POLIVY and Health Insurance Denials

On June 10th, 2019, the FDA granted accelerated approval to the use of POLIVY with a bendamustine and rituximab product (BR) as a treatment for patients suffering from diffuse large B-cell lymphoma (DLBCL), the most common type of non-Hodgkin lymphoma in America. It was approved for patients that have either returned after two prior treatments or who’s condition is worsening.

Despite DLBCL lymphoma having a cure, POLIVY with BR provides a new option for people who have not responded to other treatments. The FDA indicates that about 30-40% of patients will face a relapse of DLBCL, therefore POLIVY with BR can successfully prevent these relapses from causing damage.

POLIVY is an antibody-drug conjugate, meaning it is an antibody conjoined with a chemotherapy drug. This enables it to target and destroy cancerous cells. POLIVY attaches to protein CD79b, a protein commonly found in B cells in people with lymphoma, therefore targeting that specific type of white blood cell. Once attached to the B cell, the chemotherapy drug is released into the cancerous cell.

POLIVY with BR achieved accelerated FDA approval after a successful drug trial involving 80 patients. In the trial, some patients were given POLIVY with BR, while others were treated with just BR. The results of the study showed that 40% of patients exhibited a complete response to POLIVY with BR compared to the 18% of patients who showed a complete response with just BR. In total, 25 patients responded either partially or completely to POLIVY with BR treatment. Of the 25, 16 of them experienced a state of remission from DLBCL for six months and 12 of them experienced it for 12 months. Thus showcasing the potential POLIVY with BR treatment has to suppress or cure a very dangerous disease in diffuse large B-cell lymphoma.

If your insurance company has denied or delayed access to POLIVY then contact us for a free case evaluation.

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