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7284Ribavirin unbundling update: The Good, The Bad, & the Ugly

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  • claudine intexas
    Sep 30, 2001
    • 0 Attachment
      From The HCV Advocate


      53 Divisadero Street
      San Francisco, CA 94117
      Email: HAAC_SF@...

      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?

      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

      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
      infringement issues.

      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.

      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
      hepatitis C.

      Please start by sharing this alert with patients and

      Brian D. Klein, HAAC/SF

      Email: HAAC_SF@...

      James Learned, HAAC/NY

      Email: James_Learned@...

      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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