Questions remain on patient costs, formulary for expanded immunosuppressive drug benefit
Click Here to Manage Email Alerts
Demand for transplantation has rapidly increased around the world during the past decade due to an increase in incidence of comorbidities leading to organ failure along with a rise in longevity in patient years.
This increase in demand has outpaced current graft survival and resulted in the need for re-transplantation – and for more organs. Consequently, there has been a major increase in the number of patients on transplant waitlists, as well as an increase in the number of patients dying waiting for a transplant.
Currently, about 100,000 patients are waiting for an organ transplant in the United States despite transplant centers performing a record 40,000 transplants in 2021. Obviously, the demand outweighs the supply and mortality becomes eminent the longer potential recipients wait on the list; some kidney transplant recipients may wait longer than 5 years.
This past year alone, as noted by the Organ Procurement and Transplantation Network (OPTN), more than 9,000 patients died on the U.S. deceased donor kidney waitlist or were removed by transplant centers that deemed patients too sick for a transplant. Unfortunately, these numbers may continue to increase since most organ failure patients throughout the world and in the U.S. are from end-stage kidney disease.
Despite our efforts to continue to provide transplants, this organ shortage crisis has deprived thousands of patients of a new and better quality of life, diminished patient survival and driven up the costs of health care, including the costs for dialysis and hospitalizations.
Further, while Medicare pays for the organ procurement and the transplant surgery, patients of working age – younger than 65 years – who elect to have a transplant currently only receive immunosuppressive drug coverage for 3 years after the transplant. As a result, patients who cannot afford the drugs will start cutting back to save their supply. That can lead to organ rejection and a return to dialysis – an option that is costly to Medicare.
Change needed
The need for change is imperative and the U.S. government, under the guidance of the United Network for Organ Sharing, remains cognizant of the situation. Thus, collaboration between the organ procurement organizations and transplant centers throughout the country has improved organ availability, utilization and ultimately patient and graft survival outcomes.
In 2019, then-President Donald J. Trump signed an executive order to improve kidney health care in the U.S. The goal, based on the Trump directive, is to have 80% of new patients in 2025 either receiving home dialysis or a kidney transplant.
A second goal is to achieve a 25% reduction in the number of cases of end-stage kidney disease by 2030.
Drug coverage
To help with this initiative, Congress passed the Comprehensive Drug Coverage for Kidney Transplant Patients Act of 2020. The law, which takes effect in January 2023, revises the current Medicare-funded immunosuppressive coverage plan for patients with a kidney transplant.
The legislation allows for kidney transplant patients younger than 65 years whose transplant was funded by Medicare to have lifetime access to immunosuppressive drug coverage. Currently, only Medicare patients older than 65 years have lifetime coverage of these important medications.
This initiative will not only help patients to remain compliant with their anti-rejection medication but in turn, will minimize the need for aggressive interventions, such as biopsies, and hospitalizations that result from a growing concern by transplant providers of medication noncompliance and mismanagement, leading to a decline in allograft function and survival.
An analysis by the HHS estimated that the availability of the additional drug coverage will prevent approximately 375 allograft failures annually, and the Congressional Budget Office projects Medicare savings in the range of $400 million during the course of 10 years by reducing the number of re-transplants or having to place patients back on dialysis.
The new immunosuppressive drug benefit is a historic step in the right direction for patients with a kidney transplant.
Requirements
Limitations exist for this program, however. It is expected that Medicare patients will need to cover monthly premiums for the expanded drug coverage. The cost is expected to be $97.10/month, or 35% of standard immunosuppressive drug costs (average of $243/month).
Disadvantaged patients who are already paying Medicare premiums may not be able to afford the additional premium, putting compliance with their immunosuppressive drug therapy in flux.
It also remains unclear which drugs will be included in the program. Many immunosuppressive drugs currently being used (two to three different drug regimens) have yet to be listed in the regulations and thus may still prove costly for patients.
Immediate analysis and revision to the program should include Envarsus wXR (tacrolimus, Veloxis Pharmaceuticals), Astagraf XL (tacrolimus extended-release formulations, Astellas), Myfortic (mycophenolate sodium, Novartis), Rapamune (sirolimus, Pfizer), Zortress (everolimus, Pfizer) and Nulojix (belatacept, BristolMeyersSquibb).
As noted, the ability to pay for immunosuppressive drug regimens is linked to patient compliance and outcomes. Patients who are disadvantaged may fall short of proper coverage; and unfortunately, these underrepresented populations tend to be the most afflicted with chronic kidney disease leading to organ failure. The intention of HHS and Congress to help support such a comprehensive transplant drug program will fall short. Patient and allograft survival may still be impacted in this cohort of patients due to a lack of funding.
The National Kidney Foundation, the American Society of Transplantation and other organizations within the transplant community are in full support of various financial assistance programs to offset the premium costs of immunosuppressive drugs for patients. In addition, other factors that have not been considered in the bill need to be accounted for, including outside coverage by other insurance providers that will not be able to support lifelong medication coverage.
The transplant community is excited to see so much progress being made to help advance the availability of transplantation for those in need with kidney failure. However, there remains much work to be done to ensure a comprehensive coverage plan within transplantation is available that encompasses all socioeconomic and historically underrepresented groups across the United States. The demand and necessity are there along with the goal to achieve best quality outcomes and protect the gift of life.
- For more information:
- Giselle Guerra, MD, is professor of medicine and medical director of transplant services at the University of Miami as well as medical director of the kidney transplant program at the Miami Transplant Institute.
Collapse
Read more about
Click Here to Manage Email Alerts