Limited Coverage Drugs – letermovir

Generic Name

letermovir

Strength

240 mg, 480 mg

Form

tablet

Special Authority Criteria

Approval Period

For the prophylaxis of cytomegalovirus (CMV) infection in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT)

AND

Who are at high risk of CMV infection meeting the following criteria:

  • Umbilical cord blood as stem cell source transplant recipients, OR
  • Haploidentical recipients, OR
  • Recipients of T-cell depleted grafts, OR
  • Recipients of related or unrelated mismatched allogenic stem cell transplant, OR
  • Recipients treated with antithymocyte globulin (ATG) for conditioning, OR
  • Recipients requiring high-dose steroids (defined as the use of ≥ 1 mg/kg/day of prednisone or equivalent dose of another corticosteroid) for acute graft versus host disease (GVHD), OR
  • Recipients treated with ATG for steroid refractory acute GVHD treatment, OR
  • Recipients with documented history of CMV disease prior to transplantation

AND

Patients must have an undetectable CMV DNA at baseline

AND

The treatment is prescribed by a specialist physician with the leukemia/bone marrow transplant program.


Notes:

  • The maximum dosage for coverage approval is 480 mg administered orally per day.
  • Letermovir should be started after HSCT. Letermovir may be started on the day of transplant and no later than 28 days post-transplant.

Maximum coverage is for 100 days per allogeneic HSCT

Practitioner Exemptions

  • None

Special Notes

  • None

Special Authority Request Form(s)