Limited coverage criteria – maribavir

Last updated on April 3, 2025

 

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Generic name

maribavir

Strength & form

200mg oral film-coated tablet

Special Authority criteria

Approval period

Initial

For the treatment of patients aged 18 years or older with post-hematopoietic cell transplant cytomegalovirus (CMV) infection or disease who are refractory to one or more prior antiviral therapies meeting either of the following criteria:

  • CMV viral load has plateaued or increased after a minimum of 21 days of treatment with any of the following medications:
    • ganciclovir
    • valganciclovir
    • foscarnet
    • cidofovir

OR

  • Documentation of 1 or more CMV genetic mutations associated with resistance to ganciclovir or valganciclovir

AND meeting ALL of the following conditions:

  • CMV baseline viral load level was above 1000 IU/mL and required treatment, and
  • Coverage is requested by a transplant infectious disease (ID) specialist physician

8 weeks

Renewal

For the continued treatment of adult patients with post-hematopoietic cell transplant CMV infection or disease who meet the following conditions:

  • Patient has persistent viremia with CMV viral load above 200 IU/mL after 8 weeks of treatment with maribavir

AND

  • Coverage renewal is prescribed requested by a transplant ID specialist physician
4 weeks (only 1 renewal per treatment course)

Practitioner exemptions

  • None

Special notes

  • Treatment should be discontinued if patients have no change or an increase in CMV viral load after at least 2 weeks of maribavir treatment or confirmed CMV genetic mutation associated with resistance to maribavir
  • Submission of quantitative CMV DNA report or resistance testing report may be required to support request, where it is applicable

Special Authority request form(s)