Cell and Gene Therapy
The cell and gene therapy market is rapidly evolving, presenting new challenges for stakeholders and shifting traditional policy and access paradigms. Our cell and gene experts help stakeholders navigate the landscape through data-driven, end-to-end life cycle support to advance key commercialization and patient access goals.
Evolving Policy Trends in Cell and Gene Therapy
Changes in state and federal policies will drive patient access, financing, and provider reimbursement of cell and gene therapies.
New CAR-T Policies Affect Access, Reimbursement
Medicare CAR-T payment will increase in FY 2026, improving hospital reimbursement; CMS will consider shifting to market-based rate-setting in future rulemaking.
FDA Eliminates CAR-T REMS Requirements, Ushering in a New Era
Elimination of REMS requirements signals growing confidence in the safety of CAR-T, and potential for expanded access to CAR-T therapies.
Social Determinants May Affect Access to CAR-T Treatment
Analysis highlights potential access barriers to a broad set of CAR-T therapies
Examining Variation in Gene Therapy Access Across States
State Medicaid programs take a range of approaches to gene therapy coverage, management, and reimbursement.
CGT Payment Changes Proposed in FY 2025 IPPS Proposed Rule
Medicare CAR-T payment remains stable; CMS proposed structural changes for New Technology Add-on Payments (NTAP).
Specialty Pharmacies Adapt to Support Cell and Gene Therapies
Specialty pharmacies are evolving to support the unique distribution requirements of CGTs and the complex patient journey from diagnosis to treatment.
Understanding the CMS Cell and Gene Therapy Access Model
The CGT Access Model will allow CMS to negotiate outcomes-based agreements on behalf of state Medicaid programs for CGTs, beginning with sickle cell disease.
CAR-T Reimbursement Updated in FY 2024 IPPS Final Rule
Medicare CAR-T payment remains stable, but changes to outlier payments and NTAP eligibility may create challenges.
CAR-T Reimbursement Updates Proposed for FY 2024
Policy proposals for Medicare’s CAR-T inpatient reimbursement reflect additional cases and increase clinical trial payment.
Pipeline Transformative Therapies May Require Payment Model Innovation
Avalere’s assessment highlights a diverse set of over 200 products in development that could challenge payment models across care settings and payers.
The Fast-Paced Future of Cell and Gene Therapies
New report on the evolving cell and gene landscape features Avalere Health experts Kylie Stengel and Mark Von Eisenburg.
Cell and Gene Therapy: Fundamental Development Questions for Sponsors
Cell and gene therapy (CGT) technology continues to outpace regulatory and reimbursement mechanisms, requiring sponsors to think proactively about development.
Webinar: The Evolving Cell & Gene Therapy Market
Join Avalere’s panel of market access and policy experts for a discussion on the growing cell and gene therapy (CGT) pipeline, an in-depth look at the unique opportunities and challenges these novel therapies present, and an overview of the many hurdles stakeholders need to navigate for success.
CAR-T Reimbursement Continues to Evolve in FY 2023 IPPS Proposed Rule
Policy proposals for Medicare’s CAR-T inpatient reimbursement build on market developments as bundled payment incorporates additional treatments.
Socioeconomic Factors May Impact Patient Access to Cell Therapies
Analysis finds that patients face barriers to cell therapy treatments regardless of proximity to cell therapy treatment sites.
Video: Cell and Gene Therapy in Oncology, Part III
Tune into another episode of the Avalere Health Essential Voice podcast series focused on disease education. In this segment, the final in our series on cell and gene therapies, experts from our Market Access practice discuss the need for patient support in cell and gene therapies, and the role that manufacturers and other stakeholders can play in providing it.
Interview: Cell and Gene Therapy in Oncology, Part III
Tune into another episode of the Avalere Health Essential Voice podcast series focused on disease education. In this segment, the final in our series on cell and gene therapies, experts from our Market Access practice discuss the need for patient support in cell and gene therapies, and the role that manufacturers and other stakeholders can play in providing it.
CMS Updates CAR-T Reimbursement for 2022 in IPPS Final Rule
Finalized policy for Medicare’s CAR-T inpatient reimbursement builds on policies solidified in last year’s rulemaking. Looking ahead, stakeholders will continue to weigh the appropriateness of payment.
Video: Cell and Gene Therapy in Oncology, Part II
Tune into another episode of the Avalere Health Essential Voice podcast series focused on disease education. In this segment, the second in a series focused on cell and gene therapies, experts from our Policy and Market Access practices discuss value-based payment arrangements in cell and gene therapies, and the role they play in facilitating access to these therapies.