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Saving Protected Class of Immunosuppressant Drugs

The Honorable Fred Upton
Committee on Energy & Commerce
United States House of Representatives
2125 Rayburn house Office Building
Washington, Dc 20515
The Honorable Henry Waxman
Ranking Member
Committee on Energy & Commerce
United States house of Representatives
2322A Rayburn House Office Building
Washington, DC 20515

Dear Chairman Upton and Ranking Member Waxman:

As organizations who advocatefor the needs oftransplant recipients,we request you to contact the Administration and the Centers for Medicare & Medicaid Services (CMS) and urge them notto proceed with the proposal to remove immunosuppressive drugs for transplant recipients as a protected class under Medicare Part D.On January 6, 2014 CMS released a proposed regulation to change the criteria for the six protectedclasses ofprescription drugs under MedicarePart D.Under the proposal, Part D plans may no longer be required to cover all approved immunosuppressivemedications.The proposed rule referenced a report from an unidentified panel the agencyhadengaged to evaluate the new criteria against the current protected classes.That panel recommended eliminating protection for immunosuppressive drugs in addition to two otherdrug classes.Citing a review of clinical guidelines, the panel incorrectly concluded that a more specific formulary that ensures only each subclass of immunosuppressive drugs isavailablewould suffice.However, the drugs under each subclass arenot interchangeable.Each subclass includes different agents with different mechanisms of action. Patient access to all immunosuppressive drugs is necessary.Immunosuppressive drugs are prescribed in combinations tailored to meet the unique needs of the individual transplant recipient in order to achieve sufficient immunosuppression while minimizing the toxicity associated with individual agents. Restrictive formularies limit physicians’ ability to prescribe the right combination of medications to protect the recipient from organ rejection and other serious side-effects.This delicate balance was recognized in the original decision to include these medications under protected status.

Not all patients respond the same to just one or two combinations of medications. Often, the first prescribed drug combination needs to be adjusted or replaced altogether, further underscoring the need to have all drugs available under Part Dplans.While CMS hasrecognized that subjecting transplant recipients toan appeals process would put patients’ lives and organs at risk, the agency has not provided guidance as to how it will make sure patients are able to accessthecombination of medications prescribed to them by their physician if immunosuppressants arenolonger a protected class.

While we understand the need to control healthcare spending, this is not the way to achieve savings. Last year there were 26,513 organ transplants in the U.S. and manywere Medicarebeneficiaries for whom Medicare Part B covers immunosuppressive drugs.While this proposal will impact a small number of organ recipients, it puts those who do get their immunosuppressive drugsunder Part D, health and lives at risk.It is also likely to result in higher spending under Medicare Parts A and B,


particularly if more patients’ organs fail, fueling the need for more health careservicesand/or the need for another Medicare covered transplant.While each of our organizations will submit written comments to CMS, we ask that you please contact the Administration and CMS as soon as possible and askthem to maintain immunosuppressants as a protected class.


National Kidney Foundation
American Association of Kidney Patients American Kidney Fund
Dialysis Patient Citizens
Hepatitis Foundation International Leukemia & LymphomaSociety Lupus Foundation of America
PKD Foundation
Renal SupportNetwork