3TC: Glaxo Wellcome Broadens Patient Assistance

On May 20 Glaxo Wellcome Inc. broadened its Patient Assistance Program for Epivir(TM) (3TC, lamivudine), to no longer deny the drug to patients who qualify for their state ADAP (AIDS Drug Assistance Program) in states which have not included the drug in their program. A large majority of states already cover the drug, but several still do not. (California included 3TC in its program on April 25). 3TC was approved for combination use with AZT in November 1995.

Almost all major pharmaceutical companies have patient assistance programs for at least some of their drugs, although these vary greatly from company to company. The programs cost the companies little, since patients who receive a drug would otherwise not be customers but would go without, as they have no way otherwise to buy or obtain it. And the companies benefit by avoiding the public relations fallout that would occur from many people being denied expensive but life-critical drugs, due to their economic circumstances.

Recently there has been a problem of some companies excluding any patient whose public or private health insurance or managed care plan has rejected coverage for their drug (and sometimes also those patients whose health coverage has not yet made a decision). The pharmaceutical companies want to be sure that they are not used as the provider of last resort, allowing other institutions to refuse to pay for drugs they would otherwise have to cover. The problem is that patients then become pawns in the battles between large organizations. (This was not a major problem until recently, because traditionally it was taken for granted that if the FDA approved a treatment, it would be covered by health plans.) The problem around ADAP has been particularly acute, because of the current funding crisis for that program, and also because it ostensibly covers everyone in the state within certain income limits who needs HIV treatment, resulting in more widespread exclusion than private insurance or managed care programs, which only cover their enrolled members.

Glaxo Wellcome noted in a May 15 letter that its program "was never intended or designed to serve as an alternative funding resource for inadequately funded state ADAP programs. Obviously this is a stop-gap approach to the immediate problem, and the need for a viable long-term solution grows in significance every day... This kind of solution is only going to take place as a result of collaborative efforts between government, community and industry."

Merck still has a similar policy of disqualifying patients from its patient assistance program for Crixivan(R) if they qualify for other programs which have rejected Crixivan coverage, although they will cover people up until the time a state formally rejects coverage. The Glaxo Wellcome policy was even more restrictive, excluding people until the state took a positive action allowing coverage.

Comment

While Glaxo Wellcome clearly deserves credit for this change in policy, people should know that Project Inform was a key community group that undertook the difficult negotiations without which the change would not have happened. Other groups, including ACT UP/Golden Gate, had earlier pressured the company to extend its expanded access program in some states, but the extension had run out and Glaxo Wellcome had still refused to change its basic policy of excluding people in states which failed to put 3TC in their ADAP formulary.

"This issue represents a growing economic tug of war between industry and government over who should be paying the bill for uninsured patients and others not adequately served by Medicaid," said Martin Delaney of Project Inform. "The total cost of HIV drugs is dramatically rising with the routine use of combination therapy, the approval of protease inhibitors, and the fact that some patients who had previously rejected the available drugs are now coming in for treatment."

With the new policy on 3TC, many people have access to treatment recommended by their physicians, when they did not before. But now community groups will need to work with industry to lobby state governments, and the Federal government, at least as effectively as they have lobbied companies.