[Ip-health] Fwd: Please Share: Fair Pricing Coalition Disappointed at Launch Price of Janssen’s Protease Inhibitor-based Single-tablet Regimen Symtuza

Bryn Gay bryn.gay at treatmentactiongroup.org
Tue Jul 24 05:52:12 PDT 2018

Fair Pricing Coalition Disappointed at Launch Price of Janssen’s Protease
Inhibitor-based Single-tablet Regimen Symtuza
*First PI-based single-tablet regimen debuts in the United States at
record-high price.*

*July 23, 2018 –* The Fair Pricing Coalition (FPC), an ad hoc coalition of
HIV and hepatitis C virus (HCV) activists, today expressed its strong
dissatisfaction with Janssen Therapeutics over its launch price for Symtuza
(darunavir/cobicistat/emtricitabine/tenofovir alafenamide). At a wholesale
acquisition cost (WAC) of $41,784 a year, Janssen has set a record-high
price for single-tablet antiretroviral regimens (STRs), ignoring the need
for cost containment in HIV care and defying a groundswell of public and
governmental demands for lower prescription drug prices.

“Symtuza is a useful addition to the HIV treatment toolbox for people
living with HIV requiring a protease inhibitor and single-tablet dosing,”
said FPC Chair Tim Horn. “However, the unprecedented price is very
difficult to swallow. Symtuza is roughly $4,700 to $6,400 more than the
current WAC prices for Stribild, Genvoya, and Biktarvy, until now the most
expensive STRs on the market. We understand that Janssen isn’t charging any
more than the components included in Symtuza, specifically Prezista
(darunavir), Tybost (cobicistat), and Descovy (emtricitabine/tenofovir
alafenamide), but the original development costs of these components have
already been recovered many times over. Janssen missed the opportunity to
introduce both an easier-to-take and less costly version of antiretrovirals
that have all been available for some time now, which is unfortunate.”

When in doubt about STR research and development investments, FPC does
advocate for parity pricing with the individual components – but with a
very important stipulation.  “We urge companies to factor out the egregious
annual price increases taken on the components over the years and focus
instead on what the component prices should be, based on either standard or
medical inflation rates,” said FPC member Paul Arons. “We’re being punished
twice – by price increases on older drugs that have snowballed compared to
actual inflation rates, and on new drug products with prices based on these
bloated benchmarks.”

Had prices of Symtuza’s component drugs risen only 28.8%, in line with the
medical inflation rate over the years during which most of them were
launched, the maximum price should have been $30,394 – $12,390 less than
Janssen’s WAC. And with overall U.S. inflation, the WAC could reasonably
have been 16.6% higher, or as low as $27,508. Having shared such
calculations with Janssen, the Fair Pricing Coalition considers the
company’s pricing decision especially regrettable.

The Symtuza launch price is particularly problematic in the context of
comparable generic and quasi-generic drugs becoming widely available in the
U.S. For example, the darunavir in Symtuza is one of two protease
inhibitors (the other being atazanavir, which is now available as a
stand-alone generic) classified as components of “Recommended Initial
Regimens in Certain Clinical Situations” in the Department of Health and
Human Services’ *Guidelines for the Use of Antiretroviral Agents in Adults
and Adolescents Living with HIV*, meaning they are not among the primary
initial regimens. That means Symtuza is likely to have a more limited
market than a drug that is listed in the guidelines for more widespread
use. Common sense would dictate that Janssen would assign a lower price to
a drug like Symtuza that is less clinically important.

Other components of Symtuza have generic or quasi-generic equivalents.
“Using current and anticipated generic drug prices as a benchmark, a
minimal fair price for Symtuza should have been below $10,000 annually,”
said Horn. “Symtuza’s launch price goes to show that fairness rules aren’t
being applied to newer HIV drug products with marginal advantages over
older offerings, which is, at best, a shame, and at worst, a genuine threat
to our stretched-thin systems of HIV care coverage.”

“We take some solace at the news Janssen has increased its copay assistance
limit to $10,500,” said FPC member John Peller. However, the maximum
eligibility for full indigent coverage under the Johnson & Johnson Patient
Assistance Foundation remains at only 300% of the Federal Poverty Level –
40% short of the current pharmaceutical standard. Thus, the cost of Symtuza
for a person living with HIV who earns just above that level could be as
much as a full year’s income. “To what extent Janssen’s financial support
programs defray out-of-pocket costs, particularly for such high-priced HIV
drug products in an era of copay accumulators and an upswing in public and
private policy attacks on products intended to defray patient costs,
remains to be seen,” Peller added.


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