Top oncologists and cancer centers question exorbitant drug prices

[radnyc]

The cost of drugs, specially cancer ones, really needs to be explained, it's becoming clear that they cannot just attribute the cost to R&D. My feeling here is that it's pure greed.

http://www.nytimes.com/2015/07/23/busin ... ref=health

[sjring]

I'm not going to make the argument that drugs, in general not just limited to oncology drugs, aren't overpriced. Especially in the U.S.

That said, lets consider:
[*]Of 5,000 compounds conceived only 5 make it to Phase I testing
[*]Of those 5, only 1 will become an approved drug.
[*]Completion of pre-clinical, Phase I-III testing and the New Drug Application (NDA) process with FDA takes, on average 12 years.

There are some pretty significant R&D costs, not just associated with the approved drug, but with all of the failures/false starts that go into getting an approved drug.

In terms of legislation forcing drug companies to disclose the costs to develop the drug, I'm on the fence. We don't require airlines to disclose the cost of transporting us from Point A to Point B so we can determine the suitability of the airfare, we just grumble about it. We don't require a restaurant to disclose what it costs us to prepare a meal for us, we either pay it or cook at home. And we don't ask our local supermarket to disclose the cost of getting that gallon of milk from the cow to the refrigerator case, we just determine if we are lactose intolerant or not. Seems a bit of a double standard to me, to force the drug companies to disclose the development of a specific drug. Overall R&D costs are disclosed annually by most publically held pharmas.

The larger question is should be be paying $150k/year for MethylEthylDoorknob (my name for any random compound) that only provides 6-months additional life. I know as a patient, as long as those 6-months provide a reasonable quality of life, and insurance covers it, I want it. If insurance doesn't cover it, well let's just say I can see the lawyers lining up. That's the society we live in.

I don't know that I have the answer, I just don't think this is the solution.

[rp1954]

US drug prices are an artificial product of a heavily politicized FDA system (and process) with many expensive regulations and controls of dubious efficacy and efficiency. It is the resultant lack of competition that allows such creative pricing for drugs that aren't brand new molecular entities, or are very low in volume. By brand new, I mean the first few years, not patent expiration in 20+ years. We now have situations where brand marketers buy out or pay off their competitors to not compete, and our doctors often do not know older, cheaper, better answers.

Generic drugs like folinic acid (generic leucovorin) are a demonstration of non-competitive pricing. Oral, racemic leucovorin delivers mostly levo-leucovorin (the good handed version of folinic acid) into the bloodstream, much better than IV leucovorin. Levoleucovorin was sold IV for an outrageous cost in the US during those "convenient" leucovorin shortages several years ago. Somebody probably made a killing, both ways. Leucovorin/folinic acid is like a slightly fragile version of folic acid, best kept cool, dry, perhaps initially vacuum or nitrogen packed, with a potentially shorter shelf life, still +- a year. Prescription tablets need somewhat tighter specifications than supplements. In the US, the generic leucovorin tablet might be $10 a tablet. Overseas, you might get refrigerated generic leucovorin tablets home delivered for about a dollar each, or folinic acid in larger quantities of a few ounces, perhaps for 2-6 cents per 15 - 25 mg. Generic leucovorin prices beyond 2-3x cheap folic acid tablets sold as small bottle GMP supplements, reflect an excessive cost/price structure.

Sometimes better drugs are never allowed into the US. This happened with tegafur-uracil, an oral 5FU drug that preceded xeloda by 15-20 yrs, that still has some advantages. In 2010, such generic treatment+-leucovorin might cost $150-300/mo vs $5000-$9000/mo for Xeloda (capecitabine). Tegafur-uracil treatments are usually safer and less disruptive with better QoL for longer term use.

Sometimes, the FDA has expanded its regulatory reach in ways that increase the prices of century old products to first create an absolute shortage, then followed with huge price rises for new supplies e.g. 4-10 cents to $1-2, of a regulated/reformulated product, commonly consumer judged as distinctly inferior.