Pennsylvania this month became the second state – after California – to pass legislation providing reimbursement for patient expenses associated with participation in cancer clinical trials.
Pennsylvania Governor Tom Wolf is expected to sign the bill (HB126), which was presented to him last week.
Dana Dornsife, founder of the Lazarex Cancer Foundation, which has been spearheading efforts at the state and federal level, said the bill clarifies that reimbursement is not coercion – in line with FDA Guidance Language changes in January 2018 that removed coercion or inducement as a concern.
The guidance reads, “Paying research subjects in exchange for their participation is a common and, in general, acceptable practice.”
The bill language recognizes that reimbursing patients for out-of-pocket travel expenses is a “pathway for patients to participate in cancer clinical trials,” Dornsife told us.
Dornsife said, “This lays a path forward for change.”
It pulls back the curtain and acknowledges this massive problem so we can take the necessary to steps address it. Every approved therapy that exists has completed a clinical trial. Without fully enrolled, successfully completed clinical trials, approval of new therapies is not possible.”
Most clinical trials don't cover the cost of travel to the clinical trial site – though companies have been working to address this issue through partnerships with ride-hailing companies such as Lyft and Uber.
Improving Patient Access to Cancer Clinical Trials
The Lazarex Cancer Foundation is a US-based non-profit that assists patients with finding clinical trials and reimbursement for the out-of-pocket travel costs.
Over the past five years as part of its IMPACT Program (IMproving Patient Access to Cancer Clinical Trials) the foundation has been working to engage with pharma to fix “the disconnect between cancer patients for whom standard treatment has failed and want to enroll in cancer clinical trials, and clinical trials that need more patients to succeed,” Dornsife explained.
The program’s goal is to improve patient enrollment, minority participation, and retention by removing barriers for all patients.
“Currently, most cancer patients pay enormous out-of-pocket expenses associated with clinical trial participation, leaving many underserved communities without access,” Dornsife said.
According to a national survey, patients with lower income are less likely to participate in a clinical trial, even accounting for comorbidity and education.
The vast majority of drug companies Lazarex has engaged with agree that patient enrollment, especially minority patient enrollment, has historically plagued the industry, Dornsife said.
To fix this problem and build awareness, the foundation has been working with pharma and lawmakers at both the federal and state level. In January 2017, Lazarex worked to pass of AB1823 in the State of California. Massachusetts, Texas, and Florida are next, Dornsife said.
Since passing AB1823 and re-engaging with multiple drug companies, Amgen has stepped forward as the founding sponsor of IMPACT, with a $2m grant to launch IMPACT at UCSF and USC Norris Comprehensive Cancer Centers.
The FDA Guidance Language and state legislation efforts have allowed Lazarex to re-frame its discussions with drug companies, Dornsife explained, and its efforts have been more favorably received because pharma can now particulate in IMPACT.
The foundation hopes to secure full funding of IMPACT from several drug companies by the end of 2019.
On the federal level, Lazarex and member of Congress led efforts to include language in The House Appropriations Committee Fiscal Year 2019 Labor, Health and Human Services, Education Funding Bill, which President Trump signed earlier this year.
The bill (page 52) includes a directive to the National Cancer Institute (NCI) to implement "a new pilot initiative to investigate the impact of providing navigation and direct patient expense reimbursement associated with participation in cancer clinical trials on cancer clinical trial enrollment, retention, patient outcomes, and research outcomes, including among underrepresented and minority communities."
Dornsife said, “The volume is being turned up in discussions among drug companies regarding minority participation in trials in order to improve the statistically valid assessment of the safety, efficacy and value of new cancer therapies for all segments of our population.
“Now drug companies need to step up and invest in getting the job done.”