ASGCT Advocacy Annual Plan 2019

The American Society of Gene & Cell Therapy led a busy and fruitful 2018 supporting the interests of its members through legislative and regulatory advocacy work. Among the highlights:

• Hosted two first-time events:
  • A field-wide Value Summit to address sustainable patient access to approved gene therapies.
  • An ASGCT/FDA liaison meeting on gene therapy.
• Submitted 74 recommendations through comments to FDA on gene therapy and regenerative medicine draft guidance documents.
• Advocated for robust NIH research funding in fiscal year 2019 (a $2 billion increase), including dedicated funding to the Regenerative Medicine Innovation Project (the $10 million authorized by the Cures Act).
• Supported a bill that was enacted into law—the Sickle Cell Disease (SCD) and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2018.
• Submitted comments to the Centers for Medicare and Medicaid Services to support enhanced Medicare reimbursement to CAR T-cell providers, resulting in some improvements in 2019.

Emboldened by our success last year, ASGCT is doubling down on our advocacy efforts and plans to establish the Society and its membership as a leading voice for policy decisions by increasing our presence in Washington, D.C.

First and most excitingly, ASGCT will be expanding the Value Summit to incorporate the various legislative and regulatory policies relevant to the field. Rebranded as the ASGCT Policy Summit, the event will include a wider range of experts and topical discussion when it returns to Washington, D.C. later this year.

As part of our ongoing legislative outreach, ASGCT will continue to advocate for the removal of regulatory and legal barriers to new payment model arrangements. Of particular interest to our membership has been payment-over-time models. While the Society does not endorse specific individual pricing decisions, ASGCT supports sustainable patient access through sufficient reimbursement of durable, potentially-curative gene and cell therapies.

As part of our accessibility mission, ASGCT continues to support improved Medicare reimbursement levels of CAR T-cell therapies and continued patient access to CAR T-cell therapy during the Medicare national coverage analysis. ASGCT will also monitor state Medicaid coverage and reimbursement of approved gene therapies.

Finally, ASGCT will continue our ongoing efforts to increase federal funding to the NIH and FDA; to communicate with the FDA on regulatory policies; and to address societal and ethical implications of gene therapy. For more on all of these efforts or to get involved with the Society’s advocacy mission, consider ASGCT membership and follow us on Twitter @ASGCTherapy.

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