Wiki drug therapy for Multiple Myeloma issue with Palmetto GBA

[SMfowler]

Our practice in Tennessee has been recently transitioned to Palmetto GBA MAC. We are having issues with drug therapy claims for Multiple Myeloma denying as not medically necessary. Drug examples are Kyprolis and Darzolex. There are no LCD's on file. We think they are in need of additional information, such as box 19 comments. Does anybody have any information that could help us out?

 

[OncologyOKC]

Good morning,
Make sure you are covering all of the FDA approved reasons for the drug and send all of that proof with your appeal. For example, on Kyrpolis the FDA approved uses are : •KYPROLIS® (carfilzomib) is a prescription medication used to treat patients with relapsed or refractory multiple myeloma who have received one to three previous treatments for multiple myeloma. KYPROLIS is approved for use in combination with dexamethasone or with lenalidomide plus dexamethasone, which are other medicines used to treat multiple myeloma.
•KYPROLIS® is a prescription medication used to treat patients with relapsed or refractory multiple myeloma who have received one or more previous treatments for multiple myeloma. KYPROLIS is approved for use alone to treat relapsed or refractory multiple myeloma.

So you want to be able to prove that the patient has the necessary diagnosis (Relapsed or refractory MM) has had 1 to 3 prior treatments for MM. If you prove all of these things then you have met Medical necessity.

Same with DARZALEX: is a CD38-directed cytolytic antibody indicated:
• in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy
• in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor
• as monotherapy, for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.

I hope this helps and please feel free to contact me with any further questions.

thanks!

 

[leighannefaust@yahoo.com]

Prior Therapy

We are having the same issue. Palmetto requires that the prior lines of therapy are reported in box 19. However, our challenge is fitting all the needed information into the space provider. So much for a seamless transfer.