Provenge : A (small) Tree Falling in the Woods?

Provenge a new agent that mobilizes the immune system in prostate cancer has shown small effect in improving the survival of patients, 4 months median benefit. But it’s ridiculous cost ($31,000/shot) may stimulate changes in our drug review and approval non-system.

In April 2010, the Food and Drug Administration (FDA) approved sipuleucel-T (Provenge), a novel cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic, metastatic, castration-resistant (hormone-refractory) prostate cancer.1,2 The pivotal clinical trial demonstrated the benefits of sipuleucel-T: an increase in median survival of 4.1 months as compared with placebo and fewer side effects than occur with docetaxel.2 Priced at $31,000 per treatment, with a usual course of three treatments, sipuleucel-T is one of the most expensive cancer therapies ever to hit the marketplace.

Because of the high cost and limited benefit Centers for Medicare and Medicaid Services (CMS) are doing their own review of the drug. In part this is essential as FDA is not at all allowed to consider cost in its approval process. As noted FDA and CMS somewhat different missions:

The FDA approves for marketing and otherwise regulates prescription drugs and medical products. The CMS administers Medicare, a health insurance program for people 65 years of age or older and people with certain disabilities. The agencies’ distinctions are underscored by the legal criteria they use in making decisions regarding new medical products. The FDA evaluates the “safety and effectiveness” of drugs and devices, whereas the CMS covers medical products that are “reasonable and necessary” for the diagnosis or treatment of illness.

Read the article for a more complete review of the agencies differences. Suffice it to say CMS gets to look into the reasonableness of use of the drug as well as the cost impact.

Medicynical Note: We now have drugs costing twice the median and average income in the US that are not curative and offer only limited survival benefit.

Are such unaffordable drugs analogous to the sound made by trees falling in the woods?

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