Accelerating cures, ensuring access

Driving cures

Thanks to decades of work by Breakthrough T1D and our many partners, 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. 

There are also several promising trials of cell-based cures that are starting to show improved outcomes for those with long-standing T1D. 

While these and other therapies move toward regulatory approval, we are working to ensure that, when they are available, our community has access to them. 


As these revolutionary therapies advance toward regulatory approval, Breakthrough T1D is working with all stakeholders to achieve affordable access to these therapies while continuing to promote 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, and many other stakeholders. We are dedicated to ensuring this happens.

The next generation of T1D therapies will be transformational. Our team is laying the groundwork today for coverage when they come to market.”

Campbell Hutton

Breakthrough T1D VP, Regulatory and Health Policy

Strategy for access

Broad coverage
  • Health plans, pharmacy benefits managers, and employers should ensure that everyone has access to approved cure therapies. This includes existing therapies like Tzield that delay onset and future disease-modifying therapies.
  • Benefit plans must cover T1D risk screening and monitoring, which will identify those who are eligible for cure therapies.
  • Insurance plans must cover the therapies themselves and the associated medical services. This may include services like drug infusions, 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

The next generation of therapies has the potential to change the health and quality of life for people with T1D and those likely to develop the condition. They may also be significantly more expensive than insulin and other drugs commonly used today by people with T1D.  

Insurers and manufacturers must make these therapies available at a low, predictable, out-of-pocket cost.  

To do this, 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

Breakthrough T1D’s strategy to expand access should not delay the development of future cures.  

Our partnership with industry and government has created incredible momentum towards a future without T1D.  We will continue to build on that momentum without slowing down the development of future cures by continuing to invest in research and development.