Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Bilateral lung transplant
Treatment: Continued use of Prevymis 480mg tablet (prevention of cytomegalovirus infection or disease) (90 tablets for 90 days)
The insurer denied the Continued use of Prevymis 480mg tablet (prevention of cytomegalovirus infection or disease) (90 tablets for 90 days)
The denial is overturned.

The patient is a male with long term immunosuppression after lung transplant; Bilateral Lung Transplant for RA-ILD (rheumatoid arthritis-interstitial lung disease), CMV (cytomegalovirus) D+/R- (donor positive/recipient negative) EBV (Epstein-Barr virus) D+/R- (donor positive/recipient negative). Post transpant, patient has been on immunesuppressive meds including Prograf and Everolimus, Cellcept, Prednisone. The patient has been on Prevymis(letermovir) for CMV (cytomegalovirus) prophylaxis, and the treating physician plans to continue this medication.

The request was denied on prior review. The reason for denial is below.

Plan prior authorization criteria have a limit on the use of this drug.   Based on the prior review patient has been approved for 100 tablets (1 tablet per day for 100 days of treatment). However, additional quantity request for 90 tablets per 90 days was not approved as plan criteria has quantity limit for use of this medication.

Yes, the Continued use of Prevymis is medically necessary.
The patient is a male with long term immunosuppression after lung transplant; Bilateral Lung Transplant for RA-ILD (rheumatoid arthritis-interstitial lung disease), CMV (cytomegalovirus) D+/R- (donor positive/recipient negative) EBV (Epstein-Barr virus) D+/R- (donor positive/recipient negative). Post-transplant, the patient has been on immunosuppressive meds including Prograf and Everolimus, Cellcept, Prednisone. The patient has been on letermovir for CMV (cytomegalovirus) prophylaxis and the treating physician plans to continue this medication.

The patient is CMV (cytomegalovirus) seronegative and has a history of CMV (cytomegalovirus) viremia when he was taken off CMV (cytomegalovirus) prophylaxis. The patient developed primary CMV (cytomegalovirus) infection was treated with valganciclovir and developed leucopenia, which persisted even on low dose maintenance. Due to this adverse effect, the patient was switched from valganciclovir to letermovir, and his WBC (white blood count) was maintained in normal range after the switch.

Letermovir is an anti-CMV (cytomegalovirus) agent with a novel mechanism of action; it inhibits the viral terminase subunit pUL56 (pseudorabies virus protein UL56), a component of the terminase complex involved in DNA (deoxyribonucleic acid) cleavage and packaging that has no equivalent target enzyme in the human body. Letermovir was approved by the US Food and Drug Administration and Health Canada in for CMV (cytomegalovirus) prophylaxis in adult CMV (cytomegalovirus)-seropositive (R+) allogeneic HCT (hematopoietic cell transplantation) recipients.

Letermovir is a new antiviral agent with activity against human cytomegalovirus (CMV). Letermovir works as an inhibitor of the CMV (cytomegalovirus) DNA (deoxyribonucleic acid) terminase complex which further inhibits viral DNA (deoxyribonucleic acid) processing and packaging. Letermovir has a novel mechanism of action, exerting its antiviral effect by interfering with the viral pUL56 (pseudorabies virus protein UL56) gene product and in the process disrupting the viral terminase complex. Letermovir is available both orally and intravenously in 480-mg (milligrams) and 240-mg (milligrams) dosage forms, and is approved for use in the prophylaxis of CMV (cytomegalovirus) infection and disease in CMV (cytomegalovirus)-seropositive recipients of allogeneic hematopoietic stem cell transplant (HSCT) over the age of 18.  Cross-resistance with other useful antiviral agents in the treatment of CMV (cytomegalovirus) has not been observed. Additionally, letermovir is active against DNA (deoxyribonucleic acid) polymerase inhibitor-resistant viral strains. Letermovir has shown promising clinical efficacy and is generally well tolerated, thus providing a favorable new option in the prophylaxis of CMV (cytomegalovirus) infection and disease. Advantages of letermovir include its good oral bioavailability, its lack of toxicity, and the apparent absence of drug-drug interactions. Letermovir (Prevymis) is a new anti-viral agent which has been found to be a well-tolerated alternative without significant bone marrow suppression or toxicity and has been effectively used in the transplant population as a prophylactic agent.
The patient was unable to tolerate Valganciclovir due to Severe Neutropenia. Since starting Prevymis, his WBC (white blood count) and Absolute neutrophil count have been low but within an acceptable range. The patient needs to continue CMV (cytomegalovirus) prophylaxis on Prevymis at this time in view of the immune suppressed state and risk for CMV (cytomegalovirus) reactivation.

Due to concern for possible CMV (cytomegalovirus) reactivation, and worsening thrombcytopenia, neutropenia in this patient, it is medically appropriate and necessary that the patient receive the medication letermovir (Prevymis) to prevent CMV (cytomegalovirus).

Lung transplant recipients can experience aggressive replication of CMV (cytomegalovirus) as a result of their immunosuppression. Prophylaxis and treatment of CMV (cytomegalovirus) is imperative in efforts to decrease risk of serious complications such as viral infection, rejection, graft loss and reduced survival. Cytopenias and decreased kidney function are unwanted side effects from anti-viral therapies such as foscarnet, ganciclovir and valganciclovir. Despite not being a hematopoletic stern cell transplant, the use of letermovir for secondary prophylaxis of CMV (cytomegalovirus) is well-established in solid organ transplant patients and supported by clinical evidence. Patient is still at increased of CMV (cytomegalovirus) infection or CMV (cytomegalovirus) disease due to her Immunosuppressive medications including prednisone and tacrolimus.

No, the health plan did not act reasonably, with sound medical judgment, and in the best interest of the patient.