CurrentUnitedHealthcarePolicy 2025 P 1246-10

Pa Notification Prevymis

Policy governs prior authorization/notification requirements for Prevymis (letermovir) prophylaxis in specified transplant populations (allogeneic HSCT recipients who are CMV-seropositive and certain high-risk kidney transplant recipients). It includes initial approval criteria and instructions for reauthorization (which requires appeal).

Policy Summary

PayerUnitedHealthcare

PolicyPa Notification Prevymis

Policy CodePolicy 2025 P 1246-10

Change TypeAnnual review / revisions

Effective DateDec 1, 2025

Next Review Date

Key ActionPrior authorization/notification is required for Prevymis; initial approvals follow the specified clinical criteria and provider attestation of initiation window and prophylactic intent.

SourceLink

POLICY UPDATE CHANGES

10/2025 annual review with updated formatting and reference; no change to clinical intent.

10/2024 background updated with expanded FDA approved indications in pediatric population; no changes to coverage criteria.

7/2023 updated background with additional FDA approved indication and updated coverage criteria.

2Covered Indications (populations specified)

1Reauthorization pathway

2025-12-01Effective Date

Coverage Summary

Scope: This policy governs prior authorization/notification requirements for Prevymis (letermovir) prophylaxis in specified transplant populations: CMV-seropositive allogeneic hematopoietic stem cell transplant (HSCT) recipients and certain high-risk kidney transplant recipients (Donor CMV seropositive / Recipient CMV seronegative [D+/R-]). It defines initial approval criteria, required provider attestations including initiation windows, and instructions for reauthorization (which requires appeal through UnitedHealthcare Pharmacy appeals; OptumRx will deny reauthorization requests).

Population summary: Prevymis is indicated and covered with criteria for (1) allogeneic HSCT recipients who are CMV-seropositive — adults and pediatric patients 6 months of age and older and weighing at least 6 kg — when initiated between Day 0 and Day 28 posttransplantation and used as prophylaxis (provider attestation required); and (2) high-risk kidney transplant recipients (D+/R-) — adult and pediatric patients 12 years of age and older and weighing at least 40 kg — when initiated between Day 0 and Day 7 post-transplantation and used as prophylaxis (provider attestation required).

Age/weight (labeled indications)Adults and pediatric patients 6 months of age and older and weighing at least 6 kg for HSCT; kidney transplant recipients 12 years of age and older and weighing at least 40 kg for D+/R-

Initiation window (HSCT)Day 0 to Day 28 posttransplantation (before or after engraftment)

Initiation window (Kidney transplant D+/R-)Day 0 to Day 7 post-transplantation (before or after engraftment)

Effective Date12/1/2025

Policy Number2025 P 1246-10

Initial Therapy Criteria

Initial Therapy

Prevymis will be approved based on one of the following criteria:

ANY of the following

All of the following (Allogeneic HSCT recipients)
- Patient is a recipient of an allogeneic hematopoietic stem cell transplant
- Patient is CMV-seropositive
- Provider attestation
  - Prevymis will be initiated between Day 0 and Day 28 posttransplantation (before or after engraftment)Day 0 to Day 28 posttransplantation
  - Prevymis is being prescribed as prophylaxis and not treatment of CMV infection
All of the following (Kidney transplant recipients - D+/R- high risk)
- Patient is a recipient of a kidney transplant
- Patient is CMV-seronegative
- Donor is CMV-seropositive
- Provider attestation
  - Prevymis will be initiated between Day 0 and Day 7 post-transplantation (before or after engraftment)Day 0 to Day 7 post-transplantation
  - Prevymis is being prescribed as prophylaxis and not treatment of CMV infection

Continuation Therapy & Reauthorization

Reauthorization

Reauthorization process and coverage limits

ALL of the following

All requests for reauthorization will be denied by OptumRx
Requests for continuation of therapy must be submitted through the appeals process to UnitedHealthcare Pharmacy appeals for consideration

Prior Authorization

Prior authorization/notification required

Prior authorization/notification is required for Prevymis; initial approvals follow the specified clinical criteria and provider attestation of initiation window and prophylactic intent.

Documentation Required

Provider attestation required

Provider must attest that Prevymis will be initiated within the required post-transplant window (Day 0–28 for HSCT; Day 0–7 for D+/R- kidney) and that use is prophylaxis, not treatment.

Prior Authorization

Reauthorization requirement

All reauthorization requests are denied by OptumRx; continuation requires submission through UnitedHealthcare Pharmacy appeals for consideration.

Billing Rule

Automated approvals possible

UnitedHealthcare may approve initial and reauthorization requests based on previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic using automated processes.

Clinical Evidence & References

Primary reference: Prevymis package insert (Merck), January 2025.

Note: FDA labeling was expanded to include pediatric indications per the program change history on 10/2024 (expanded pediatric indication added); see Prevymis package insert (January 2025) for full details.

Background

Indication summary: Prevymis (letermovir) is a CMV DNA terminase complex inhibitor indicated for prophylaxis of cytomegalovirus (CMV) infection and disease in (a) adult and pediatric patients 6 months of age and older and weighing at least 6 kg who are CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (HSCT), and (b) adult and pediatric kidney transplant recipients 12 years of age and older and weighing at least 40 kg who are at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]).

Mechanism: Prevymis is a CMV DNA terminase complex inhibitor.

Labeled age/weight thresholds: For HSCT recipients: ≥6 months of age and ≥6 kg; for high-risk kidney transplant (D+/R-) recipients: ≥12 years of age and ≥40 kg.

Definitions: D+/R- = Donor CMV seropositive / Recipient CMV seronegative. HSCT = Hematopoietic stem cell transplant.

Definitions

D+/R-Donor CMV seropositive / Recipient CMV seronegative

HSCTHematopoietic stem cell transplant

Revision History

7/2023revised

Updated background with additional FDA approved indication and updated coverage criteria. Updated reference.

10/2024revised

Updated background with expanded FDA approved indications in pediatric population; no changes to coverage criteria. Updated reference.

10/2025revisedLatest

Annual review. Updated formatting with no change to clinical intent. Updated reference.