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Re: excessive price of HCV Treatment,Peg. [nt]



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Replying to:

PLEASE CIRCULATE TO HCV AND HIV GROUPS AND LISTS


SIGN-ON LETTER IS COPIED BELOW AS WELL AS IN ATTACHMENT




INTRODUCTION


Please note the attached community letter that will be sent to


Hoffman-La


Roche regarding the excessive price they had set for their new and


improved


version of interferon called Pegasys. Pegasys alone will cost nearly


$14,000


for a year's treatment. In addition, it must be used in combination


with an


antiviral drug, ribavirin. Currently, ribavirin must be purchased


separately


from Schering Plough at a cost of an additional $14,000 to $21,000


(depending on dosage). Thus, the total cost of 1 year's treatment for


HCV,


using Pegasys plus ribavirin, would range from $28,000 to $35,000


wholesale


(figures are approximate). Hoffman-La Roche is offering the first 12


weeks


of Pegasys free,


but this offer extends only until the end of the 2002 calendar year.




At these prices, the great majority of people in need of treatment


for HCV


will be unable to access it. For those who have only HCV without HIV,


there


are no such things as ADAP and Ryan White funding, and it is unclear


whether


Medicaid will be able to put the drug on the formulary for


reimbursement.


For those with both HCV and HIV, the price all but makes it


impossible to


cover the drug under the ADAP program or Ryan White funded programs.


In


short, only those with high quality private insurance have much


chance of


getting access to treatment.




We feel it is critical that community groups express their strongest


possible concern about these prices. One good way to do this will be


by


signing on this letter, which already has the endorsement of many


prominent


HCV and HIV activist groups. Please read the letter and, as quickly as


possible, send confirmation and how you or your organization wishes


to be


listed. Sign-on confirmations should be sent to Ryan Clary at Project


Inform, using this address: tan@projectinform.org. Ryan has graciously


agreed to manage the sign-on process. Sign-on confirmation should be


sent by


5 PM, Pacific Time, Friday November 1.




Thank you for your prompt attention to this critical matter, and


thanks to


all who helped in getting this letter out.




Martin Delaney, Project Inform and the Fair Pricing Coalition


Brian Klein, Hepatitis C Action and Advocacy Coalition




PS. Apologies in advance to anyone who had already agreed to sign-on


but


whose name or organization is not currently listed on the letter. We


may


have lost track of an email or two along the way.


--------------------------------------------------------




Mr. George Abercrombie


Chief Executive Officer


Hoffmann-La Roche




(cc to Franz Humer, Basel Switzerland)




Dear Mr. Abercrombie,




We are writing on behalf of the undersigned groups, organizations and


individuals. We are writing to express our extreme dismay at the


pricing


actions taken by Hoffmann- La Roche in the launch of its new product,


Pegasys, for treatment of HCV infection.




Several of our members spent a great deal of time and effort


attempting to


convince your firm that it had an important opportunity in the launch


of


Pegasys to undercut the outrageous pricing set by Schering for its


version


of pegylated interferon. We talked about how much easier it would be


to


establish reimbursement for Pegasys if the price were substantially


lower.


We hoped to see a price that would make it possible to put the drug on


formularies for Medicaid, MediCal and perhaps even the AIDS Drug


Assistance


Programs (ADAPs), as well as to secure similar forms of reimbursement


for


HCV patients who are not co-infected with HIV. We stressed how the


bulk of


the target markets for HCV treatment are not covered by private


insurance.


We pointed out how high drug prices are forcing people out of the


market for


private insurance and causing dramatic increases in the "co-pays" for


prescription drugs. Earlier on, many advisory board members,


activists and


HCV coalition members worked with the FDA to clear the path for


regulatory


approval of Pegasys, stressing the need for competition because of the


incredible price charged by Schering. Most of all, we warned Hoffmann-


La


Roche not to use the Schering price as a standard of reference, but


rather


make its pricing decision on a higher moral and ethical plane..




To our dismay, it appears that Hoffman-La Roche wasn't listening. Your


company chose a price that, unbelievably, is in fact higher on an


annual


basis than Schering's: $13,963 for a year's treatment with Pegasys,


versus


$13,116 for Peg Intron. We have all experienced this as betrayal.


Since the


price is so close to that set by Schering, it is obvious that your


company


simply decided that all it had to do was come near their price.




It's also striking that the Pegasys price is higher, by a large


amount, than


that any of the antiviral drugs developed for treatment of HIV, which


may be


the most reasonable point of reference. By comparison, Pegasys isn't


even a


new drug, but rather the application of a well-known modification to


an


existing drug. It is hard for us understand how such excess can be


ethically


justified. We recognize that Pegasys requires a greater quantity of


base


interferon as a raw material, but certainly not so much that it


justifies


the incredible annual price.




We recognize and appreciate that Hoffman-La Roche is providing free


drug for


the first twelve weeks, but that program will be forgotten after


January of


2003, just a few weeks from now. Its effect on overall pricing is


minimal.


We hear that the "real difference" might come when Roche's version of


ribavirin is added to the mix, that the price for this very old, very


cheap


and easy-to-make, off-patent drug will be substantially lower than


that


charged by Schering. We should certainly hope so, since Schering'


ribavirin


price borders on the criminal. Yet we have no reason at present to


believe


that Hoffmann-La Roche will suddenly change its spots and sell


ribavirin at


an appropriately low price. We expected a lower price for Pegasys


and got


one even higher than anyone imagined. Given the history, age, and


manufacturing simplicity of ribavirin, it would be impossible to


justify a


price even as high as the lowest priced nucleoside analogue used in


HIV


disease, which is under $3000 per year. Will your company listen to


us this


time?




We also made a major point that your pricing for Pegasys would be


closely


watched as an indicator of your intentions with regard to the pricing


of the


upcoming HIV entry inhibitor Fuzeon. Based on the Pegasys pricing, we


are


now gravely concerned about your plans for Fuzeon. An excessive price


will


surely lead some state ADAPs into virtual bankruptcy while further


reducing


the number of indigent HIV-infected Americans who can access this


program.


ADAP programs are already struggling underneath an anticipated


deficit of at


least $162 million in FY 2003. Many of us have worked for the last


few years


helping Roche and Trimeris ensure that the development of Fuzeon was


responsive to community concerns and the needs of people with HIV. In


light


of the Pegasys pricing, the company's protestations about the extreme


costs


of manufacturing Fuzeon will now fall on deaf ears. In it's pricing of


Pegasys, Hoffmann- La Roche has demonstrated that its pricing


policies are


based on greed and opportunism rather than legitimate need.




We await now with a sense of grave foreboding the pricing of both


ribavirin


and Fuzeon. The bonds of trust we had striven so hard to build with


Hoffmann-La Roche have suffered a severe setback. Hoffmann-La Roche


is


unlikely to enjoy the level of open communications and trust it had


recently


achieved with the hepatitis and HIV communities. Hoffmann-La Roche has


demonstrated the limits of that trust and communication by its


indefensible


price for Pegasys.




This letter is not the end of the matter from our point of view. We


will


continue to explore ways of lowering these prices. We believe your


company


has made a profound mistake, the result of which will be a much


smaller


market for Pegasys than might otherwise have been the case. We will


explore


all possible methods of telling this story in the media and the US


Congress,


both of which are currently very interested in the subject of drug


pricing.




We remain willing to meet with you or your designees to discuss this


matter


further. But as of now, we can only express our complete and utter


discontent, dismay and disappointment with your actions.




Sincerely, (in no implied order)




D.O.C. Religious Advisory Committee, Frontline Hepatitis Awareness


Fair Pricing Coalition


Hepatitis C Action & Advocacy Coalition (HAAC)


Hoffman-La Roche HCV Community Advisory Board


HIV and Hepatitis.com


AIDS Action Baltimore


AIDS Community Research Initiative of America


AIDS Treatment Data Network


Project Inform


Treatment Action Group


David Gilden, New York, NY


Michael Marco, Washington, DC


Tracy Swan, Co-Infection Project Director, TAG


Lynda Dee


Martin Delaney


James Learned


Allan Clear, Executive Director, Harm Reduction Coalition