Don’t Forget Organ Transplant Drug Coverage

Don’t Forget Organ Transplant Drug Coverage

Kwaku Marfo, PharmD, BC
Organ Transplant Pharmacist
Montefiore Medical Center, Bronx, New York

Patients who receive a solid organ transplant (heart, kidney, liver, pancreas or small bowel) require anti-rejection medications for the life of their transplanted organ. Without the medications, organs can be rejected within days or weeks, not only threatening the patients’ lives but also creating a huge increase in overall health care spending. Why then, is coverage for anti-rejection medications so spotty?

Consider, as an example, federal health coverage. If Medicare covered an individual’s transplant, then Medicare Part B pays 80% of the cost of these anti-rejection medications for 36 months post-transplant. The remaining 20% is a financial hardship for most patients, but one that only gets worse when the 36 months are over, at which point Medicare coverage cuts off and the patients are expected to pay $1,000 to $3,000 per month for their anti-rejection medications.

Currently the 36-month limitation only applies to end-stage renal disease (ESRD) beneficiaries, but not Medicare beneficiaries who are aged or disabled. Still, that is a large group of patients facing an extended period without coverage for these life-saving anti-rejection medications. Patients with private insurance also face financial hardship, in the form of co-pays. These patients also contend with paying full price for their medications if and when they reach the lifetime maximum coverage amount stipulated by their policies. Then there are the 16% of American adults who do not have any form of health coverage at all.

All told, the cost of anti-rejection medications places a heavy burden on transplant recipients. In a survey by the United Network for Organ Sharing and the American Society of Transplantation, 70% of transplant centers report that patients have “extreme” or “very serious” problems paying for their medications, and 68% of kidney transplant deaths or graft failures are thought to result from lack of access to anti-rejection medications.

Need more proof? Consider the plight of kidney patients who lose access to anti-rejection medications. In a study of 1,000 kidney transplant recipients, graft loss more than doubled when Medicare coverage for anti-rejection drugs ended. This is associated with a significant cost to society because patients who lose transplanted kidneys must return to dialysis. Often, they end up undergoing organ re-transplantation. Furthermore, once a transplanted kidney no longer works, the patient’s risk for death increases ninefold.

According to the most recent report from the United States Renal Data System, Medicare spends an average of $77,000 per year indefinitely dialyzing patients with kidney failure. However, it spends $106,000 the first year after transplant and an average of $17,000 per year thereafter, including the cost of anti-rejection medications. It thus makes financial sense for Medicare to remove the 36-month coverage limitation for anti-rejection medications.

Sen. Richard J. Durbin (D-Ill.), along with other members of the U.S. Senate, supports extending coverage for anti-rejection medications for kidney transplant recipients. The Durbin Kidney Immuno Drug Amendment in the Senate’s health care reform bill (S.Amdt. 3102 to H.R. 3590, The Patient Protection and Affordable Care Act) mirrors a provision in the health care reform bill in the U.S. House of Representatives (H.R. 3962, The Affordable Health Care of America Act). This amendment would lift the current 36-month rule for Medicare anti-rejection drug coverage. Not only will it save money by preventing unnecessary re-dialyzing and re-transplantation in patients with kidney failure, it will save lives. Whether these amendments survive reconciliation of the health care reform bill signed into law on March 22 remains to be seen. Regardless of the fate of S.Amdt. 3102, it should serve as a model for continued efforts to make drug coverage for organ transplant recipients more affordable.

As for private insurance, drug coverage varies widely. In some cases, anti-rejection drugs are covered adequately. Other plans require very high co-pays or may not offer coverage at all. For these patients, the Medicare program—without the onerous 36-month cap on drug coverage—can help them afford their lifesaving medications and maintain their transplanted organ.

Reform Efforts Are Not the Only Answer

Because no immediate relief may be in sight from health care reform, other strategies are needed to help lower the cost of anti-rejection medications. One option is to reduce reliance on costly brand-name drugs and instead to use less expensive bioequivalent generics as substitutes. Laws governing substitution vary by state, but in general, patients can expect a 30% to 50% reduction in anti-rejection medication costs when a generic bioequivalent is substituted for a brand-name drug (Table 1).

Table 1. Brand and Generic Anti-rejection Medication Prices
Brand   Price/Quantity   Generic   Price/Quantity   Savings From Generics, %
CellCept, Genentech 500 mg tablet   $865.62/ 100 tablets   Mycophenolate mofetil 500 mg tablet   $129.99/ 100 tablets   85
Neoral, Novartis 100 mg capsule   $319.87/ 60 capsules   Cyclosporine modified 100 mg capsule   $160.99/ 60 capsules   50
Prograf, Astellas 1 mg capsule   $409.93/ 100 capsules   Tacrolimus 1 mg capsule   $350.01/ 100 capsules   15

Table 2. Mycophenolate Mofetil Products And Their Manufacturers
Pharmaceutical Product   Manufacturer
CellCept 500 mg tablet   Genentech
Mycophenolate mofetil 500 mg tablet   Accord Healthcare, Inc.
Mycophenolate mofetil 500 mg tablet   Apotex Corp
Mycophenolate mofetil 500 mg tablet   Mylan Pharmaceuticals Inc
Mycophenolate mofetil 500 mg tablet   Roxane Laboratories Inc
Mycophenolate mofetil 500 mg tablet   Sandoz Inc
Mycophenolate mofetil 500 mg tablet   Teva Pharmaceuticals USA Inc
Mycophenolate mofetil 500 mg tablet   UDL Laboratories Inc
Mycophenolate mofetil 500 mg tablet   Zydus Pharmaceuticals (USA) Inc

However, in the field of solid organ transplantation, generic substitution has been an emotional issue. Much of the tension occurs as a result of two opposing forces that are brought to bear on the organ transplant team: insurance companies that promote the use of lower-cost generics, and innovator companies that want to protect their branded products’ market share, sometimes by calling into question the bioequivalence of those medications.

Transplant clinicians must walk a fine line. Although they recognize the financial hardship that using brand-name anti-rejection medications can impose on their patients, many feel that the proposed guidelines for demonstrating bioequivalence for transplant indications are too loose and could be potentially dangerous. Also, the availability of several generic bioequivalents for each anti-rejection drug creates a potential for medication errors. For instance, there are eight FDA-approved generic mycophenolate mofetil bioequivalents available as substitutes for Genentech’s CellCept (Table 2). Depending on manufacturers’ supply and shifting purchasing costs as competitors jockey for sales to pharmacies, patients may receive a different mycophenolate mofetil product each time they refill a prescription. That raises the possibility of patients unknowingly doubling up on their prescriptions, which can lead to potentially serious adverse reactions.

These are just a few of the clinical and policy challenges facing the organ transplant team. By pressing for workable solutions to these challenges, hopefully we can bring about safer and more affordable health care for our organ transplant patients.

Please go to article to view the TABLE 1 AND 2
http://www.pharmacypracticenews.com/index.asp?section_id=451&show=dept&issue_id=624&article_id=15000