JDRF Advocacy Agenda

Policies to Accelerate Life-Changing Breakthroughs to Cure, Prevent and Treat Type 1 Diabetes and its Complications

Type 1 diabetes (T1D) is an autoimmune disease that requires management 24 hours a day, 7 days a week, 365 days a year. Even with intensive management, people with T1D spend a significant portion of time with high or low blood-sugar levels, putting them at risk for medical emergencies and devastating complications.

But thanks to recent advances, we are improving lives, today and tomorrow, and helping people stay healthy until we have cures. Life-changing technologies such as continuous glucose monitors (CGMs) and first-generation artificial pancreas (AP) systems are now a reality. Next-generation therapies such as beta cell replacement therapies and disease modifying therapies are now in human clinical trials and moving through the regulatory process, while groundbreaking research continues. Through both research and advocacy, JDRF is accelerating scientific discovery, commercial development, regulatory approval, and healthcare access for a wide range of T1D breakthroughs and committed to addressing health disparities experienced by members of the T1D community.Ā 

In 2021, JDRF advocacy will play an important role in accelerating innovation and ensuring access for all Americans. To that end, JDRF’s advocacy priorities for 2021 are:

  • Invest in Innovation: Advocate for continued Federal funding for T1D research.
  • Ensure Regulatory Frameworks that Promote Innovation: Ensure United States regulatory policies provide clear and reasonable pathways for scientific research and therapy approvals.
  • Promote Access for Life-Changing T1D Breakthroughs: Advocate for coverage, affordability, and choice of T1D therapies in the health care system and for national policies that protect those with pre-existing conditions like T1D.

JDRF is the leading global organization funding type 1 diabetes (T1D) research, with a mission to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications. To accomplish this, JDRF has invested more than $2 billion in research funding since our inception, and spurred billions more from public and private sector partners to generate a pipeline of innovative therapies to people living with T1D. Our staff and volunteers throughout the United States and our five international affiliates are dedicated to research, advocacy, community engagement and our vision of a world without T1D.

I. Invest in Innovation

A strong, continued Federal investment in T1D research is critical to complement JDRF’s funded research and drive progress to deliver treatments and therapies to people with T1D sooner. The Special Diabetes Program (SDP), a key component of the Federal investment in T1D research, is currently funded at $150 million annually until September 30, 2023, thanks to the tremendous advocacy from JDRF volunteers, staff, champions in Congress, and other interested stakeholders. Throughout this year, JDRF will continue to educate Members of Congress, their staff, and Administration officials and their staff on the vital importance of this program and new research progress that is the result to ensure continued strong bipartisan support for the program.

JDRF will also work to ensure the creation and funding of the newly proposed Advanced Research Programs Agency for Health (ARPA-H). Modeled after the Defense Advanced Research Program Agency (DARPA), this new Federal entity would help fill critical gaps and accelerate diabetes research more than ever. JDRF approaches research similar to DARPA, with a focus on high-risk/high-reward projects with milestone-driven payments and engagement of private venture capital. We have had great success with this model. Once established, ARPA-H would be able to do similar work on a much larger scale.

In addition to the SDP and ARPA-H, JDRF supports increasing the overall budgets for the National Institutes of Health and the U.S. Food and Drug Administration. With robust funding, additional diabetes-related research can be conducted, and promising treatments and therapies can be promptly reviewed and ultimately made available sooner.

II. Ensure Regulatory Frameworks that Promote Innovation

JDRF is engaging the FDA to ensure regulatory policies provide clear and reasonable pathways for scientific research and therapy approvals, including:

  • Artificial Pancreas: JDRF worked closely with the FDA to establish guidance for artificial pancreas device systems, which was finalized in 2012, and led to approval of the first insulin-dosing system in 2016. To support technological advancements, JDRF has advocated for additional regulatory pathways for open protocol artificial pancreas components – those from different manufacturers that are interoperable with each other. FDA has created three new device types, the integrated continuous glucose monitor (iCGM), the alternate controller enabled (ACE) insulin pump and the interoperable automated glycemic controller (iAGC) and several are on the market and in development. JDRF continues to work with the agency and the community to ensure efficient regulatory processes and, most importantly, increased choices for people with T1D.
  • T1D Outcomes: Following on the T1D Outcomes Program publication defining outcomes for use in the evaluation of T1D therapies in research, regulatory review, and healthcare reimbursement, JDRF is partnering with FDA and other stakeholders to ensure that the outcomes, including those measured by CGMs, are fully integrated into the regulatory paradigm, with a particular focus on hypoglycemia and time in range.
  • Disease modifying therapies: To complement the scientific advancements in the area of disease modifying therapies for T1D, JDRF is engaging FDA and other stakeholders to translate what has been learned scientifically into the regulatory process. We are engaged with FDA, EMA (European regulators) as well as experts in the scientific community to optimize the regulatory pathway for therapies intended for people newly diagnosed. Additionally, JDRF is playing a leading role in a consortium, part of the Clinical Path Institute, actively engaged with FDA and EMA to achieve regulatory acceptance of certain T1D biomarkers, specifically a set of islet autoantibodies that help define the earliest stages of T1D, to facilitate their use in regulatory decision making and accelerate research and development of potential T1D prevention therapies.
  • Cell Therapies: JDRF hosts a seminar series with FDA staff focused on cell therapies for T1D, which involve combining a replenishable source of insulin-producing cells to replace cells destroyed by T1D with various approaches to protect those cells. The first human clinical trial for such a product was approved to proceed by FDA in 2014 and multiple additional approaches are under development, with some nearing advancement into human clinical trials.
  • Regulatory Pathways for Other Priority T1D Therapies: As additional priority research initiatives are advanced – in areas such as restoring vision, metabolic control, and others – JDRF will work to ensure clear and reasonable regulatory pathways to foster research, development, and approval.

III. Promote Access to Life-Changing T1D Breakthroughs

JDRF is fighting for access to therapies and services needed by people with T1D to stay healthy until there is a cure. Our Coverage2Control campaign advocates for coverage, affordability, and choice for T1D therapies. We are also fighting to preserve insurance protections for those with pre-existing conditions.

Affordability, Choice and Coverage of T1D Therapies

    • Affordable Insulin: JDRF is advocating strongly for actions by insulin manufacturers, health plans, employers, and the government to make insulin more affordable. This includes:
      • Ending the system of prescription drug rebates which is driving up the price of insulin and, in the meantime, for insurers to pass rebates received to beneficiaries in the form of reduced prices;
      • Insurance to cover insulin like the life-saving drug that it is, with low co-payments that stay the same throughout the year (e.g., treating it like a ā€œpreventive medicineā€ made available without the application of a deductible);
      • More help for the uninsured, such as support for community health centers and other public and private resources. To help our community navigate the complex insurance environment, JDRF’s insurance guide provides advice on picking a plan, getting prior authorizations, appealing a denial, and getting help with costs of insulin and supplies.

    We’re seeing results: Medicare announced a new initiative to offer insulin coverage at $35 per month; there are multiple manufacturer and insurer programs to cap monthly out of pocket costs for insulin; and IRS guidance now enables high deductible health plans to treat insulin as a preventive drug. But, more needs to be done and JDRF is actively working for long-term solutions.

    • Insulin Pump and CGM Choice: People with T1D should have access to the diabetes management tools that are prescribed by their doctor and work best for them. JDRF strongly opposes health plan policies that limit choice of insulin pumps or CGMs, and advocates for a competitive marketplace that fosters innovation. For example, JDRF rallied the community through the Coverage2Control campaign to urge UnitedHealthcare to change their limitations on insulin pumps which they did in July 2020. In addition, JDRF supports exempting insulin pumps and CGMs from the deductible so that people who need them can have better access.
    • Medicare CGM Coverage: After a robust advocacy campaign by JDRF and other stakeholders, in early 2017, the Centers for Medicare & Medicaid Services (CMS) announced that coverage under the Medicare program would be extended to CGM devices authorized by FDA to make treatment decisions. In 2020 CMS proposed to cover all FDA-authorized CGM devices, as JDRF has been advocating, including continuing to allow Medicare beneficiaries to use smart devices in conjunction with a CGM, enabling loved ones to be alerted during diabetes medical emergencies. JDRF strongly supports the proposal.
    • Artificial Pancreas Coverage: JDRF supports broad healthcare coverage for artificial pancreas systems. The first insulin dosing system was authorized by the FDA in 2016 and the second in 2019. JDRF has successfully advocated to private insurers for coverage for these groundbreaking devices, and now the 25 largest plans all cover the first system. Medicare currently covers one system and JDRF is actively engaging the agency to achieve broad coverage. JDRF will continue to advocate for coverage of current as well as future systems by private plans and Medicare. JDRF will also explore whether there are steps at the federal level JDRF can take to encourage access in Medicaid, given that JDRF is not set up to lobby at the state level.
    • Screening for T1D Risk: We now understand that it is possible to know if someone is at risk of developing T1D before they become insulin dependent through a blood test for certain blood markers called islet autoantibodies. Most autoantibody testing has been of first-degree relatives of those with T1D in the research setting, but as it becomes more broadly available to the general population in the healthcare setting, JDRF will work to increase awareness and knowledge about this testing and will advocate for broad coverage.
    • Telehealth Coverage: The coronavirus pandemic disrupted the healthcare system and caused the T1D community to rely on telehealth for much of their care and it has been shown to be beneficial. This was enabled by policy changes that allowed easy access to and coverage of these services. JDRF supports continuation of these policies so that the T1D community continues to have this access even after the current crisis has ended.

Protections in Health Reform for Those with Pre-Existing Conditions

JDRF is fighting to preserve insurance protections for people with pre-existing conditions. In 2017, JDRF released a set of healthcare principles and joined with other organizations representing people with chronic, serious, and life-threatening diseases to oppose legislation that violated these principles. JDRF is pleased with the 2021 Supreme Court of the United States decision that keeps in place the healthcare principlesĀ and protectionsĀ for which JDRF has been advocating for many years.Ā Even with this favorable decision, we will continue to emphasize to Congress and other decision-makers the importance of insurance protections for people with T1D. JDRF’s healthcare principles include:

  • Preserve protections for those with pre-existing conditions: Individuals with pre-existing health conditions should have access to comprehensive health insurance at rates similar to their counterparts without pre-existing health conditions.
  • Allow young adults to stay on their parents’ insurance until the age of 26: Young adults should be allowed to stay on their parents’ health insurance plan until the age of 26.
  • Prohibit yearly and lifetime dollar limits for essential health benefits (EHBs): Insurance companies should not be allowed to set annual or lifetime dollar limits on their spending for an individual’s covered benefits.