What's New in Advocacy?
Excerpts From Hotline Memos of October, 2000
from the Information Department of Project Inform
The Food and Drug Administration's (FDA) approval on Friday of Abbott Labs' new protease inhibitor, lopinavir (Kaletra), represents more than just another new drug. On two levels, it is an example of a new and more effective advocacy relationship between the community and industry. Perhaps more than with any earlier drug, the development of Kaletra was guided by an extensive consulting process with AIDS activists, from the drug's earliest days through the clinical trial designs, and up through the expanded access program.
Ben Cheng, Martin Delaney and Project Inform board member Linda Grinberg all played in-depth roles as leaders of the community process around this effort. Their involvement included participating in a series of meetings with Abbott and other community activists as well as in many smaller, private consultations.
On a second front, Kaletra represents the growing success of the FAIR Pricing Coalition, a large ad-hoc coalition of activist groups and AIDS agencies organized by Martin Delaney and Linda Grinberg. The coalition works by creating position papers on any impending pricing of drugs, which are then used to collect support from hundreds of activist groups, agencies and individuals. When the sign-on process reaches its peak, meetings are demanded with the people at the companies who actually make the pricing decisions, usually the president and heads of marketing and public relations.
Who Is the FAIR Pricing Coalition and What Do They Do?
The community team is made of Martin, Linda, and Bill Arnold of the national AIDS Drug Assistance Program (ADAP) Working Group. Some ADAP key personnel have also been invited to meetings including Michael Montgomery, Chief of the HIV Care Branch of the California State Office of AIDS, Lanny Cross, Program Director, NY State Department of Health/ADAP, and Carmine Grasso, Program Coordinator, NJ Department of Health and Sr. Services. A small number of other activists and Medicaid personnel attend meetings as well on an ad hoc basis.
The group's first success was with Glaxo Wellcome over the pricing of abacavir (Ziagen). Glaxo had been floating a figure of around $6,000 per year, wholesale, for the drug to various state agencies when the FAIR Pricing team went in. The team's first goal was to create a price freeze on new drugs so that as new drugs became available, they wouldn't exceed the existing price of other drugs in the same class. Glaxo cooperated with the team and the outcome was a price only slightly higher than AZT and thousands below the $6,000, protease inhibitor-like price the company had hoped for.
The team was not as successful with DuPont, which priced efavirenz (Sustiva) well above other drugs in its class. However, subsequent action at least secured a three-year price freeze.
At the initial meeting with Abbott over lopinavir (Kaletra), it was clear the company viewed the drug as a significant advance over all previous protease inhibitors and intended to price it accordingly. A price that would significantly exceed that of ritonavir (Norvir), already the highest priced protease inhibitor, was the expected result. The team did its thing, laying out the consequences of such a price on ADAP and Medicaid, as well private insurance.
In the end, Abbott backed off and its president announced a price that was substantially lower than ritonavir, as well as lower than nelfinavir (Viracept) at around $6,700 per year. Ritonavir is nearly $1,000 higher, so this represents a reversal of direction on pricing at Abbott, plus it holds the line on the price of protease inhibitors. Unfortunately, it is still well above the price of indinavir (Crixivan), which has always been the lowest priced protease inhibitor by far (under $5,000).
The success of this negotiating process is unique in the history of the pharmaceutical industry. It encourages us that we will be able to make a difference on international pricing as well. For people interested in participating by signing consensus statements and supporting the FAIR Pricing Coalition, contact FAIRFoundation@aol.com.
This article was provided by Project Inform. It is a part of the publication What's New. Visit Project Inform's website to find out more about their activities, publications and services.