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.
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.
CAR-T Reimbursement Updated in FY 2023 IPPS Final Rule
Policy proposals for Medicare’s CAR-T inpatient reimbursement will reflect additional data, though high-cost outliers present challenges.
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.
Final CMS Alzheimer’s Coverage Memo Will Impact Access Beyond Medicare
The final CMS NCD for amyloid beta-targeting monoclonal antibodies for Alzheimer’s Disease establishes a dual pathway to Medicare coverage based on FDA approval and likely creates access and operational challenges for stakeholders.
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.
Podcast: 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.
Podcast: 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.
CMS Introduces Changes to CAR-T Reimbursement in IPPS Proposed Rule
Policy proposals for Medicare’s CAR-T inpatient reimbursement build on policies finalized in last year’s rulemaking. Looking ahead, stakeholders will continue to weigh the appropriateness of payment.
Podcast: Cell and Gene Therapy in Oncology, Part I
Tune into another episode in the Avalere Health Essential Voice podcast series focused on disease education. In this segment, the first of several discussing cell and gene therapies, experts from our Policy and Market Access practices highlight many of the challenges surrounding these therapies from both the patient and payer perspective.
Advancements in Cell Therapies Require New Patient Support Solutions
Manufacturers seeking Food & Drug Administration (FDA) approval for cell therapies will need to assess the financial and logistical burden on patients and develop novel solutions to help alleviate these challenges.
Podcast: Data Deep Dive: CAR T-Cell Therapy for Large B-Cell Lymphoma
Tune into our first episode in the Avalere Health Essential Voice podcast series focused on disease education. In this segment, our experts discuss recent research that, using Medicare fee-for-service claims data, studied healthcare utilization, costs, outcomes, and other characteristics of patients who received CAR T-cell therapy for large B-cell lymphoma.
Video: Data Deep Dive: CAR T-Cell Therapy for Large B-Cell Lymphoma
Tune into our first episode in the Avalere Health Essential Voice series focused on disease education. In this segment, our experts discuss recent research that, using Medicare fee-for-service claims data, studied healthcare utilization, costs, outcomes, and other characteristics of patients who received CAR T-cell therapy for large B-cell lymphoma.
Cell and Gene Therapy Pipeline Patient Affordability Opportunities
With a number of cell and gene therapies (CGTs) expected to obtain Food & Drug Administration (FDA) approval in the next 3 years, stakeholders must consider the unique patient access and affordability barriers that may limit patient ability to receive these novel treatments. Stakeholders should explore affordability solutions that can optimize access, or they risk excluding patients from obtaining potentially life-saving treatments.
Medicaid Programs Seek New Approaches for Cell and Gene Therapies
State Medicaid programs are likely to face significant budget impacts from emerging cell and gene therapies and may seek to implement a variety of strategies to manage utilization and address provider reimbursement and financing challenges.
CMS Finalizes New Reimbursement Method for CAR-T Treatments
Policy changes to Medicare’s CAR-T inpatient reimbursement set a precedent for high-cost durable treatments. Looking ahead, questions and concerns remain for pipeline cell and gene therapies that have high up-front costs.