IBM-Micromedex® Expansion of Endorsed Immunosuppressant Off-Label Uses

Thursday, April 14, 2022

Jennifer McDermott, PharmD, BCTXP, BCPS on behalf of the AST Transplant Pharmacy COP Public Policy Workgroup

The AST Transplant Pharmacy COP Public Policy Workgroup has been working on an important initiative for several years with the support of the AST Transplant Pharmacy COP Executive Committee and AST leadership. We are happy to share recent progress that will allow for broader medication access for solid organ transplant recipients.

As a compendium recognized by the Centers for Medicare and Medicaid Services (CMS), Medicare Part D plans utilize the information in IBM-Micromedex® for determination of medically-accepted off-label indications.  This determination is critical, as it dictates whether a drug claim will be reliably paid by a Medicare Part D plan for a specific beneficiary.  Monographs for many immunosuppressive drugs in IBM-Micromedex® have not adequately addressed off-label organ transplant uses.  As a result, transplant recipients have been vulnerable to, and some have experienced, denial of coverage by Part D plans for their lifesaving immunosuppressive drug therapy. 

The AST first became aware of this issue in 2016 and formalized a position.  The AST Transplant Pharmacy COP Public Policy Workgroup drafted letters, first in 2019 then an update in 2021, that were submitted by AST leadership to IBM-Micromedex® to describe this issue and petition for consideration of expanding "Non-FDA Uses" for select immunosuppressants.  Specifically, the letters identified off-label indications for immunosuppressants that were not endorsed but we felt should be, along with supportive evidence. 

We are pleased to share that IBM-Micromedex® has been responsive to this request. 

Recognizing the importance of this work, the following endorsed uses have been added to IBM-Micromedex® with ongoing review of additional requested off-label uses.  

Heart Transplant

  • Rejection, prophylaxis: Azathioprine (adults + pediatrics), Mycophenolate sodium (adults), Everolimus (adults + pediatrics), Sirolimus (adults + pediatrics)
  • Desensitization therapy: Bortezomib, Rituximab, IVIG
  • Rejection, treatment: Bortezomib, Rituximab, IVIG

Pancreas Transplant 

  • Rejection, prophylaxis: Cyclosporine, modified (Neoral®), Mycophenolate mofetil, Mycophenolate sodium, Prednisone, Prednisolone, Alemtuzumab

Liver Transplant

  • Rejection, prophylaxis: Mycophenolate sodium (adults + pediatrics), Prednisone (adults + pediatrics), Prednisolone (adults + pediatrics), Anti-thymocyte globulin, rabbit (adults + pediatrics), Methylprednisolone (adults + pediatrics) 
  • Rejection, treatment: Anti-thymocyte globulin, rabbit, Bortezomib, Rituximab (adults + pediatrics)

Kidney Transplant

  • Rejection treatment: Bortezomib, Rituximab

The AST is thrilled with the progress on this initiative and hopes this information will be helpful to the transplant community with ongoing navigation of immunosuppressant drug coverage.  

Ongoing updates regarding this initiative will also be shared on the Transplant Pharmacy Community of Practice Twitter (@AST_TXPHARMCOP) and Instagram (ast_txpharmcop) accounts.