Chimeric antigen receptor (CAR) T cell therapy is an adoptive cell immunotherapy procedure that is gaining significant attention from oncologists across the United States in recent years. Its innovative use of the patient’s own white blood cells, which interact with an artificial receptor to produce cancer-fighting chemicals, is unlike any other cancer treatment. The promising results of this therapy in clinical trials, along with two types of it—Kymriah and Yescarta—being approved by the FDA in 2017, has generated a fair amount of excitement in the healthcare community regarding its future use.
Despite this excitement, only a limited number of organizations currently offer this treatment due to some uncertainties surrounding its sustainability. While the potential of the therapy in eliciting a complete—or even partial—response in cancer patients is definitely encouraging, cost remains a major concern. A recent article in STAT highlights this financial uncertainty clouding hospitals and cites the lack of a standard CMS reimbursement policy to be one of the reasons.
Temporary Solutions Amid Cost Concerns
The absence of an established coverage policy complicates the treatment process and adds significantly to delays in patients receiving the therapy. Some hospitals and private insurers are setting up single-case agreements for covering the cost of therapy to quicken the reimbursement process and enable patients to receive necessary treatment on time.
Given the individualized nature of this therapy, however, estimating the cost of this treatment is oftentimes not an easy endeavor for hospitals. Additionally, costs seem to vary widely across health systems, with location—particularly whether the procedure is carried out in inpatient or outpatient settings—often altering treatment costs.
While current scenarios involve hospitals working on case-by-case arrangements with insurers, there is a widespread need for a policy that enables long-term success and implementation of this promising therapy. Although a CMS memo from February 2019 does propose “coverage with evidence development” for this therapy, a final decision on the national coverage determination has yet to be made. If finalized, this CMS reimbursement policy might offer physicians and organizations a better method to integrate the procedure into their cancer treatment protocols and increase the reach of this potentially curative therapy.
In the meantime, organizations can also monitor the success of this therapy by tracking certain key metrics and outcomes similar to those being tracked in some of the clinical trials. These potential metrics include:
- Objective/Complete response rate
- Cytokine release syndrome
- Neurological toxicity
- Mortality rate
- Remission/Progression-free survival rate
- Long-term safety
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