Who's Life Is It Anyways?

Tykerb is one of the newest tyrosine kinase inhibitors (TKI).  It interrupts the signaling pathway that produces a specific protein involved in the creation and support of cancer cell growth.  It is a small molecule drug that can target both HER 2 and HER 1 breast cancers.  Because it is a small molecule drug and not a large molecule it can also enter the brain where up to half of all late stage breast cancers spread.  Also, recent studies presented at the American Society of Clinical Oncology Breast Cancer Symposium on September 5, 2008. have shown that Tykerb can be used in combination with new gene profiling tests to tailor treatment to patients who would gain the most benefit and least risk:
http://community.breastcancer.org/forum/73/topic/721033

"Conclusions of the study had shown that Tykerb has antivascular activity superior to that of Nexavar. Avastin + Tykerb may be the first clinically-exploitable antivascular drug combination. High dose, intermittent 'bolus' schedules of Tykerb to coincide with Avastin administration may be clinically advantageous, even in HER2-negative tumors.

The system utilized for the study was a functional profiling assay, which may be used to individualize antivascular therapy. It can be adapted for simple, inexpensive and sensitive/specific detection of tissue and circulating microvascular cells in a variety of neoplastic and non-neoplastic conditions, for drug development, and individualized cancer treatment.

The cell-based assay can accurately sort drugs into categories of above average probability of providing clinical benefit on one hand and below average probability of providing clinical benefit on the other hand, based both on tumor response and patient survival."


And so how doth the comparative effectiveness institute known as NICE rule upon the value of Tykerb:
 

The Wall Street Journal (10/15, B2, Berton) reports, "GlaxoSmithKline PLC's breast-cancer drug Tyverb (lapatinib) shouldn't be eligible for reimbursement under the U.K.'s publicly funded healthcare system," the U.K.'s National Institute of Clinical Excellence (NICE) recommended on Tuesday. The company said that NICE, "which decides what treatments are made available free to U.K. patients, isn't recommending Tyverb's use by the National Health System. In its decision, NICE rejected the drugmaker's offer to bear part of the cost of the treatment."

        The U.K.'s Telegraph (10/14, Smith) added that "trials of the drug...have shown it can reduce the size of a tumor by 60 percent and extend life by an average of two months, compared to standard treatment." But NICE "says it does not extend life by long enough to justify the extra cost."

As long as comparative effectiveness is conducted by the payor, for the payor and of the payor, the value of personalized medicine will be in the words of the Faber College's Dean Wormer:

"Zero, point zero." 

For a look at how NiCE conducts its comparative effectiveness work, take a look at this video: 

http://www.youtube.com/watch?v=xVdUsgYA_D4