AIDSWEEKLY Plus; Monday, September 21, 1998
Daniel J. DeNoon, Senior Editor
Companies that bring potent new antiretroviral drugs to market deserve a reward in addition to compensation for development costs. But this reward cannot come at the cost of collapsing the fragile system that makes it possible for many people with HIV disease to stay alive.
Two new AIDS drugs are on the verge of entering the market: DuPont Pharma's efavirenz and Glaxo's abacavir. These drugs will mean life or death to many patients who already have failed currently available treatments. They will greatly strengthen the AIDS drug armamentarium.
How ironic it would be if overpricing of these and other drugs in the development pipeline overwhelmed the ability of government and private programs to provide anti-HIV drugs to those who need them.
The Fair Price Working Group has developed the following "Consensus Statement on the Pricing of Abacavir and Efavirenz:"
"We, the undersigned, have grave concerns regarding the overall cost of therapy for HIV disease.
"While we are heartened by the progress made in moving toward simpler, easier to use regimens, we are dismayed by the possibility that prices of new drugs in the nucleoside and non-nucleoside RT inhibitor class might be similar to those of protease inhibitors, rather than other drugs in their own respective classes. Such inappropriate pricing will quickly outweigh any possible added benefits of new drugs like abacavir (Ziagene) and efavirenz (Sustiva).
"As drugs become available which might facilitate better adherence and possibly more durable long-term treatment, manufacturers should be planning to lower the daily cost of their regimens, not increase them. The long-term survival afforded by the present generation of therapies makes it possible for manufacturers to set lower, or at least stable prices, and still have adequate incentive to reinvest in continued development of HIV/AIDS drugs. Recently cited reductions in the overall cost of health care for HIV infected people will almost certainly be reversed in coming years if manufacturers continue to increase or maintain current pricing levels.
"We are in a new era in the treatment of HIV disease and rethinking drug pricing which reflects this changing reality is long overdue.
"To the best of our knowledge, the development costs of these drugs were not comparable to those of the first protease inhibitors, nor is on-going cost of product as high. Quite the contrary, because of the efficiency of the new drugs, far fewer pills and thus much less physical product is required for dosing on a daily basis. Similarly, there has been nothing extraordinary about the cost of clinical trials required to bring these drugs to market.
"Abacavir and efavirenz are likely to be used by both treatment-naive and treatment-experienced patient populations, making their potential market very large. If the prices are high and either or both drugs used in naive populations in place of existing drugs, the overall cost of therapy will go up. An even greater cost penalty will occur for treatment- experienced patients, who are likely to use both drugs together, often in combination with a protease inhibitor. This would lead to an unacceptably high cost of therapy. We cannot stand idly by while the price of living with HIV disease escalates so rapidly.
"State ADAP [AIDS drug acquisition] programs have limited amounts of money allocated to them each year. Many of the state's annualized programs are bankrupt prior to fiscal year- end. Some state ADAP and Medicaid programs have removed vital medications to prevent and treat opportunistic infections from their formularies. State ADAP and Medicaid programs are under close scrutiny by governmental panels in order to cut costs.
"The price of one drug can affect the availability of other medications. Increasingly, this same sad scenario is beginning to affect the availability of drugs within HMO settings. The price of these drugs will have a pervasive impact on the overall quality of care people with HIV/AIDS receive in this country.
"The sponsors of abacavir and efavirenz have both expressed a strong desire to create goodwill and cooperative working relationships with the community. No one wants to see those relationships jeopardized or eroded over this issue, but that surely will happen if pricing is inappropriate. As we face another round of price setting, industry must recognize this is an issue that is now moving to the forefront.
"Exploitative pricing will trigger widespread hostility, contentious debate and closer scrutiny of industry practices in general. This will have far-reaching consequences. Have DuPont Pharma and Glaxo Wellcome considered the possible repercussions of opening this Pandora's box? Are you willing to risk the aftermath of ill will within the community and to be held accountable within industry?
"Therefore, we must clearly state for the record that the only acceptable prices for these drugs must be in accordance with other drugs of their respective classes. We urge manufacturers to immediately begin a dialogue with the community about this pricing issue and not presume it can simply announce a price immediately prior to regulatory approval, without consequences, as a fait accompli."
FAIR PRICE WORKING GROUP:
Martin Delaney, Project Inform; Dave Gilden, GMHC/Gay Men's Health Crisis; Ron Baker, San Francisco AIDS Foundation; Linda Grinberg, FAIR/Foundation for AIDS & Immune Research; Bill Bahlman, ACT UP New York; and John James, AIDS Treatment News
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