Embracing Advocacy: Your Role as Public Fundraisers & Champions of Affordability,

Choice & Coverage

JDRF ADVOCACY

Overview of JDRF Advocacy

Special Diabetes Program

Affordability, Choice, & Coverage

Regulatory Efforts

Interactive Session

Agenda

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OVERVIEW OF JDRF ADVOCACY

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ADVOCACY OVERVIEW

Four teams partner together to support & empower the T1D community:

Grassroots Legislative Health Policy Regulatory Affairs

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GRASSROOTS TEAM

• Design programs that recruit, train, motivate, and activate JDRF’s nationwide network of grassroots advocates in service of our legislative and policy priorities.

• Strong staff / volunteer partnership.

• Steady drumbeat of touchpoints with Congress

• Share the impacts of T1D, advocate for funding:

Promise to Remember Me

New Member Outreach Initiative

Government Day

Children’s Congress

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LEGISLATIVE TEAM

• Lobbies Congress and the Administration to secure Federal funding for T1D research and addresses policy and legislation that impacts the community.

• Key Legislative Priorities:

• Special Diabetes Program (SDP) Renewal ($150 mil)

• Robust Funding for the NIH and FDA

• Healthcare reform that works for those living with T1D

HEALTH POLICY TEAM

• Ensure that people with T1D have adequate health insurance including affordable coverage for the drugs, devices, and services needed to best manage their disease.

Identify Barriers

Encourage Access

Provide Resources (T1D Health Insurance Guide)

• Coverage2Control Campaign:

Affordability, Choice, & Coverage (Insulin)

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REGULATORY AFFAIRS TEAM

• Partner w/ the FDA and other agencies to:

Inform decisions and policies

Support clinical research

Address knowledge gaps

Shape regulatory pathways

Support advancement of new therapies

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ACCOMPLISHMENTS

• Helped secure a base of over $2.76 billion for T1D research through the SDP, since 1998.

• Expanded private and public coverage for CGMs.

• Accelerated the course for Artificial Pancreas (AP) technology at the FDA.

• Expanded private coverage of AP systems.

• Created one of the most respected nationwide grassroots networks for patient advocacy.

• Secured a $9 billion dollar increase to the NIH Budget over the last four fiscal years (FY).

• Facilitated creation of the House and Senate Diabetes Caucuses

• Moved forward groundbreaking cures legislation – Cures 2.0 is on the horizon.

• Launched Coverage2Control campaign to better address affordability, choice and coverage.

SPECIAL DIABETES PROGRAM (SDP)

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SPECIAL DIABETES PROGRAM (SDP)

• Established in 1997, secured a base of $2.76 billion for T1D research through the SDP.

• We have SDP champions in the House and Senate, on both sides of the aisle. Our non-partisan approach and engagement are key!

• Throughout the year we mobilize campaigns online, in DC, and back home to tout the successes of the SDP, to work to renew it, or thank Congress for their support of it.

• Thanks to the SDP we’ve seen incredible progress – technology advances have revolutionized how people manage T1D, new approaches are preventing complications, and beta cell replacement therapy and immunotherapy are promising avenues toward cures.

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SDP SUCCESSES

• Glucose Control

• Artificial Pancreas

• Kidney Disease

• Diabetic Retinopathy

• Environmental Triggers

• Immune Therapies

• Beta Cell Replacement

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• Congress passed a short-term funding patch of nearly $21.5 mil for the SDP that expires THURSDAY! Yesterday the House voted to approve an additional $12 mil, and today the Senate is expected to follow suit, extending funding through Dec. 20.

• Renewal of the SDP is JDRF’s top legislative priority – it provides $150 mil annually for T1D research at the National Institutes of Health (NIH) – and has historically received strong, bi-partisan support.

• Advocates across the country are calling upon Congress to pass a multi-year renewal of the SDP to ensure promising research can continue delivering results toward better treatments, therapies, and – ultimately – cures for T1D.

• We need strong engagement from our Field staff and volunteer leadership to ensure the SDP renewal crosses the finish line!

CURRENT SDP LANDSCAPE

INSULIN AFFORDABILITY

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INSULIN AFFORDABILITY

• Congress is actively engaging in the drug pricing / insulin affordability space.

• This spring Aaron Kowalski testified at a Congressional hearing on this topic, and the Health Policy Team continues to drive other efforts through our Coverage2Control campaign.

• Why we engage strategically at the Federal level.

• What do to do if you are pinged by a Congressional office to offer perspectives from the T1D community.

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QUESTIONS?

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AFFORDABILITY, CHOICE, & COVERAGE

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#COVERAGE2CONTROL

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Affordability

Make out-of-pocket insulin and other costs predictable

and reasonable

Coverage

Cover all life-saving technology, including the

artificial pancreas

Choice

Give people the freedom to choose the insulin pump

that’s right for them

AFFORDABILITY: INSULIN

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AFFORDABILITY: INSULIN

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Making insulin more affordable requires action from drug companies, health plans, employers, pharmacy benefit managers, and the Federal Government.

List prices rising

Health insurance

covering less

We need systemic change

CHOICE: PUMPS

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Making insulin more affordable requires action from drug companies, health plans, employers, and the Federal Government

• UnitedHealthcare is no longer covering all brands of insulin pumps.

• People w/ T1D & their doctors – not an insurance company – should choose which pump to use.

• Insurance restrictions like these are bad for people with T1D for our healthcare system. JDRF strongly opposes this policy.

• #MyPumpMyChoice is gaining steam!

COVERAGE: PROTECT PRE-EX

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Making insulin more affordable requires action from drug companies, health plans, employers, and the Federal Government

• Individuals with pre-existing conditions should have affordable access to comprehensive health insurance.

• Those with T1D should not be denied insurance, charged more, or have limited insurance.

• This issue is playing out in the courts, and we’ve stated our case to Congress.

• There is bi-partisan support for protections of pre-ex, but we’re prepared to mobilize!

REGULATORY EFFORTS

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REGULATORY EFFORTS: BETA CELL REPLACEMENT

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• Symposia Series – Beta cell replacement

• Highlights early stage T1D research.

• JDRF-funded beta cell replacement researchers present their work to FDA staff.

• Collaboration between researchers and FDA staff ensures regulators better understand T1D, unmet needs, and scientific progress.

• Will help to shape regulatory pathways in the future.

REGULATORY EFFORTS: TEPLIZUMAB

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• The FDA granted ’Breakthrough Therapy Designation’ to teplizumab, an anti-CD3 monoclonal antibody, for the prevention or delay of T1D in at-risk individuals.

• Longtime JDRF grantee, Kevan Herold, M.D., of Yale, presented the results of the clinical trial this summer.

• The FDA’s decision to provide this designation recognizes the importance of these results to the T1D community.

• JDRF continues to fight for the development of teplizumab and other treatments that show the potential to make a significant difference to people with—and at risk for—T1D.

QUESTIONS?

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ENGAGEMENT & RESOURCES

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• Get to know your Advocacy Team Chair.

• Save us a spot at events – new advocate recruitment is key!

• Visit MyJDRF.org (Our Programs Advocacy Advocacy Resources Advocacy Engagement for Field Staff).

• Engage on social (@JDRFAdvocacy); include us in e-comms.

• Ensure your key stakeholders are advocates www.jdrf.org/join.

• Take action on our current alerts.

• Visit www.jdrf.org/advocacy& www.jdrf.org/sdp for updates!

• Support in-District campaigns (Promise, NMOI).

• Help w/ LTEs, round tables, town halls, etc.

SUCCESSES

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PARTNERSHIP OPPORTUNITIES

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PARTNERSHIP OPPORTUNITIES

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• What have you seen work in your Chapters / Markets?

• Where do you see creative synergies, or natural pairings?

• What would you need from Advocacy to set those in motion?

QUESTIONS?

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CONTACT US

Aaron Hunter Director, Government Relations ahunter@jdrf.org

Carla Falasco Director, Grassroots Advocacy cfalasco@jdrf.org

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Campbell Hutton Vice President, Regulatory Affairs & Health Policy chutton@jdrf.org

Jesse Bushman Senior Director, Health Policy jbushman@jdrf.org

THANK YOU

jdrf.org