Zack Struver's blog
On September 14, 2016, the United Nations Secretary-General’s High-Level Panel on Access to Medicines released its report, in which they had a mandate to “review and assess proposals and recommend solutions for remedying the policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies.”
On September 7, 2016, the National Cancer Advisory Board Blue Ribbon Panel issued a draft report with recommendations directed to the Cancer Moonshot Task Force.
The draft included 10 interesting and useful recommendations (see A - J) related to cancer research, but none to address the pricing or affordability of products.
The attached briefing note analyzes transparency legislation that has been proposed in 14 states in 2015 and 2016. The bills would require various degrees of transparency for research and development (R&D) and marketing costs, as well as for drug prices and price changes.
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.
Letter from 56 non-profits and experts to Secretary of State John Kerry on pressure on global access to medicines initiativesSubmitted by Zack Struver on 20. July 2016 - 12:39
20 July 2016
For Immediate Release
Public Health, Human Rights, and Faith Organizations Question State Department Pressure Against Global Access to Medicines Initiatives
Evidence shows pattern of interference in national and international efforts to improve access to affordable medicines, according to Doctors Without Borders (MSF USA), Knowledge Ecology International, Public Citizen, Oxfam, and other leading public interest groups.
Washington, DC — More than 50 public interest organizations and experts asked Secretary of State John Kerry today to explain evidence that the State Department recently pressured the United Nations and the governments of Colombia and India against taking action to improve access to affordable medicines, citing U.S. business interests and implying that relations with Washington would suffer.
Briefing Call on National Institutes of Health (NIH) patent policies, 29 June 2016, 11:00 A.M. (EST)Submitted by Zack Struver on 29. June 2016 - 7:40
KEI will host a conference call at 11:00 A.M. today to brief interested stakeholders and the press on issues related to NIH patent policy, including the recent decision in KEI's Xtandi petition (additional background here: http://keionline.org/xtandi), the grant of exclusive licenses on government-owned inventions (http://keionline.org/nih-licenses), and transparency of decision-making at NIH more broadly.
For call-in information, please contact Zack Struver at firstname.lastname@example.org.
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.
28 Organizations Ask President Obama to Support Colombian Compulsory License on Expensive Leukemia DrugSubmitted by Zack Struver on 27. May 2016 - 13:14
(U.S.) Andrew Goldman, KEI: email@example.com or +1 (202) 332-2670
(Colombia) Andrea Carolina Reyes Rojas, Misión Salud: firstname.lastname@example.org
(Colombia) Dr. Francisco Rossi, IFARMA: email@example.com
(More on Colombia here: http://keionline.org/colombia)
Washington, DC — Today, 28 organizations that support the advancement of public health, as well as the successful continuation of the peace process in Colombia, urged President Obama to voice U.S. support for Colombia’s right to grant a compulsory license on an expensive leukemia drug.
13 non-profits urge Senate HELP Committee to block floor amendments to 21st Century Cures Act counterpartSubmitted by Zack Struver on 18. May 2016 - 14:39
Before the U.S. Senate Committee on Health, Education, Labor and Pensions (HELP) presents a legislative package of healthcare reforms to the Senate floor for an up-or-down vote, 13 consumer, patient and health non-profit groups sent a letter to HELP Chairman and Ranking Member to ensure that the final legislative package includes only those bills that the HELP Committee reviewed in mark-up sessions.
122 experts defend Colombia's right to issue compulsory license on imatinib in face of U.S. pressureSubmitted by Zack Struver on 17. May 2016 - 12:55
(More on Colombia here: http://keionline.org/colombia)
On May 16, 2016, 122 health, trade, and intellectual property experts defended the Colombian government's right to issue a compulsory license on imatinib, an expensive leukemia drug that is being sold at a high price by the Swiss drug company Novartis, in a letter to Colombian President Juan Manuel Santos.
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.
2016: NIH FOIA office withholds all records related to exclusive license on HER2+ breast cancer treatment technologySubmitted by Zack Struver on 3. May 2016 - 13:46
Other KEI comments on NIH licenses are found here: http://keionline.org/nih-licenses
In response to a February request under the Freedom of Information Act (FOIA) for documents related to the grant of an exclusive patent license on a HER2+ breast cancer treatment technology, the National Institutes of Health (NIH) withheld in full all responsive records.
Rep. Lloyd Doggett keynote address at CAP drug pricing event highlights Xtandi, federal funding of pharmaceutical R&DSubmitted by Zack Struver on 29. April 2016 - 13:46
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.
Biolyse Pharma offers to supply enzalutamide (Xtandi) for $3 per pill to Medicare and developing countriesSubmitted by Zack Struver on 27. April 2016 - 14:03
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.