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How Should Oncologists Decide Which New Anti-Cancer Drugs to Use?

Posted Sep 11 2012 12:00am

I have posted previous notes pertaining to what I have been calling efficacy in regard to cancer treatment (see: Biomarkers Used to Assess Treatment EfficacyRapid Assessment of the Efficacy of Neoadjuvant Therapy for Soft Tissue Sarcomas ). This is to say, how well does does the treatment work. In these days of increased emphasis on cost efficiency, we need to better understand the extent to which some of the very expensive chemotherapy result in "real" (i.e., cost-effective) benefits to patients. A recent article addressed this topic (See: How Do Oncologists Sort Through All the New Anticancer Drugs? ). Below is an excerpt from it:

The decades of research into the various molecular mechanistic pathways that cause the constellation of diseases known as “cancer” have produced literally hundreds of new, exciting experimental medicines....This bounty of drugs, while offering great hope to anyone diagnosed with cancer, poses two issues new to oncology care. The first is efficacy. How do oncologists determine which compounds are the best treatment, now that there is more than one type of drug to treat any given cancer? The second involves pricing. These drugs are very expensive and, since many are used in combination with other cancer drugs, the costs can be prohibitive for those with limited or no health insurance.  The financial strain these new medicines can cause is frightening....[T]he Fred Hutchinson Cancer Research Center has decided to establish a new institute “to improve the efficiency and effectiveness of cancer prevention, early detection and treatment to reduce the economic and human burdens of cancer.”....The institute, called ICORE, hopes to utilize databases at the National Cancer Institute, and will also call on health providers to understand not just the treatments that patients are given but also the treatment results (see:  ICORE to Shed Light on the Costs of Cancer Treatments ). By stitching together all of these data, a “more holistic view of cost and effectiveness” can be achieved.  For drugs that cost in excess of $100,000/year, such information is invaluable.  The time has clearly come for this initiative....Sadly, drug companies tend to be more interested in satisfying the short-term profit desires of their investors than they are in truly delivering cost-effective care to patients.....As all of the new drugs for cancer begin to emerge from company pipelines, the FDA is asking harder questions for pre-approval.  For example, it is no longer significant that a drug shrinks tumors. Does it also extend the lives of patients and, if so, by what length?  Payers are also asking the same questions.  Why should payers reimburse a new drug at a high cost when other alternatives exist without a demonstration of superiority? ....Biopharmaceutical companies have been building such comparative effectiveness studies in their clinical development programs for the past decade....Any company trying to bring forward a new oncology drug without comparative effectiveness data would be making a big mistake.  It would risk both FDA approval and acceptance by health care providers.

For the record, no one is discussing NOT treating cancer patients when intervention is appropriate. Rather, and as emphasized in this excerpt, this discussion revolves around the related issued of cost effectiveness and comparative effectiveness of chemotherapeutic agents. This first idea relates to the question of effectiveness versus the cost of a drug. The second relates to how a newer drug (and presumably a more expense one) compares to an older drug (presumably a less expensive one). 

What are the parameters of effectiveness as they relate to cancer chemotherapy, referred to above, as treatment results. Obviously, the most desired outcome is for the cancer to disappear. However, cancer is a tough adversary and often the best result to be expected from a drug is for the lesion to go into remission and perhaps recur at some later time. One crude measure of effectiveness is years of survival after therapy. There also are various ways to asses the quality of a patient's life post treatment. All of this seems like a proper area for investigation by the FDA. A company that brings  a newer and more expensive drug to market must surely be called upon to demonstrate its superiority to drugs already available and for which the side-effects are well known.

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