CurrentCignaPolicy N/A

Prevymis (letermovir) drug quantity management

Cigna Drug Quantity Management policy limiting dispensed quantities of Prevymis (letermovir) tablets per 365 days and outlining approval criteria for CMV prophylaxis in HSCT and high-risk kidney transplant patients. Applies to health benefit plans administered by Cigna companies; approvals are provided for 1 year.

Policy Summary

PayerCigna

PolicyPrevymis (letermovir) drug quantity management

Policy CodePolicy N/A

Change TypeClarified; Revised

Effective Date

Next Review Date

Key ActionIf quantity rules are not met at point of service, document the indication (HSCT high-risk or kidney transplant high-risk CMV prophylaxis) to approve up to 224 tablets per 365 days; approvals are granted for 1 year.

POLICY UPDATE CHANGES

Override criteria updated to approve the requested quantity, not to exceed a total of 224 tablets per 365 days at retail or home delivery for high-risk kidney transplant patients.

Annual revision on 10/23/2024 with no criteria changes indicated for that annual review.

2Covered indications

112Standard annual tablet limit

224Maximum with criteria

Coverage Summary

Prevymis (letermovir) tablets are covered with criteria for CMV prophylaxis in CMV-seropositive hematopoietic stem cell transplant (HSCT) recipients and in high-risk kidney transplant patients. Coverage is provided when the specified medical necessity criteria are met and any other use is considered not medically necessary.

Medically Necessary Criteria / Quantity Overrides

Prevymis product(s) is(are) covered as medically necessary when the following criteria is(are) met. Any other exception is considered not medically necessary. All approvals are provided for 1 year in duration.

HSCT high-risk CMV prophylaxis: Medication requested for the prophylaxis of cytomegalovirus in a high-risk hematopoietic stem cell transplant (HSCT) patient
Approve for the requested quantity, not to exceed a total of 224 tablets per 365 days at retail or home delivery; override quantity may be rounded up to accommodate packaging.
High-risk kidney transplant CMV prophylaxis: Medication requested for the prophylaxis of cytomegalovirus in a high-risk kidney transplant patient
Approve for the requested quantity, not to exceed a total of 224 tablets per 365 days at retail or home delivery; override quantity may be rounded up to accommodate packaging.

Provider Actions & Billing Rules

Prior Authorization

Quantity Management / Prior Authorization at Point of Service

If the standard Drug Quantity Management rule is not met at the point of service, coverage will be determined by the policy criteria; approvals are granted for 1 year. Requesters must document the indication as either HSCT high‑risk CMV prophylaxis or kidney transplant high‑risk CMV prophylaxis to allow approval of up to 224 tablets per 365 days.

Billing Rule

Per-Rx and Packaging Rounding

Standard maximum quantity is 112 tablets per 365 days and 30 tablets per prescription. Override quantities may be rounded up to accommodate packaging.

Operational notes: approvals for exception/override quantities may be limited to dispensing via retail or home delivery as specified in the criteria (e.g., approval not to exceed a total of 224 tablets per 365 days at retail or home delivery for listed indications).

Rounding and dispensing limits: override quantities may be rounded up to accommodate packaging, and standard maximums apply (e.g., 112 tablets per 365 days and 30 tablets per Rx unless an approved override is granted).

Background

Prevymis is FDA-indicated for CMV prophylaxis in adult and pediatric CMV-seropositive recipients of allogeneic HSCT who are ≥ 6 months of age and weigh ≥ 6 kg, and for CMV prophylaxis in high-risk kidney transplant recipients (donor CMV seropositive / recipient CMV seronegative) who are ≥ 12 years of age and weigh ≥ 40 kg.

Tablets are available in 240 mg and 480 mg strengths. Although oral pellets are FDA-approved, they are not commercially available and are not addressed in this policy.

Definitions

High-risk kidney transplant patientDonor CMV seropositive / recipient CMV seronegative (D+/R-)

Revision History

2023-09-27material_change

Override criteria updated to approve the requested quantity, not to exceed a total of 224 tablets per 365 days at retail or home delivery for high-risk kidney transplant patients; existing HSCT criterion also updated to specify approval not to exceed 224 tablets per 365 days.

2024-10-23annual_reviewLatest