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The release by the American Society of Clinical Oncology of what it calls its “value framework,” is part of a change in thinking among doctors, who once largely chose drugs based on their medical attributes alone. The major cardiology societies, for instance, are also now starting to factor cost into their evaluation of drugs.
“The reality is that many patients don’t get this information from their doctors and many doctors don’t have the information they need to talk with their patients about costs,” Dr. Richard Schilsky, chief medical officer of the oncology society, said in a news conference on Monday.
He said the price of new cancer drugs now averaged about $10,000 a month, and some cost $30,000 a month, which can mean prohibitive co-payments even for some patients with good insurance. “Many cancer patients are facing severe financial strain, even bankruptcy in some cases,” he said.
The value framework envisions considering two costs: the out-of-pocket costs for the patient and the overall cost of a drug to the health system.
Evaluating the latter cost would put doctors in the role of being stewards of societal resources. That is somewhat of a controversial role for doctors, since it might conflict with their duty to the patient in front of them. But the oncology society said it did not see those roles as being in conflict.
Some of the sample valuations presented by the society were far from flattering for the drugs involved.
Roche’s Avastin, when added to chemotherapy, had a net health benefit of 16 out of 130 possible points when used as an initial treatment for advanced lung cancer. Its monthly cost was $11,907.87, compared to $182.09 for the chemotherapy alone.
Eli Lilly’s Alimta for that same use had a net heath benefit of zero with a cost exceeding $9,000 a month compared to about $800 a month for the drugs it was compared to in the clinical trial.
A spokeswoman for Lilly said the trial analyzed by the oncology society understated Alimta’s effectiveness because it covered a broad population, whereas Alimta is approved for only one type of lung cancer. A spokeswoman for Roche said Avastin was the first drug to help lung cancer patients live longer than a year, and that the choice of treatments for life-threatening diseases was complex and personal.
The framework, published online Monday by The Journal of Clinical Oncology is more a proposed methodology that will now be open for public comment. It will take time to input the data on the effectiveness, side effects and costs of each drug, and convert it to a system that can be used on computers and mobile phones.
There is no requirement that doctors use the framework and it remains to be seen if they will. But the authors of the document say it is a start.
“It allows the patient and the doctor to at least talk through the issues,” said Dr. Lee N. Newcomer, senior vice president for oncology at UnitedHealthcare, the big insurance company, and a member of the task force that developed the framework. “Before, the information wasn’t there.”
UnitedHealthcare is mounting a similar effort of its own, Dr. Newcomer said. Starting this month, it is requiring oncologists to get prior approval from the insurance company for every cancer drug they administer. The company will then track what happens to patients and eventually provide information to doctors about how well each drug works.
Concern about cancer drug prices has been rising for years and doctors have been becoming increasingly vocal. At its annual meeting late last month, the oncology society included a talk sharply criticizing the prices of cancer drugs as part of its plenary session.
Randy Burkholder, vice president for policy and research at the Pharmaceutical Research and Manufacturers of America, the drug industry trade group, said that drugs represented only 20 percent of cancer treatment costs. He also said that the big clinical trials that the oncology society used to make its value calculations might not be as relevant as treatment becomes increasingly personalized based on genetic analysis of a patient’s tumor.
Some experts say that ideally, the price of a drug should reflect its value, but that does not seem to be the case with cancer drugs. A recent study by researchers from the National Cancer Institute, published in JAMA Oncology, surveyed cancer drugs approved from 2009 through 2013. It found that prices did not correlate very well with how novel a drug was or whether it prolonged life versus just shrinking tumors.
The framework computes a score — called the net health benefit — based on clinical trial data.
Drugs for advanced cancer are given a score from 0 to 130. Up to 80 of the points are based on a drug’s effectiveness in prolonging lives, delaying the worsening of cancer or shrinking tumors. Then up to 20 points can be added or subtracted based on side effects. And up to 30 bonus points can be granted if the drug relieves cancer symptoms or allows a patient to go without treatment for a period of time.
The costs of the drug are listed separately, rather than incorporated into the final score for a drug. That is a step short of what is done in some evaluations, such as those by the National Institute for Health and Care Excellence in Britain, in which drugs are rated by the cost per extra year of life they provide, adjusted by side effects and symptoms.
Researchers at Memorial Sloan Kettering Cancer Center recently announced a tool that allows people to evaluate the cost-effectiveness of cancer drugs.
These other institutions “take the next step to say ‘What do we think about this amount of benefit at this cost?’” said Dr. Steven D. Pearson, president of the Institute for Clinical and Economic Review, a nonprofit organization that evaluates the clinical and cost effectiveness of treatments.
Dr. Lowell E. Schnipper, chairman of the task force that developed the oncology society’s framework, said that patients wanted to know how medically effective a drug is. Adding the cost into an overall rating would obscure that information, he said.
Each drug is evaluated based on how it did in clinical trials compared to a control group, and the control groups can be different. That makes it difficult to compare one drug to another.
“This is not a way of ranking drugs,” said Dr. Schnipper, who is clinical director of the cancer center at Beth Israel Deaconess Medical Center in Boston. “This is simply a way of understanding the outcome of a clinical trial.”
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Posted by: Greg Lance-Watkins