Advanced, targeted, anticancer drugs and immunotherapies are transforming the treatment of lung cancer. But treatment with these innovative agents comes at considerable cost.

Results from a retrospective observational study conducted by researchers at the University of Colorado Cancer Center study, published in the Journal of the National Cancer Institute conforms that while the use of these drugs rose 27% from 2007 to 2015, new, high-cost lung cancer drugs are not used equally in all places, with all patients. This, in turn may widen survival disparities between patients who receive these novel agents and those who do not. [1]

Socioeconomic disparities
Patients who lived in high-poverty areas were 4% less likely to be treated with high-cost lung cancer drugs (two-sided p < 0.001). In contrast, patients treated at National Cancer Institute (NCI-) designated cancer centers were 10% more likely to be given these drugs than were patients treated in other settings (two-sided p < 0.001).

Cathy Bradley Ph.D, University of Colorado Cancer Center Deputy Director and Associate Dean for Research at the Colorado School of Public Health. Photo Courtesy: University of Colorado Cancer Center
Cathy Bradley Ph.D, University of Colorado Cancer Center Deputy Director and Associate Dean for Research at the Colorado School of Public Health. Photo Courtesy: University of Colorado Cancer Center

“Without these drugs, they may not have the same outcome as those who receive treatment. Some of these drugs have the potential to increase the lifespan of cancer patients,” noted Cathy J. Bradley, PhD, CU Cancer Center Deputy Director and Associate Dean for Research at the Colorado School of Public Health.

Bradley suggests that in addition to the socioeconomic disparity in the use of these drugs, the fact that they are used more often at NCI-designated cancer centers also implies a disparity between research-oriented treatment centers and those that are not.

“If you live in a rural area, it can be challenging to access an NCI-designated cancer center where these drugs are more commonly used. And even if you are in an urban area and didn’t go to an NCI center, you also were less likely to get these drugs,” Bradley noted.

Medicare patients
The study examined SEER-Medicare data supplemented with data from the Area Health Resource File from 2007-2015. The data included information from patients aged 66 years or older enrolled in fee-for-service Medicare Part D, who were diagnosed with a first primary diagnosis of metastatic nonsquamous non‒small cell lung cancer (mNSCLC), and received an antineoplastic agent.

The researchers looked at how race/ethnicity, urban or rural residency, poverty, and treatment facility type were associated with the use of drugs costing more than US $ 5,000.00 per month in patients diagnosed with metastatic (stage IV) non-small cell lung cancer. Medicare spending during the 12 months following diagnosis was lower for rural patients by about US $ 17,000.00 per patient.

“There is an underlying concern about whether the widespread use of these high-cost drugs is sustainable. But leaving aside the question of Medicare’s affordability and sustainability, what we’re seeing in the use of these agents is problematic. Our findings suggest that uneven access to specialized care due to poverty or living in remote areas may explain some of the observed disparities,” says paper co-author Marcelo Perraillon, Ph.D.

Forbidden to negotiate
Currently the Centers for Medicare and Medicaid are forbidden by law to negotiate prescription prices with drug manufacturers. Likewise, the Federal Food and Drug Administration (FDA) is not allowed to take drug’s price into account a when considering approval. In contrast, the FDA’s counterpart in Europe, the European Medicines Agency or EMA.

The European regulations include a provision that, once a marketing authorization has been granted, decisions about price and reimbursement take place at the level of each European member state considering the potential role and use of the medicine in the context of the national health system of that country. As a result, drug prices vary significantly between the various European Member States.

In the United States, factors forbidding the CMC to negotiate price and reimbursement and the FDA not considering price in the marketing authorization process, among many others, means that as new and more expensive anti-cancer agents are developed, the cost to society as a whole and to individuals who pay indirectly for the use of these drugs through insurance premiums increases, without taking into account increases in drug effectiveness that could establish the value added by the new drugs.

“The societal cost of these medications doesn’t mean that they are not worth it,” Perraillon says, indicating that the current paper did not study whether the high cost of these medications is justified.

“Our study does not say whether prescribing these agents is good or bad. What it means, and what we show, is that location or income should not hinder the use of these agents by some,” Perraillon concluded.

Reference
[1] Bradley CJ, Eguchi M, Perraillon MC. Factors associated with utilization of high cost agents for the treatment of metastatic non-small cell lung cancer [published online ahead of print, 2019 Nov 9]. J Natl Cancer Inst. 2019;djz223. doi:10.1093/jnci/djz223