Ribavirin unbundling update: The Good, The Bad, & the Ugly
- From The HCV Advocate
HEPATITIS C ACTION & ADVOCACY COALITION (HAAC)
53 Divisadero Street
San Francisco, CA 94117
August 1, 2001
GOOD NEWS: Schering-Plough To Market Unbundled
BAD NEWS: Prohibitive Pricing & Attempts To Block
Generic and Compounded Alternatives Likely
Schering-Plough has received FDA approval to market
Rebetol (ribavirin) separately from Rebetron
(ribavirin and Intron-A packaged together in one kit).
This is long overdue. Community and health care
advocates have been fighting for separately available
ribavirin for over three years.
People with hepatitis C must have access to ribavirin
so that dosing and choice of interferon for
combination treatment can be individualized to achieve
the best possible results. But will the unbundling
provide real access? Should we applaud Schering for
its belated action?
Shortly after the Rebetron package was approved in
June of 1998, the FDA issued a letter to Schering
stating that the agency was willing to work with the
company to unbundle ribavirin from the package.
Schering could have done so at any time over the past
three years. So why now?
SCHERING�S BOLD NEW PLAN
As much as we wish Schering�s action were a response
to the needs of patients, the timing of the unbundling
has everything to do with market manipulation. The
needs of people with hepatitis C don�t figure into the
equation. We�re concerned that the company is playing
out another strategy to hold patients and providers
hostage to Schering�s products. Consider the facts:
� Schering�s exclusivity on ribavirin expires in
� A generic ribavirin is eligible to enter the
market in January;
� Compounded ribavirin continues to be available
by individual prescription through compounding
� Schering�s pegylated interferon (PEG-Intron)
was approved early this year as monotherapy;
� FDA approval of PEG-Intron + ribavirin
combination therapy is expected as early as this
month; and; (Note: since this was written it has been
� FDA approval of Roche�s brand of pegylated
interferon (Pegasys) as monotherapy is expected soon.
Schering is likely to set an exorbitant price for
Rebetol (ribavirin) while charging very little mark-up
in their combination kits (the �convenience�
packaging). This would discourage off-label use of
Rebetol with other interferons. Any price higher than
the $225 for an average month�s supply charged by
compounding pharmacies is unacceptable and should be
met with public outcry.
At $18,000 a year before adding in the ribavirin,
PEG-Intron has already set the price bar ridiculously
high. With this new strategy, Schering can claim to be
helping patients by providing separate ribavirin,
while actually making it prohibitively expensive to
use with any other interferon. Institutions and
third-party payers (the VA, Medicaid, HMOs, private
insurers) may refuse to pay the higher price of
separately packaged Rebetol.
The result? Patients will be forced to use Intron-A or
PEG-Intron for combination therapy whether or not that
is the best option for their individual treatment
ACTIONS TO BLOCK GENERIC AND COMPOUNDED RIBAVIRIN
Compounded ribavirin has been available by individual
prescription since July of 1999. Yet Schering has not
sued any of the compounding pharmacies. If the company
had filed suit against a compounding pharmacy and
lost, they would have no standing to challenge a
generic manufacturer in the courts on the same patent
We�re concerned that Schering is likely to block a
generic ribavirin from receiving a marketing license
when the company�s exclusivity on ribavirin expires in
December. Once Schering has been notified that a
generic manufacturer has applied to the FDA, the
company can sue the generic maker for patent
infringement. After that, regulations force the FDA to
delay issuing any generic license until 30 months have
elapsed or the case is settled, whichever comes first.
Based on Schering�s history of extensive litigation,
the company may drag the matter out in court as long
as possible to delay the FDA from issuing that generic
license. Schering may use similar litigation to try to
shut down access to compounded ribavirin as well.
The result? People with hepatitis C who might achieve
better results from combination treatment with Pegasys
or another interferon will be left with little
alternative but to use Schering�s Rebetol in
combination with Schering�s PEG-Intron.
THE BOTTOM LINE
In essence, Schering�s likely strategy is to abuse the
intent of the patent infringement provisions to extend
its exclusivity on ribavirin, while setting the price
of unbundled ribavirin so high as to put combination
treatment with other interferons out of reach of most
patients. The strategy is clever, cruel, and
Community pressure is needed to ensure equitable
access to treatment and allow patients and their
providers to choose the best treatment option. We must
develop community strategies to counter Schering�s
latest manipulations. Working together and with
members of Congress, the FDA, the Federal Trade
Commission, the Veterans Administration and
third-party payers, we can put treatment choice where
it belongs � in the hands of people living with
Please start by sharing this alert with patients and
Brian D. Klein, HAAC/SF
James Learned, HAAC/NY
HAAC receives no money from any pharmaceutical company
or pharmacy, including those mentioned in this alert.
Our goal is to help folks like us in the HCV community
make informed choices and have the access and
flexibility to choose the treatment that will best
meet their individual needs.
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