[Ip-health] Gilead Subsidiary to Launch Authorized Generics of Epclusa (Sofosbuvir/Velpatasvir) and Harvoni (Ledipasvir/Sofosbuvir) for the Treatment of Chronic Hepatitis C

James Love james.love at keionline.org
Mon Sep 24 09:05:59 PDT 2018


Gilead will create new generic versions of its HCV drugs, priced at $24,000
for the most common form of treatment, and also proposes new "subscription"
pricing models, similar to what has been negotiated in Australia and
perhaps other countries, to make eradication of HCV more economically
viable.   The press release regarding the new authorized generics explains
the rationale for doing this.

Jamie

* "Since the launch of Gilead’s first HCV medication in 2013, the average
price paid for each bottle of medicine in the United States has decreased
by more than 60 percent off of the public list prices, across health
insurers and government payers. Due to the complexity and structure of the
U.S. healthcare system, however, these discounts provided by Gilead may not
always translate into lower costs for patients."

*  "The authorized generics will launch at a list price of $24,000 for the
most common course of therapy and will be available in January 2019."

*  "Beyond the company’s efforts to reduce patient costs, Gilead is
continuing to pursue innovative collaborations and long-term financing
models, such as a potential subscription model, that could not only expand
access, but aim to eliminate HCV in the United States and around the world."

--------------------
https://www.businesswire.com/news/home/20180924005499/en/

Press Releases
Gilead Subsidiary to Launch Authorized Generics of Epclusa
(Sofosbuvir/Velpatasvir) and Harvoni (Ledipasvir/Sofosbuvir) for the
Treatment of Chronic Hepatitis C

FOSTER CITY, Calif.--(BUSINESS WIRE)--Sep. 24, 2018-- Gilead Sciences, Inc.
(NASDAQ: GILD) announced today plans to launch authorized generic versions
of Epclusa® (sofosbuvir 400mg/velpatasvir 100mg) and Harvoni® (ledipasvir
90mg/sofosbuvir 400mg), Gilead’s leading treatments for chronic hepatitis C
virus (HCV), in the United States, through a newly created subsidiary,
Asegua Therapeutics LLC. The authorized generics will launch at a list
price of $24,000 for the most common course of therapy and will be
available in January 2019.

Since the launch of Gilead’s first HCV medication in 2013, the average
price paid for each bottle of medicine in the United States has decreased
by more than 60 percent off of the public list prices, across health
insurers and government payers. Due to the complexity and structure of the
U.S. healthcare system, however, these discounts provided by Gilead may not
always translate into lower costs for patients. Further, existing
contracts, together with laws associated with government pricing policies,
make it challenging to quickly lower a product’s list price once it is on
the market.

The authorized generics are priced to more closely reflect the discounts
that health insurers and government payers receive today. Insurers will
have the choice of offering either the authorized generics or the branded
medications for both Epclusa and Harvoni. In the Medicare Part D setting,
the authorized generics could save patients up to $2,500 in out-of-pocket
costs per course of therapy. The authorized generics will also offer
substantial savings to state managed Medicaid plans that do not currently
benefit from negotiated rebates and that represent a significant number of
people in need, potentially opening up access to our medications to
beneficiaries who were previously denied coverage.

“Launching these authorized generics is the best solution available to us
today to quickly introduce a lower-priced alternative to our HCV
medications without significant disruption to the healthcare system and our
business,” said John F. Milligan, PhD, President and Chief Executive
Officer, Gilead Sciences. “This launch also will hopefully help increase
transparency by more closely aligning our medications’ list prices with
their cost. Our ultimate goal is to lower the list price of Epclusa – a
medication we believe is of great importance given its clinical profile
across genotypes – and Harvoni. We are committed to working with all of our
partners in the healthcare system to help enable list price reductions of
our HCV medications and find better solutions to reduce patients’
out-of-pocket costs.”

Beyond the company’s efforts to reduce patient costs, Gilead is continuing
to pursue innovative collaborations and long-term financing models, such as
a potential subscription model, that could not only expand access, but aim
to eliminate HCV in the United States and around the world.

About Gilead Sciences, Inc.

Gilead Sciences, Inc. is a research-based biopharmaceutical company that
discovers, develops and commercializes innovative medicines in areas of
unmet medical need. The company strives to transform and simplify care for
people with life-threatening illnesses around the world. Gilead has
operations in more than 35 countries worldwide, with headquarters in Foster
City, California.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995 that are subject to
risks, uncertainties and other factors that could cause actual results to
differ materially from those referred to in the forward-looking statements.
The reader is cautioned not to rely on these forward-looking statements.
These and other risks are described in detail in Gilead’s Quarterly Report
on Form 10-Q for the quarter ended June 30, 2018, as filed with the U.S.
Securities and Exchange Commission. All forward-looking statements are
based on information currently available to Gilead, and Gilead assumes no
obligation to update any such forward-looking statements.

For more information on Gilead Sciences, please visit the company’s website
at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call
Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.


View source version on businesswire.com:
https://www.businesswire.com/news/home/20180924005499/en/

Source: Gilead Sciences, Inc.

Gilead Sciences, Inc.
Investors
Sung Lee, 650-524-7792
or
Media
Amy Flood, 650-522-5643


-- 
James Love.  Knowledge Ecology International
http://www.keionline.org <http://www.keionline.org/donate.html>
twitter.com/jamie_love


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