Biden-Harris Initiative Significantly Boosts Access to Key Sickle Cell Therapies

WASHINGTON, D.C. — The Biden-Harris Administration is taking a decisive step towards equality in healthcare with its announcement of the Cell and Gene Therapy (CGT) Access Model, an initiative designed to increase access to treatments for sickle cell disease (SCD). This painful condition affects over 100,000 Americans, predominantly within the Black community, and the new initiative signals a vital move towards improving healthcare outcomes.

SCD is no trivial matter. It significantly reduces life expectancy by over 20 years and exacerbates long-term health complications, including stroke, acute chest syndrome, and chronic end-organ damage. To compound these issues, access to quality, affordable care often poses a challenge for those suffering from SCD.

Into this fray steps the CGT Access Model, an initiative under the broader umbrella of the Administration’s efforts to lower prescription drug costs. Initially announced in February 2023, and led by the Centers for Medicare & Medicaid Services’ (CMS) Innovation Center, the CGT Access Model is designed to increase access to groundbreaking cell and gene therapies by testing outcomes-based agreements (OBAs). By doing so, this initiative aims to make these innovative therapies more affordable and accessible, potentially saving lives and reducing long-term healthcare expenses.

The cost of treating SCD is not insignificant. With nearly 60% of those suffering from SCD enrolled in Medicaid, and with $3 billion spent annually on SCD-related health episodes, the potential of gene therapies to improve patient outcomes and lower long-term healthcare spending is unmistakable. However, the high costs associated with these therapies present budgetary challenges.

Herein lies the game-changer: Under the CGT Access Model, CMS will negotiate OBAs with manufacturers, linking the price of SCD treatments to improved health outcomes for Medicaid beneficiaries. The negotiations will also incorporate additional pricing rebates and a standardized access policy. This could allow states to enter into agreements with manufacturers based on negotiated terms, granting the agreed-upon access policy in exchange for rebates.

Additionally, the CGT Access Model aims to bridge the delivery gaps faced by individuals receiving cell and gene therapy. For example, manufacturers may be required to include fertility preservation services when individuals receive gene therapy for SCD treatment. CMS may also provide optional funding to states involved in activities promoting equitable access to cell and gene therapies and comprehensive care for Medicaid beneficiaries with SCD.

In essence, the Biden-Harris Administration’s announcement of the CGT Access Model targeting SCD signifies a major leap toward improving access to treatments for this debilitating condition. By focusing on SCD and negotiating OBAs, the model aims to make innovative therapies more affordable and accessible to Medicaid beneficiaries. This initiative not only has the potential to improve health outcomes and reduce healthcare costs, but it could also provide hope for individuals and families grappling with sickle cell disease.

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