US Medical Waste Is Endemic — But Today’s NY Times Highlights Keytruda® Waste: Projected $400 Million A Year?

I guess it comes with being a very high priced, and high profile biologic.

The standard dosing size(s) of very expensive drugs and biologics has long been a sore spot in US medical service delivery efforts. What is occasionally lost is that if too small a vial is manufactured and sold, then two doses, at double the price — are burned in one treatment, with one patient, but a portion of the second vial is then wasted. [And the Gray Lady has rightly made it front page news, again, this morning.]

Doubly so, where (as has been true for over two decades, in oncology) the optimal dose is highly-dependent on the height and weight of the patient. So, it is a delicate balance for the drugmaker — to provide a vial that is both economically efficient to manufacture — and is likely to cover the bulk of the patient population without undue waste (i.e., in a single vial). In general, larger vials drive larger waste — as only a very few cancer patients weight over 280 pounds and stand over 6’6″ tall. But there will always be some waste, no matter the vial size.

Even so, I am not sure that Merck is really as “cynical” (related to the 100 ml vial, depicted at right) as the two doctors quoted in the article would suggest — I would be slow to attribute dark motives here. That said, I think it is a real issue, and I am pretty sure re-using partially drawn vials is not something American patients and doctors want to address. Here is a link to the article, and a quote, of a bit:

. . . .Dr. Saltz first noticed the problem of waste when he was considering adding Keytruda, a new drug for metastatic lung cancer and melanoma, to the hospital’s list of drugs to be used on patients. Although a 150-pound patient would need 136 milligrams of the drug, Dr. Saltz noticed that Merck, its manufacturer, sold the medicine only in 50-milligram vials — ensuring waste.

“I thought that was really cynical,” Dr. Saltz said in an interview. “And then it got worse.”

In February 2015, Merck introduced 100-milligram vials and stopped selling Keytruda in 50-milligram vials, ensuring far larger amounts of waste. The company still sells 50-milligram vials of the drug in Europe. . . .

Under its present dosing, Merck would earn $2.4 billion over the next five years from discarded quantities of Keytruda, half of which would result from switching to 100-milligram vials, the researchers estimated.

Some cancer drugs have little waste.

Treanda, which is used to treat leukemia and non-Hodgkin’s lymphoma and is manufactured by Teva Pharmaceuticals, is packaged in four separate dosages so only 1 percent of the drug is wasted, on average. . . .

I think Kenilworth should view this through the same lens as the wide-spread concern about pricing generally, and proactively offer four vial sizes — from 25 ml to 45 ml to 85 ml, and 100 ml. Showing leadership will engender goodwill. It is time to accept that making four vial size runs will cut into profits at Merck, but the entire industry faces a real possibility of stringent new regulations, imposed by government actors, in 2017 and beyond — if it doesn’t start to show bold statesmanship now, and voluntarily.

Onward (as ever) on a lazily, occasionally-flurry-festooned Tuesday morn, here. Smile.

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