Drug vials Insurers say costsaren't their only concern; they argue that evidence is lacking toshow the precision medicine approach will work consistently.(Photo: Shutterstock)

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When Kristen Kilmer was diagnosed with incurable breast cancer at age 38, her first thought wasof her 8-year-old daughter. Kilmer lost her own mother as ateenager and was determined to get more time with her onlychild.

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Kilmer searched for experimental treatments, opting for an unprovenapproach in which researchers select drugs based on the genes in patients' tumors. Doctorshave selected her treatments for the past three years based on theunique, ever-changing DNA of her cancer cells. Now 41, Kilmer hasresponded better than anyone dared to hope. Her cancer has goneinto hiding; her tumors are no longer visible on medical scans.

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Researchers call the strategy “precisionmedicine.”

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Related: Breakthrough cancer drug given to just 5 patients,200 more wait

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Kilmer's insurance company calls it experimental. As aconsequence, her insurer has covered only a fraction of her care,forcing Kilmer to make an agonizing choice: stop taking a drug thatcosts nearly $17,000 a month or pay out-of-pocket, burdening herfamily with tremendous debt.

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“When you are looking at your daughter, you ask yourself, 'Do Itake a medication that might allow me to see her graduate highschool?'” asked Kilmer, of Spearfish, S.D. “Or do you stop takingit to avoid causing her financial harm?”

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The high cost of cutting-edge tests and treatments isthreatening to keep precision medicine — one of the most celebratedareas in cancer research — out of reach for many patients. Patientswho pay for these new treatments on their own “could be in debt fordecades,” said Dr. Scott Ramsey, director of the HutchinsonInstitute for Cancer Outcomes Research in Seattle.

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Already cancer care is hugely expensive. A recent studyin theAmerican Journal of Medicine found that 42 percent ofpatients depleted 100 percent of their assets — an average loss of$92,000 — within two years of diagnosis.

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Precision medicine involves running expensive tests calledgenomic sequencing, which scan the DNA of tumors to find mutationsthat might be susceptible to available drugs. Although the field isrelatively new, hundreds of thousands of cancer patients have had their tumorssequenced to identify cancer-related mutations, according to testingcompanies.

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Medicare, the government insurance plan for people 65 and older,announced in March that it will pay for genomic testing forpeople with advanced cancers — a decision that could add $2.5billion to federal health care costs, according to a May analysisin Health Affairs.

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Few private insurers cover the tests, leaving some patients withsurprise medical bills.

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Carrie Wyman, who also has advanced breast cancer, discoveredthat her insurance plan doesn't cover genomic sequencing only aftershe received a $5,800 statement.

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“I just assumed it would be covered,” said Wyman, 50, a residentof La Plata, Md., who has six children and stepchildren. “I wasblindsided, to be honest with you.”

Looking for financial assistance

Yet paying for that initial test is just the beginning. AsKilmer learned, finding the money for ongoing treatment is far morechallenging, said Dr. Gary Lyman, who studies way to improve healthcare quality at Seattle's Fred Hutchinson Cancer ResearchCenter.

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Related: What does the research say about crowdfunding formedical bills?

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In some cases, genomic tests match patients to experimentaldrugs available only in clinical trials. Although these trialssometimes provide free medications, many cancer patients can'tafford to travel to participate in them. Kilmer drives 12 hoursround-trip every month to participate in a clinical trial in Sioux Falls, S.D. The expenses add upquickly, she said.

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Kilmer's genomic tests identified a rearrangement in the PALB2gene. Preliminary studies suggest that tumors with this geneticrearrangement could be susceptible to the drug Lynparza, but thoseeffects haven't been definitively proven in large-scale studies.The Food and Drug Administration has approved Lynparza only forbreast cancer patients with a mutation called BRCA.

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Legally, doctors can prescribe Lynparza “off label” to anyonewith cancer. But insurance programs are reluctant to coveroff-label treatments, unless they're specifically recommended inexpert guidelines.

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Kilmer has spent much of the past three years battling insuranceofficials and begging drug companies for financial assistance. Thedrugmakers have been generous, allowing her to take a rotatingcocktail of experimental drugs for free because of her modestincome.

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In September, however, AstraZeneca decided to end Kilmer'sfinancial aid. Kilmer appealed the drug company's decision.

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Paying thousands of dollars a month is not an option, Kilmersaid. Her family already carries significant credit card debt fromearlier cancer treatments. She estimates that she has spent about$80,600 out-of-pocket treating her illness, including $23,600 onher early breast cancer therapy and $57,000 treating metastaticdisease.

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Kilmer said she would rather stop taking Lynparza thanfinancially burden her daughter and husband, a truck driver.

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“It's not worth it,” Kilmer said. “I will not put my family intothat kind of debt.”

Uncertain benefits

Insurers say costs aren't their only concern. Evidence islacking that the precision medicine approach will workconsistently, they argue.

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America's Health Insurance Plans, an industry group, saidgenetic sequencing remains unproven.

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Cathryn Donaldson, the group's spokeswoman, described recentscientific advances as “remarkable and noteworthy.” But she saidinsurers “need a more definitive answer” about whether the testshelp the average patient live longer.

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The South Dakota State Employee Health Plan — which runsKilmer's insurance plan — said it bases its coverage decisions onscience and reviews “published, randomized data about the safetyand efficacy of the requested drugs.”

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Although genetic testing has become the standard of care formelanoma and a common type of lung cancer, no one knows if genomicsequencing will extend the lives of people with other types ofcancer, said Dr. Carolyn Presley, an assistant professor at theOhio State University Comprehensive Cancer Center.

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Without insurance coverage, some cancer patients simply give upon treatment.

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A study of more than 1,000 women with advanced breast cancer —presented at a September meeting of the American Society ofClinical Oncology — found that 54 percent had stopped or refusedtreatment due to cost. The women in the study may have been morevulnerable than most, because 30 percent were uninsured, abouttwice the national rate.

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In an August studyin JAMA, researchers found that relatively few of those whohoped to benefit from precision medicine actually ended up on amedication. Just 15 percent of those who underwent genomicsequencing ended up taking a targeted therapy, according to thestudy. The study didn't ask participants why they failed to get atargeted drug, but Presley, the lead author, said it's likely thatsome patients couldn't afford them.

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“We're finding the mutations, but patients aren't getting thedrugs,” Presley said. Without insurance, she said, “you and I wouldnot be able to afford these medications. It's a huge barrier.”

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Within hours of the publication of this story, AstraZenecacalled Kilmer to notify her that it would continue to providefinancial aid. Her medication arrived in the mail the next day.

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“It's a huge relief,” Kilmer said.

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Kaiser Health News is a nonprofit news service coveringhealth issues. It is an editorially independent program of theKaiser Family Foundation, which is not affiliated with KaiserPermanente. KHN's coverage of these topics is supported by Laura and John ArnoldFoundation and Gordon andBetty Moore Foundation.

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