional clinical attack implicating different CNS site
• 1 or more MS-typical T2 lesions in 2 or more areas of the Central Nervous System (CNS): periventricular, cortical, juxtacortical, infratentorial or spinal cord AND
3. Failure or documented intolerance to at least one of an interferon OR glatiramer acetate OR dimethyl fumarate OR teriflunomide OR ocrelizumab; AND
4. Patient has experienced a clinical relapse and/or new MS lesions in the last 2 years; AND
5. Patient has an EDSS score less than 6.0 before start of therapy; AND
6. Cladribine is used as monotherapy for the treatment of RRMS; AND
221 Cladribine Brand(s): Mavenclad DOSAGE FORM/ STRENGTH: 10 mg tablet
7. The drug request is from a neurologist experienced in the management of RRMS or includes a consult note from a neurologist from an MS clinical recognized by the MS Society of Canada supporting the diagnosis.
Requests from community neurologists not working with an MS Clinic will be considered case-by-case. (Please include MRI reports or labwork to support the diagnosis pf RRMS aligned with McDonald 2017 criteria.)
*Note: Requests for patients who is under the care of a community neurologist working outside of one of the MS Society recognized Ontario MS clinics can be considered on a case-by-case basis. Submit MRI and relevant history with your request.
Exclusion criteria:
1. Combination therapy with another disease modifying therapy for RRMS will not be reimbursed.
2. Patients with an EDSS score equal to or greater than 7.0 Dosage: Refer to the Mavenclad product monograph for dosing regimen based on body weight. Taken as two treatment courses over 2 years. Each treatment course consists of 2 treatment weeks, which are one month apart at the beginning of each treatment year. 1.75 mg/kg per year administered as a treatment course in year 1 and a second treatment course starting 12 months after the first course in the respective year upon monitoring for recovery of lymphocytes before the second course of treatment is administered in accordance with prescribing information. The recommended cumulative dose of is 3.5 mg/kg body weight over 2 years (1.75 mg/kg per year).
Approval Duration: Two treatment courses over 2 years are funded
222

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