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Letermovir (Prevymis™)
Commercial Medical Policy
Version Date: September 2024

Restricted Product(s):

  • letermovir (Prevymis™) intravenous infusion for administration by a healthcare professional

FDA Approved Use:

  • For prophylaxis of cytomegalovirus (CMV) infection and disease in adult and pediatric patients 6 months of age and older and weighing at least 6 kg who are CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT) 
  • For prophylaxis of CMV disease in adult and pediatric patients 12 years of age and older and weighing at least 40 kg who are kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-])

Criteria for Medical Necessity:

The restricted product(s) may be considered medically necessary when the following criteria are met:

  1. The requested agent will be used for the prophylaxis of cytomegalovirus (CMV) infection and disease; AND 
  2. ONE of the following: 
    1. The patient is a recipient of an allogeneic hematopoietic stem cell transplant (HSCT) [medical record documentation required]; AND 
      1. The patient is 6 months of age or older and weighs at least 6 kg; AND 
      2. The patient is a confirmed CMV seropositive recipient [R+] [medical record documentation required]; AND 
      3. The patient will be starting the requested agent no later than 30 days post-transplantation; AND 
      4. The duration of therapy with the requested agent will NOT exceed 200 days post-transplantation; OR 
    2. The patient is a recipient of a kidney transplant [medical record documentation required]; AND 
      1. The patient is 12 years of age or older and weighs at least 40 kg; AND 
      2. The patient is a confirmed CMV seronegative recipient [R-] AND the donor is confirmed CMV seropositive [D+] [medical record documentation required]; AND 
      3. The patient will be starting the requested agent no later than 7 days post-transplantation; AND 
      4. The duration of therapy with the requested agent will NOT exceed 200 days post-transplantation; AND 
  3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., hematologist, oncologist, infectious disease specialist, transplant specialist) or has consulted with a specialist in the area of the patient’s diagnosis; AND 
  4. The patient has a documented contraindication to oral formulations of the requested agent that is NOT expected to occur with the requested agent [medical record documentation required]; AND 
  5. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below); AND
  6. For requests for injection or infusion administration of the requested medication in an inpatient or outpatient hospital setting, Site of Care Criteria applies (outlined below)*

 Duration of Approval: 200 days

FDA Label Reference   
Medication  Indication  DosingHCPCS  Maximum Units*
letermovir (Prevymis™) intravenous (IV) infusionCMV prophylaxis in patients ≥ 6 months old weighing ≥ 6 kg who are CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT) CMV prophylaxis in patients ≥ 12 years old weighing ≥ 40 kg who are kidney transplant recipients at high risk (Donor CMV seropositive/ Recipient CMV seronegative [D+/R-])

HSCT:

  • 6 months to < 12 years old, or ≥ 12 years old weighing < 30 kg: 
    • 6 kg to < 7.5 kg: 40 mg 
    • 7.5 kg to < 15 kg: 60 mg 
    • 15 kg to < 30 kg: 120 mg 
    • ≥ 30 kg: 480 mg 
    • Weight-based dosing above given IV once daily through 100 days post-transplant, or through 200 days posttransplant in patients at risk for late CMV infection and disease. If co-administered with cyclosporine and weight is ≥ 30 kg, decrease dose to 240 mg IV once daily. 
  • ≥ 12 years old weighing ≥ 30 kg: 480 mg IV once daily through 100 days post-transplant, or through 200 days post-transplant in patients at risk for late CMV infection and disease. If coadministered with cyclosporine, decrease dose to 240 mg IV once daily.

Kidney Transplant:

  • 480 mg IV once daily through 200 days post-transplant. If coadministered with cyclosporine, decrease dose to 240 mg IV once daily.

C9399**

J3490**

J3590** 

96,000

*Maximum units allowed for duration of approval
**Non-specific assigned HCPCS codes, must submit requested product NDC

*Site of Care Medical Necessity Criteria

  1. For requests for injection or infusion administration in an inpatient setting, the injection or infusion may be given if the above medical necessity criteria are met AND the inpatient admission is NOT for the sole purpose of administering the injection or infusion; OR 
  2. For requests for injection or infusion administration in an outpatient hospital setting, the injection or infusion may be given if the above medical necessity criteria are met AND ONE of the following must be met: 
    1. History of mild adverse events that have not been successfully managed through mild pre-medication (e.g., diphenhydramine, acetaminophen, steroids, fluids, etc.); OR 
    2. Inability to physically and cognitively adhere to the treatment schedule and regimen complexity; OR 
    3. New to therapy, defined as initial injection or infusion OR less than 3 months since initial injection or infusion; OR 
    4. Re-initiation of therapy, defined as ONE of the following: 
      1. First injection or infusion after 6 months of no injections or infusions for drugs with an approved dosing interval less than 6 months duration; OR 
      2. First injection or infusion after at least a 1-month gap in therapy outside of the approved dosing interval for drugs requiring every 6 months dosing duration; OR 
    5. Requirement of a change in the requested restricted product formulation; AND 
  3. If the Site of Care Medical Necessity Criteria in #1 or #2 above are not met, the injection or infusion will be administered in a home-based infusion or physician office setting with or without supervision by a certified healthcare professional.

References:

all information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information:

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q2 annually.

September 2024: Criteria change: For HSCT, expanded indication to include pediatric patients 6 months and older weighing at least 6 kg per updated FDA label and updated FDA label reference table with corresponding dosing; adjusted duration of therapy criteria to not exceeding 200 days post-transplantation from 100 days per updated FDA label; expanded length of approval to 200 days and adjusted maximum units to 96,000. For kidney transplant, expanded indication to include pediatric patients 12 years and older weighing at least 40 kg per updated FDA label and updated FDA label reference table with corresponding dosing. Removed dosing criteria regarding co-administration with cyclosporine and added it to FDA label reference table.

June 2023: Criteria change: Added newly approved indication for prophylaxis of CMV disease in adult kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]) with corresponding criteria, duration of approval, and dosing table updates.

October 2021: Criteria change: Added Site of Care medical necessity criteria. Policy notification given 8/2/2021 for effective date 10/1/2021.

June 2021: Criteria change: Added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021.

*Further historical criteria changes and updates available upon request from Medical Policy and/or Corporate Pharmacy.
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