01.26.22

AcCELLerate Forum: Session 2 Recap

Session 2 - Cellular Immunotherapy Reimbursement: Challenges and Opportunities

Cellular Immunotherapy Reimbursement: Challenges and Opportunities

The second general session of the 2021 AcCELLerate Forum, presented on November 18, was chaired by Stephanie Farnia and Dr. Krishna Komanduri. Kicking off this session, the chairs provided an overview of the financial challenges that cell-based therapies are facing. The session objectives were to consider a transition from episode-based care to value-based payment, to consider how data may be used in this transition, and to discuss how meaningful outcomes would be measured.

Cellular Immunotherapy Reimbursement: Challenges and Opportunities

The first presentation was by Dr. Jennifer Malin, the Senior Vice President and Chief Marketing Officer of Optum Health Solutions. Currently, CAR T-cell therapy can incur a high cost, with an average billed charge of $1.4 million per case. This includes the product and associated costs such as the hospital, physician, invoice markup, and ongoing treatment for the patient’s underlying conditions.

Providing an overview of Optum Transplant Solutions, Dr. Malin presented on the benefits of the program, which aims to reduce medical expenses. There are currently over 73 million members with access and 184 facilities involved in this program. Additionally, Optum’s Center of Excellence (COE) qualification process helps organizations offer quality care options through creating a COE network. This COE network is comprised of high quality care centers and helps members find the highest quality and value centers.     

The Payer Industry - Dr. Dave McLean

Next, Dr. Dave McLean, Co-Founder and Chief Executive Officer of Emerging Therapy Solutions (ETS), discussed his observations of the current status and future directions of the payer industry. In 2018, Dr. McLean and Kevin Roche performed market research to determine the current pipeline for cell therapies and presented their findings to payers.

The outcome of their discussions were questions that led to the foundation of ETS to help facilitate this decision making. Several questions are being addressed, including pricing, coverage, treatment centers of use, and manufacturers. By purchasing claim data, ETS was able to look at the incidence and prevalence of the underlying conditions that trials were performed on. As a predictive tool, ETS created simulations and actuarial solutions to work directly with stop-loss carriers and insurers.

Paying for Value: New Solutions and Opportunities

The fourth presentation was performed by Dr. Lucas de Breed, the Managing Director of August Care, and focused on the assessment of value in cell therapies. Traditionally, value assessments have focused on quality-adjusted life year (QALY) gains and cost. This has led to the underappreciation of the full value of therapeutic products.

To improve this process, the Institute for Clinical and Economic Review (ICER) recommended that manufacturers and insurers have outcome-based pricing arrangements with sufficient follow-up. To navigate the value uncertainty, value-based contracts can be used as learning opportunities to evaluate the appropriateness of use. To predict the future value of treatments, machine learning can be used on existing Cellular Immunotherapy Data Resource (CIDR) datasets.

Strategies to Align Evidence Generation for Cell and Gene Therapies

The final presentation of the session by Dr. Marianne Hamilton Lopez, the Senior Research Director of Biomedical Innovation at the Duke-Margolis Center for Health Policy, focused on post market strategies for new technology performance. Currently, data collection occurring by individual stakeholders can be misaligned. This can lead to increased administrative burden for providers, increased resource costs, and inconsistent evidence for new technologies.

Dr. Lopez’s team focuses on building a coordinated evidence strategy. The goal of their work is to clarify the understanding and long-term outcomes and risks in populations, ensure continued learning on the effectiveness of new therapies, and understand how to manage and improve new classes or therapies. To reach these goals, a multi-stakeholder coordinated policy framework has been developed, where data collection and key outcomes are aligned between stakeholders. To encourage post market evidence development, Dr. Lopez suggests using data platforms, incentivizing the clinical community to collect and report data, and using value-based payment models.

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