TRIO Legislative Outreach Activities
Patient advocate groups continue their efforts to stay ahead of congressional and executive branch efforts to change prescription drug therapies. This is particularly true as the pressure mounts on controlling the cost of prescription drugs by imposing severe restrictions on access to drugs by patient communities like transplant recipients.
Grassroots organizations, like TRIO, continue to respond to the requests to add their voices on behalf of any affected group. Two recent efforts demonstrate how TRIO and many other organizations are participating to keep prescriptions open and available.
Safe Step Act (S.464/H.R.2163)
A bi-partisan coalition of House and Senate members has taken up the cause for one of the insurance industry’s most onerous provisions, the issue of step therapies. This is a way that the insurance industry approves the use of the cheapest prescription drug first until it’s proved either non-working or worse, harmful. A more complete discussion of step therapies can be found at the following website:
The Senate and House Acts create a specific set of protocols that require insurance companies to accept prescriptions even if there are cheaper varieties. One of the five protocols is that the patient is stable on the current prescription regimen. The other four protocols are equally important to the protected classes.
This bill has just been introduced into the Congress; we’ll keep you posted as it progresses through the congressional process.
Mental Health Needs and Protections
Senators Crapo and Wyden from the Senate Finance Committee solicited input from the mental health community on ways the Congress should focus on addressing its needs. The mental health community has been an integral part of the efforts to maintain the Part D 6 Protected Classes (6PC) provision since the beginning of the efforts to change the 6PC almost 10 years ago.
The National Council on Mental Wellbeing, with assistance from Venn Strategies, sent a letter to the Senators Wyden and Crapo asking for continuation of the 6PC provisions as a major step in the mental health efforts in the United States. More than thirty grassroots organizations, including TRIO, co-signed this letter as an indication of our support for and solidarity with the mental health proponents. There will be more activity in the coming months; we will continue to keep you informed as these legislative efforts continue.
XENOTTRANSPLANTATION
Within the past several weeks, extraordinary activity has occurred
with xenotransplantation. Dr. Robert Montgomery and his team
from the NYU Langone Transplant Institute in New York City led a
ground-breaking effort to get a fully functioning pig kidney to work
successfully in a human subject, a brain-dead donor who had consented
to organ donation research.
The American Association of Kidney Patients (AAKP) interviewed
Dr. Montgomery recently and put the interview on the AAKP website.
You can watch the entire interview on YouTube at the following link:
https://www.youtube.com/watch?v=sgahK4Q20-M
BUILD BACK BETTER ACT
The Build Back Better Act which has been passed by the House and is currently under consideration by the Senate includes many health care related provisions including changes to Part D, additional Medicare benefits including a hearing benefit and changes to drug pricing. It is not clear which provisions may be included in any final bill and how or if they may be changed from current House language during negotiations with the Senate. The Public Policy committee will continue to closely monitor the status of the Act and will report on those provisions which become law and will impact our transplant community.
FDA APPROVES NEW DRUG FOR CYTOMEGALOVIRUS
The FDA recently announced its approval for a new drug to treat Cytomegalovirus (CMV). This new drug is named LIVTENCITY and is produced by Takeda Pharmaceutical. CMV is one of the most challenging opportunistic infections post-transplant and this new drug will greatly benefit transplant recipients over the coming years. CMV infection can significantly increase the risk of transplant rejection, graft failure and mortality, as well as result in longer hospitalization and transplant costs. Additional background on this drug and the potential impact on the transplant community can be found in a news release at the following link:
https://www.takeda.com/newsroom/newsreleases/2021/takeda-livtencity-maribavir-approved-by-us-fda
