VA Adds Cancer Immunotherapy Monjuvi to National Formulary

The Department of Veterans Affairs has added Monjuvi (tafasitamab-cxix) to its national formulary. Monjuvi has received accelerated approval to be used in combination with lenalidomide to treat adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Within the Department of Veterans Affairs, Monjuvi has been given a status of PA-F, which stands for Prior Authorization – Facility. This means it is on the VA formulary but may have prior authorization requirements at the local facility level.

Monjuvi is available for veterans with diffuse large B-cell lymphoma upon request provided the patient meets the Criteria for Use, which functions similar to prior authorization. It outlines the inclusion and exclusion criteria for approval for use.

According to the Criteria for Use, patients must meet certain requirements to be eligible, including being previously treated for relapsed or refractory diffuse large B-cell lymphoma in combination with lenalidomide; ineligible for autologous stem cell transplant; and receiving care provided by a VA or VA Community Care oncology or hematology provider.

Some veterans are exempt from copays based on their disability rating, service history, or income. The VA provides free healthcare for conditions related to military service, for Veteran’s with catastrophic disabilities and disability ratings of at least 50%. Copays for medications are generally low, with brand name medications on tier 3 having a $33 copay for a 90-day supply. For those veterans who are required to pay copays for medication, the maximum cost is $700 per calendar year.

Monjuvi is a CD19-targeting monoclonal antibody that is marketed by Incyte. It has a wholesale acquisition cost of $1,348.20 per vial. The therapy is marketed as Minjuvi in Europe. In the first nine months of 2024, Monjuvi generated $86.43 million for Incyte, which is an increase from the first nine months of 2023.

Monjuvi received accelerated approval in July 2020 as a second-line treatment for diffuse large B-cell lymphoma. DLBCL is a fast-growing subtype of non-Hodgkin lymphoma with a five-year survival rate of about 65%. The rate of new cases is about 5.5 per 100,000 men and women per year, according to the National Cancer Institute.

In February 2024, Novartis acquired Morphosys and at that tme Incyte obtained exclusive rights to develop and commercialize tafasitamab globally. Incyte previously had a commercialization agreement with Morphosys.

In August 2024, Incyte announced topline results from a phase 3 trial evaluating Monjuvi in relapsed or refractory follicular lymphoma (FL). The inMIND trial met the primary endpoint of progression free survival. No new safety signals were observed. Follicular lymphoma is a slow growing form of B-cell non-Hodgkin lymphoma and accounts for approximately 13% to 26% of overall non-Hodgkin lymphoma. Data from the inMIND trial are expected to be presented at an upcoming medical meeting.

Incyte expects to file a supplemental biologics license application for Monjuvi by the end of 2024 to be used in combination with lenalidomide and rituximab in follicular lymphoma.