JDRF Advocacy Agenda
Policies to Accelerate Life-Changing Breakthroughs to Cure, Prevent and Treat Type 1 Diabetes and its Complications
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 about $2.5 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 help 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.
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. The first disease modifying therapy that can prevent the onset of T1D for up to two years in at-risk individuals is available in the United States. Next-generation therapies such as beta cell replacement therapies and additional 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.
In 2023, JDRF advocacy will play an important role in accelerating innovation and ensuring access for all Americans. To that end, JDRF’s U.S. advocacy priorities for 2023 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.
While this agenda outlines our work focused on U.S. decision makers, JDRF is an international organization and we have a global reach, with initiatives by our affiliates and others focused globally.
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 pursue enactment of a 5-year, $200 million per year renewal of the SDP and support efforts to renew its sister program, the Special Diabetes Program for Indians.
JDRF will also advocate for increasing the overall budgets for the National Institutes of Health and the U.S. Food and Drug Administration (FDA), and strong funding for the newly created Advanced Research Programs Agency for Health. 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:
- 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. This is being informed by a patient preference study on the outcomes that found that people with T1D and caregivers prioritized reducing weekly hypoglycemic and hyperglycemic events. We are also focused on understanding the landscape for use of patient reported outcomes (PRO) in the regulatory setting to help inform JDRF’s strategy and next steps.
- Disease modifying therapies: The first disease modifying therapy to delay the onset of T1D is now available in the U.S. and many other therapies are in clinical development. To complement these scientific advancements, JDRF is engaging FDA and other stakeholders to translate what has been learned scientifically into the regulatory process. Through a Critical Path Institute consortium that JDRF plays a leading role in, islet autoantibodies have been qualified by EMA (European regulators) as enrichment biomarkers and FDA’s perspective on these biomarkers will be published soon. We are engaged with FDA, EMA as well as experts in the scientific community to establish the outcomes, like c-peptide, that should be used in clinical trials for people newly diagnosed with T1D and are also launching a patient preference study to better understand the patient and caregiver perspectives on risks and benefits related to these types of therapies.
- Cell Therapies: JDRF is working to ensure the regulatory pathway for 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, is clear, reasonable and incorporates the latest scientific understanding and evidence. 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 in early-stage clinical trials with initial, highly promising results. JDRF hosts a seminar series with FDA staff focused on the latest research of cell therapies for T1D. Additionally, JDRF engaged FDA staff in a JDRF/NIH workshop in 2022 focused on accelerating the translation of these types of therapies and is also launching a patient preference study to better understand the patient perspectives on risks and benefits related to cell therapies.
- Artificial Pancreas: JDRF worked closely with the FDA as part of its efforts to advance artificial pancreas systems, which use innovative technology to improve glucose control and improve outcomes. JDRF’s work led to FDA guidance for artificial pancreas device systems, which was finalized in 2012, and the ultimate approval of the first insulin-dosing system in 2016 and many more since then – a true breakthrough for the T1D community. To support ongoing 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, to increase interoperability and choices for people with T1D.
- Regulatory Pathways for Other Priority T1D Therapies: As additional priority research initiatives are advanced – in areas such as restoring vision, kidney and heart complications, 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 are cures. 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.
- Affordable Insulin: JDRF is advocating strongly for actions by insulin manufacturers, health plans, employers, and the government to make insulin more affordable. We’re seeing results: Thanks to JDRF’s advocacy efforts and that of other stakeholders, Medicare now caps insulin 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. JDRF is also partnering with Civica, a nonprofit pharmaceutical company, which will manufacture and distribute three low-cost insulins starting in 2024, available at $30/vial regardless of insurance status. But, more needs to be done and JDRF is actively working for long-term solutions to ensure that everyone has access to affordable insulin.
- 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 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.
- Access to Cures Therapies: We are at a new frontier for T1D with the first disease modifying therapy now available in the U.S. Many other therapies to delay, prevent and eventually cure T1D are in clinical development. As these revolutionary therapies advance through research and development, it is vital that they be made available to everyone who could benefit. JDRF is committed to working with all stakeholders to achieve affordable access to these therapies while continuing to foster an environment that promotes innovation.
- 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 2022 CMS updated policies 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. JDRF has successfully advocated to private insurers for coverage for these groundbreaking devices, and now the 25 largest plans all cover artificial pancreas systems. In 2022, Medicare expanded its coverage to include all systems currently available as well as future systems, thanks to advocacy by JDRF and others. JDRF will also explore what actions at the federal level JDRF can take to encourage access in Medicaid.
- Insurance Protections: During the passage of the Affordable Care Act in 2010, JDRF strongly supported insurance protections that expanded access to care 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 continues to fight to preserve and expand these protections. 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.