“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, a study shows … Although the newest cancer drugs offer a number of improvements over older therapies, they often cost thousands of dollars more a month …Treating a colorectal cancer patient with a drug called Erbitux, for example, costs more than $61,000 for a typical treatment with 24 doses, according to a study presented Tuesday at the American Society of Clinical Oncology meeting in San Francisco … Even patients with good insurance could pay thousands of dollars out-of-pocket for Erbitux or a similar drug, Vectibix …Over the past year or so, several studies have shown neither Erbitux or Vectibix works in patients with a certain genetic mutation, which occurs in 36% to 46% of tumors, says Veena Shankaran, a fellow at the Veterans Administration Center for the Management of Complex Chronic Care in Chicago, whose study focused on Erbitux … Giving Erbitux only to patients without the mutations would save the country up to $604 million a year, Shankaran says …Skipping Erbitux also would spare patients from its side effects, including a severe, acne-like rash, she says …Testing tumor tissue for the mutations "saves tons of money, and makes medical care better at the same time," says Leonard Saltz, a colorectal cancer specialist at New York's Memorial Sloan-Kettering Cancer Center … But no matter how many patients are treated, Shankaran says, the $452 cost of genetic testing will always be a bargain compared with wasting tens of thousands of dollars giving drugs to people who have no chance of being helped …That would allow patients to get the best medications right away, instead of wasting time and money on drugs that won't work, Shankaran says.”
Amen.
Personalized medicine is not about denying care. It’s about providing “the four rights” (the right medicine in the right dose to the right patient at the right time). Personalized medicine can (indeed must!) be both cost-effective and patient-centric.
Yet, on the reimbursement front, many payers aren’t ready to accept the up front expense – even though the longer-term savings can be substantial. For more on this issue see "Diagnostical Materialism.”
Diagnostics reimbursement should be based on value rather than activity.
On the regulatory front greater clarity and predictability are required. At present, FDA guidance on diagnostic approvals are vague. To reinforce the agency’s commitment to personalized medicine, the FDA should embrace ever-greater clarity and commitment to diagnostic tool review. This should be a top priority of the agency’s Critical Path program.
The Critical Path Institute (created in 2005 by the University of Arizona and the U.S. Food and Drug Administration to standardize an approach to validating medical products) is working on a solution, a “GoodHousekeeping Seal of Approval” for diagnostics. C-PATH plans to launch its United States Diagnostic Standards in the coming months.
“The United States Diagnostic Standards will offer a voluntary certification for laboratory and pathology diagnostics, much like the Underwriters Laboratories certification for many tools and equipment. Companies already submit their tests to data test sites for evaluation prior to FDA submission, says Jeffrey Cossman, chief scientific officer of C-Path. This would take the place of a data test site.”
This speaks directly to the contentious issue of partnership between the FDA, industry and academia. No one entity can do it alone. This is a core philosophy that will, no doubt be vigorously debated in Congress – and by the next FDA commissioner. We need a stated policy of pragmatic partnerships.
Nobody said it going to be easy.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
