Letermovir (Prevymis™)

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

For prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT) 

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

1. The patient is 18 years of age or older; AND

2. The requested agent will be used for the prophylaxis of cytomegalovirus (CMV) infection and disease; AND

3. The patient is a confirmed CMV seropositive recipient [R+] [medical record documentation required]; AND

4. The patient is a recipient of an allogeneic hematopoietic stem cell transplant (HSCT) [medical record documentation required]; AND

5. 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

6. The patient will be starting the requested agent no later than 30 days post-transplantation; AND

7. The duration of therapy with the requested agent will NOT exceed 100 days post-transplantation; AND

8. The patient has a documented contraindication to the oral formulation of the requested agent that is NOT expected to occur with the requested agent [medical record documentation required]; AND

9. If the 240 mg dose is being requested, the patient will be treated with cyclosporine at the same time; AND

10. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below); AND

11. 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: 100 days 

*Maximum units allowed for duration of approval

**Non-specific assigned HCPCS codes, must submit requested product NDC

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.

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

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.