[A2k] Diagnostic Testing and NICE

Peter Pitts ppitts at cmpi.org
Wed Feb 8 13:25:28 PST 2012


NICE has issued draft guidance recommending against the use of three breast cancer diagnostics to guide decisions about chemotherapy use in women with estrogen receptor-positive, lymph node-negative, HER2-negative breast cancer.

According to NICE, the tests aren’t cost effective because evidence for their clinical efficacy is "limited." 

But isn’t that the whole idea of personalized medicine?  And “limited” for whom? 

Molecular diagnostics are what make medicines personal. Diagnostics are how drugs can be made safer through safe use. They make the “four rights” (right medicine for the right patient in the right dose at the right time) possible. And the four rights lead to lower costs through better outcomes.

Studies show that testing for HER2 breast cancer delivers savings that are 65 times its cost. That reimbursement should be based on value rather than activity is an essential paradigm shift.

This message is finally reaching a mass audience. Consider the recent USA Today story, “Genetic testing boosts efficacy in cancer care,” which reports that “tailoring cancer therapies to fit a person’s genetic makeup could spare thousands of patients from harmful side effects and save millions of dollars a year.”

Even NICE said the test's incremental cost-effectiveness ratio (ICER) -- aka cost effectiveness ratio -- per quality-adjusted life year (QALY) was "dominant" compared to current practice -- but the lack of data on analytical reliability and clinical utility made a recommendation for widespread use unwarranted “at this time.” 

In other words, no reimbursement until more data is available. Whether or not that’s a convenient excuse or a scientifically based belief –it’s the wrong decision to dissuade the use of a validated diagnostic tool that saves lives though (1) more personalized care and (2) saves money by not spending it where it isn’t going to work.

NICE noted that most studies were retrospective, which it said is associated with increased bias compared to prospective trials. Maybe so.  But tell that to the 20 percent of women whose lives are at risk.

Research shows, not surprisingly, that many breast cancer patients who might benefit from Herceptin are not receiving it, while some women on the drug had never been properly tested. 

"Our review of the literature suggests that there are important knowledge gaps regarding the real world use of HER2 testing and trastuzumab," said Elena Elkin, a researcher at Memorial Sloan-Kettering Cancer Center in New York. "Filling these gaps may help optimize limited healthcare resources and improve care for women with breast cancer."

But how will data be collected if these tests aren’t being used in regular clinical practice? (And they won’t be without reimbursement.) Are these approved and validated tests to be relegated to the narrow confines of lengthy clinical trials? What message does this send to the developers of advanced diagnostics – and for those who invest it such enterprises? What message does it send to pharmaceutical companies about the future of high-risk adaptive clinical trials? What message does it send about the future of targeted therapeutics?

To borrow an over-used adjective from the world of global climate change – what does this say about our ability to protect "sustainable" innovation?

Most disturbingly, what message does NICE’s decision send about medical ethics in the age of personalized medicine? Is this but the latest malignant manifestation of choosing short-term savings over long-term results, of cost-based choices over patient-centric care? Skimping on a diagnostic test today but paying for an avoidable hospital stay later is a fool’s errand, pernicious to both the public purse and the public health. The implications for the healthcare debate in the United States are uncomfortably obvious.

And considering the white-hot debate over the Komen Foundation/Planned Parenthood imbroglio – where’s the anger and indignation?

More research?  By all means.  Better-designed research? Absolutely. But by denying reimbursement for HER-2 tests until this research is designed, fielded, studied, reported and debated many lives will be lost and many millions of dollars wasted. 


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