[Ip-health] AJMC: Will CMS Accept Offer of a 95% Cheaper Enzalutamide?

Zack Struver zack.struver at keionline.org
Thu Apr 28 12:59:41 PDT 2016


http://www.ajmc.com/newsroom/will-cms-accept-offer-of-a-95-cheaper-enzalutamide
​

Will CMS Accept Offer of a 95% Cheaper Enzalutamide?

A company in Canada, Biolyse Pharma, has offered to manufacture a generic
version of enzalutamide at a significantly lower price than what CMS paid
in 2014.

Published Online: April 28, 2016

Surabhi Dangi-Garimella, PhD

The battle over the cost of the prostate cancer drug enzalutamide
(Xtandi)—an androgen receptor antagonist—is far from over. A company in
Canada, Biolyse Pharma, has offered to manufacture a generic version of the
drug at a significantly lower price than what CMS paid in 2014.

The case of enzalutamide loops back to the drug price discrepancy that
exists between the United States and nearly the rest of the world.
Enzalutamide was developed by Medivation, in collaboration with the
Japanese company, Astellas Pharma. Initially approved in August 2012 by the
FDA for the treatment of patients with metastatic castration-resistant
prostate cancer who have progressed on docetaxel, the drug subsequently
received expanded approval for use in the pre-chemotherapy setting. Priced
at $129,000 for the entire course in the United States, the drug is priced
at almost one-third that cost in Japan and Sweden ($39,000) and at less
than one-fourth the cost in Canada ($30,000).

A month back, legislators sent a letter
<http://www.ajmc.com/newsroom/legislators-urge-hhs-and-nih-to-intervene-with-the-price-of-enzalutamide>
to HHS Secretary Sylvia Matthews Burwell and to Francis Collins, MD, PhD,
who heads the National Institutes of Health (NIH), asking them to intervene
with the price of enzalutamide. Since the drug was invented by scientists
at the University of California, Los Angeles, using funding from the NIH,
the federal agency can gain a nonexclusive, partially exclusive, or
exclusive license for the said invention, the letter said—so called
“march-in rights.”

In her letter to CMS <http://freepdfhosting.com/7419fa835d.pdf>, the
president of Biolyse, Brigitte Kiecken, points to the fact that Medicare
has a royalty free right in all 3 patents for enzalutamide and promises “an
FDA approval for the generic version in less than 3 years” if granted the
license by the US government. The company expects to supply a 40 mg tablet
of enzalutamide at $3/tablet, instead of at the $69.41 that Medicare paid
in 2014.

Collins, however, is opposed to the idea of using the march-in rights in
the context of drug pricing. “I am concerned that the negatives that may be
flowing forward if we begin to use march-in in a very broad way about drug
pricing may in fact be substantial in terms of a loss of interest in
industry participation in discoveries that NIH has supported,” Collins said
at a Congressional hearing in early April, according to STAT.

Meanwhile, Astellas is arguing that company rebates and contracts with
government agencies as well as pharmacy benefit managers, results in a
substantially lower out-of-pocket (OOP) cost for patients. However, since
CMS cannot negotiate drug prices, the OOP savings for enrolled
beneficiaries does not translate into savings for CMS…so a solution is
warranted.

The composition of matter patent for Xtandi expires in 2027, according to
the United States Securities and Exchange Commission.

-- 
Zack Struver, Communications and Research Associate
Knowledge Ecology International
zack.struver at keionline.org
Twitter: @zstruver <https://twitter.com/zstruver>
Office: +1 (202) 332-2670 Cell: +1 (914) 582-1428
keionline.org



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