Tuesday, March 1, 2016

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.


Anonymous said...

I would argue it is not so simple.

I'm not sure of the capacity of Merck's filling lines but, having all the different sizes you suggest put financial and equipment expenses on the line. So, it isn't as simple to 'just sub in' the particular size you want and then process.

All of the parameters from crimping the lid to the type of stopper used has to be adjusted. Then all of the changes have to be documented and presented to the FDA. This just escalates costs.

Remember what happened to S/P for not advising the FDA to changes in the filling of Albuterol.

Condor said...

Oh -- I quite agree, Anon.

I just think that it would be wise to take the lead here, and acknowlege the issue.

At perhaps $130,000 per treatment, and a market of hundreds of thousands of patients, across many solid organ/tumor cancers, in the coming years -- Merck and BMS (Opdivo) should begin making multiple-sized vial fills available, now. Is Opdivo making multiple sizes? They (BMS) aren't being pilloried, so my hunch is that BMS is -- and that would make Merck an. . . outlier. In a bad way. But if BMS is NOT doing it, then Merck may have some breathing room here.

I know it requires investment, but on these sorts of figures -- middle single digit billions of dollars, this year, and more next. . . it would be smart not to seem too greedy.

Just my $0.02.

Namaste -- and do stop back -- great observations!

Anonymous said...

Wow! This sounds in-line with what I know about biologics- I have been working downstream manufacturing of biologics for over 8 years. Also, not surprised if they feel they can pull this over on us in the US as we pay the most for our drugs than anyone else in the world.