Pennsylvania-based Independence Blue Cross鈥� announcement that it will cover a complex type of genetic testing for some cancer patients thrusts the insurer into an ongoing debate about how to handle an increasing array of these expensive tests.
Independence 鈥斅爓ith its approximately 3 million members 鈥斅燽ecame the largest insurer to cover whole genome sequencing for select cancer patients. The analysis looks at the entire sequence of each tumor鈥檚 DNA and identifies mutated genes. Physicians can request this sequencing for children with tumors, patients with rare cancers, people with a type of breast cancer called triple negative and patients who have exhausted conventional therapies for metastatic cancer.
While the hope is the results will help patients and their doctors pinpoint the best treatments based on genetic differences, there may not be any such drug regimens yet available. It鈥檚 also unclear whether the information the tests provide make any difference in a patient鈥檚 treatment and prognosis.
鈥淥nly some of the information is useful,鈥� said Donna Messner, vice president and senior research director with the聽Center for Medical Technology Policy, a nonprofit organization working with insurers, genetic test companies, patient groups and clinicians to try to develop a common approach to insurance coverage. 鈥淭hat鈥檚 a challenge for payers.鈥�
Cost is also a factor. Estimates of national spending on genetic and molecular testing vary, partly because there are so many different types of tests for different conditions. A of national trends estimated the U.S. could see overall spending on genetic tests reach between $15 billion and $25 billion by 2021, up from $5 billion in 2010.
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.
鈥淟et鈥檚 jump in the pool,鈥� said Hilferty of the decision to cover the complex test for a limited group of cancer types. 鈥淚f evidence shows it works and is helpful, then we can do more.鈥�
The testing 鈥渋dentifies genes for which there may be a target [treatment] available today 鈥斅爋r maybe a target tomorrow when new drugs come to market,鈥� said Don Liss, Independence鈥檚 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 鈥斅爋utlining a tumor鈥檚 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 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 for certain late-stage, complex cancers in an effort to help target treatments.聽Patient advocacy groups, particularly those for people with lung cancer, are pushing hard for such testing,
鈥淎 lot of insurers decide on a case-by-case basis about these tests,鈥� said Lynn Matrisian, vice president of scientific and medical affairs for the Pancreatic Cancer Action Network, a patient advocacy group. 鈥淜nowing that it鈥檚 covered, I think goes a long way in reassuring the patient that they will be able to get some of these therapies.鈥�
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鈥檚 particular genetic profile. Sometimes that could involve prescribing a drug that is 鈥渙ff label,鈥� 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.聽 found that 鈥渙ff label鈥� use didn鈥檛 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 鈥斅燼nd the data gathered and shared. That could speed the development of new drugs, vaccines or combinations of treatments, part of the current focus on 鈥減recision medicines鈥� and President Obama鈥檚 鈥渕oon shot on cancer.鈥�
鈥淭he key to all this is if we鈥檙e going to advance this whole personalized medicine thing efficiently, we have to get all the insurance companies working in some kind of similar policy 鈥� and to incentivize standardized data that can be shared,鈥� said Sean Tunis, founder of the Center for Medical Technology Policy.
The collaborative has recommended changes in coverage guidelines so that聽tests that assess five to 50 genes would no longer be considered 鈥渋nvestigational鈥� and would be covered by all U.S. health plans.
Patients who want whole genome sequencing analysis even if it鈥檚 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鈥檚 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.
鈥淲hen you pretty much have a terminal disease 鈥� you鈥檙e looking for all the options,鈥� said Murza, managing director at the Genetic Alliance, a Washington-based coalition of disease advocacy groups, academic institutions and private companies. 鈥淵ou always have a hope that something will come up. Doing sequencing was that for us 鈥� we鈥檙e hoping to find those targets we can attack with medicine.鈥�
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鈥檛 tried it yet.
Instead, they鈥檝e gone through several rounds of chemotherapy commonly used for pancreatic cancer. Now, there鈥檚 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鈥檛 changed the course of his treatment, Murza says her husband is glad they did the sequencing: 鈥淗e says it鈥檚 still good for him as a cancer patient to know there is another target, that something else can come up.鈥�