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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“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.”

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)

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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Market Access and Pricing Strategy

We help your best ideas become market leaders. Regardless of where you are in the product life cycle, we can take it to the next level. We create and communicate value, accelerate growth, optimize access, and confidently navigate the shifting market landscape.

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Federal And State Policy

Our team monitors qualitative and quantitative trends and policy and legislation in real time. We create customized models to inform successful strategies and tactics so you can act decisively.

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Strategic Analytics. Value and Economics

Your product must pass muster with payers. We help you define, measure, and report value across settings of care, prospective payment systems, and insurance benefit structures.

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Coding and Reimbursement

Understanding Medicare, Medicaid, VA-DOD, and private payers is vital. There is no easy button. We help you stay ahead of changing regulations and ensure you are prepared for what’s next.

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Financial Services Due Diligence

Thinking like investors, we deliver customized, deep, data-driven analysis to quantify relevant risks, opportunities, and trends to inform financial models and recommend how to achieve goals.

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