CurrentMolina HealthcarePolicy C15922-A

Prevymis (letermovir) Coverage Criteria

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This policy governs prior authorization coverage for oral or intravenous Prevymis used to prevent cytomegalovirus infection or disease in eligible hematopoietic stem cell transplant and kidney transplant recipients.

Policy Summary

PayerMolina Healthcare

PolicyPrevymis (letermovir) Coverage Criteria

Policy CodePolicy C15922-A

Change TypeNo material change

Effective DateApril 1, 2026

Next Review DateJanuary 1, 2027

Key ActionSubmit prior authorization with indication-specific medical information, transplant and CMV documentation, applicable treatment history, and specialist prescribing or consultation documentation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2Covered transplant-related indications

6 months+Minimum HSCT age

12 years+Minimum kidney transplant age

28 daysMaximum quantity per fill

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CurrentMolina HealthcarePolicy C15922-A

Prevymis (letermovir) Coverage Criteria

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Sign up for Molina Healthcare Policy C15922-A alerts

Get alerted when Policy C15922-A changes without checking for updates manually.

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Policy Summary

PayerMolina Healthcare

PolicyPrevymis (letermovir) Coverage Criteria

Policy CodePolicy C15922-A

Change TypeNo material change

Effective DateApril 1, 2026

Next Review DateJanuary 1, 2027

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2Covered transplant-related indications

6 months+Minimum HSCT age

12 years+Minimum kidney transplant age

28 daysMaximum quantity per fill

FDA-approved prophylaxis populations

Coverage Criteria

Initial HSCT prophylaxis

Covered for HSCT prophylaxis when ALL of the following are met:

HSCT prophylaxis criteria

Clinical and treatment requirements
- Member has received, or is scheduled to receive, an allogeneic hematopoietic stem cell transplant (HSCT).
- Member is a confirmed cytomegalovirus (CMV) seropositive recipient (R+).
- The prescriber attests that Prevymis (letermovir) will be initiated between Day 0 and Day 28 posttransplant.Between Day 0 and Day 28 posttransplant
- The member's medication profile has been reviewed, and the member is not concurrently receiving medications contraindicated with Prevymis, including pimozide, ergot alkaloids such as ergotamine or dihydroergotamine, or pitavastatin and simvastatin when co-administered with cyclosporine.
- If intravenous therapy is requested, medical justification with supporting documentation explains why the member is unable to use oral therapy, the anticipated duration of IV therapy is documented, and the member will be switched to oral Prevymis when able to take oral medications, if applicable.
- Member weighs at least 6 kg.At least 6 kg
- ONE of the following treatment-history alternatives
  - Documentation shows inadequate treatment response, serious side effects, contraindication, or nonsusceptibility to treatment with both intravenous ganciclovir and valganciclovir.
  - The request is for continuation of therapy started in an inpatient setting within the last 14 days, and the member is transitioning to an outpatient site of care. Discharge documentation must include specialist prescriber notes, duration of therapy, and therapy start and end dates.
    Discharge documentation is required.

Initial kidney transplant prophylaxis

Covered for kidney transplant CMV disease prophylaxis when ALL of the following are met:

Kidney transplant prophylaxis criteria

Clinical and treatment requirements
- Member has received, or is scheduled to receive, a kidney transplant.
- Member is a confirmed CMV seronegative recipient receiving a kidney from a CMV seropositive donor (D+/R-).
- The prescriber attests that Prevymis (letermovir) will be initiated between Day 0 and Day 7 posttransplant.Between Day 0 and Day 7 posttransplant
- The member's medication profile has been reviewed, and the member is not concurrently receiving medications contraindicated with Prevymis, including pimozide, ergot alkaloids such as ergotamine or dihydroergotamine, or pitavastatin and simvastatin when co-administered with cyclosporine.

Coverage is precluded when Prevymis (letermovir) is used concurrently with pimozide, ergot alkaloids including ergotamine or dihydroergotamine, or pitavastatin or simvastatin when co-administered with cyclosporine. The member’s medication profile must be reviewed and documented before authorization.

There are no compendial approved off-label uses listed for Prevymis (letermovir).

Uses of Prevymis (letermovir) other than the specified FDA-approved indications are considered experimental or investigational and are subject to Molina’s Off-Label policy.

Prevymis (letermovir) must not be used concurrently with pimozide, ergot alkaloids including ergotamine or dihydroergotamine, or pitavastatin or simvastatin when co-administered with cyclosporine.

Coding and Eligibility Parameters

Drug Billing CodeHCPCS

J3490

Unclassified drugs (Prevymis intravenous)

HSCT Minimum Weight

Minimum weightAt least 6 kg

Covered populationCMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant

AdministrationPrevymis may be administered orally or intravenously

Kidney Transplant Minimum Weight

Minimum weightAt least 40 kg

Covered populationHigh-risk kidney transplant recipients with donor CMV seropositive/recipient CMV seronegative status (D+/R-)

Minimum age

Provider Requirements and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization is required for Prevymis (letermovir). Submit indication-specific clinical information, transplant documentation, required CMV serostatus evidence, treatment timing, weight, medication review, and documentation supporting the applicable treatment-history or transition-of-care pathway.

HSCT prophylaxis: document receipt or scheduled receipt of an allogeneic HSCT and confirmed CMV-seropositive recipient status (R+).
Kidney-transplant prophylaxis: document receipt or scheduled receipt of a kidney transplant and CMV-seronegative recipient status from a CMV-seropositive donor (D+/R−).
The prescriber must be or consult with an infectious disease specialist, hematologist, nephrologist, or transplant specialist; submit consultation notes when applicable.

Step Therapy

Ganciclovir and Valganciclovir History

Document the member’s prior or attempted treatment with both ganciclovir (IV) and valganciclovir when using the treatment-history pathway. Coverage requires inadequate response, serious side effects, contraindication, or nonsusceptibility to both therapies.

Clinical Background

Prevymis (letermovir) is a CMV antiviral used for prophylaxis to help prevent cytomegalovirus infection or disease after transplantation in patients at elevated risk. Covered populations include CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant and high-risk kidney transplant recipients who are CMV-seronegative receiving an organ from a CMV-seropositive donor (D+/R-). The policy supports oral and intravenous administration; intravenous therapy requires documentation explaining why oral therapy cannot be used, the anticipated IV duration, and a plan to transition to oral therapy when possible.

Definitions

CMV R+ Definition

TermCMV R+

DefinitionA recipient who is confirmed cytomegalovirus seropositive

Applicable settingAllogeneic HSCT prophylaxis

CMV D+/R- Definition

TermCMV D+/R-

Donor statusDonor is CMV seropositive

Recipient statusRecipient is CMV seronegative

Initial Therapy Authorization

HSCT initial authorization

HSCT prophylaxis requires ALL of the following, including ONE treatment-history alternative:

Member has received, or is scheduled to receive, an allogeneic hematopoietic stem cell transplant (HSCT).
Member is a confirmed cytomegalovirus (CMV) seropositive recipient (R+).
The prescriber attests that Prevymis (letermovir) will be initiated between Day 0 and Day 28 posttransplant.Between Day 0 and Day 28 posttransplant
The member's medication profile has been reviewed, and the member is not concurrently receiving medications contraindicated with Prevymis, including pimozide, ergot alkaloids such as ergotamine or dihydroergotamine, or pitavastatin and simvastatin when co-administered with cyclosporine.

Step Therapy Requirements

Step	Required treatment history	Inpatient continuation exception
1	For initial therapy, document inadequate treatment response, serious side effects, a contraindication, or nonsusceptibility to both intravenous ganciclovir and valganciclovir.	This treatment history is not required when the request is for continuation of therapy started in an inpatient setting within the last 14 days and the member is transitioning to outpatient care. Submit discharge documentation that includes specialist prescriber notes, therapy duration, and start and end dates.

Quantity Limits

Prevymis Tablets Quantity Limit

Carton quantity4- to 28-count cartons per 100 days

Maximum tablets112 tablets

Maximum fill duration28 days per fill

Prevymis Pellet Packet Quantity Limit

Dosage formPrevymis oral pellet packets

Maximum daily quantity4 packets per day

Limit basisDaily quantity limit

Site of Care Guidance

Note

Home: oral Prevymis

Oral Prevymis is recommended under the pharmacy benefit and is patient self-administered.

Note

Infusion center: infused Prevymis

Infused Prevymis is recommended under the pharmacy or medical benefit and administered in a non-inpatient hospital facility-based location.

Policy Summary

PayerMolina Healthcare

PolicyPrevymis (letermovir) Coverage Criteria

Policy CodePolicy C15922-A

Change TypeNo material change

Effective DateApril 1, 2026

Next Review DateJanuary 1, 2027

SourceLink

On This Page

If intravenous therapy is requested, medical justification with supporting documentation explains why the member is unable to use oral therapy, the anticipated duration of IV therapy is documented, and the member will be switched to oral Prevymis when able to take oral medications, if applicable.

Member weighs at least 40 kg.At least 40 kg

ONE of the following treatment-history alternatives

Documentation shows inadequate treatment response, serious side effects, contraindication, or nonsusceptibility to treatment with both intravenous ganciclovir and valganciclovir.
The request is for continuation of therapy started in an inpatient setting within the last 14 days, and the member is transitioning to an outpatient site of care. Discharge documentation must include specialist prescriber notes, duration of therapy, and therapy start and end dates.
Discharge documentation is required.

12 years of age and older

HSCT Minimum Age

Minimum age6 months of age and older

Transplant typeAllogeneic hematopoietic stem cell transplant (HSCT)

CMV statusRecipient must be CMV seropositive (R+)

Kidney Transplant Minimum Age

Minimum age12 years of age and older

Transplant typeKidney transplant

Risk statusDonor CMV seropositive and recipient CMV seronegative (D+/R-)

HSCT Prevymis Initiation Timing

Permitted initiation windowBetween Day 0 and Day 28 posttransplant

Window startDay 0 posttransplant

Window endDay 28 posttransplant

Kidney Transplant Prevymis Initiation Timing

Permitted initiation windowBetween Day 0 and Day 7 posttransplant

Window startDay 0 posttransplant

Window endDay 7 posttransplant

Allogeneic HSCT Recipient Eligibility

Transplant requirementRecipient has received or is scheduled to receive an allogeneic HSCT

Age and weightAt least 6 months of age and at least 6 kg

CMV statusRecipient is CMV seropositive (R+)

High-Risk Kidney Transplant Recipient Eligibility

Transplant requirementRecipient has received or is scheduled to receive a kidney transplant

Age and weightAt least 12 years of age and at least 40 kg

CMV risk statusDonor is CMV seropositive and recipient is CMV seronegative (D+/R-)

Submit clinical documentation identifying the treatment response, adverse effects, contraindication, or nonsusceptibility for ganciclovir and valganciclovir.
This requirement applies to both HSCT and kidney-transplant indications unless the request qualifies as inpatient-to-outpatient continuation therapy.

Documentation Required

Medical Necessity Documentation

Provide complete medical-necessity documentation with the request. Molina may require patient records, test results, provider credentials, member-specific dosing data, and the clinical rationale supporting coverage.

Include records and test results that support the diagnosis, requested indication, and medical necessity.
Include credentials of the provider ordering or performing the drug or service.
Provide weight, body-surface-area, or other member-specific measurements when relevant to dosing.
Explain any exception request with complete medical rationale.

Unsupported block type: documentation

Prior Authorization

IV Therapy Justification

For an IV Prevymis request, explain why the member cannot use oral therapy and provide supporting documentation. Document the anticipated IV duration and the plan to transition to oral Prevymis as soon as the member can take oral medication, if applicable.

Provide a medical justification for inability to use oral therapy.
Document the anticipated duration of IV therapy.
Document the oral-transition plan and timing when applicable.

Documentation Required

Transition and Specialist Documentation

For continuation therapy initiated in an inpatient setting, document that treatment started within the last 14 days and that the member is transitioning to an outpatient site of care. The request must include discharge documentation with specialist prescriber notes and treatment dates.

Submit discharge documentation and specialist prescriber notes.
Include the duration of therapy and treatment start and end dates.
The prescriber must be or consult with an infectious disease specialist, hematologist, nephrologist, or transplant specialist.

Denial Risk

Insufficient Supporting Documentation

Molina may deny reimbursement or take other appropriate action when submitted documentation does not support medical necessity, non-investigational status, benefit eligibility, or appropriate billing practices. Additional documentation may be requested during coverage determination and related oversight processes.

Unsupported patient records, test results, provider credentials, or clinical rationale may result in denial.
Documentation must support that the drug is medically necessary, not investigational or experimental, and within the member’s benefits.
Inadequate documentation or evidence of inappropriate or excessive billing may create denial or recovery risk.

Denial Risk

Indication Criteria Not Met

Coverage may be denied when the requested use does not satisfy the applicable transplant, CMV, timing, weight, medication, or treatment-history requirements. Ensure every criterion is documented before submission.

HSCT requests must meet allogeneic transplant, CMV R+, Day 0–28 initiation, and at-least-6-kg requirements.
Kidney-transplant requests must meet kidney transplant, CMV D+/R−, Day 0–7 initiation, and at-least-40-kg requirements.
The prescriber must attest that contraindicated medications are not being used concurrently.
The request must document either qualifying ganciclovir/valganciclovir treatment history or eligible inpatient-to-outpatient continuation.
Failure to provide required transplant or CMV serostatus evidence may result in denial.

Denial Risk

Unapproved or Investigational Use

All other uses of Prevymis (letermovir) are considered experimental or investigational under this policy and follow Molina’s applicable Off-Label policy.

Submit requests for non-approved or otherwise unlisted uses under the applicable Off-Label policy.

Denial Risk

Contraindicated Concomitant Medications

Do not use Prevymis concurrently with specified contraindicated medications. Requests involving these combinations are excluded from coverage unless the contraindicated medication is appropriately discontinued or otherwise resolved.

Pimozide.
Ergot alkaloids, including ergotamine and dihydroergotamine.
Pitavastatin.
Simvastatin when co-administered with cyclosporine.

Billing Rule

Billing and Coding Risk

Submit claims using appropriate industry-standard coding and billing practices. Molina may reject or deny a claim and recover payments when the service is billed incorrectly or is not a covered benefit.

J3490 — Unclassified drugs (Prevymis intravenous).
Codes are provided for reference and may not be all-inclusive or applicable to every state or line of business.
A listed code does not guarantee coverage; eligibility and coverage are determined by the member’s benefit document.
Deleted or inactive codes at the time of service may not be eligible for reimbursement.

Posttransplant Day

DefinitionThe period beginning on the date of transplantation

HSCT initiation windowDay 0 through Day 28 posttransplant

Kidney transplant initiation windowDay 0 through Day 7 posttransplant

Prophylactic Therapy

TermProphylactic therapy

DefinitionAdministering an antiviral drug to prevent CMV infection

Target populationPatients at increased risk of CMV infection

Preemptive Therapy

TermPreemptive therapy

TriggerScreening with a sensitive assay to detect early CMV infection

GoalAvoid disease progression

Member weighs at least 6 kg.At least 6 kg

ONE of the following

Treatment-history alternative: Documentation shows inadequate treatment response, serious side effects, contraindication, or nonsusceptibility to treatment with both intravenous ganciclovir and valganciclovir.
Inpatient-to-outpatient continuation alternative: The request is for continuation of therapy started in an inpatient setting within the last 14 days, and the member is transitioning to an outpatient site of care. Discharge documentation must include specialist prescriber notes, duration of therapy, and therapy start and end dates.
Discharge documentation is required.

Kidney transplant initial authorization

Kidney transplant prophylaxis requires ALL of the following, including ONE treatment-history alternative:

Member has received, or is scheduled to receive, a kidney transplant.
Member is a confirmed CMV seronegative recipient receiving a kidney from a CMV seropositive donor (D+/R-).
The prescriber attests that Prevymis (letermovir) will be initiated between Day 0 and Day 7 posttransplant.Between Day 0 and Day 7 posttransplant
The member's medication profile has been reviewed, and the member is not concurrently receiving medications contraindicated with Prevymis, including pimozide, ergot alkaloids such as ergotamine or dihydroergotamine, or pitavastatin and simvastatin when co-administered with cyclosporine.
If intravenous therapy is requested, medical justification with supporting documentation explains why the member is unable to use oral therapy, the anticipated duration of IV therapy is documented, and the member will be switched to oral Prevymis when able to take oral medications, if applicable.
Member weighs at least 40 kg.At least 40 kg
ONE of the following
- Treatment-history alternative: Documentation shows inadequate treatment response, serious side effects, contraindication, or nonsusceptibility to treatment with both intravenous ganciclovir and valganciclovir.
- Inpatient-to-outpatient continuation alternative: The request is for continuation of therapy started in an inpatient setting within the last 14 days, and the member is transitioning to an outpatient site of care. Discharge documentation must include specialist prescriber notes, duration of therapy, and therapy start and end dates.
  Discharge documentation is required.

Prevymis Infusion Quantity Limit

Dosage formPrevymis infusion

Maximum daily quantity1 vial per day

Limit basisDaily quantity limit

Prevymis Maximum Days per Fill

Maximum days per fill28 days

Applies toPrevymis quantity limits

Fill basisPer fill