Policy Solutions to Push Progress Forward

Innovation Requires Policy Solutions

We are in a new era of medical discovery with the potential and power to revolutionize treatment for costly and debilitating diseases. But we must not take this progress for granted. To ensure medical innovation continues for patients, we need public policies that take into account the investment and time needed to develop life-saving treatments and cures.

To enhance competition and improve affordability for patients, our country must:

1. Make Medicines More Affordable by Rewarding Better Outcomes for Patients

2. Ensure Patients Get the Best Deal on Medicines

3. Make New Breakthroughs Accessible and Promote Competition

Learn more about these goals below.

1. Make Medicines More Affordable by Rewarding Better Outcomes for Patients

Breakthrough medicines are revolutionizing how we fight disease, but too often patients have to fight with insurers to access these treatments. We can improve patient access and affordability by moving toward a system that prioritizes results for patients.

Different patients respond differently to different medicines. How we pay for medicines should reflect these differences. That’s why America’s biopharmaceutical companies are working with insurers to develop innovative and flexible ways to pay for medicines that focus on results, lower out-of-pocket costs and enable patients to access the right treatments the first time.

In order for biopharmaceutical companies to pursue more and larger scale value-based arrangements, we need to modernize regulations developed for an earlier era. Recently the U.S. Food and Drug Administration (FDA) released guidance on communications with payers, which was a substantial and positive step forward in allowing biopharmaceutical companies to communicate in support of value-based arrangements. However, additional barriers to these arrangements remain. We need to reform regulations that discourage companies from offering discounts that are tied to outcomes, rather than volume. And we need to clarify existing Medicaid best price requirements that inhibit companies from entering into a range of new payment arrangements.

2. Ensure Patients Get the Best Deal on Medicines

While biopharmaceutical companies set the list price for a brand medicine, more than one-third is rebated back to payers and the supply chain. Insurers negotiate large rebates, but often do not share these discounts with patients.

3. Make New Breakthroughs Accessible and Promote Competition

We need to make it easier for patients to access breakthrough medicines. It simply takes too long to get new medicines approved – between 10 to 12 years. The U.S. Food and Drug Administration has been focused on efforts to enhance the drug development and review process and laws recently enacted are a step forward to helping to make the process better.

To enhance our ability to bring new medicines to patients, we need keep pace with 21st century science by incorporating new and innovative approaches to the drug development process. Innovative clinical trial design, patient perspectives and real-world evidence all hold potential speed the development and review of innovative new medicines and enhance the competitive marketplace.

At the same time, we must avoid policies that deter risk-taking or siphon funding away from the research and development of new medicines that can improve patients’ lives. Learn more about our plan to build a sustainable, science-based health care system that harnesses today’s hopes to discover tomorrow’s cures here.