Diagnosis: Acute Myeloid Leukemia
Treatment: Formulary exception for Prevymis 480mg
The insurer denied the Formulary exception for Prevymis 480mg.
The denial is upheld.

The patient is a female. The patient has acute myeloid leukemia (AML). She had breast cancer three years prior, and her leukemia was a treatment-related secondary AML. She was treated with Vyxeos and had partial response. Bone marrow revealed persistent AML with 20% blasts. She was recommended for treatment most likely with venetoclax and azacitidine with allogeneic transplantation planned. She underwent haploidentical allogeneic transplantation. Prevymis was prescribed for CMV (cytomegalovirus) prophylaxis.

No, the health plan should not cover the Formulary exception for Prevymis.

This patient is to be treated with pre-emptive therapy to prevent CMV reactivation. Standard agents for this indication include ganciclovir, valganciclovir, and foscarnet. Letermovir (Prevymis) is a newer agent that has been studied in solid organ transplant recipients in a limited fashion, but it has not been studied in allogeneic transplant recipients. It is not considered a standard treatment in this setting. A recent study examining this type of treatment did not include any patients treated with this agent, highlighting that it is not a standard option in this treatment setting.

Given the lack of sufficient supporting evidence for use of this medication in patients treated with allogeneic transplantation, given that the health plan's preferred formulary alternative (valganciclovir) is an available effective standard treatment, and given that no evidence is provided evidence showing why valganciclovir cannot be used, the proposed Formulary exception for Prevymis (letermovir) is not medically necessary and should not be covered.

While valganciclovir has potential side effects and while the appeal letter stating that it is felt this medication would not be well tolerated was noted, there is no medical record information provided to substantiate exactly why this patient is not a suitable candidate for treatment with valganciclovir. This patient underwent allogeneic transplantation but provided medical records are only from the period of time before the transplant was carried out.