US prostate cancer patients battle for their lives over $156,000/yr price of drug our taxes paid for

*Will the Biden administration use ‘march-in’ to protect prostate cancer
patients from excessive drug prices?*

I am posting this letter that I saw on the ip-health mailing list web site.


By Peter Arno, Robert Sachs and Kathryn Ardizzone
Jan. 3, 2022

Astellas Pharma, a drug company headquartered in Japan, is charging U.S.
patients $156,000 a year for the prostate cancer drug Xtandi (enzalutamide)
— more than three to five times

it charges residents of other wealthy countries, and five times more than
it charges in Japan . Adding
insult to injury, Xtandi was discovered by scientists at the University of
California, Los Angeles, with grants from the National Institutes of Health
(NIH) and the U.S. Army.

A petition that has languished

the Army since 2019 was recently forwarded

the Department of Health and Human Services (HHS). It asks the government
to protect taxpayers from Xtandi’s excessive price by exercising “march-in
rights” for the drug. This would require HHS to make a modest
determination: that it is unreasonable to force Americans to pay three to
five times more than people in other high-income countries for a drug
developed with U.S. taxpayers’ dollars.

It’s hard to dispute that the U.S. price of Xtandi is unreasonable. But
with federal agencies heavily lobbied by the pharmaceutical industry, what
appears straightforward is not. The Xtandi case is thus a litmus test of
whether the Biden administration will exercise its existing legal authority
to restrain unreasonable drug prices. While by no means mutually exclusive
with President Biden’s “Build Back Better” drug pricing provisions,
march-in authority offers an opportunity to take action now on drug prices,
without enacting any new federal legislation.
An earlier petition to march-in on Xtandi’s patents was filed in 2016

HHS, the Department of Defense (DoD), and the NIH. The NIH rejected it
without a hearing on the grounds that making the drug publicly available *at
any price* was acceptable.

In 2019, Vietnam War veteran Clare Love and former MIT scientist David Reed

updated march-in petition on Xtandi to the Army. In April 2021, one of us
(R.S.), a former chair of the National Coalition for Cancer Survivorship
who is also battling prostate cancer, joined the 2019 petition
Seven months later, having received no response from the U.S. Army or the
Department of Defense, Sachs and Love redirected their petition

HHS. A few weeks later, HIV activist Eric Sawyer, who also is contending
with prostate cancer, joined the Sachs and Love petition. All of the
petitioners simply seek the opportunity to present their case at an
evidentiary hearing. On Dec. 23, 2021, the petitioners were advised that
their request has been referred to the NIH for review.

The petition has strong legal underpinnings. Under the Bayh-Dole Act
also known as the Patent and Trademark Law Amendments Act of 1980, the
federal government can exercise march-in rights to remedy unreasonable drug
pricing. The term “march-in rights” refers to the government’s authority,
under Section 203

the Bayh-Dole Act, to authorize third-party licenses to federally funded
patents if the original patent holder fails to make the invention
“available to the public on reasonable terms.” If the government were to
exercise march-in rights for Xtandi, other manufacturers would be able to
produce a generic version of the drug, reducing its price substantially.

Prostate cancer is the most common cancer among American men. This year,
nearly 250,000 men

be diagnosed with it. The racial/ethnic disparities are dramatic: African
American men experience among the highest prostate cancer rates
in the world. Prostate cancer
is also the most common cancer diagnosis

in Hispanic
or Latino men in the U.S., amounting to more than 20% of new diagnoses.

Because prostate cancer tends to affect older men regardless of ethnicity,
the price of Xtandi drains the Medicare budget, harming all U.S. taxpayers.
>From 2015 to 2019, the last year for which data are available, Medicare spent
$5.2 billion on Xtandi
This is extraordinary given that the tablet is easy to manufacture, and a
Canadian company has offered

supply enzalutamide to Medicare for $4,380 a year, a savings of more than

March-in would be an effective remedy for Astella’s price gouging, which is
enabled by a monopoly on the drug’s patents.

As background, UCLA, where Xtandi was invented, exclusively licensed

rights to Xtandi’s patents to a company called Medivation in 2005. Four
years later, Medivation partnered with

to commercialize Xtandi, which the FDA approved
in 2012. Four years after that,
Pfizer acquired Medivation

through the acquisition, the company’s partnership with Astellas on Xtandi.
Astellas holds exclusive rights in Xtandi’s patents through at least 2027.

So far, the march-in petition on Xtandi has not generated any government
action. The real obstacle to the petition’s success is not the strength of
the case it presents — it is the government’s failure to have exercised its
statutory authority when it comes to abusive pricing of taxpayer-funded

No agency has held a hearing on a march-in petition since 2004 hearings

the HIV drug Norvir (ritonavir), which drew public scrutiny when Abbott
Laboratories increased its price by 400%
. Facing an outcry over the
price hike in the U.S., Abbott agreed to roll back the entire price
increase for patients on federal programs and, during the hearing on the
march-in petition, promised to “permanently freeze the price” to federal
programs and made commitments on its patient-assistance program.

In the past, the NIH has justified its failure to exercise march-in
authority by asserting that march-in rights are not an appropriate method
for dealing with excessive prices. Not only is that contrary to the
specific mandate of the Bayh-Dole Act, it’s also out of sync with American
consumers who, after the Trump administration issued a last-minute proposal

eliminate pricing as a basis for march in, filed more than 80,000 public
comments in
opposition to the proposal.

The Biden administration has issued statements seeming to support march-in
rights, including the president’s Executive Order on Promoting Competition
in the American Economy

HHS’s Comprehensive Plan for Addressing High Drug Prices
but it has yet to act.

How the Biden administration responds to the Xtandi petitions will have
consequences for all Americans. Xtandi is certainly not the only
pharmaceutical product invented with federal funds

Many drugs, vaccines, and gene or cell therapies for the treatment of
cancer, rare diseases, HIV, Covid-19, and more were developed using
patented inventions that benefited from federal funding. Some of these
products have more complicated patent landscapes or present other
challenges to the introduction of generic competition, but the Xtandi case
is particularly straightforward and one that provides a clear test of the
willingness of the government to enforce Bayh-Dole Act safeguards.

Exercising march-in rights for Xtandi would send a strong message to the
public and the pharmaceutical industry: If a drug company gouges Americans
on a taxpayer-funded drug, there will be repercussions. Failing to grant a
hearing on the Xtandi petitions would signal that the federal government
will continue to be a paper tiger when it comes to demonstrably
unreasonable drug pricing, letting pharmaceutical companies be even more
confident that there’s one tried-and-true patient group they can always
price gouge: American consumers.

*Peter Arno is an economist and director of health policy research at the
Political Economy Research Institute at the University of Massachusetts,
Amherst. Robert Sachs is an attorney in Boston. Kathryn Ardizzone is
counsel for Knowledge Ecology International, a nonprofit organization that
promotes access to medicine.*

Kathryn Ardizzone, Esq.
Knowledge Ecology International
110 Maryland Avenue, Suite 511
Washington, DC 20002
kathryn.ardizzone at
(202) 332-2670

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