As a relatively new and unique therapeutic area, CAR-T’s represent a high level of uncertainty to payers given the high price points for a single-use product and novel therapeutic approach associated with these agents. To manage overall use, it is critical for insurers and PBM’s to manage these agents through the application of appropriate utilization management criteria.
Chimeric Antigen Receptor T-cell (CAR-T) therapies represent a breakthrough in cancer care due to the significant clinical response seen in patients that have relapsed or have not responded to currently available treatments. Since 2017, six CAR-T therapies have been approved by the Food and Drug Administration (FDA), three of which have been approved for relapsed or refractory (R/R) large B-cell lymphoma - KYMRIAH™ (Novartis) in May 2018, YESCARTA™ (Kite Pharma) in October 2017 (and most recently in April as a 2nd line therapy), and BREYANZI™ (Bristol-Myers Squibb) in February 2021.
As a relatively new and unique therapeutic area, CAR-T’s represent a high level of uncertainty to payers given the high price points for a single-use product and novel therapeutic approach associated with these agents. To manage overall use, it is critical for insurers and PBM’s to manage these agents through the application of appropriate utilization management criteria.
It can be difficult to accurately assess CAR-T utilization management as the criteria payers use to manage these products is typically found in unstructured policy documents which are not easily analyzed. To solve for this problem, Qualia Bio applied its unique utilization management framework to provide a comprehensive analysis of the key criteria payers are using to shape access to CAR-T therapies. As part of this process, Qualia Bio compared and contrasted brand product labels and clinical trials with publicly available medical policies of the top 25 targeted commercial plans. The plans included in this analysis represent over 150 million commercial medical lives (approximately 71% of people in the US with private health insurance coverage).1
Overall access is favorable for all three marketed (R/R) B-cell lymphoma CAR-T brands with policies being less restrictive than product label and/or clinical trial inclusion and exclusion criteria.
Payer utilization management efforts are primarily focused on initial authorization criteria, suggesting that primary abandonment (prescription is written but not filled and/or patient does meet qualifying criteria for treatment) will be a potential brand risk factor.
Competitive access dynamics are muted – brand access is more similar than dissimilar between CAR-T brands which share the same indication.
When differences in access occur between brands at the same payer, these differences are seen in initial authorization criteria and are unlikely to have a material impact on utilization.
It is expected that payer policies will evolve as additional CAR-T competitors reach the market and/or existing agents receive new indications which require P&T review; thus, the findings from this initial report represent a point in time. The addition of new CAR-T agents and new indications which increasingly move CAR-T therapy into earlier lines of treatment may lead to changes in utilization management criteria which have material impact on access to these therapies.
Current policies reflect a landscape where CAR-T’s are primarily administered at inpatient facilities which are part of an approved treatment network. As additional clinical data becomes available, it is conceivable that select products may be safely administered in outpatient settings of care. Any potential shifts in site of care (inpatient to outpatient) may lead to increased utilization management as payers are subject to increased financial risk associated with CAR-T utilization in an outpatient setting. Qualia Bio will be monitoring these potential changes as part of future reports on the status of CAR-T access in the US market.
Additional changes which payers may contemplate over time could include a shift from today’s focus on initial authorization criteria to an approach which also considers net cost. While rebate contracting in oncology has historically been limited, payers may pursue options such as preferred placement in treatment pathways and outcomes-based contracts to manage price in addition to utilization.
Payer access for CAR-T therapies is an emerging therapeutic area and coverage policies should be monitored to fully understand how access for these new therapies will evolve over time.
A burgeoning gene-modified cell therapy pipeline (over 348 agents in clinical development, including CAR-T’s and other gene-modified cell therapies2) suggests competitive intensity among the CAR-T’s may strengthen over time.
It will be important for manufacturers who enter the CAR-T market in the future to understand how utilization management may impact future levels of access. CAR-T market events will be monitored closely by Qualia Bio and future CAR-T UM policy reports will evaluate payer changes in policy driven by market events such as the launch of a new agent or the addition of new indications to existing agents.
For more information, or to arrange for a complimentary 30-minute webcast which highlights select findings from our Q4 2021 CAR-T Market Access Report, please contact: [email protected]
1. U.S. Census Bureau, Health Insurance Coverage in the United States: 2019
2. Innovation in the Biopharmaceutical Pipeline, PhRMA