Institute of Medicine
Committee on Medicare Coverage Extensions
Workshop on Immunosuppressive Drugs For Transplant Patients
June 18, 1999
Ladies and Gentleman of the committee and honored guests,
I want to thank you for inviting me here today to speak before this very important committee. I stand before you as a transplant professional and a transplant patient. I feel that the decision to extend Medicare payments for anti-rejection medications, to lifetime, is one that will save many organs, but more importantly, many lives. In my experiences over the past 14 years, I have met and spoken with several thousand transplant patients. It is clear to me that there are many problems that these patients face coping with transplantation, the treatment of their disease. One of the most important is how to pay for the medications, to the tune of an estimated $1,000 to $1,700 per month long term, with 75% of this expense being anti-rejection medications. A survey of kidney transplant patients in Chicago suggests that 10% of patients out from transplant more than three years are unable to be compliant with their medications due to financial constraints. This group of patients was mostly Caucasian, and in my opinion under-estimates the percentage significantly. In a lower socioeconomic group of patients the rate is more likely 20 to 30%.
Patients find many creative ways to circumvent this dilemma. Some are fortunate to rely on family and friends to help them afford their life-saving medications. They live month to month trying to find the money to pay for their medications. Others rely on indigent programs, including some state and pharmaceutical industry funds. These programs are shrinking in number, and the qualifying income continues to rise. Still more patients use a commonly known "Grey Market" to recycle medications other patients are no longer on. This practice is illegal and turns honest people into criminals. Some patients tell stories of approaching the families of deceased transplant patients, many of them friends, to retrieve any unused medications, so they may be used by other patients. A few patients have even traveled to Mexico to purchase medications much cheaper and bring them back into this country. There is a danger here, since there is no FDA to regulate the production of these medications. If patients purchase an inferior product, they may not get the therapeutic effect desired. This could result in an acute rejection, and possibly early loss of the organ or death of the patient. Other patients resort to charging their medications on a credit card with a monthly compounded interest rate of 18 to 23%. Many end up filing for bankruptcy because they can never dig themselves out of their hole. Some of my patients and friends have admitted to what we call "creative dosing" of their medications. They will cut the dose by 25 to 50% daily or take a full dose every other day, or full dose one day and half dose the next. A new type of medication purchasing will occur now that generic immunosuppression is available. Patients paying for their own medications will begin to price shop from pharmacy to pharmacy. They will select the drug that is cheapest that day. This will cause patients to switch brands of medication on a monthly basis. The issue of variability of critical-dose drugs like cyclosporine and tacrolimus, as well as future drugs like sirolimus and others, will cause fluctuations in a patient's blood level of these drugs. This practice could result in a significant amount of patients having sub-therapeutic blood levels, and increase the incidence of acute rejection, and shortened half-life of transplanted organs.
Every time a patient loses a functioning transplant he or she must be put back on the waiting list for another organ. Approximately 20,000 solid organ transplants are done each year. If 10% are admittedly non-compliant for financial reasons, and a very low estimate of 10 to 20% of those lose their graft each year, then 200 to 400 patients will be added back to the transplant waiting list each year. Not only do these patients require more government expenses, as either dialysis or disability, but they prevent 200 to 400 other patients from being transplanted each year. Thus, the net effect will be 400 to 800 patients on the transplant waiting list that otherwise would not have to be.
A study done in Tucson, Arizona, looked at how Medicare beneficiaries managed capped prescription benefits. This study looked at a questionnaire mailed to 600 enrollees of a Medicare HMO-risk plan in Southern Arizona. They found that the following were strategies used to avoid reaching their prescription cap: 35.5% obtained samples from physicians; 20.9% took less than the prescribed dose; 18.5% used an over-the-counter medication instead of the prescription; 14.8% discontinued the prescribed medication; 9.4% purchased their medications in Mexico; 12% went without another necessity; and 9.4% borrowed money to pay for their medications.
There are also humanitarian issues related to this decision. First is the psychological conundrum. Before their illness, many patients were the breadwinners in their family. During their illness and after the transplant, they become dependent upon their family, friends and society to provide for them. It is one of the most degrading things a person can go through. After a few months, patients become empowered and begin to put their lives back together. Hopefully, they go back to work or find new work. Then one day their benefits are taken from them. The lucky ones go back to depending on family and friends. The unlucky ones make daily decisions between feeding and clothing themselves and their families or taking their medications. They sacrifice their future for the present, as any of us would do, living paycheck to paycheck, scrambling for food and clothes and depriving themselves of all of the things that a second chance at life once promised. The psychological impact of their decisions are devastating. Second is our duty the donors families and donors, including living donors. The highest gift that can be given on this earth is the gift of life. We graciously receive this gift at a time of great tragedy and duress for another family. We have a responsibility in the transplant community as caregivers, both professionals and insurers- including the U.S. government- to honor that gift, to care for and nurture that gift for its altruistic value, THE GIFT OF LIFE! Not one transplant should be lost in this country for any reason that is within our control. We owe this, at the very least, to the brave families who said yes to donation in their darkest hour.
In closing I want to leave you with several representative patient cases that emphasize the seriousness of this issue clearly.
One kidney transplant patient in Gainesville, Florida lost coverage and began taking half of his prescribed cyclosporine dose. The patient had a severe rejection and lost his graft.
Another kidney transplant patient from West Virginia lost her Medicaid coverage shortly after her transplant. She stopped her Prograf and only took her Cellcept, using her own money to pay for it. She rejected and had to be treated with Orthoclone (OKT3). She is now being maintained using old Prograf returned by another patient- an example of the "Grey Market."
A 55 year-old gentleman from South Dakota recently celebrated his three-year kidney transplant anniversary. His daughter had given him this gift. His present this year was loss of his Medicare benefits for immunosuppression. He had a $700 a month immunosuppression bill, and his state had no renal program. His social security income was too high and this disqualified him from Medicaid. He feared that all of his savings and retirement funds would be used up and his wife, whom he felt would outlive him significantly, would have nothing. In hindsight, he would have stayed on dialysis and not put his daughter through the donation, if he had known the financial consequences, and the potential of losing his kidney, by not being able to afford his medications.
A gentleman from Vermont is divorcing his wife because they make too much money to qualify for Medicaid. They tried to get individual insurance to help with the cost of medications, but the insurance was more costly than the medications. This couple now has to maintain separate living arrangements to qualify for coverage.
Another patient relies on her husband's insurance to pay for her medications. She says, "I have been trying to find help in paying for my medications when my husband retires in 11 years. Everyone tells me to wait, but it's a great concern for us. I want him to be able to retire. Maybe I'll die before then- happy, though, isn't it?"
A letter to Senator Bob Graham states, " I fear being forced to ration my immunosuppressive medications because of risk of my new kidney and rejection. The doctors tell me this is a serious matter and should not be done! I trust that I won't be forced to make this poor choice."
The last case is the saddest and most upsetting example. A teenager received a liver transplant in Indiana at the age of 15. Three years later the teenager's benefits ran out. This teen began cutting the dose of Prograf in half to "make it last longer." Subsequently the teen developed rejection, was hospitalized and received steroids to reverse the rejection. The patient became infected and died of this overwhelming infection at the age of 19. The age of 19!!
There are several things that the government can do to help eliminate this problem. Step one is to fund the medications that breathe life into these patients and their new organs. Step two is to ensure that transplant patients have the ability to obtain reasonable health insurance if they are not employed. Unfortunately, many patients have other diseases that keep them from getting well enough to work full-time again. They need a shared risk insurance plan to help them with these costs- one that encourages them to work. Step three is to increase the percentage of transplant patients that get back into the workplace and have their benefits carried by their employer. We must enlighten the public about the success of transplantation and show future employers that these are hard-working, intelligent, and, most of all, healthy individuals. Currently, we are horribly deficient in all three of these areas. If we institute the first step and find ways to implement the second and third steps, we will have a win-win situation for everyone involved in transplantation. We will also help to cut into the increasing disparity between patients on the transplant waiting list and patients being transplanted each year.
The issues these patients face are difficult and dangerous. They destroy marriages, burden families, and tear at the very fiber of transplantation. They cause honest people to become involved in illegal activities or turn their backs while those activities go on. The gift of life is the most precious gift we can give on this earth. It is the recycling of our most valued commodity. We are obligated as a society to guard this gift at all cost!!
Thank you ladies and gentleman for affording me this time, and for taking your time in making these important decisions.
Andrew Silverman, Pharm.D.
Pharmacotherapy Specialist, Transplantation Services
Tampa General Healthcare
Email: dsilverman@tgh.org
