ARM influences policy to ensure our systems can accommodate the growing pipeline of cell and gene therapies
The EU Joint Clinical Assessment (JCA), which will begin in January 2025, will significantly impact patient access to cell and gene therapies in EU Member States. ARM is working to ensure that the EU JCA will be fit for cell and gene therapies, adopting real-world evidence and the most advanced methodological approaches.
The revision of the EU pharmaceutical legislation offers the opportunity to improve the regulatory framework for ATMPs and to move towards a more harmonized interpretation and use of the Hospital Exemption across the EU by better defining the conditions in which the HE may be used. ARM advocates for the scheme to be used only when the specific needs of the patient cannot be met with a product that has been evaluated by the EMA and has received an EU marketing authorization.
Medicaid patients frequently encounter delays in coverage for cell and gene therapies and challenges when traveling across state lines to receive care in qualified treatment centers. ARM supports streamlining cross-state care and physician credentialing, increasing Medicaid payment and reimbursement rates, ensuring that necessary ancillary services are accessible, and eliminating coverage delays.
Value-based payment agreements (VBAs) can help facilitate access to cell and gene therapies. ARM encourages the adoption of VBAs in state Medicaid programs, addressing price reporting implications and portability concerns. To optimize the impact of VBAs, ARM advocates for removing financial barriers and enhancing equitable access to specialized healthcare by seeking safe harbors from the anti-kickback statute.
ARM’s advocacy efforts in Medicare focus on ensuring the Centers for Medicare and Medicaid Services recognize the unique characteristics of cell and gene therapies. As the sector expands, we advocate for policy frameworks that foster the construction of Diagnosis Related Groups (DRGs) to ensure adequate incentives that enhance patient access. Further, ARM supports strengthening the New Technology Add-On Payment (NTAP) designed to promote innovation by providing additional payment for advanced therapeutics.