In some cases, genomic tests match patients to experimental drugs available only in clinical trials. Although these trials sometimes provide free medications, many cancer patients can’t afford to travel to participate in them. Ms. Kilmer drives 12 hours round-trip every month to participate in a clinical trial in Sioux Falls, S.D. The expenses add up quickly, she said.
Ms. Kilmer’s genomic tests identified a rearrangement in the PALB2 gene. Preliminary studies suggest that tumors with this genetic rearrangement could be susceptible to the drug olaparib (Lynparza), but those effects haven’t been definitively proven in large-scale studies. The Food and Drug Administration has approved Lynparza only for breast cancer patients with a BRCA mutation.
Legally, doctors can prescribe Lynparza “off label” to anyone with cancer. But insurance programs are reluctant to cover off-label treatments, unless they’re specifically recommended in expert guidelines.
Ms. Kilmer has spent much of the past 3 years battling insurance officials and begging drug companies for financial assistance. The drugmakers have been generous, allowing her to take a rotating cocktail of experimental drugs for free because of her modest income.
In September, however, AstraZeneca decided to end Ms. Kilmer’s financial aid. Ms. Kilmer appealed the drug company’s decision.
Paying thousands of dollars a month is not an option, Ms. Kilmer said. Her family already carries significant credit card debt from earlier cancer treatments. She estimates that she has spent about $80,600 out-of-pocket treating her illness, including $23,600 on her early breast cancer therapy and $57,000 treating metastatic disease.
Ms. Kilmer said she would rather stop taking Lynparza than financially burden her daughter and husband, a truck driver.
“It’s not worth it,” Ms. Kilmer said. “I will not put my family into that kind of debt.”
Uncertain benefits
Insurers say costs aren’t their only concern. Evidence is lacking that the precision medicine approach will work consistently, they argue.
America’s Health Insurance Plans, an industry group, said genetic sequencing remains unproven.
Cathryn Donaldson, the group’s spokeswoman, described recent scientific advances as “remarkable and noteworthy.” But she said insurers “need a more definitive answer” about whether the tests help the average patient live longer.
The South Dakota State Employee Health Plan – which runs Ms. Kilmer’s insurance plan – said it bases its coverage decisions on science and reviews “published, randomized data about the safety and efficacy of the requested drugs.”
Although genetic testing has become the standard of care for melanoma and a common type of lung cancer, no one knows if genomic sequencing will extend the lives of people with other types of cancer, said Carolyn J. Presley, MD, an assistant professor at the Ohio State University Comprehensive Cancer Center, Columbus.
Without insurance coverage, some cancer patients simply give up on treatment.
A study of more than 1,000 women with advanced breast cancer – presented at a September meeting of the American Society of Clinical Oncology – found that 54% had stopped or refused treatment because of costs. The women in the study may have been more vulnerable than most, because 30% were uninsured, about twice the national rate.
In an August study in JAMA, researchers found that relatively few of those who hoped to benefit from precision medicine actually ended up on a medication. Just 15% of those who underwent genomic sequencing ended up taking a targeted therapy, according to the study. The study didn’t ask participants why they failed to get a targeted drug, but Dr. Presley, the lead author, said it’s likely that some patients couldn’t afford them.
“We’re finding the mutations, but patients aren’t getting the drugs,” Dr. Presley said. Without insurance, she said, “you and I would not be able to afford these medications. It’s a huge barrier.”
Within hours of the publication of this story, AstraZeneca called Ms. Kilmer to notify her that it would continue to provide financial aid. Her medication arrived in the mail the next day.
“It’s a huge relief,” Ms. Kilmer said.