Xtandi / Enzalutamide Price Fixing Probe..

Here is an article that details how Xtandi was developed with public funding, patented, but then the patent sold to a private drug company who has been accused of price gouging...

keionline.org/sites/default/files/Xtandi-Press-Release.pdf

NIH rejected the petition:

/www.statnews.com/pharmalot/2016/06/20/nih-rejects-patent-petition/

Some relatively minor corrections:
A patent usually gets licensed, not sold
Without patents no clinical trials would ever take place because pharma wouldn't spend the major dollars to conduct phase III trials.

And yes, there have been similar unsuccessful attempts to enforce march-in clauses defined in the Bayh-Dole act.

It's my opinion that our anger should be directed at the company (Astellas) that manufactures enzalutamide, not the tech transfer process.

The Pharma drug development and business model is indeed complex. However, many attempts to more strongly regulate it have been counterproductive, including price controls. Just look at the problems with most flu vaccinations. The American companies have been run out of the business and we are at the mercy of foreign companies that aren't always in line with our country's needs.

Where has it been proven consistently that the non-profit drug development system works better than the profit based? Once in a blue moon a developer says they will forgo their compensation, but other than Salk and the Polio vaccine, where has that really worked? Where will the investment money come from if not the profit motivated private investment? Do you really want the governments running this and changing direction each election cycle?

I am not defending all elements of the status quo, but it has provided we PCa patients with an explosion of treatments in the last several years that are helping thousands of men extend worthwhile living. The same is in so many other treatment areas as well. And remember, any of us that have a mutual fund, or IRA or 401(k) or depend on a pension is literally a "Wall Street Investor". We depend on the growth of the private sector companies to provide investment returns that historically are reliable and well ahead of inflation. Over long periods of time the stock follows the profitability of the company. The large Pharma companies and the ancillary businesses and organizations in their sphere would result in a huge economic and treatment void if the profit motive were removed.

With Medicare, Medicaid, the Affordable Care Act, the VA and compassionate provisions by all of the Pharma companies who is being driven into bankruptcy due to the cancer drugs? There is no such epidemic, though it is a popular topic used to support more regulation and controls.

I have seen reports that UCLA received more than $1.14 billion for the Xtandi patent. Were they "profitable" ? Doesn't the company that invested that much money have the right to then become profitable on their investment? Why didn't UCLA simply give away the patent to a manufacturer that would promise not to be profitable? If UCLA was profitable won't this enable them to continue to do much more of this great research and development? I have seen reports that these deals bring UCLA millions of dollars each year, as they do for so many research organizations. If not for the private money how would the government provide funds for this research???? Right, through increased taxes. How would that be better?

And as to reasons that drugs cost much more in the US than many other countries there are many other reasons like the inherently higher legal liability costs in the US. The company that bought the patent is Japanese and will sell the drug in many different jurisdictions all with their own unique pricing models. The US is more expensive for a lot of reasons that have little to do with the development costs. If the answers were so obvious and easy, it wouldn't be the problem it is.

I have been trying to find out what patients actually pay out of pocket for Xtandi. Of course it will depend on their insurance, Medicare, VA, Medicaid, uninsured, etc. A report from KEI, the organization that brought the actions, references one man in Arizona that paid $441.00 per month for the drug. It is difficult for me to figure out what Medicare D and a supplement would actually cost for a year, but I am going to call my company (Silverscript) and find out. Astellas, the drug company, has a formula for compassionate coverage that assures an uninsured person who earns less than $100,000 per year free medication.

So as we have come to learn, essentially no one pays retail for drugs and services. Uninsured and low income people have many methods of assistance. While the Xtandi list price of some $129,000 per year is significant, what people actually pay for the drug does not appear to me to be out of reach of the average person.

Astello expects to bill about $1 billion per year in the US for Xtandi and reports that in 2015 20,000 men took the drug. Probably few of these were on for the entire 12 months, but on average Astella was paid about $50,000 per man they reported taking the drug. Again, this is not what the patient paid. As far as I can tell, out of pocket costs would be in the area of several thousand dollars at most.

It would be interesting to hear from men on the forum about what their actual cost experience taking Xtandi, or any of the other very expensive treatments like Provenge, Xgeva, Taxotere etc. I just don't recall many people saying they absolutely can not afford the treatments and received no assistance with costs.

Again, not a defense for Pharma and what is charged, but breaking it down to the personal level as to what the actual cost to the patient is and to what extent are people actually doing without drugs and treatments due to their portion of the cost.

To Compiler's desire for catastrophic coverage, with which I agree, remember The Affordable Care Act outlaws such plans. And Medicare is not at all catastrophic when you can combine it with a Plan F supplement and essentially have no deductibles or co-pays. So we are very far away from catastrophic coverage. Also with most all universal health care plans around the world, none are based on low premiums, high deductible catastrophic coverage. Universal care essentially means all treatment goes through the payor, not the individual. Unfortunately with all the mandated coverage in the law, there is no hope for catastrophic coverage.

Think what your car insurance would cost if you had to have the insurer pay for the oil changes, car washes and gasoline. Or your homeowners coverage cleaning your gutters and raking your leaves. Think what those services would actually cost once you had third parties paying for the administration of payments, confirming that the services were performed, approving a list of businesses you could use and requiring you to get prior approval before replacing the screen door. That is basically what has happened in the delivery and payment of health care and why we have so many of the cost and access issues we all gripe about.

There are 2 companies that profit from Xtandi sales. The other partner is Medivation; today Pfizer bought Medivation for 14 billion dollars.


www.fiercepharma.com/pharma/pfizer-ready-to-shell-out-14b-for-most-wanted-m-a-target-medivation-ft

Post Edited (RobertC) : 8/22/2016 11:25:25 AM (GMT-6)

I also think Medivation bought Provenge from the original drug manufacturer.
Michael

I am charged $9444 per month for Xtandi. Now that I have exhausted my ~ $10k deductible and OOP, the self-funded company insurance arrangement pays for it, as long as I get it through the management company's pharmacy. But I am not under any delusion that the cost is shared in a pool any larger than our employees.

So those of us on high cost meds get those on a shared cost basis, but the sharing is with the folks in the next cubicle.

We are told each year exactly how much money is taken from the potential raise pool to fund the plan, and that has a lot to do with why we get 1 or 2% raises (before taxes).

I would feel a little more guilt, but there are folks within 10 cubicles who make my costs look like coffee change.

Here is another headline story about the Pfizer / Medivation $14 billion dollar deal...

www.latimes.com/business/la-fi-pfizer-medivation-acquisition-20160822-snap-story.html

Patents indeed serve a worthwhile purpose to protect inventions of every description. But when it comes to granting a monopoly to the patent holder of a lifesaving cancer drug, where you have your customers in a pay or die situation and you use that power to extract every last penny possible, where Big Pharma jumps in and places multi-billion dollar bets they hope to recover by charging as much as they possibly can with little regard to the financial impact this might have on those dependent on these drugs for their very lives....

The Wall Street Cowboys have no limits on how much money they can extract from hapless cancer victims and their insurance companies.. There is another thread running on this board highlighting the announcement made by a major health insurance company that they were no longer going to cover treatment with Xtandi because of "price hyperinflation".....