2018 Advocacy Agenda
To ensure people have access to the most effective T1D treatments and therapies, JDRF has set an ambitious advocacy agenda for 2018.
- Invest in Innovation: Support continued funding for the Special Diabetes Program (SDP), which provides $150 million a year in 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: Encourage health plan policies to cover physician-prescribed T1D therapies at affordable costs and advocate for national policies that protect those with chronic diseases like T1D.
Invest in Innovation
Support continued funding for the Special Diabetes Program
Multi-year, continuous funding for the Special Diabetes Program (SDP) which provides $150 million a year in T1D research through the National Institutes of Health (NIH), is a top advocacy priority for JDRF.
The SDP has accelerated the development of life-changing artificial pancreas systems, which became available to people with T1D in 2017. The SDP also supports cutting-edge research that could ultimately lead to prevention and a cure for T1D, as well as new treatments and therapies for burdensome and costly diabetes-related complications.
Congress recognizes the importance of this critical research program and continues to provide broad, bipartisan support. In late 2017 and early 2018, a total of $300 million for SDP was enacted, funding the program through September 30, 2019. JDRF also supports increasing the overall level of appropriations for the NIH as well as robust support for the Food and Drug Administration (FDA).
Promote Regulatory Frameworks that Spur Innovation
Ensure United States regulatory policies provide clear and reasonable pathways for scientific research and therapy approvals.
JDRF is engaging the FDA to encourage regulatory frameworks for T1D therapies that promote continued innovation and improve public health, 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. JDRF continues to work with the agency to shape regulatory expectations for next-generation AP systems, including facilitating interoperability of components and the open protocol model.
- Prevention Therapies: JDRF plays a leading role in a consortium seeking FDA qualification of certain T1D biomarkers, or measurable indicators of the disease. Qualification facilitates the agency’s regulatory decision-making and may accelerate research and development of promising prevention therapies to stop or slow the progression of T1D.
- Beta Cell Replacement: JDRF educates FDA staff on beta cell encapsulation technologies—which wrap insulin-producing islet cells in a protective barrier before implanting them into the body. These therapies may give people with T1D freedom from insulin injections for up to two years. The FDA approved the first clinical trials of one product in 2014, and several others are in development.
- JDRF also supports current research policies which provide strict ethical oversight for federal research using stem cell-based technologies in encapsulation and cell-based therapies for other diseases.
- T1D Outcomes: JDRF organized the T1D Outcomes Program, which resulted in publishing a consensus statement defining outcomes for use in evaluation of T1D therapies in research, regulatory review and healthcare reimbursement. JDRF is continuing to work with regulators to ensure the outcomes are utilized in their processes.
- Pediatric Enrollment in Clinical Trials: Inclusion of pediatric subjects in T1D clinical trials is important for research and development of T1D therapies, but regulatory approval for this has been challenging in some cases. JDRF is working with the T1D community to facilitate regulatory approval for the inclusion of pediatric patients in trials through education and establishment of best practices.
- Regulatory Pathways for Other Priority T1D Therapies: As additional priority research initiatives are developed – in areas such as restoring vision, immunotherapies and others – JDRF will work to ensure regulatory pathways allow needed research, development and approval.
Promote access to T1D Therapies and Technologies
People with T1D need access to exciting new innovations to benefit from them.
JDRF is proud to spearhead a series of initiatives to improve healthcare access for people with T1D along with our allies, including The Leona M. and Harry B. Helmsley Charitable Trust, T1D Exchange and various diabetes clinical and advocacy organizations.
Coverage, Affordability and Choice of T1D Therapies
- Medicare CGM Coverage: JDRF calls for Medicare to cover the full range of approved blood glucose measurement and control devices.
- Artificial Pancreas Coverage: JDRF supports broad healthcare coverage for artificial pancreas (AP) systems. JDRF has successfully advocated to private insurers for coverage for these ground breaking devices, the first of which came to the market in 2017, and now the 25 largest plans all cover them. JDRF will continue to advocate for coverage of current as well as future systems by private plans as well as Medicare and Medicaid.
- Insulin Pump Choice: JDRF strongly opposes health plan policies that limit choice of insulin pumps, and advocates for a competitive marketplace that fosters innovation. JDRF also supports expansion of Medicare pump coverage to include patch pumps, a change enacted by The Center for Medicare and Medicaid Services (CMS) in early 2018.
- Out-of-Pocket Costs for Insulin and Diabetes Management Tools: JDRF urges employers, health plans and manufacturers to put in place policies that enable insulin and other diabetes management tools to be available at low, predictable out-of-pocket costs. This will prevent life-threatening conditions such as diabetic ketoacidosis and severe hypoglycemia.
- Barriers to Improved Care: JDRF is evaluating barriers to adoption for T1D therapies to ensure the T1D community can benefit from new technologies. JDRF also supports plans for a diabetes clinical care commission to address potential federal barriers to improved care.
Protections in Health Reform for 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. This includes:
- Preserving protections for those with pre-existing conditions
- Allowing young adults to stay on their parents’ insurance until the age of 26
- Prohibiting yearly and lifetime dollar limits for essential health benefits (EHBs)
- Closing the donut hole in Medicare Part D
Evaluation of New Therapies
- Clinical Evidence: JDRF collaborates with partners to advance research evaluating the effectiveness of T1D therapies and to help provide healthcare decision-makers with adequate information to make coverage decisions.
- T1D Unmet Need: JDRF commissioned new analyses of T1D healthcare data to better understand and educate healthcare decision-makers about unmet needs in the population.
- T1D Outcomes Program: JDRF organized the T1D Outcomes Program, which proposes an expanded set of outcomes upon which to evaluate T1D therapies.
For more details about these advocacy priorities and our support for healthcare access, please read our 2018 JDRF Advocacy Agenda.