Addendum/background to Roche Pricing Letter

On October 16th, 2002, Roche's peg interferon alfa-2a, Pegasys, was approved by FDA, with an indication for adults with chronic hepatitis C who have compensated liver disease and who have not been previously treated with interferon alfa.. Treatment activists from the HIV and HCV communities were infuriated upon hearing the average wholesale price of Pegasys: $291/vial, making it even costlier than rival Schering's Peg-Intron. A 48-week supply will cost $13, 968.00.

In an attempt to soften the blow and disguise a marketing campaign as a viable access initiative, Roche announced a Pegasys giveaway program for 15,000 HCV-infected individuals. In a "first taste is always free" initiative worthy of the shrewdest illicit drug dealers, a twelve week supply of Pegasys monotherapy is being provided on a first-come, first-served basis until the end of 2002. The course of treatment for HCV generally runs at least six months, and more commonly, for twelve months. Ribavirin will not be provided, even though combination therapy—interferon with ribavirin is the standard of care for chronic hepatitis C. Nor is Roche providing its HCV viral load assay, (Amplicor). Viral load testing is used as a primary measurement of treatment efficacy.

The giveaway program is being framed by Roche as an attempt to familiarize medical providers with the twelve-week treatment paradigm. Week 12 viral load is highly predictive of a sustained virological response to treatment. Most people end up clearing the virus and remaining undetectable six months after completion of treatment will experience either an undetectable viral load or a two-log drop in HCV levels after twelve weeks on treatment. Early recognition of responders will spare non-responders the severe side effects associated with treatment.

Although Roche has a patient assistance program available and is working on securing reimbursement from insurers, the price of Pegasys may effectively guarantee that cash-strapped ADAP programs will not be including it on their formularies. Treatment activists are gravely concerned about Roche's plans for the of their HIV fusion inhibitor, T-20 (Fuzeon). Roche's decision to render Pegasys all but inaccessible to those who need it most does not bode well for community relations.

Tracy Swan & Daniel Raymond

[Consensus Statement on Roche Pricing of Pegasys for Treatment of HCV Infection]