Product Details

Prevymis

Letermovir
480 mg/24 mL (20 mg/mL)
Solution for Injection
Single-Dose 480-mg Vial Pack (Preservative-Free)

DIN/PIN/NPN

02469405

Manufacturer

Merck Canada Inc.

Formulary Listing Date

2020-01-22  

Unit Price

469.0910

Amount MOH Pays

469.0910

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

J05AX18

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Anti-Infectives

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:

  1. Age 18 years and older; AND

  2. Patient is a CMV-seropositive recipient [R+] meeting one of the following circumstances:
    i) Recipient using umbilical cord blood as the stem cell source;
    OR
    ii)     Patient is a haploidentical recipient;
    OR
    iii)     Recipient of T-cell depleted grafts;
    OR
    iv) Recipient with documented history of CMV disease prior to transplantation;
    OR
    v)     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
    vi)     Recipients treated with antithymocyte globulin (ATG) for conditioning,
    OR
    vii) Recipient treated with ATG for steroid-refractory acute GVHD treatment.

  3. Patient must have undetectable CMV viremia at baseline (results should be from samples collected within a week of transplant date); AND

  4. 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.

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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