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

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LETERMOVIR

All products: not a benefit

Other products in the same Health Canada class (J05A, J05AX) — coverage varies; not interchangeable

  • Maraviroc (Celsentri): general benefit
  • Abacavir + lamivudine + zidovudine (Trizivir): general benefit
  • Abacavir (Ziagen): general benefit
  • Abacavir + lamivudine (Kivexa): general benefit
  • Acyclovir (Zovirax): general benefit, Not a benefit
  • Atazanavir (Reyataz): general benefit, Not a benefit

48 more in the class list below

Lupin-Letermovir · DIN 02559331 · 480mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-20
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.

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): Prevymis; DOSAGE FORM/ STRENGTH: 240mg and 480mg tablet; 240mg and 480mg Injection — 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 Letermovir Brand(s): Prevymis DOSAGE FORM/ STRENGTH: 240mg and 480mg tablet; 240mg and 480mg Injection For the prophylaxis of cytomegalovirus (CMV) infection in adult patients who have received an allogeneic hematopoietic stem cell transplant (HSCT) meeting the following criteria: • Age 18 years and older; AND • Patient is a CMV-seropositive recipient [R+] meeting one of the following circumstances; o Recipient using umbilical cord blood as the stem cell source; OR o Patient is a haploidentical recipient; OR o Recipient of T-cell depleted grafts; OR o Recipient with documented history of CMV disease prior to transplantation; OR o Recipient requiring high-dose steroids (defined as the use of greater than or the same as 1 mg/kg/day of prednisone or an equivalent dose of another corticosteroid) or other immunosuppression for acute graft versus host disease (GVHD); OR o Recipients treated with antithymocyte globulin (ATG) for conditioning, or o Recipient treated with ATG for steroid-refractory acute GVHD treatment. • Patient must have undetectable CMV viremia at baseline (results should be from samples collected within a week of transplant date); AND • Treatment is prescribed by a clinician with expertise in the management of HSCT (e.g. medical oncologist, hematologist, infectious disease specialist) Exclusion criteria: • Treatment of CMV with letermovir is not funded. • Patients receiving autologous hematopoietic stem cell transplant • Concomitant use with antiviral drugs used for the management of CMV (e.g. ganciclovir, valganciclovir) Notes: Patients should be transitioned to oral letermovir as soon as clinical circumstances permit to optimize cost-effectiveness Funded dosage: A maximum dose of 480mg administered orally or intravenously per day to be started within 28 days of transplant (i.e.as early as the day of transplant and no later than 28 days post-transplant). (240mg when co-administered with cyclosporine) Approval duration: A maximum duration of funding of 100 days (includes both in-hospital and out-patient utilization) will be provided per patient per HSCT procedure. 45 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 45, record 24, corpus 2025-01-01; name match only, not an eligibility decision
1 brand, same coverage
Lupin-Letermovir · DIN 02559331 Manufacturer: Lupin Pharma Canada Limited; listing date 2026-07-31 Health Canada: Marketed since 2026-06-03 · brand LUPIN-LETERMOVIR · ATC J05AX18 LETERMOVIR · form Tablet · route Oral · ingredients LETERMOVIR 480 MG · company Lupin pharma canada limited · schedule Prescription
Check this DIN again · Health Canada product record

Lupin-Letermovir: Formulary list price $179.0370/unit (unit not stated in source; not the patient's cost)

Ministry pays: $179.0370 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=106250 · Verify on the e-Formulary ↗ (DIN 02559331)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02559331). DIN 02559331: Lupin-Letermovir Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 081800400; group id 97; item number 0170; lccId None; manufacturer id LUP Source form: Tab; strength: 480mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $179.0370; ministry $179.0370 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02559331 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=106250
Interchangeable products
Prevymis · DIN 02469383 · $179.0370
Shortage status: not checked (no credentials)
Other drugs in the same formulary class (08:18 Antivirals) and how they are covered

Matched class: 08:18 Antivirals

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: ABACAVIR & LAMIVUDINE & ZIDOVUDINE, ABACAVIR SULFATE, ABACAVIR SULFATE & LAMIVUDINE, BICTEGRAVIR SODIUM/EMTRICITABINE/TENOFOVIR ALAFENAMIDE HEMIFUMARATE, CABOTEGRAVIR, CABOTEGRAVIR & RILPIVIRINE, COBICISTAT & ELVITEGRAVIR & EMTRICITABINE & TENOFOVIR DISOPROXIL FUMARATE, DARUNAVIR & COBICISTAT, DARUNAVIR & COBICISTAT & EMTRICITABINE & TENOFOVIR ALAFENAMIDE, DELAVIRDINE MESYLATE, DOLUTEGRAVIR, DOLUTEGRAVIR & ABACAVIR & LAMIVUDINE, DOLUTEGRAVIR & RILPIVIRINE, DOLUTEGRAVIR SODIUM/LAMIVUDINE, DORAVIRINE, DORAVIRINE/LAMIVUDINE/TENOFOVIR DISOPROXIL FUMARATE, EFAVIRENZ/TENOFOVIR DISOPROXIL FUMARATE/EMTRICITABINE, ELVITEGRAVIR & COBICISTAT & EMTRICITABINE & TENOFOVIR ALAFENAMIDE, EMTRICITABINE & RILPIVIRINE HCL & TENOFOVIR ALAFENAMIDE HEMIFUMARATE, EMTRICITABINE & RILPIVIRINE HCL & TENOFOVIR DISOPROXIL, EMTRICITABINE & TENOFOVIR DISOPROXIL FUMARATE, ETRAVIRINE, FOSAMPRENAVIR CALCIUM, GANCICLOVIR SODIUM, LAMIVUDINE & ZIDOVUDINE, LOPINAVIR & RITONAVIR, MARAVIROC, NELFINAVIR MESYLATE, RALTEGRAVIR POTASSIUM, RILPIVIRINE HYDROCHLORIDE, RITONAVIR Some products covered without a code (check the product listing): ACYCLOVIR, ATAZANAVIR SULFATE, DARUNAVIR, EFAVIRENZ, LAMIVUDINE, NEVIRAPINE, VALACYCLOVIR 08:18 Antivirals

MARAVIROC

· 4 products · General benefit · strengths: 150mg, 300mg · Tab

ABACAVIR & LAMIVUDINE & ZIDOVUDINE

· 2 products · General benefit · strengths: 300mg & 150mg & 300mg · Tab

ABACAVIR SULFATE

· 4 products · General benefit · strengths: 20mg/mL, 300mg · O/L, Tab

ABACAVIR SULFATE & LAMIVUDINE

· 7 products · General benefit · strengths: 600mg & 300mg · Tab

ACYCLOVIR

· 15 products · Listed, not a benefit (2), General benefit (13) · strengths: 200mg, 400mg, 800mg · Tab

ATAZANAVIR SULFATE

· 12 products · General benefit (8), Off-Formulary Interchangeable, not an ODB benefit (4) · strengths: 150mg, 200mg, 300mg · Cap

BICTEGRAVIR SODIUM/EMTRICITABINE/TENOFOVIR ALAFENAMIDE HEMIFUMARATE

· 1 products · General benefit · strengths: 50mg & 200mg & 25mg · Tab

CABOTEGRAVIR

· 3 products · General benefit · strengths: 200mg/mL, 30mg · Inj Sol-ER Susp 3mL Vial Kit Pk, Tab

CABOTEGRAVIR & RILPIVIRINE

· 2 products · General benefit · strengths: 200mg/mL & 300mg/mL · Inj Sol-2mL Kit, Inj Sol-3mL Kit

COBICISTAT & ELVITEGRAVIR & EMTRICITABINE & TENOFOVIR DISOPROXIL FUMARATE

· 1 products · General benefit · strengths: 150mg & 150mg & 200mg & 300mg · Tab

DARUNAVIR

· 8 products · Listed, not a benefit (2), General benefit (6) · strengths: 600mg, 800mg · Tab

DARUNAVIR & COBICISTAT

· 1 products · General benefit · strengths: 800mg & 150mg · Tab Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 08:18 and 42 more
Full class listing Related classes: 08:08 Anthelmintics, 08:12 Antibiotics, 08:14 Antifungals, 08:16 Antitubercular Agents, 08:20 Plasmodicides (Antimalarials), 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 PREVYMIS® (letermovir) is indicated for: • the prophylaxis of cytomegalovirus (CMV) infection in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). • the prophylaxis of CMV disease in adult kidney transplant recipients who are at high risk (donor CMV-seropositive [D+]/recipient CMV-seronegative [R-]). 1.1 Pediatrics 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 Geriatrics (≥ 65 years of age): Safety and efficacy were similar across older and younger subjects in the Phase 3 trials in HSCT recipients and in the Phase 3 trial in kidney transplant recipients. https://pdf.hres.ca/dpd_pm/00074933.PDF PM date: November 1, 2017 Source product: PREVYMIS; DIN 02469375; 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

Letermovir (Prevymis)

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 45

Letermovir Brand(s): Prevymis DOSAGE FORM/ STRENGTH: 240mg and 480mg tablet; 240mg and 480mg Injection
For the prophylaxis of cytomegalovirus (CMV) infection in adult patients who have received an allogeneic hematopoietic stem cell transplant (HSCT) meeting the following criteria:
• Age 18 years and older; AND
• Patient is a CMV-seropositive recipient [R+] meeting one of the following circumstances; o Recipient using umbilical cord blood as the stem cell source; OR o Patient is a haploidentical recipient; OR o Recipient of T-cell depleted grafts; OR o Recipient with documented history of CMV disease prior to transplantation; OR o Recipient requiring high-dose steroids (defined as the use of greater than or the same as 1 mg/kg/day of prednisone or an equivalent dose of another corticosteroid) or other immunosuppression for acute graft versus host disease (GVHD); OR o Recipients treated with antithymocyte globulin (ATG) for conditioning, or o Recipient treated with ATG for steroid-refractory acute GVHD treatment.
• Patient must have undetectable CMV viremia at baseline (results should be from samples collected within a week of transplant date); AND
• Treatment is prescribed by a clinician with expertise in the management of HSCT (e.g. medical oncologist, hematologist, infectious disease specialist)
Exclusion criteria:
• Treatment of CMV with letermovir is not funded.
• Patients receiving autologous hematopoietic stem cell transplant
• Concomitant use with antiviral drugs used for the management of CMV (e.g. ganciclovir, valganciclovir)
Notes: Patients should be transitioned to oral letermovir as soon as clinical circumstances permit to optimize cost-effectiveness
Funded dosage:
A maximum dose of 480mg administered orally or intravenously per day to be started within 28 days of transplant (i.e.as early as the day of transplant and no later than 28 days post-transplant). (240mg when co-administered with cyclosporine)
Approval duration: A maximum duration of funding of 100 days (includes both in-hospital and out-patient utilization) will be provided per patient per HSCT procedure.
45

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

Other review policies

For Lupin-Letermovir: 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