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Doctors Tried To Lower $148K Cancer Drug Cost; Makers Tripled Its Price (arstechnica.com)
Slashdot reader Applehu Akbar writes: Imbruvica, a compound that treats white blood cell cancers, has until now been a bargain at $148,000 per year. Until now, doctors have been able to optimize dosage for each patient by prescribing up to four small-dose pills of it per day.
But after results from a recent small pilot trial indicated that smaller doses would for most patients work as well as the large ones, its manufacturer, Janssen and Pharmacyclics, has decided on the basis of the doctors' interest in smaller dosages to reprice all sizes of the drug to the price of the largest size. This has the effect of tripling the price for patients, and doctors have now put off any plans for further testing of lower dosages.
The researchers are retaliating by urging clinical investigators to test whether the expensive pill could be safely given every other day -- and by calling on America's public health regulators to investigate the drug's pricing.
But after results from a recent small pilot trial indicated that smaller doses would for most patients work as well as the large ones, its manufacturer, Janssen and Pharmacyclics, has decided on the basis of the doctors' interest in smaller dosages to reprice all sizes of the drug to the price of the largest size. This has the effect of tripling the price for patients, and doctors have now put off any plans for further testing of lower dosages.
The researchers are retaliating by urging clinical investigators to test whether the expensive pill could be safely given every other day -- and by calling on America's public health regulators to investigate the drug's pricing.
The company made all doses the same price. You can buy the four times stronger pills, cut them in four parts and save yourself 75%.
That doesn't work with all drugs - for example, some drugs have an enteric coating that prevents it from dissolving in the stomach, others may have a time release coating, etc.
In the Netherlands you are and this is now being used as a loophole. However, insurance companies are hesitant to pay for it, and it is only allowed for the pharmacists registered patients.
The name of this option is "magistrale bereiding" - magisterial preparation.
The manufacturer of a generic drug still has to prove that their product is as equivalent to original.
The approval process for a new drug is more complex; they have to prove it is safe and that it is effective in rigorous clinical trials. For a generic, they merely have to demonstrate equivalent pharmacological effects (e.g. absorption into the bloodstream in similar quantities and in a similar time, etc.), which is much easier, and requires fewer test subjects, less complex follow-up, etc.
However, to do this sort of trial, you still require access to the original drug, because this type of trial will require head-to-head testing. One of the ways in which Shkreli aimed to stop this was to completely shut down all distribution of the drug. Instead, his company would employ their own pharmacists who would dispense a limited quantity of the dug only on receipt of a named patient's prescription sent directly to the company. By not selling the drug to wholesalers and pharmacies the intention was to make it impractical for other companies to purchase stocks of the drug against which to run trials.
It always blows my mind when I see users who constantly post pro-Trump free market posts on slashdot calling for the death and hanging of someone or some organization who is doing just that!
Except last year the con artist said he'd lower drug prices. Then he picked a guy who is a former pharmaceutical executive who raised drug prices.
Even in February's State of the Union address he said he'd lower drug prices.
What has he done so far? Reduce regulations on oil and gas drillers, put a guy in charge of the EPA who is vowed and determined to let polluters off the hook, and started a trade war with China which is already costing Midwest farmers.
A New York Times article stated that this drug was developed with three other non-viable drugs for a total cost of $388,000,000. Dividing by the stated cost of $143,000 dollars, 2,713 patients have to be treated with this drug for 1 year to recover development costs.
This drug treats Chronic Lymphocytic Leukemia (CLL). Approximately 20,000 people are diagnosed with CLL each year, and those people have an average age of 71 years. Approximately 4,500 people die each year from CLL. Your lifetime risk of developing CLL is 1 in 175.
Cancer.org lists 5 other treatments (Obliersenn, Lumiliximab, HA22, Lenalidomide, 'standard' chemotherapy) for CLL , and mentions dozens of drugs are in testing for CLL treatment.
You now have more information to discuss alternative treatments, their costs, and why folks would choose one over the other, as well as a greater ability to evaluate the potential profitability of this drug (Imbruvica) at any price point.
Alcohol, Tobacco and Firearms should be the name of a store, not a government agency.
This 2017 article from the New York Times has some of those answers.
Summary: According to SEC filings, Imbruvica cost Pharmacyclics $388 million to develop, which included the development cost of three other drugs that were not successful. Not mentioned in the article is that Pharmacyclics actually paid $2 million in cash and $1 million in stock for the compound from its actual inventor, Celera Genomics, and their expense was mostly related to developing the compound into an salable drug. After the Phase II clinical trials, J&J paid Pharmacyclics $975 million to jointly continue development of the drug. The drug was approved for CLL in 2014, and just over a year after that, Abbvie bought Pharmacyclics for $21 billion (a 5400% return on investment for Pharmacyclics's shareholders), and the drug is now being sold under the "Janssen and Pharmacyclics" name. In 2016, J&P projected Imbruvica sales of $1 billion for that year, increasing to $5 billion by 2020.
In my opinion, the developers of the drug have already been very well paid for their efforts, certainly well enough "to promote the progress of science and useful arts". I haven't been able to find any other information that would lead me to believe that this isn't a simple money grab, and/or that Abbvie simply paid too much for the drug and is extracting the cost of their mistake from patients. If there are other concrete facts that would argue for other legitimate development costs that need to be recouped, I genuinely would be interested to see them.
Please stand clear of the doors, por favor mantenganse alejado de las puertas
We already fund up to 80% of pharmaceutical R&D through our taxes. You forget that the pharmaceutical lobby is the most powerful one in Washington. It's a rigged system and we pay the price. Privatize the profits, socialize the losses.
I live in Japan, where the government is allowed to negotiate prices and can declare certain things (such as MRIs) benefits to the common good and therefore mandate that they be made cheaply available. Finally, drug patents only last for three years. One of the reasons the TPP would be bad news for the other countries: the US wants everyone to extend the patents to 12.
"Give a man fire, and he'll be warm for a day; set a man on fire, and he'll be warm for the rest of his life
OK...I'd think by know you ACs would know better than to challenge me.
This one is to show R&D and clinical trial costs are inflated.
https://www.npr.org/sections/h...
And this one is to show that profit is being reported as costs when a pharma does R&D and clinical trials (this one might be behind a paywall for you).
https://www.nature.com/article...
Forbes did a survey of 100 pharmaceutical companies. The average estimate they gave for the cost of developing a new prescription drug and bringing it to market was $5 billion (with a "b"). It turns out that the average new drug costs $30-40 million for R&D plus clinical trials.
You are welcome on my lawn.
The npr.org link discussion is not that clear cut as you make it sound. You mention "thousand percent" (ten times), and the npr.org link mentions (650+100) versus industry claiming 2800. That is barely 4 times larger.
I just fast looked up how other companies are doing, and got: http://fortune.com/2016/06/08/fortune-500-most-profitable-companies-2016/ - where is only one pharma as far as I can tell.
So, I am not sure why people are thinking that phrama's are "that bad", and I always sense a big sense of "entitlement" from the people complaining. I have worked indirectly with people in bio-tech and there are many failures, lots of money that should not have been spent, failed research and so on.