Rezurock Is Approved With More Transplant Agents in Pipeline

by Leslie Small

The FDA on July 16 approved Rezurock (belumosudil) for the treatment of patients 12 years and older who have chronic graft vs. host disease (GVHD) and for whom at least two prior systemic therapies have failed. But that isn’t the only therapy used to treat organ and tissue transplant patients that payers should be watching.

Background:

• Rezurock targets patients whose cases are more difficult to treat, and it appears to be safe and well tolerated, according to Mesfin Tegenu, R.Ph., president and CEO of RxParadigm. Roughly 60% of chronic GVHD patients fail two or more lines of systemic therapy, meaning they could benefit from Rezurock — a first-in-class ROCK2 inhibitor and Kadmon Holdings, Inc.'s first FDA-approved drug.
• With GVHD, "the donated bone marrow or peripheral blood stem cells view the recipient's body as foreign, and the donated cells/bone marrow attack the host's body. This is in contrast to organ transplant rejection where the recipient's immune system attacks (rejects) the transplanted organ," explains Arash Sadeghi, a clinical pharmacist at UnitedHealth Group's OptumRx.

Other agents for transplant patients:

• Maintenance treatments for prevention of organ transplant rejection (the opposite of GHVD) include drugs like calcineurin inhibitors (such as tacrolimus and cyclosporine), mTOR inhibitors (including sirolimus and everolimus), antimetabolic agents (e.g., mycophenolate and azathioprine), and glucocorticoids like prednisone, Sadeghi says.
• Mesfin Tegenu, R.Ph., president and CEO of RxParadigm, highlights polyclonal antibodies, which include thymoglobulin and atgam, and monoclonal antibodies (rituximab), as other available treatments.

How payers manage those therapies:

• "These agents are generally on formulary; however, there may be variations in tiering," Tegenu says. "Additionally, formulary positioning for monoclonal and polyclonal antibodies [is] more closely monitored with prior authorizations and placement in [the] specialty tier."
• OptumRx, however, does not have clinical utilization management in place for anti-organ-rejection drugs, according to Sadeghi. Generally, such therapies are generic and inexpensive, he says; a point on which Tegenu agrees.

More drugs in pipeline:

• The drug pipeline for GVHD is beginning to get interesting. For acute GVHD, agents being studied include an anti-CD6 antibody that prevents T-cell activation and T-cell migration, called alpa-1 antitrypsin, and a double antibody conjugate that is an anti-CD3 and anti-CD7 agent, Tegenu says.

From RADAR on Drug Benefits