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 Such groups have traditionally lobbied for insurance coverage of
newer HIV drugs regardless of expense. But at least three U.S.
organizations now question whether Gilead’s Descovy would be the
best option for most people at risk of exposure.
A generic version of the current prevention pill, Truvada, is due in
the United States next September, which should bring down costs and
give many more people access to the therapy, they say.
Their resistance is being echoed by some insurers, including the
pharmacy benefit arm of Cigna Inc, which are hinting that price will
be a barrier to providing coverage for Descovy.
"Based on the science that we have seen thus far, there is no
indication that everyone needs to be taking Descovy," Tim Horn,
director of medication access and pricing at the National Alliance
of State and Territorial AIDS Directors (NASTAD) told Reuters.
"We see no reason to push back against commercial payers or Medicaid
programs that would move to prefer generic Truvada (for prevention),
provided there are guard-rails that do not deny access to Descovy
for those who need Descovy," he said.
Truvada, also made by Gilead, has been used to treat people infected
with HIV since 2004. It was approved as a daily pill for
pre-exposure prophylaxis, or PrEP, in 2012, and remains the only
preventive therapy on the U.S. market.
Descovy, shown to be less toxic than Truvada to the kidneys and
bones in clinical trials, was approved in 2016 for people already
infected with HIV. Advisors to the U.S. Food and Drug Administration
will meet on Wednesday to decide whether to recommend Descovy for
PrEP, with agency approval widely expected before the end of the
year.
When asked about the patient groups' criticism, Gilead said Descovy
is safer than Truvada and offers more efficient delivery of its
antiviral component, resulting in greater concentration of the drug
in cells where HIV infection can occur.
The Centers for Disease Control and Prevention estimates that 1.1
million people in the United States could benefit from PrEP.
High-risk populations include people having sex with someone who is
infected with HIV or who share injection needle equipment. Gilead
said 213,000 people were taking Truvada for HIV prevention in the
second quarter of this year.
The company has pledged to help the Trump administration achieve a
goal of stopping the spread of HIV in the United States within a
decade. In May, Gilead said it would donate enough Truvada annually
to supply 200,000 uninsured Americans with PrEP until Descovy is
approved for HIV prevention, then switch patients to the new drug.
PRICING IMMUNITY
HIV drugmakers have largely been shielded from generic competition.
Each time one of their therapies came close to losing patent
protection, scientific advances allowed them to introduce a new drug
that improved on its predecessor, often with a higher price.
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Both Truvada and Descovy are priced at $21,000 per year, before
discounts provided to public and private health insurers. In the
first half of 2019, Gilead's Truvada sales totaled $1.32 billion.
Descovy sales amounted to $700 million and are expected to rise to
$3 billion dollars annually by 2024, according to IBES data from
Refinitiv.Teva Pharmaceutical Industries Ltd <TEVA.TA> is due to
sell a generic version of Truvada next year. More significant price
competition is expected when other generic competitors emerge in
2021.
Some prominent patient advocates, including community-based advocacy
organization Treatment Action Group (TAG) and NASTAD, which
advocates for public health, told Reuters that Gilead has not proven
the newer treatment provides enough of a benefit to justify its use
beyond people at risk of kidney or bone density problems. At a time
when HIV drug prices are soaring, their views may provide support to
health insurers who routinely push generic drug use to curb costs.
Jeremiah Johnson, HIV project director at TAG, told Reuters he is
open to a conversation about health plans requiring individuals try
a generic drug before using a significantly more expensive regimen
like Descovy.
TAG and PrEP4All Collaboration, which aims to expand access to PrEP
for all Americans, earlier this year called for the FDA to convene
the advisory committee review of Descovy, citing concerns over
Gilead's trial data and pricing practices.
Not all experts are as vocal in questioning Gilead's aims. Dr. Paul
Volberding, director of the AIDS Research Institute at the
University of California, San Francisco, told Reuters that Descovy
for PrEP should be made available to people that have insurance to
pay for it, while a generic could make sense for people with less
access to coverage.
"The safety difference is small, but real," he said.
Dr. Anthony Fauci, director of the National Institute of Allergy and
Infectious Diseases, told Reuters that Descovy may provide an
advantage because it remains in the body for longer than Truvada.
"If you miss a dose or two it is unlikely that there is going to be
a gap in protection," he said.
But some health insurers, which largely cover Truvada for PrEP, are
not convinced of a significant benefit from Descovy.
"Based on the current information and data available to us at this
time, we believe generic Truvada will be the most cost effective
option for PrEP," said David Lassen, chief clinical officer at Prime
Therapeutics, which manages pharmacy benefits for Blue Cross Blue
Shield health plans.
Express Scripts, the pharmacy benefit manager owned by Cigna, said
cost is a big barrier to U.S. use of Truvada for PrEP.
"We would certainly look to leverage cost savings from generic
Truvada to help improve affordability for patients and payers," the
company told Reuters.
(Editing by Michele Gershberg and Edward Tobin)
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