This week the American Society of Clinical Oncology released a tool that it claims will help oncologists measure the value of drugs and discuss their costs with patients. The Task Force that developed this so-called value framework proclaims that the perspective of the patient is of central importance in defining value. It notes that “patient perception of value is highly individualized, can be subjective, may change over time and include convenience and quality of life as well as cost. “
Yet value framework – which will be used to develop an app -- does not take into account any measure of the value of individual responses to treatments. It admits that it doesn’t measure the costs saved by taking newer medicines or the productivity gains generated by treatments that require quitting a job and spending months in the hospital.
The app only measures value by more or less estimating how much would be spent on cancer drugs for the additional survival the medicine has shown in clinical trials. (“Bonus” points are added if studies show the drug to generate fewer side effects than a placebo). In addition, the app uses the out of pocket cost to the patient as the benchmark.
There are several defects with this approach that will likely reduce the number of lives saved from cancer.
First, the app uses average response obtained in clinical trials to measure value. For example, most news accounts have made a big deal about how treating people with advanced non small cell lung cancer (NSCLS) with Avastin with two older drugs costs $10000 to add 2 months of survival compared to using the older drugs alone for $800.
But average response is virtually meaningless in treating cancer. Yet the comparison does not take into account lung cancer patients with specific genetic mutations who are likely to live much beyond that average. It can't measure the relative value of "regimens..not directly compared in clinical trials. "That’s just about 90 percent of cancer treatment combinations approved for use. Combining Tarceva with Avastin in lung cancer patients with specific mutations adds 4 months to people who would otherwise die.
Multiply the number of treatments by the number of genetic mutations shaping each and every tumor and then combine these targeted medicines with therapies that teach the immune system to shut down tumor growth. Waiting for randomized clinical trials that compare each and every of these combinations would deny thousands of people potentially life saving and life enhancing care.
Further, the Task Force claims there is no clinical benefit to increasing overall survival by less than 20 percent. That would eliminate the use of a whole host of treatments for pancreatic, brain, lung, stomach and cancers in use or being studied today. By way of comparison, the increase in average life expectancy for people with AIDS was less than 20 percent a year between 1987 and 2000. The ASCO app would have completely rejected these increases, which in turn would have denied life to thousands of people alive today.
Indeed, the Task Force asserts – without evidence – that the use of new drugs is being driven by “sometimes unrealistic patient and family expectations that lead clinicians to offer or recommend some of these services, despite the lack of supporting evidence of utility or benefit.” For all it’s lofty rhetoric about the primacy of patient value, the Task Force sneers that cancer patients “overestimate the benefits of treatments that sometimes extend life by only weeks or months or not at all. “ In fact the evidence suggests just the opposite.
As a result, the app does not calculate the value of hope as measured by the significant progress made in reducing the death and cost associated with cancer. Since 2000, new cancer drugs have been responsible for nearly 90 percent of the decline in cancer death rates. The number of cancer survivors has increased from about 9.8 million to nearly 14 million today. Over that time we have added 26 million additional life-years worth over $2 trillion in better, healthier life.
As the number (and price) of targeted treatments have increased the percent of health care dollars devoted to cancer spending has remained at 4.6 percent. How? New cancer drugs reduce spending on more expensive medical services. In 2001, 64 percent of cancer care went to hospitals and only 3.6 percent to drugs. By 2012 drug spending ‘skyrocketed’ to 11.3 percent of cancer costs but hospitalizations dropped to 38 percent of care. That’s why a government study concluded, “The net value of (cancer) treatment has grown substantially, consistent with medical technology improving over time and leading to better health outcomes at a lower cost per patient.”
All these benefits have been generated by new medicines that are only .7 percent of health spending. The Task Force acknowledges that new medicines are a small fraction of total costs but then asserts that use of new medicines is driving up premiums, reducing wages, etc., when the evidence clearly concludes the opposite is the case.
If the app completely disregards the evidence of patient preferences, cumulative life years saved from small gains in survival, the reduction in treatment costs and increase in the economic value of health, what it’s good for?
It turns out that the app will be very helpful to health insurers who want to
“evaluate the relative value of new treatments” as they develop “benefit structures, adjustment of insurance premiums, and implementation of clinical pathways and administrative controls.”
The task force acknowledges that one important effect of these benefit structures is “patients will find themselves increasingly responsible for a greater proportion of the cost of their health care. Cost shifting or sharing can occur through the increased use of high-deductible policies and larger copayments. “ Which appears to be acceptable to ASCO since it does not take into account evidence of how such practices, by reducing the cost of drugs, drives up the number of deaths and the cost of care.
Health plans are forcing cancer patients to pay thousands of dollars out of pocket for new medicine. And they are requiring them to ‘fail first’ on less costly treatments that insurers want to claim are as, on average, effective as new therapies. Conveniently insurers are already using the ASCO calculation to restrict access.
Meanwhile, the Department of Health & Human Services has warned “placing most or all drugs that treat a specific condition on the highest cost tiers discourages enrollment by individuals based on age or based on health conditions, in effect (is) making those plan designs discriminatory.”
If the app is used by health plans as ASCO hopes – to support the development of pathways and administrative controls – it will be powerful tool for trampling on the civil rights of cancer patients.
ASCO has asserted that oncologists should be aware of the value of an intervention in terms of societal cost when making treatment decisions. It assures patients that this does not conflict with the Hippocratic oath. It doesn’t just conflict; it out right violates that solemn pledge.
