SummaryManufacturers 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.
Five next-generation cellular therapies are on the market today, and another 54 are in late-stage development worldwide.1 The growing cell therapy market highlights an imminent need to address patient access barriers unique to these therapies, including the limited number of treatment sites, high drug and non-drug costs, complex logistics associated with travel, post-treatment monitoring, and long-term-care follow-up. Life sciences manufacturers should consider how to redesign and optimize existing and innovative patient support service offerings to address these challenges.
The cell therapies currently approved by the FDA include chimeric antigen receptor T-cell (CAR-T) therapies, which function by extracting and modifying a patient’s own immune cells to target cancer cells and infusing them back into the patient. Due to adverse events that can follow shortly after treatment, such as cytokine release syndrome, patients are usually required to be admitted to the hospital for treatment and then remain near treatment centers for post-treatment monitoring for up to 30 days.2 The complexity of this course of care also requires providers to be well equipped to handle any adverse events and operate out of an accredited site, limiting the number of sites at which care can currently be delivered.
Challenges limiting access to CAR-T therapies for patients who might otherwise benefit can include significant geographic distance to an appropriate facility and the potential need to travel across state lines to access treatment sites. Patients also may not have a clear understanding of their insurance benefits, including insurance coverage parameters for out-of-state or out-of-network treatment and the additional costs that could accrue. Drug cost sharing, as well as transportation and lodging costs, could result in additional access and affordability challenges to patients. Disparities in healthcare across patient populations only exacerbate these issues.
To illustrate one of the access barriers potential CAR-T patients may experience, Avalere assessed the availability of CAR-T treatment based on provider and patient geographic location. Avalere identified 276 sites of care possessing accreditation from the Foundation for the Accreditation of Cellular Therapy, 64 of which actively administer CAR-T for diffuse large B-cell lymphoma (DLBCL).
Avalere quantified the distance patients travelled to see their treating provider, divided into cohorts. Cohort A consisted of DLBCL patients receiving CAR-T treatment, while Cohort B comprised DLBCL patients receiving other treatment (e.g., immunotherapy/monoclonal antibody, chemotherapy).
*Analysis specific for DLBCL indication.
Cohort A and Cohort B were used to differentiate level-of-access burden across patient and treatment types. The variation in patient travel distance to sites of care across the US included:
- In New England, the median distance patients had to travel to receive CAR-T therapy (Cohort A) versus other treatments (Cohort B) was an additional 2.4 miles.
- In western mountain states such as Arizona, Colorado, Utah and Nevada, the median additional distance needed to travel was 14.5 miles.
- In west southern states such as Arkansas, Louisiana, Oklahoma, and Texas, the median additional distance needed to travel was 21.9 miles.
- In east southern states such as Alabama, Kentucky, and Mississippi, and Tennessee, the median additional distance needed to travel was 46.7 miles.
Travel-related costs, including transportation and lodging, may prove logistically and financially cumbersome to patients who live farther from treatment sites, and even further compounded in areas of the country where there are historically lower median household income rates.3 Patients are likely to find that payer coverage of ancillary costs is highly variable across benefit types and plan designs, and overall insufficient to cover costs.
Solutions to Patient Access Challenges
Traditional patient support programs may include care coordination, benefits and reimbursement support, copay support, insurance counseling, site of care locators, educational support, and free drug support.
However, given the new and more acute nature of access challenges associated with cell therapy, enhanced patient support options may also include or consider:
- Assistance with diagnostic monitoring throughout patient care journey
- Support for site-of-care changes across patient journey
- Compliance challenges with regards to free or reduced-price drugs in the inpatient bundled payment system
- Bolstered patient support program services that take into account the cost of the procedure, patient travel, non-drug expenses, long-term follow-up, and care coordination
- Patient reported outcomes tracking longitudinal patient engagement despite limited clinical interventions beyond cell therapy administration
With hands-on experience in designing patient support programs through market analytics and a multi-stakeholder approach, Avalere is helping life sciences manufacturers, health plan stakeholders, and patient advocacy organizations create innovative solutions that address patient access barriers to CAR-T.
This analysis utilized the 100% sample of Medicare fee-for-service (FFS) claims between 2017 and 2019, accessed by Avalere via a research-focused CMS Data Use Agreement. The final population included in the analysis was less than 20% of the total Medicare FFS population.
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- Alliance for Regenerative Medicine, “2020: Growth and Resilience in Regenerative Medicine—Annual Report” (Accessed March 16, 2021).
- University of Utah Huntsman Cancer Institute, “CAR-T Cell Therapy” (Accessed March 10, 2021).
- Guzman, Gloria. “U.S. Median Household Income Up in 2018 From 2017,” US Census Bureau (Accessed March 10, 2021).
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