As we enter an era of healthcare reform with increased pressure to reduce costs, the issue of "who not to treat" will begin to loom as large in our minds as the therapeutic imperative. I have addressed one aspect of this question in a recent post (see: A Look at Deloitte's Healthcare Reform Pyramid: A Strategy for Reducing Costs) with the references to the comparative effectiveness of diagnosis and treatment. Physicians will be increasingly asked whether a lower cost treatment will be just as effective as a higher cost one or whether treatment is even justified, as in the terminally ill. The increasing use of lower-cost generic drugs is a reflection of this same question.
I will be lecturing on this topic at Lab InfoTech Summit 2009. My lecture title will be the following: Biomarkers as a Key Enabler for Monitoring and Modifying Drug Therapy. Companion diagnostics will be increasingly used to select candidates for treatment with expensive biotech drugs. A recent article on the web (see: The Next Step in Cancer Drugs: Who Should NOT Get Them) raised the interesting and challenging topic of which cancer patients NOT to treat or which to treat differently. Below is an excerpt from the article with boldface emphasis mine:
Lots of patients with advanced colon cancer shouldn’t get some of the most advanced drugs used to treat the disease, according to a new recommendation from the American Society of Clinical Oncology (ASCO). It may seem odd that a group of cancer docs is recommending against a popular treatment for many patients. But figuring out which patients are unlikely to benefit from cancer drugs — which are not only very expensive but can also be toxic — is a high priority in cancer research these days....The new ASCO recommendation says patients whose tumors have certain mutations in a gene called KRAS should not receive a class of drugs that includes Erbitux, co-marketed in this country by Eli Lilly...and Bristol-Myers Squibb, as well as Amgen’s Vectibix. Studies have shown pretty clearly that patients with the mutations — which occurred in about 35% of cases this large study — don’t benefit from the drugs. Not using Erbitux as a first-line drug for these patients could save about $600 million a year, the WSJ reports. Amgen said the data warrant a label change for Vectibix, and a Bristol spokesman told the WSJ that Bristol and Lilly look forward to working with the FDA.
Interestingly enough, KRAS, mentioned in this excerpt, is the only biomarker that I know of with its own web site. It's very professionally done. A few clicks reveals that the sponsor or this web site is Merck, the developer of Erbitux.
In previous notes (see: Moving Resources from the Therapeutic to the Diagnostic Silo, Genetic Testing to Cull Out the "Un-Right Patient" as a Candidate for a Particular Drug Therapy), I commented on the feasibility and desirability of moving resources from the treatment silo to the diagnostic silo and sometimes making the decision of withholding treatment from the "un-right" patients. In the article cited above, we learn that not using Erbitux as a first-line drug for certain patients could save about $600 million a year. That's a fairly good start in moving resources, considering that the KRAS testing itself would consume only a tiny fraction of the resources that will be saved by not using the drug as the first-line agent. Look for more attention to drug label changes as directives from the FDA become more common requiring the use companion diagnostics to properly select patients for the use of certain chemotherapeutic agents.
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