Ensuring Access to Affordable Innovative T1D Therapies

JDRF exists to accelerate life-changing breakthroughs to cure, prevent and treat type 1 diabetes (T1D). Thanks to decades of JDRF-funded research, we know the ingredients to finding cures for T1D. The first disease-modifying therapy (DMT) for those at high risk of developing T1D – Tzield – is now available. This innovative therapy delays the onset of T1D by approximately two years in people almost certain to develop the disease.

This is the first disease-modifying therapy approved for T1D—but it will not be the last.

Today, there are also several promising trials of cell-based that are starting to show improved outcomes for those with long-standing disease. As these revolutionary therapies advance through the pipeline to regulatory approval, JDRF is committed to working with all stakeholders to achieve affordable access to these therapies while continuing to foster an environment that promotes innovation. Specifically:

• Coverage: Health plans should cover T1D risk screening and monitoring, cure therapies and the associated medical services.
• Affordability: Cure therapies and risk screening/monitoring should be available at a low, predictable out-of-pocket (OOP) cost.
• Innovation: Any policy and benefit designs should facilitate continued research and development of DMT and cell therapies.

Achieving these goals will require commitment and action by government policymakers, insurers, employers, pharmacy benefit managers (PBMs), and many other stakeholders. We are dedicated to ensuring this happens.

Here are the specifics we are fighting for.

Broad Coverage

• Health plans, PBMs, and employers should ensure that everyone has access to approved cure therapies. This includes therapies like Tzield that delay onset and future therapies that potentially halt progression or reverse T1D.
• T1D risk screening and monitoring is required to identify those who are eligible for cure therapies, and benefit plans must support it.
• Insurance plans must cover the therapies themselves as well as the associated medical services. For example, some will require infusion, so it will be essential that benefit plans cover the drug, infusion, education, and provider monitoring services.
• Benefit plans should not require prior authorization or other utilization management techniques that restrict access to these innovative therapies

Achieving Affordability

Cure therapies will be new—as will most aspects of the treatments. For example, they are likely to be delivered in a new manner that the T1D community and providers who commonly treat T1D may not be familiar with. These therapies may also require treatment in an inpatient or outpatient settings and some will require one or more drug infusions. They may also be considered a specialty drug – which are typically priced much higher than insulin and other drugs commonly used by a person with T1D.

These therapies have the potential to have a significant impact on the health and quality of life for the person with T1D and those people at risk of developing T1D. To fully realize these benefits, it is essential that insurers and manufacturers make these therapies available at a low, predictable out-of-pocket cost. Further, to ensure these therapies remain affordable, insurance benefit plans should:

• Pass any rebates or other list price discounts on the therapy directly to the person with T1D.
• Apply a low, flat-dollar cost-sharing rather than co-insurance.
• Exempt from the deductible (first dollar coverage).

Promoting Innovation

Strategies aimed at expanding access to cure therapies should not impede the development or investment in research that will lead to additional T1D cures in the future. In the same way that recent technological advances, like artificial pancreas technology and continuous glucose monitors, have allowed people with T1D to avoid finger pricks and insulin injections while benefitting from improved glucose control and other long-term benefits, cure therapies hold similar promise. It is vital that we continue to build momentum toward a future without T1D by continuing to invest in research and development.

JDRF Resources

We are committed to access to cures. We have created several resources that can help people with T1D today to ensure they have access to the therapies they need—like the T1D Health Insurance Guide. This resource helps individuals with T1D navigate common insurance challenges – including information regarding appeal rights, clinical exceptions, and prior authorization requests