On August 5, 2016, KEI received a response from the Department of the Army to KEI and UACT’s January 14, 2016 request that the Army and the National Institutes of Health (NIH) exercise the governments’ rights in the patents for… Continue Reading
Bloomberg reported on August 2, 2016, that CVS Health announced that it plans to exclude 35 drugs from its formulary beginning in 2017, including Xtandi, bringing the total number of excluded drugs to 131.
The Associated Press recently released a chart from the Centers for Medicare and Medicaid Services’ Office of the Actuary that outlines spending for the top 20 costliest drugs to Medicare in 2015 after reaching Medicare’s catastrophic spending threshold: http://www.nytimes.com/aponline/2016/07/25/us/ap-us-medicare-pricey-drugs-glance.html.
UPDATE: The AP also released another story, on July 24, 2016, outlining the overall program costs of catastrophic spending and explaining various spending increases: http://www.nytimes.com/aponline/2016/07/24/us/politics/ap-us-medicare-pricey-drugs.html.
Dr. S. Ward Casscells took the stage at the 2011 Innovative Minds in Prostate Cancer Today (IMPaCT) Meeting as a prostate cancer patient, a doctor, an Army Reserve colonel, and the former top doctor for the Pentagon. There, he praised the central role of the Department of Defense in bringing important prostate cancer medicines to market, including Xtandi (referred to by its experimental name, MDV3100), an expensive prostate cancer drug that was funded from basic research through phase I and II clinical trials by taxpayer and charitable funds. Continue Reading
National Institutes of Health Declines to Exercise Authority to Lower Xtandi Price
The National Institutes of Health will not use its rights under the Bayh-Dole Act to end the monopoly on the expensive prostate cancer drug Xtandi and allow low-priced generic versions to compete on the market.
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Alfred Engelberg and Aaron Kesselheim have published an opinion article in Nature titled:
“Use the Bayh-Dole Act to lower drug prices for government healthcare programs,” Nature Medicine 22, 576 (2016) doi:10.1038/nm0616-576, Published online 07 June 2016.
http://www.nature.com/nm/journal/v22/n6/abs/nm0616-576.html
Astellas has claimed that patients taking Xtandi face very small co-payments. One patient living in Arizona contacted KEI with proof that Astellas’ claims just aren’t true. The patient, who is on Medicare, provided a copy of a summary of his expenses for the first quarter of of 2016.
His monthly patient co-payment is $441.97 a month.
On April 26, 2016, Congressman Lloyd Doggett (D-Texas) delivered the keynote address at a panel discussion on drug pricing at the Center for American Progress, where he addressed the Federal government’s role in subsidizing drug development, ensuring affordable access at reasonable prices for U.S. citizens, industry practices related to monopoly pricing, and legislative solutions to promote rational and affordable drug prices.
On April 22, 2016, the President of Biolyse Pharma — a Canadian pharmaceutical company that specializes in the manufacture of oncology drugs — offered to supply the prostate cancer drug enzalutamide (Xtandi) to the Centers for Medicare & Medicaid Services (CMS) for $3 per pill ($12 per day; $4,383 per year). The Biolyse price for enzalutamide is 4-percent of the 2014 Medicare price, $69.41 ($277.64 per day; $101,408.01 per year), and lower than any other price in the world.
KEI submitted the attached letter to Secretary Burwell and Director Collins in support of the KEI/UACT petition that asked the NIH (or the Army) to use the federal government rights in the patents on the prostate cancer drug Xtandi, to remedy the excessive and discriminatory price in the United States. The letter calls attention to findings of an article from the the Journal of Oncology Pharmacy Practice, in which the authors conclude that a reduction in price would make Xtandi the most-cost effective option.
The text of the letter follows:
