Prevymis - NC Standard

Restricted Products:

• Prevymis™ (letermovir)

FDA Approved Use:

• For prophylaxis of cytomegalovirus (CMV) infection and disease in adult and pediatric patients 6 months and older and weighing at least 6 kg who are CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).
• For prophylaxis of cytomegalovirus (CMV) disease in adult and pediatric patients 12 years and older and weighing at least 40 kg who are kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]).

Criteria for Approval of Restricted Product(s):

1. The patient is a recipient of an allogeneic hematopoietic stem cell transplant (medical record documentation required); AND
   1. The patient is 6 months of age or older and weighs at least 6 kg; AND
   2. Therapy with Prevymis will be initiated between Day 0 and Day 30 post-transplantation; AND
   3. Therapy duration with Prevymis will not exceed 200 days post-transplantation; AND
   4. The patient is a confirmed CMV seropositive recipient (R+) (medical record documentation required); AND
      1. ONE of the following:
         1. The requested product will be used as preemptive therapy for CMV infection and disease; AND
            1. The patient has experienced an inadequate response to valacyclovir (medical record documentation required); OR
            2. The patient has a clinical contraindication/intolerance to valacyclovir (medical record documentation required); OR
         2. The requested product will be used for prophylaxis of CMV infection and disease; OR
2. The patient is a recipient of kidney transplant (medical record documentation required); AND
   1. The patient is 12 years or older and weighs at least 40 kg; AND
   2. Therapy with Prevymis will be initiated between Day 0 and Day 7 post-transplantation; AND
   3. Therapy duration with Prevymis will not exceed 200 days post-transplantation; AND
   4. The patient is considered high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]); (medical record documentation required); AND
3. If the request is for the oral pellet packets:
   1. The patient is 6 Months to less than 12 Years of Age; OR
      1. 12 Years of age and older and weighing less than 30 kg; OR
   2. ALL of the following:
      1. The provider attests that the patient is unable to take the requested product in a standard formulation; AND
      2. The patient is not taking any other medication in a standard dosage form; AND
      3. If a patient is using an enteral feeding tube, the tablet formulation cannot be crushed for administration (via nationally recognized organization such as the Institute for Safe Medication Practices); AND
4. The patient is being managed by a specialist in the area of the patient’s diagnosis (e.g hematologist/oncologist, infectious disease, or transplant specialist) or in consultation with a specialist in the area of the patient’s diagnosis; AND
5. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: determined by indication (see below)

Hematopoietic stem cell transplant: 200 days

Kidney transplant: 200 days

Quantity Limitations:

Quantity limitations apply to brand and associated generic products.

Quantity Limit Exception Criteria:

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).

Duration of Approval: determined by indication (see below)

Hematopoietic stem cell transplant: 200 days

Kidney transplant: 200 days

References:

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

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q2 annually.

February 2025: Criteria change: Updated criteria to remove co-administration of cyclosporine requirement with 240 mg tablet. Added P&T statement. Updated policy to include new oral pellet packets and added to quantity limit chart. Added age, weight administration requirements for use of packets.

September 2024: Criteria change: Added expanded indications for prophylaxis of cytomegalovirus (CMV) infection and disease in pediatric patients 6 months and older and weighing at least 6 kg who are CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant, and for prophylaxis of CMV disease in pediatric patients 12 years and older and weighing at least 40 kg who are kidney transplant recipients at high risk (donor CMV seropositive/recipient CMV seronegative [D+/R-]). Update duration of approval for Hematopoietic stem cell transplant to 200 days.

June 2023: Criteria change: Added expanded indication for adult kidney transplant recipients at high risk. Duration of approval changed to be determined by indication: Hematopoietic stem cell transplant: 100 days and Kidney transplant: 200 days.

October 2021: Criteria change: Step through valacyclovir required when used for preemptive therapy.

September 2020: Annual Criteria Review.

April 2018: Original utilization management criteria issued.