CurrentBluecross IdahoPolicy MP 5.01.520

Letermovir (Prevymis) for CMV prophylaxis in allogeneic HSCT recipients

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This policy defines medical necessity criteria and coverage parameters for letermovir (Prevymis) used to prevent cytomegalovirus (CMV) infection and disease in CMV-seropositive adult recipients of allogeneic hematopoietic stem cell transplants.

Policy Summary

PayerBluecross Idaho

PolicyLetermovir (Prevymis) for CMV prophylaxis in allogeneic HSCT recipients

Policy CodePolicy MP 5.01.520

Change TypeNo material change

Effective DateMay 28, 2026

Last ReviewMay 28, 2026

Next Review DateMay 28, 2026

Key ActionObtain prior authorization with documentation confirming allogeneic HSCT recipient status and CMV seropositive (R+) status; provide IV justification only if oral therapy is not feasible.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Day 100Length of approval post-transplant

>=18Minimum patient age for coverage

240 mgDose with cyclosporine

R+Required CMV serostatus

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CurrentBluecross IdahoPolicy MP 5.01.520

Letermovir (Prevymis) for CMV prophylaxis in allogeneic HSCT recipients

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Policy Summary

PayerBluecross Idaho

PolicyLetermovir (Prevymis) for CMV prophylaxis in allogeneic HSCT recipients

Policy CodePolicy MP 5.01.520

Change TypeNo material change

Effective DateMay 28, 2026

Last ReviewMay 28, 2026

Next Review DateMay 28, 2026

Key ActionObtain prior authorization with documentation confirming allogeneic HSCT recipient status and CMV seropositive (R+) status; provide IV justification only if oral therapy is not feasible.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Day 100Length of approval post-transplant

>=18Minimum patient age for coverage

240 mgDose with cyclosporine

R+Required CMV serostatus

Coverage Criteria — Letermovir (Prevymis)

Initial Therapy (Prophylaxis)

Covered when ALL of the following are met:

Initial prophylaxis criteria: A. The patient is 18 years of age or older; AND B. The patient is a recipient of an allogeneic hematopoietic stem cell transplant (clinical documentation required); AND C. The patient has a confirmed CMV seropositive recipient (R+) (clinical documentation required); AND D. The patient is being treated for the prophylaxis of CMV infection and disease; AND E. The 240 mg dose will only be approved in those treated concomitantly with cyclosporine; AND F. The patient has not exceeded 30 days post-transplantation; AND G. If request is for IV Prevymis, must provide medical justification why the patient cannot use oral therapy.

Length of Approval: Through Day 100 post-transplantation

Letermovir is contraindicated in patients receiving pimozide or ergot alkaloids. Concomitant use with these agents may cause significant and potentially harmful drug interactions, and therefore such combinations are not permitted under this policy.

Therapy with letermovir is considered not covered when the request falls outside the policy’s specified criteria. Examples include use in patients under 18 years of age, recipients who are not CMV‑seropositive (non‑R+), recipients of non‑allogeneic HSCT, initiation of therapy > 30 days post‑transplant, or any other scenario that does not meet all of the listed initial prophylaxis conditions. Requests that do not meet these criteria are not supported by the medical necessity guidelines in this policy.

Initial Therapy

Initial coverage criteria

Initial prophylaxis: See policy for full AND logic: age >=18; recipient of an allogeneic HSCT (documentation required); confirmed CMV seropositive (R+) (documentation required); being treated for CMV prophylaxis; 240 mg dose only approved when concomitant cyclosporine is used; initiation within 30 days post-transplant; if IV formulation requested, provide medical justification why oral therapy cannot be used.

Length of Approval: Through Day 100 post-transplantation

Continuation / Duration Criteria

Continuation/Duration

Duration and continuation rules for therapy

Duration: Length of Approval: Through Day 100 post-transplantation.

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization required; include clinical documentation and codes

Prior authorization is required. Submit clinical documentation that demonstrates the patient meets all policy criteria for letermovir prophylaxis and include billing code(s) as applicable for reference.

Prior authorization must be requested and supported by clinical documentation showing all required coverage criteria are met (age ≥18, allogeneic HSCT recipient, confirmed CMV seropositive (R+), prophylaxis intent, dosing conditions, initiation within 30 days post-transplant, and IV justification if IV formulation requested).
Billing/coding references for submission (for general reference only): HCPCS C9399, J3490, J3590; ICD-10-CM Z41.8.

Step Therapy

No step therapy required

No step-therapy sequencing requirements are specified in this policy for letermovir prophylaxis.

Coding & Timing

Referenced codesHCPCS | ICD-10

C9399	Unclassified drugs or biologicals
J3490	Unclassified drugs
J3590	Unclassified biologics
Z41.8	Encounter for other procedures for purposes other than remedying health state

Post‑transplant initiation window

Maximum initiation window post-transplantInitiation must occur within 30 days post-transplantation (patient has not exceeded 30 days)

Related approval durationLength of approval through Day 100 post-transplantation

Context in criteria logicOne of the ALL required initial prophylaxis criteria; requests initiated >30 days post-transplant do not meet policy criteria

Definitions

CMV seropositive (R+) — definition

DefinitionCMV seropositive (R+): a transplant recipient with prior exposure to CMV confirmed by serologic testing

Documentation requiredClinical documentation must confirm recipient CMV seropositive (R+) status for coverage

Coverage implicationPolicy covers only CMV‑seropositive (R+) adult allogeneic HSCT recipients for prophylaxis

Allogeneic HSCT recipient — definition

DefinitionAllogeneic HSCT recipient: recipient of hematopoietic stem cells transplanted from a donor to the recipient

Documentation requiredClinical documentation must demonstrate allogeneic HSCT recipient status for coverage

Site of Care and Formulation

Note

Site-of-care and route: oral preferred; IV only with justification

Prevymis is administered orally once daily; intravenous administration is allowed only when the patient cannot take oral therapy and must be justified in the clinical record.

Oral route is standard: once daily tablet.
IV administration requires medical justification that the patient is unable to take oral therapy.

Background

Allogeneic hematopoietic stem cell transplant recipients are immunosuppressed and at high risk for cytomegalovirus (CMV) infection and disease; an estimated 65%–80% of HSCT recipients have prior CMV exposure. Letermovir (Prevymis) is an antiviral agent approved for the prophylaxis of CMV infection and disease in CMV‑seropositive (R+) adult recipients of allogeneic HSCT. In the pivotal phase 3 trial, letermovir significantly reduced the incidence of clinically significant CMV infection through week 24 post‑HSCT and was associated with lower all‑cause mortality at week 24 compared with placebo.