The Assistance Fund (TAF), an independent charitable patient assistance organization that helps patients and families facing high medical out-of-pocket costs, today announced the release of a new white paper: “Access to New Cures & Innovative Care for Medicaid Patients: Examining Challenges and Opportunities for Cell and Gene Therapies in Medicaid.” The paper, which was researched and written by Leavitt Partners, provides in-depth analysis of the challenges cell and gene therapy (CGT) present to the Medicaid program’s antiquated coverage and payment policies, as well as potential solutions. Its proposed recommendations to improve access to and sustain Medicaid coverage of CGT are based on a comprehensive landscape assessment and interviews with over 45 expert stakeholders, including patient advocacy groups, state Medicaid directors and experts, healthcare providers, Medicaid health plans, federal policymakers, and manufacturers.
“The Assistance Fund is committed to ensuring patients’ access to all FDA-approved treatments, including transformative therapies entering the market now and those coming in the future,” said Christina Hartman, Senior Director of Advocacy at The Assistance Fund. “As the parent of a child with a rare neurogenetic disorder, I know first-hand the struggles patients and families face every day. Many new therapies have six- or seven-figure price tags, and we must ensure patients’ out-of-pocket costs do not restrict or prohibit access.”
The current healthcare system cannot accommodate access to transformative therapies for all who need them. While only a handful of cell and gene therapies are on the market today, more than 350 medicines are in development to treat or cure human diseases, including hemophilia, rare diseases, cancers, and other disorders. Currently, only about five percent of human diseases have a treatment approved by the Food and Drug Administration (FDA).
A great deal of progress has been made to incentivize research and facilitate FDA approval of treatments and cures, but ensuring patients have coverage and access remains a challenge. The FDA uses various methods to expedite review of products where there is an urgent medical need and, sometimes, with limited evidence from smaller clinical trials. However, these methods often create difficulties for states and payers that make coverage decisions based on clinical evidence. Collaboration between the FDA and the Centers for Medicare and Medicaid Services is critical to ensuring patients have immediate access to CGTs when they come to the market.
“Access to New Cures & Innovative Care for Medicaid Patients: Examining Challenges and Opportunities for Cell and Gene Therapies in Medicaid” outlines meaningful and actionable steps that will help modernize a 20th-century payment model to bring timely access to 21st-century treatments and cures to patients and their families.
“The paper highlights the tremendous hope that cell and gene therapies offer many Medicaid patients, as well as the substantial challenges that Medicaid programs and stakeholders face in ensuring access to and coverage for these treatments,” said Josh Trent, principal for Leavitt Partners. “Ground-breaking new therapies will require new value-based payment models and the ongoing cross-sector collaboration of Medicaid stakeholders. The proposed recommendations from stakeholders provide concrete opportunities for this type of collaboration.”
The white paper is available for download here: https://issuu.com/theassistancefund/docs/cgtwhitepaper_2020.
About The Assistance Fund
The Assistance Fund is an independent charitable patient assistance organization that helps patients and families facing high medical out-of-pocket costs by providing financial assistance for their copayments, coinsurance, deductibles, and other health-related expenses. The Assistance Fund currently manages more than 70 disease programs, each of which covers the FDA-approved medications that treat a specific disease. Since our founding in 2009, The Assistance Fund has helped nearly 125,000 children and adults access critical treatment for a life-threatening, chronic or rare disease. To learn more about The Assistance Fund or for information on how to donate, please visit tafcares.org.
About Leavitt Partners:
Leavitt Partners helps clients successfully improve health by advancing value. The firm informs, advises, and convenes industry leaders on market and industry influences, value-based care, alternative payment models, federal strategies, public health, digital health, and alliances. Through its family of businesses, the firm provides clients with investment support, member-based alliances, and strategic advisory services, striving to make health more accessible, effective, and sustainable. For more information, visit www.LeavittPartners.com.
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 National Center for Advancing Translational Sciences. Rare Disease Day at NIH 2020. (2020, April 27). NCATS.NIH.gov. https://ncats.nih.gov/news/events/rdd.
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Original Source: The Assistance Fund Releases White Paper: "Access to New Cures & Innovative Care for Medicaid Patients: Examining Challenges and Opportunities for Cell and Gene Therapies in Medicaid"