[Ip-health] Business Insider: Congress just fired a shot against its next drug-pricing target, and its shares took a hit

Thiru Balasubramaniam thiru at keionline.org
Tue Mar 29 05:16:37 PDT 2016


Congress just fired a shot against its next drug-pricing target, and its
shares took a hit

Lydia Ramsey

Congress is going after another drug maker's pricing tactics.

In a letter to the National Institutes of Health (NIH) and the US
Department of Health and Human Services (HHS), 12 members of Congress asked
the government agencies to bring down the price of Xtandi, a drug used to
treat prostate cancer.

The drug costs $129,000 for a course of treatment in the US, but just
one-third of that in countries like Japan and Sweden, the legislators

Xtandi was developed by California-based biopharmaceutical company
Medivation and Japan's Astellas Pharma. Medivation was down about 5% in
after-hours trading on Monday after the letter was made public.

The legislators, including Sen. Bernie Sanders (I-Vermont) and Rep. Elijah
Cummings (D-Maryland), asked the NIH and HHS to hold a public hearing that
would determine whether they should use "march-in rights" that would allow
them to lower the price of the drug, even though it's under patent

Cummings and Sanders have gone after other pharmaceutical companies in the
past, in particular Turing Pharmaceuticals and Valeant Pharmaceuticals,
which are known for buying up old drugs and jacking up their prices. Xtandi
is different from other such targets because it's still on patent and
hasn't drastically risen in price since its approval.

These march-in rights to set new prices have not been used since their
inception in 1980 in the context of high pharmaceutical prices, the letter

Xtandi, otherwise called enzalutamide, is used to treat late-stage prostate
cancer. It was originally approved by the US Food and Drug Administration
in 2012 for its ability to increase how long patients survived.

In response to the letter and its reference of the list price of the drug,
an Astellas spokesman said:

“Xtandi is a standard of care for advanced prostate cancer in the United
States and widely available as is evidenced by the 20,000 patients who
received it in 2015. During 2015, 81% of privately insured patients paid
$25 or less out of pocket per month for Xtandi and 79% of Medicare patients
paid nothing out of pocket per month for Xtandi. For eligible patients who
do not have insurance or are underinsured, and have an annual adjusted
household income of $100,000 or less, Astellas provides Xtandi for free
under the Astellas Access Program; in 2015 over 2,000 men fighting advanced
prostate cancer received Xtandi for free.

"The discussion of Xtandi's price in the KEI petition fails to reflect what
payers or patients actually pay for the medicine.”

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