ASGCT Urges Congress to Address Gene Therapy Access Hurdles

As part of ASGCT’s mission to advance knowledge, awareness, and education of cell and gene therapies (CGTs), the Society engages with Congressional decision makers on topics of importance to the field. This includes advocating to ensure patient access to approved therapies.

Recently Chairwoman Virginia Foxx of the House Committee on Education and the Workforce posted a request for information about the Employee Retirement Income Security Act (ERISA). ERISA is a federal law that sets minimum standards for retirement and health insurance plans in private industry – including the employer-sponsored health plans that cover just under 50% of the US population. The final section of the RFI focused on specialty drug coverage, which includes CGTs.

The Society’s response focused on several key themes:

• ASGCT’s comments highlighted the potential of CGTs to improve patients’ and caregivers’ lives. We noted the challenges of patient access in a healthcare system designed for chronic treatment over months or years, rather than one-time transformative therapies with a frontloaded cost.
• Employers or health plans may use different strategies to manage risk and control costs. The Society called out several strategies of concern, including trends to exclude gene therapies from coverage or put undue limitations on eligibility. That trend was illuminated in our 2023 white paper on Medicaid coverage policies. We also pointed to opaque, clinically irrelevant prior authorization requirements that can result in lengthy treatment delays.
• Challenges with forecasting and patient portability between health plans can make these challenges more acute.

ASGCT generally supports efforts to explore flexible, innovative solutions that protect patient access, including the use of value-based agreements (VBAs). ASGCT believes transparency would help address issues around carve-outs and prior authorization; the Society has proposed parallel public dashboards incorporating information about a) real-world CGT coverage and b) payers’ prior authorization requirements.

Employers or health plans may use different strategies to manage risk and control costs. The Society called out several strategies of concern, including trends to exclude gene therapies from coverage or put undue limitations on eligibility, as illuminated in our 2023 white paper on Medicaid coverage policies, and opaque, clinically irrelevant prior authorization requirements that can result in lengthy treatment delays. ASGCT believes transparency would help to address both issues; the Society has proposed parallel public dashboards incorporating information about a) real-world CGT coverage and b) payers’ prior authorization requirements.

On April 16 the House Education and Workforce Committee will hold a hearing on the Employee Retirement Income Security Act (ERISA). An agenda for that hearing will be available shortly. As conversations continue in this space, ASGCT will keep advocating for policies that can facilitate the development and accessibility of transformative treatments.

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