Despite the uncertainties, Independence CEO Daniel J. Hilferty said the insurer felt it was important to try to help some members learn more about their disease. He declined to say how much the program would cost but said the expected number of patients would be small, perhaps in the hundreds.
“Let’s jump in the pool,” said Hilferty of the decision to cover the complex test for a limited group of cancer types. “If evidence shows it works and is helpful, then we can do more.”
The testing “identifies genes for which there may be a target [treatment] available today — or maybe a target tomorrow when new drugs come to market,” said Don Liss, Independence’s medical director.
What Can Be Found In The Sequence?
Overall, genetic testing is available for more than 2,500 conditions and can be used to identify an inherited risk of a disease, the presence of a disease or whether a particular drug treatment might be effective against the specific disease.
Some types of genetic tests are already commonly covered by insurers. Patients diagnosed with breast cancer, for example, get a test that determines whether their tumors express a type of protein against which a widely available anti-cancer drug is effective.
The testing that Independence will cover goes further — outlining a tumor’s entire genetic makeup and searching for anomalies in more than 20,000 genes. Medicare and most private insurers do not cover whole genome testing for cancer tumors.
UnitedHealth Group in December said it would cover whole genome profiling for stage IV non-small cell lung cancer, but not the other cancers that Independence will cover.
Priority Health, a small insurer in Michigan last year began covering whole genome sequencing of tumors for certain late-stage, complex cancers in an effort to help target treatments. Patient advocacy groups, particularly those for people with lung cancer, are pushing hard for such testing, part of a campaign with the slogan, “Don’t guess. Test.”
“A lot of insurers decide on a case-by-case basis about these tests,” said Lynn Matrisian, vice president of scientific and medical affairs for the Pancreatic Cancer Action Network, a patient advocacy group. “Knowing that it’s covered, I think goes a long way in reassuring the patient that they will be able to get some of these therapies.”
The hope is that the analysis will help determine the subset of the type of cancer a patient has or detect characteristics of another type of cancer. Then oncologists could look for drugs that target the patient’s particular genetic profile. Sometimes that could involve prescribing a drug that is “off label,” a common practice in which a doctor prescribes a drug for a condition for which it was not initially approved by federal officials. A breast cancer drug, for example, might prove useful in another type of cancer.
While researchers believe the efforts are promising, evidence is scant. A study done in France found that “off label” use didn’t prove more effective than standard chemotherapy.
Still, as scientists increasingly study the genetic variations in cancer, researchers say more patients should have their tumors analyzed with whole genome sequencing — and the data gathered and shared. That could speed the development of new drugs, vaccines or combinations of treatments, part of the current focus on “precision medicines” and President Obama’s “moon shot on cancer.”
“The key to all this is if we’re going to advance this whole personalized medicine thing efficiently, we have to get all the insurance companies working in some kind of similar policy … and to incentivize standardized data that can be shared,” said Sean Tunis, founder of the Center for Medical Technology Policy.
The collaborative has recommended changes in coverage guidelines so that tests that assess five to 50 genes would no longer be considered “investigational” and would be covered by all U.S. health plans.
Patients who want whole genome sequencing analysis even if it’s not covered by their insurer can sometimes get it done at an academic medical center as part of a research trial, or pay for it themselves. Prices can run anywhere from $1,000 to $5,000 or more, advocacy groups say.
When Tetyana Murza’s husband was diagnosed with pancreatic cancer three years ago, their insurer would not cover a whole genome analysis of the tumor. So they spent $2,000 to pay for it.
“When you pretty much have a terminal disease … you’re looking for all the options,” said Murza, managing director at the Genetic Alliance, a Washington-based coalition of disease advocacy groups, academic institutions and private companies. “You always have a hope that something will come up. Doing sequencing was that for us … we’re hoping to find those targets we can attack with medicine.”
They learned that her husband, Michael Mariotte, has a gene mutation that is not standard for pancreatic cancer but is more commonly seen in breast and some other types of cancer. She said there is a drug approved for another type of cancer that might work on that mutation. They haven’t tried it yet.
Instead, they’ve gone through several rounds of chemotherapy commonly used for pancreatic cancer. Now, there’s another new drug on the market for pancreatic cancer, and one their insurer says they must try first before moving on to the other.
Even though it hasn’t changed the course of his treatment, Murza says her husband is glad they did the sequencing: “He says it’s still good for him as a cancer patient to know there is another target, that something else can come up.”