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

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ATOVAQUONE & PROGUANIL HCL

All products: not a benefit

Other products in the same Health Canada class (P01B) — coverage varies; not interchangeable

  • Hydroxychloroquine (Plaquenil): general benefit
  • Mefloquine (Lariam): not a benefit

Malarone · DIN 02238151 · 250mg & 100mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
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.
1 brand, same coverage
Malarone · DIN 02238151 Manufacturer: GlaxoSmithKline Inc., GlaxoSmithKline Consumer Health Care; listing date 2012-04-24 Health Canada: Marketed since 2002-08-20 · brand MALARONE · ATC P01BB51 PROGUANIL AND ATOVAQUONE, P01BB51 PROGUANIL AND ATOVAQUONE · form Tablet · route Oral · ingredients PROGUANIL HYDROCHLORIDE 100 MG, ATOVAQUONE 250 MG · company Glaxosmithkline inc · schedule Prescription
Check this DIN again · Health Canada product record

Ministry pays: $4.1308 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=61542 · Verify on the e-Formulary ↗ (DIN 02238151)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02238151). DIN 02238151: Malarone Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 082000010; group id 119; item number 0202; lccId None; manufacturer id GSK Source form: Tab; strength: 250mg & 100mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $6.4767; ministry $4.1308 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02238151 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=61542
Interchangeable products
Atovaquone Proguanil · DIN 02421429 · $4.1308 Atovaquone and Proguanil Hydrochloride · DIN 02466783 · $4.1308 Mylan-Atovaquone/Proguanil · DIN 02402165 · $4.1308 Teva-Atovaquone Proguanil · DIN 02380927 · $4.1308
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=02238151
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Other drugs in the same formulary class (08:20 Plasmodicides (Antimalarials)) and how they are covered

Matched class: 08:20 Plasmodicides (Antimalarials)

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: HYDROXYCHLOROQUINE SULFATE 08:20 Plasmodicides (Antimalarials)

HYDROXYCHLOROQUINE SULFATE

· 6 products · General benefit · strengths: 200mg · Tab

MEFLOQUINE HCL

· 2 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 250mg · Tab Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 08:20
Full class listing Related classes: 08:08 Anthelmintics, 08:12 Antibiotics, 08:14 Antifungals, 08:16 Antitubercular Agents, 08:18 Antivirals, 08:24 Sulfonamides, 08:30 Antiprotozoals, 08:32 Trichomonacides, 08:36 Urinary Anti-Infectives, 08:40 Miscellaneous Anti-Infectives 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 MALARONE (atovaquone and proguanil hydrochloride) is indicated for: • Prevention of Malaria: the prophylaxis of P. falciparum malaria including areas where chloroquine resistance has been reported. • Treatment of Malaria: the treatment of acute, uncomplicated P. falciparum malaria when oral treatment is appropriate. MALARONE has been shown to be effective in areas where P. falciparum may be resistant to some other antimalarials. 1.1. Pediatrics Prophylaxis of Malaria (≥11 kg bodyweight) Based on the data submitted and reviewed by Health Canada, the safety and effectiveness of MALARONE for the prophylaxis of malaria have not been established in children who weigh less than 11 kg (see 14. Clinical Trials); therefore, Health Canada has not authorized an indication for prophylactic use in pediatric patients weighing less than 11 kg. Treatment of Malaria (≥3 years of age OR ≥11 kg bodyweight) Based on the data submitted and reviewed by Health Canada, the safety and effectiveness of MALARONE for treatment of acute, uncomplicated P. falciparum malaria in children under 3 years of age or who weigh less than 11 kg have not been established; therefore, Health Cana… https://pdf.hres.ca/dpd_pm/00083918.PDF PM date: 2026-03-17 Source product: MALARONE; DIN 02238151; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.

Other review policies

For Malarone: 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