Livtencity

Maribavir

• Brand(s): Livtencity
• Dosage Form/Strength: 200 mg tablet
• Effective date: July 8, 2024

Initiation criteria:

For the treatment of post-transplant cytomegalovirus (CMV) infection in adult patients who meet the following criteria;

1. Diagnosed with laboratory confirmed post-transplant cytomegalovirus (CMV) viremia;
   AND
2. Treatment is refractory to valganciclovir and/or ganciclovir (Note 1);
   AND
3. Prescribed by clinicians with experience and expertise in transplant medicine, transplant infectious disease, or infectious diseases.

Discontinuation criteria:

Maribavir must be discontinued in patients meeting one or more of the following:

1. No change or an increase in CMV viral load after at least 2 weeks of maribavir treatment
2. Confirmed CMV genetic mutation associated with resistance to maribavir

Exclusion criteria:
(Patients meeting any of the below criteria will not be funded.)

1. Maribavir will not be funded in combination with valganciclovir or ganciclovir.

Notes:

1. Patients who are intolerant to, resistant to, or have contraindications to valganciclovir and/or ganciclovir may be considered on a case-by-case basis if they have been refractory to CMV treatments (e.g. foscarnet or cidofovir) that are not funded under the ODB program.
2. Maribavir should not be used for prevention of CMV as there is limited data to support its efficacy in this clinical setting.
3. Retreatment with maribavir may be considered for patients who have a recurrence of CMV viremia after a previous successful course of therapy with maribavir.
4. Pediatric patients younger than 18 years of age may be considered on a case-by-case basis for requests from a prescriber specialized in the care of pediatric transplant patients.

Recommended dose: 400mg twice daily

Duration of Approval: 3 months

Renewal criteria:

Requests for ongoing treatment of maribavir for continuation of therapy longer than 3 months will be considered on a case-by-case basis through an expert review in patients who do not meet the discontinuation or exclusion criteria.

All relevant clinical information to support the use of maribavir for an extended duration beyond 3 months, including laboratory results for resistance testing and the overall treatment plan must be provided.

Duration of Approval of Renewals: Up to 3 months