Increasing Access to Affordable, Life-Saving Medicines: Framework Released by Working Group Headed by Former FDA Commissioners

February 24, 2022

The Blue Cross Blue Shield Association and Aspen Institute bring industry stakeholders together to find solutions

Media Contacts:
The Aspen Institute: Jon Purves,
The Blue Cross Blue Shield Association: Tess Thomson,

Washington, DC, February 24, 2022 – Today, the Blue Cross Blue Shield Association (BCBSA) and the Health, Medicine & Society Program of the Aspen Institute (Aspen Institute) released “Breakthrough Cures, Blockbuster Costs: Future Directions,” a framework for ensuring high-cost medicines for rare conditions are affordable and accessible to patients.

Co-chaired by former U.S. Food and Drug Administration (FDA) Commissioners Scott Gottlieb and Margaret Hamburg, the framework identifies three key areas of focus:

  • Patients: Input from patients should be a core part of regulatory, pricing and access decisions.
  • Value: The efficacy, scientific benefits and development risks of advanced therapies must be considered when determining how a medication should be paid for. In addition to calculating upfront costs, comprehensive monitoring and data collection are needed to evaluate a drug’s long-term effectiveness.
  • Payment: Different therapies may require different payment models to ensure they are distributed widely and equitably. A value-based payment model may work well for some, risk pools or stop-loss mechanisms may be more appropriate for others, and additional options will need to be explored further.

The working group also agreed that existing regulatory policies should be reviewed to identify any barriers to access, innovation and competition, and to promote experimentation with new payment models.

“We’re advancing new innovations that have the potential to cure more diseases and change the practice of medicine, but developing these advances is costly, and the resulting products can carry high price tags,” said Scott Gottlieb, former FDA commissioner and co-chair of the Breakthrough Cures, Blockbuster Costs working group. “Making sure patients can benefit from these breakthroughs is going to require us to introduce complementary innovations in how we reimburse these treatments to enable patients to have equitable access to new treatments and recognize value from them.”

“We are trying to harness the extraordinary advances in science and technology that are unfolding today and make sure that they are both affordable and accessible to patients,” said Margaret Hamburg, also a former FDA commissioner and co-chair of the working group. “This is clearly one of the most pressing issues before us in society today.”

BCBSA and the Aspen Institute brought together the following leading health care, academic, government and patient advocacy experts to discuss the value of advanced therapies and how best to pay for them, and to identify key areas for further research:

  • Scott Gottlieb, MD, American Enterprise Institute (co-chair)
  • Margaret Hamburg, MD, National Academy of Medicine (co-chair)
  • Alan Balch, PhD, Patient Advocate Foundation and National Patient Advocate Foundation
  • Otis Brawley, MD, Johns Hopkins University
  • Doug Danison, MBA, bluebird bio
  • Diana Han, MD, GE Appliances
  • Justine Handelman, BCBSA
  • Esther Krofah, MPP, Milken Institute
  • MaryAnne Lindeblad, MPH, Washington State Health Care Authority
  • Sarah Marché, PharmD, MBA, Highmark, Inc.
  • John O’Brien, PharmD, MPH, former U.S. Department of Health and Human Services Senior Advisor
  • Mark Trusheim, MSc, MIT NEWDIGS
  • Anita Wagner, DrPH, PharmD, MPH, Harvard Medical School and the Harvard Pilgrim Health Care Institute
  • Brian Wallach, JD, I AM ALS
  • Gail Wilensky, PhD, Project Hope

“Bringing together experts across sectors allowed us to broaden our thinking as we prepare for the coming wave of advanced therapies,” said Ruth Katz, Aspen Institute vice president and director of the Health, Medicine & Society Program.

Advanced therapies are biomedical breakthroughs that often treat rare conditions and can transform or even save a patient’s life. However, these medicines tend to come with extremely high price tags — by 2031, as many as 90 gene and cellular therapies are expected to be approved for use by 550,000 patients, at an annual acquisition cost of $30 billion.

“Everyone, no matter who they are or what their health condition may be — or how rare it is — deserves affordable access to life-saving therapies,” said Justine Handelman, senior vice president for the Office of Policy and Representation for BCBSA. “Current policies and payment models should be reviewed and modernized to encourage the development and equitable distribution of these medications. We need a system that supports medical breakthroughs without breaking the bank.”


About the Health, Medicine & Society Program at the Aspen Institute
Established in 2005, the Health, Medicine & Society Program (HMS) brings together influential groups of thought leaders, decisionmakers, and the informed public to consider health challenges facing the US in the 21st century and to identify equitable solutions for addressing them. At the heart of most of our activities is a package of research, convenings, and publications that supports policymakers, scholars, advocates, and other stakeholders in their drive towards change. To learn more about HMS, please visit

About the Aspen Institute
The Aspen Institute is a global nonprofit organization committed to realizing a free, just, and equitable society. Founded in 1949, the Institute drives change through dialogue, leadership, and action to help solve the most important challenges facing the United States and the world. Headquartered in Washington, DC, the Institute has a campus in Aspen, Colorado, and an international network of partners.

About the Blue Cross Blue Shield Association
The Blue Cross and Blue Shield Association is a national federation of 34 independent, community-based and locally operated Blue Cross and Blue Shield companies that collectively provide health care coverage for one in three Americans.

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