Ribavirin for Hepatitis C: 80% Price Reduction Available July 9?
Ribavirin is used in combination with alpha interferon for treating hepatitis C; it is not effective alone. (Ribavirin was also tested as an HIV treatment years ago; we suspect that it probably would have been approved except for a bitter political dispute, and that it should be examined again for possible use as a component in modern HIV treatments.)Ribavirin has been approved and widely used throughout the world for years, except in the United States, where it was not approved for oral use until June 3, 1998, in combination with alpha interferon for treating hepatitis C. Unfortunately, Schering-Plough got the FDA to approve an unprecedented "bundling" of the drugs, meaning that U.S. patients ordinarily cannot buy ribavirin unless they also buy Schering's brand of alpha interferon, called Intron A, both at a notably high price. (Outside the U.S., ribavirin can be purchased alone).
The different brands of alpha interferon are not identical, and doctors sometimes prefer one of the other forms available in the U.S. and approved for hepatitis C (currently Roferon, Infergen, and Wellferon, in addition to Intron A), but it has been hard to obtain the ribavirin for these combinations without also paying for the Schering product and throwing it away. The bundling problem may become even more serious when a new form of alpha interferon called Pegasys--which maintains a more steady level in the bloodstream and may be a major improvement over standard alpha interferon for treating hepatitis C, at least as monotherapy--is approved and becomes widely available.
Bundling also inhibits experimentation with ribavirin as a possible element in combination treatment for HIV, which could be important for certain patients whose virus has become resistant to many of the antiretrovirals available today. Although known as an antiviral, ribavirin may actually work by helping the immune system respond to certain infections, for example by reducing production of IL-4. Ribavirin does have serious side effects, including anemia.
On June 26 the Hepatitis C Action & Advocacy Coalition, a credible grassroots advocacy organization, announced that starting July 9, 1999, ribavirin would be available from a compounding pharmacy in Pittsburgh, Pennsylvania, at a price reduction of almost 80%. HAAC had learned that the patent on ribavirin expired July 8; in the U.S., however, Schering has an additional three years of exclusivity, meaning that the FDA will not approve any rival ribavirin during that time, regardless of its medical and pharmaceutical merits. But the FDA does not approve compounded medications--so neither HAAC nor the pharmacy see any legal barrier to selling compounded ribavirin after the patent expires. Money talks, however, so no one knows what will happen July 9.
From HAAC Press Statement of June 26:
- "Safe and Reliable Access to 'Unbundled' Ribavirin at 20% of Schering's Price
"Dear Members of the Hepatitis C Patient and Health Care Communities:
"HAAC is pleased to inform you that, beginning July 9, 1999 and barring any unforeseen difficulties, a safe and reputable alternative source of ribavirin USP will be available at 20% the cost of the drug when purchased from Schering-Plough. Fisher's Specialty Pharmacy Services (SPS) in Pittsburgh is compounding ribavirin USP by individual prescription. It is NDC # 63370-219-55, properly labeled, with a patient information leaflet that includes all known side effects, warnings and recommended precautions.
"The cost is $1.25/ 200 mg capsule. At the common dose of 1,200 mg a day, the monthly cost for ribavirin from Fisher's SPS will be only $225. This is 80% less than Schering's price of $1,040. Ribavirin has only been available packaged with Schering's interferon (Intron A) as part of the Rebetron kit.
"Fisher's will work with you and your insurance provider. Contact them at:
Fisher's Specialty Pharmacy Services
3904 Perrysville Avenue
Pittsburgh, PA 15214
Phone: (412) 231-3777
Toll Free Phone: (888) 347-3416
Toll Free Fax: (877) 231-8302
...
"The Hepatitis C Action & Advocacy Coalition is a national independent HCV patient advocacy group. We do not accept money from any pharmaceutical provider including those mentioned in this announcement. Our goal is to help put the control for treatment choice, access and flexibility back in the partnerships of physicians and patients."
For more information, see http://www.HIVandHepatitis.com.
For background on compounding, see AIDS Treatment News #320, June 4, 1999.
Hepatitis C Action & Advocacy Coalition can be reached through Brian D. Klein, HAAC_SF@hotmail.com.
