Cell and Gene

Successful cell or gene therapy coverage and reimbursement requires a nuanced, multidisciplinary approach. It also requires deep knowledge in policy, pricing, and access – oftentimes alongside the right partner.

ADVI Health is a trailblazer with critical commercial launch preparation for cell and gene therapies that help treat, prevent, or cure a wide array of untreatable and difficult-to-treat diseases. We help our clients navigate the federal and state policy landscape, highlight unique value drivers, and advocate to critical stakeholders across the healthcare landscape and pride ourselves in the ability to achieve positive results.

We are your go-to partner for strategy, policy updates, data analytics and value economics in cell and gene therapies, rare and ultra-rare diseases, and oncology therapeutics, devices, and diagnostics.

Explore the latest resources and up-to-date information on cell and gene, implications for the industry, and insights on recent updates.

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ADVI Health recently released information on CMS’ Cell and Gene Therapy Access Model 
(February 7, 2024)

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Alicia Silver discusses upcoming updates to the Cell and Gene Therapy Access Model in 2024.
(January 12, 2024)

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ADVI Health partnered with Alliance for Regenerative Medicine to review Medicaid access barriers in cell and gene therapies. Review the key findings and read the full white paper
(December 28, 2023)

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Case Study: Uncovering Potential for Products with Clinical, Epidemiology, and Real-World Cost Benefits
(December 20, 2023)

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Case Study: Novel Car T-Cell Reimbursement and Positioning Strategy
(December 20, 2023)

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“The team focused on cell and gene therapy at ADVI has the expertise that is required and necessary to understand the nuances of bringing products to market.”

Marc Samuels Discusses Key Insights on Cell and Gene from Meeting on the Mesa
(Oct 24, 2023)

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ADVI Teams Up with Mix Talent on Special Edition Cell and Gene Therapy Podcast in Collaboration with Gamida Cell and Zevra Therapeutics
(September 28, 2023)

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ADVI Teams Up with Mix Talent on Special Edition Cell and Gene Therapy Podcast
(September 20, 2023)

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CAR T-Cell Therapies
For FY 2024, CMS proposes two changes in methodology for identifying clinical trials and expanded access use claims in MS-DRG 018.
(April 10, 2023)

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Evolving Healthcare Landscape: Cell and Gene
(April 7, 2023)

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OSTP Releases Report on US Biotech and Biomanufacturing Goals
(March 24, 2023)

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The Cell and Gene Therapy Access Model
(February 14, 2023)

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Marc Samuels Discusses Insights on the Evolving Landscape
Shares his perspectives on the Inflation Reduction Act, CMMI, MedPAC, and developments impacting patient access for CAR T-cell therapy for solid tumors and sickle cell therapies.

(January 12, 2023)

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AVBCC 2022 Key Takeaways: The Impact of the IRA is Beyond Impacts to Pricing
(Oct 26, 2022)

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Excitement, Anticipation, Questions Await as ASCO 2022 Begins
(June 2, 2022)

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ASCO 2022 is Back the Way it Should Be, in Person
(May 26, 2022)

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“Things are moving very quickly in cell and gene therapy, but ultimately that is a good thing. Our job is to find solutions and get the right people in the right places to get products in position for commercialization success.”

Alicia Silver, Director of Health Policy and Reimbursement

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