medwireNews: US FDA immunotherapy approval led to a significant increase in use, but did not eliminate socioeconomic disparities among users that were apparent prior to approval, study findings indicate.
Writing in JAMA Network Open, Daniel Boffa (Yale School of Medicine, New Haven Connecticut, USA) and co-authors explain that the FDA approval process typically takes around 7 years, but clinical trials, compassionate use, and other agreements mean that patients can sometimes access treatment prior to approval.
“Approval from the FDA decreases a number of access barriers; however, it is unknown whether FDA approval is associated with increases in the equitable use of novel therapies and reductions in disparities in use among patients with cancer in the US,” they say.
To investigate, the researchers analyzed data from the US National Cancer Database for 402,689 patients (56% men) aged 20 years or older (median age 68 years) who were diagnosed with stage IV non-small-cell lung cancer (NSCLC; 86.2%), renal cell carcinoma (RCC; 10.9%), or melanoma (2.9%) between 2007 and 2018.
A total of 11.8% were Black, 3.9% were Hispanic, 93.3% were non-Hispanic, 83.4% were White, and 4.1% were of other races.
During the 4 years before FDA approval, 3.2% of patients with NSCLC, 4.8% with RCC, and 8.6% with melanoma received immunotherapy. In the 3 years immediately after FDA approval the corresponding proportions were 15.6%, 19.7%, and 19.3%.
In the preapproval period, several sociodemographic and socioeconomic factors were associated with immunotherapy use but these varied by cancer type.
For example, in the NSCLC cohort, Black patients and Hispanic patients were significantly less likely to receive immunotherapy than their White and non-Hispanic counterparts, respectively, at odds ratios (ORs) of 0.78 and 0.79. Race was not associated with immunotherapy use in people with RCC or melanoma, but Hispanic ethnicity was associated with a lower likelihood of immunotherapy use in melanoma (OR=0.28).
Across the three cancer types, patients who had no insurance, Medicare, or Medicaid were consistently less likely to receive immunotherapy than those with coverage. Indeed, in the RCC cohort, the OR for immunotherapy among uninsured versus insured patients was a significant 0.31.
Living within a community with lower household incomes was also associated with a reduced likelihood of receiving immunotherapy, particularly for people with RCC or melanoma, where ORs ranged from 0.64 to 0.73 depending on the income quartile.
After FDA approval, some disparities were no longer statistically significant, but many persisted albeit with a lower magnitude. For example, Hispanic ethnicity was no longer significantly associated with a reduced likelihood for immunotherapy among people with melanoma, the OR among Black patients with NSCLC increased to 0.87, and that for uninsured patients with RCC increased to 0.60.
Conversely, associations that were not significant prior to FDA approval became significant following approval, including those for Black race and Hispanic ethnicity in the RCC cohort where ORs were a significant 0.82 and 0.81, respectively, in the latter period.
Boffa et al say that “disparities in the preapproval era likely reflect a lack of representativeness in the immunotherapy clinical trials.”
And although FDA approval was associated with significant increases in immunotherapy use overall, “numerous differences across sociodemographic and socioeconomic strata remained, suggesting that FDA approval alone does not ensure the optimal administration of novel treatments in the US,” the team concludes.
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