Organ recipients share their experiences with FDA to promote innovation in immunosuppressive therapies

Organ recipients share their experiences with FDA to promote innovation in immunosuppressive therapies

Posted on October 27, 2016 by nkf _advocacy

By Kevin Longino, CEO and Leilah Sampson, Kidney Advocacy Committee Patient Liaison
As kidney transplant recipients and advocates we were enthusiastic and hopeful to learn that the Food and Drug Administration (FDA) had scheduled a public meeting for organ transplant recipients to share their experiences with scientists and decisions makers in new drug development as part of the Patient Focused Drug Development Initiative.  For the past few years the National Kidney Foundation (NKF) has advocated for FDA to include organ recipients as part of this initiative, so we were pleased that our advocacy efforts were successful.  However, we also know following the meeting much more advocacy will be needed to advance solutions to the issues that organ recipients raised during the meeting and the National Kidney Foundation is committed to this effort.  First and foremost, if you are reading this and have not submitted your own comments on the questions raised during the meeting you can do so here.  Additionally, since we were selected as panelists we wanted to share our thoughts and experiences at the meeting.
Prior to the event, we were asked to respond to ten questions divided into two topics on life post organ transplant. The first topic was titled, “Disease Symptoms and Daily Impacts That Matter Most to Patients”.  This topic focused mainly on how your symptoms (post transplant) affected you emotionally and physically in completing daily tasks. The second topic titled, “Patients’ Perspectives on Transplant and Treatment Options” focused more on how you are managing your post transplant treatment regimen. As we mentioned, you can submit your own responses to these questions as well and we encourage you to do so.
Leilah participated in the panel on topic one, as one of five panelists and the only adult kidney transplant recipient alongside of the Pediatric kidney representative and lung, liver, and heart recipients.  In preparation for the meeting, Leilah met with FDA staff in charge of the meeting who expressed appreciation for her honesty about her post transplant experience not being “rainbows and sunshine”, but more so trial and error. They also felt because she was a transplant newbie; she could represent a fresh perspective that would help balance the other seasoned panelists perspectives. FDA briefed Leilah on what to expect when she arrived and to prepare a narrative style version of her comments (as patients get nervous on the panel). Leilah set the intention for her speech to reflect her life of self compassion and honoring her transplant process.
When we arrived at the campus we were appreciative to see so many patients, caregivers, researchers and FDA staff all committed to hearing the voices of organ transplant recipients. The first half of the day was all patient discussion on comorbidities, daily challenges, medications and side-effects post-transplant. Many recipients, like Leilah, shared their experiences having depression and anxiety post transplant. Many also highlighted social stigma as the public expecting them to be “cured” from disease with their new organ, when in reality the need to take multiple medications at specific times of the day, and that had various side-effects reminded them they were still not “normal”. Some participants indicated hesitancy to discuss symptoms post transplant with their healthcare professionals as they had received comments back that they should learn to adapt and instead focus on the fact they were still alive and no longer on dialysis.
Polling questions were asked of the audience and multiple choice responses given as options, but throughout the polling there were a significant number of patients who experienced challenges not captured by the multiple choice responses and instead indicated “other” experiences during the polling.  Some of the comments raised in those “other” categories included: fear of rejection, but also fear of infection, skin cancer, and other cancers due to immunosuppression therapies – many participants had also experienced these complications.
The addition of the afternoon sessions was different than past PFDD meetings for other conditions. The afternoon included scientific presentations and panels on non-adherence to transplant regimens and interventions to improve adherence.  Most of the patients participating in person indicated that while they faced challenges with taking multiple medications, overall they were adherent. Although they also recognized they were perhaps not reflective of all organ transplant recipients.  Webinar participants indicated through polling a greater difficulty with adherence than those participating in person. We and other participants discussed how we were active in working with our care team to modify dosing of medications to reduce side effects.  Kevin specifically indicated a need to have personalized immunosuppressive regimens, which could improve both adherence and reduce side effects.  We and other participants also acknowledged a need for greater psychosocial support from our care team post-transplant.  Of course, we were all supportive of one organ recipient’s comment on the need to have one magic combination pill that we only have to take once a day – oh and it could come with no side effects too.
We were surprised to see so little interaction from the FDA staff. They fulfilled their duty of hearing the voices of the patients. After a long day of discussions, presentations, and polling about symptoms and the impact of organ transplant regimens on patients; we left better educated but even more motivated. More importantly, we left with the obligation to spread what we learned from the research and opinions of other seasoned organ transplant patients to the pre-transplant community. I think we all agreed that laying the foundation for post-transplant life begins with implementing support and coping skills long before transplantation occurs. Although we have only scratched the surface of trying to understand how to better support organ transplant patients; we are pleased to know that the FDA, among many other organizations, are opening their ears to hear from us – the patients.  If you are an organ recipient please do take the time to send your responses to the FDA by November 27, 2017, they are listening and comments will be included in the final report.  You can also view the presentations and listen to the recorded meeting here.

NEW PETITION ON CHANGE.ORG: THE COMPREHENSIVE IMMUNOSUPPRESSIVE DRUG COVERAGE FOR KIDNEY TRANSPLANT ACT (H.R. 6139)

Please sign and share:

Pass The Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act !
From the NKF:
On September 22nd, Representatives Burgess (R-TX), Kind (D-WI), Harper (R-MI), Meehan (R-PA), Herrerra Beutler (R-WA), Cooper (D-TN), Griffith (R-VA), and McDermott (D-WA) re-introduced the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act (H.R. 6139).  H.R. 6139 will serve as a safety net by assisting kidney transplant recipients obtain the life-saving immunosuppressive medications that are necessary to maintain the viability of their new transplant.
Individuals with end-stage renal disease (ESRD), who require dialysis or a transplant to survive, are eligible for Medicare regardless of age or other disability.  If these ESRD patients remain on dialysis, there is no time limit on their Medicare eligibility.  However, despite quality of life benefits and the cost-effectiveness associated with transplantation compared to kidney dialysis, recipients who are not aged or disabled retain Medicare eligibility only for 36 months following their transplant.  As a result, they often face the challenge of finding affordable coverage that allows them to obtain medications required to maintain their new kidney.  If the transplanted kidney fails, they must return to dialysis and wait again in the hopes of receiving another transplant.  Both of these options are more costly and more detrimental to patient health than maintaining the new kidney.
The Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act would extend Medicare for immunosuppressive medications indefinitely, ensuring patients have access to these lifesaving medications.  Only immunosuppressive coverage would be extended and all other Medicare coverage would end 36 months post-transplant, as it does now.  The legislation also requires group health plans to maintain coverage of immunosuppressive drugs if they presently include this benefit.  By supporting lifetime immunosuppressive coverage, Congress will help improve long-term transplant outcomes, reduce the number of kidney patients who require another transplant, and enable more patients to choose transplantation.
Please contact your Representatives and urge them to cosponsor the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act to help transplant recipients keep access the medications they need to maintain their new kidney.

“Extending Medicare coverage of immunosuppressive drugs for kidney transplant recipients is a critical step to ensuring a patient’s best chance of success post-transplant.” – Kevin Longino, CEO of the National Kidney Foundation."
Link to Petition

From the American Transplant Association: Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act

Comprehensive Immunosuppressive Drug Coverage for     Kidney Transplant Patients Act

Why is this legislation necessary?

•Since 1972, Medicare has covered people with irreversible kidney failure, or end-stage renal disease (ESRD). There is no Medicare time limit for a patient dialysis patient. However, kidney transplant recipients lose their Medicare coverage 36 months

after a transplant.

•Extending immunosuppressive coverage beyond the 36 month limit would decrease the risk of allograft failure due to patients not taking their immunosuppression following loss of immunosuppressive coverage. When renal allografts fail, patients require dialysis and may be candidates for retransplantation, both of which would be covered by Medicare. In addition, transplant recipients have a higher quality of life, and are more likely to return to work than

dialysis patients.

•In 1972, it was estimated that the program would cost $250 million. In 2008, the Medicare ESRD program cost nearly $27 billion.

•This legislation will allow individuals who are eligible for immunosuppressive drugs whose insurance benefits under Part B have ended due to their 36 months running out to remain in

the program only for the purpose of receiving immunosuppressive drugs. If they have group health insurance with this benefit, they would not qualify for coverage beyond the 36 months. Cost benefits for the continuation of immunosuppressant coverage:

•Medicare spends $77,500 per year on a dialysis patient, which Medicare covers indefinitely;

•Medicare incurs an average first year cost of more than $100,000 for renal transplantation and will pay for both dialysis and                          re-transplantation in the case of organ failure;

•However, Medicare only spends an average of $19,100 on a kidney transplant recipient per year after the year of the transplant.

How is the premium determined for individuals eligible due to ESRD?

•A monthly premium rate will be determined based on the monthly actuarial rate for enrollees age 65 and over;

How does this affect those with private insurance?

•Coverage by private insurance varies widely; this legislation ensures Medicare is still the payer of last resort and will not usurp coverage offered by private insurers.

Does this open transplant recipients up to the full benefits of Medicare?

•No, this legislation would only eliminate the time limitation and extend coverage for transplant recipients for the purpose of immunosuppressive drugs only. Beneficiaries would pay the Part

B premium. All other Medicare coverage would end

36 months after the transplant.