Enabling an environment where innovators file first in the U.S. is crucial to CGT innovation and access. ARM supports relaxing class labeling restrictions, such as those for CAR-T cell therapies, when real-world evidence suggests it is safe and would help enable greater patient access.
CGT patients can face many barriers to treatment. ARM is advocating for Medicare payment policies that expand CGT access, streamlining out-of-state provider access and the adoption of value-based agreements in Medicaid, and additional flexibilities that mitigate patients’ access barriers.
Advancing new technologies efficiently is essential to maintaining scientific momentum in the sector. ARM supports the advancement of platform technologies for gene editing technologies and fit-for-purpose product attribute testing (CMC) & comparability requirements.
This legislation reduces care delays for pediatric Medicaid patients who must travel out of state for specialized care.
The bill reauthorizes the FDA’s Rare Pediatric Disease Priority Review Voucher program, which enables new therapies for kids with unmet medical needs.
The "MVP Act” helps facilitate value-based payment arrangements by modernizing Medicaid payment methodologies for cell and gene therapies.
These policies, which became law with President Trump’s signature, represent hope for the rare disease community and will meaningfully improve access to life-changing and life-saving treatments.
We applaud Congress for passing ARM’s top two legislative priorities and are grateful to our partner organizations whose collaboration and advocacy were crucial in securing the necessary support.
In January, the ARM team participated in the Breakthroughs in Cancer Care: Expanding CAR-T Access Open House on Capitol Hill, which was hosted by our partners at CAR T Vision. The open house highlighted important conversations about what it will take to improve patient access to CAR-T cell therapy.
ARM regularly comments on federal rules, legislative proposals, and other policies shaping the future of cell and gene therapy.
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