RELATED ITEMS On the Web A Department of Health and Human Services agency confirmed in March that triple therapy can delay HIV disease progression. The report on the nation's ADAPs is available online. From the AP Related articles from the Associated Press are available online. Editor's Note: Some of the above links will take you out of The Post's Web site. To return, use the Backbutton on your browser. Go to National Section Go to Home Page

Demand for Drug Therapy May Overtake Public Funds

The Series Part 1: Hope and Disappointment Part 2: On the Front Line Part 3: Stopping the Virus Part 4: The Hunt for a Vaccine Part 5: Third World Despair Today's Articles Poverty Entangles Promise of Powerful Treatment Demand for Drug Therapy May Overtake Public Funds After Quitting Illegal Drugs, Patient Is Skeptical of New Medicine

By David Brown
Washington Post Staff Writer
Monday, September 1, 1997;
Page A17

The recent advances in AIDS care have set money and medicine on a collision course in the United States.

Over the next year, tens of thousands of people with human immunodeficiency virus (HIV) infection will seek triple combination drug therapy for their disease. Many of them-possibly most of them-will have no obvious way to pay for the treatment, which costs about $12,000 a year and must be taken indefinitely.

The federal and state government pay for much of the treatment now through Medicaid, the medical insurance plan for the poor and disabled, and through the AIDS drug assistance programs (ADAPs) that exist in every state. Private charity, often in the form of medicines provided free by drug manufacturers, helps plug the gaps.

In June, the Health and Human Services Department published clinical guidelines strongly recommending that people in the early, symptom-free stage of infection start on triple therapy. Although the guidelines have no legal or regulatory force, officials expect them to persuade many HIV-infected people to seek triple therapy early.

In the past, many needy people with HIV qualified for Medicaid when they progressed to AIDS. Triple therapy now offers a realistic chance that many HIV-infected people can arrest the disease early. They may never progress to disability-and never qualify for Medicaid.

The Clinton administration is considering allowing a few states to loosen eligibility rules for Medicaid so that some HIV-infected people could qualify for the program-and the prescription plan that comes with it-at an earlier stage of infection. However, a state choosing that route would not get more Medicaid money from the federal government, so it's uncertain how appealing such a policy change might be.

In the absence of other options, many HIV-positive people will turn to the state-run ADAPs for help. In most states, however, they won't find as much help as they need-or help for as long as they need it.

"The system as it now stands can't do it. There is just not enough money in the system," said Gary Rose, treatment coordinator of AIDS Action, a national consortium of AIDS service organizations.

Last year, ADAPs provided medicines-both antivirals and other drugs-to about 80,000 people. (In any given month, about 40,000 got help, usually while awaiting approval for Medicaid.) Nationwide, the ADAP budgets total $385 million this year, nearly double the $208 million spent in 1996. About 80 percent of the money comes from the federal government, with the rest contributed voluntarily by state governments.

Recently, the National Alliance of State and Territorial AIDS Directors, and the AIDS Treatment Data Network, published a report on the nation's ADAPs that describes an uneven system of public charity barely able to keep up with demand.

In the last year, 35 ADAPs have had to take at least one emergency measure to keep from going broke. These included creating waiting lists for clients, limiting access to protease inhibitors and reducing the number of drugs covered in the state's ADAP "formulary."

Even so, 44 of the 52 ADAPs reported they were spending more per month in December 1996 than in July 1996, the month that roughly marked the start of widespread use of triple therapy. Fourteen ADAPs said monthly expenditures had gone up more than 50 percent. In the country as a whole, 1,000 new people each month are seeking help from an ADAP.

The authors of the report, which was funded by the Henry J. Kaiser Family Foundation, said that 140,000 to 280,000 people may be eligible for ADAP services on the grounds of income or stage of infection. Even the lower limit of that estimate is far more clients than the programs are realistically prepared to help.

Federal funds come to ADAPs through both the Ryan White Comprehensive AIDS Resources Emergency Act and a specific earmark in the HHS budget. The Clinton administration proposed $167 million for the ADAP earmark for 1998. That amount has been increased to $217 million in the Senate version of next year's budget, and $299 million in the House's. The final appropriation has not been decided.

"The federal government is by far the biggest payer for AIDS drugs-through Medicaid and ADAPs-and the Clinton administration is determined to take a leadership role," Victor F. Zonana, a Health and Human Services Department spokesman, said recently. "But states and the private sector must do their part."

A problem even the healthiest ADAPs are facing, however, is that many clients now on the rolls are getting drug combinations considered "substandard" under the HHS guidelines. For example, the state of Washington's ADAP recently audited its records and determined that 56 percent of the clients were not on triple therapy. Presumably many of these people, and their doctors, will want to upgrade the treatment to comport with the new recommendations.

There are concerns among patient advocates that some eligible people are already unable to get access to the drugs that may prolong their lives.

When the HHS treatment guidelines were unveiled in June, The Washington Post contacted state health officials, ADAP directors and workers in AIDS service organizations in six states. They included a state with many AIDS cases and a financially sound ADAP (New York); a state with many AIDS cases and a struggling ADAP (Florida); a largely rural state (Mississippi); a state in which large numbers of previously uninsured people are now in government-sponsored managed care (Tennessee); a small city that is the hub of a region (Des Moines and central Iowa); and a distinct region of a state (coastal New Hampshire).

None of the 12 people interviewed was able to recall or cite a single case in which someone who had been prescribed triple therapy and wanted to be on it had been unable to get the drugs through any source.

Nevertheless, many AIDS activists believe that in the near future thousands of HIV-infected people who want triple therapy (and are good candidates for it on medical grounds) will have to go without-unless large new sums of money are found to help pay for the medicines.

Some AIDS activists say part of the problem is that drug companies are overcharging for the new drugs. The companies counter they must be able to recoup the cost of developing and testing the medicines. Moreover, the companies point out they currently operate generous programs that offer drugs free to patients who can't get them any other way.

As an example, in the last year, Merck & Co., the maker of indinavir, the most popular protease inhibitor (which is marketed as Crixivan), provided free drugs to more than 11,000 people, for an average of more than six months per person. All the other drug makers also run "patient assistance" programs. However, it's uncertain they will be willing to cover a huge new influx of nonpaying customers.