Trump’s Proposed Budget Undermines His H.I.V. Plan, Experts Say

President Trump’s 2020 budget request of an extra $291 million to fight the spread of H.I.V., experts said on Tuesday, will not be remotely sufficient to meet the goal he announced in his State of the Union address: to nearly eliminate the AIDS epidemic in the United States within 10 years.

Mr. Trump’s plan focuses on 48 counties where about half of new infections occur, and seeks to cut the rate of new infections by 90 percent — from about 40,000 a year to about 4,000.

Virtually all H.I.V. experts agree that his plan is medically sound. People living with H.I.V. cannot transmit the virus if they are taking a daily triple-therapy drug cocktail. And a two-drug regimen, in a single daily pill known as PrEP, makes it almost impossible to get H.I.V., even through unprotected sex or needle use.

But the plan requires a vast two-pronged attack. All Americans with H.I.V. must be found, put on antiretroviral drugs and kept on them for life; and all those at high risk of infection must be put on PrEP for as many years as they are sexually active or using drugs.

The cost of doing that will be daunting. About 1.1 million Americans have the virus, and about one million are in danger of getting it. Finding, treating and keeping them all in treatment, experts estimated, could add another $25 billion a year to the $20 billion a year that the federal government, by its own estimates, already spends on H.I.V. prevention and treatment.

Calculating the total price is complicated, because so many expenses are tucked into so many budgets. One government agency does vaccine research, another does public education, and many pay for medical care.

Mr. Trump’s $291 million is discretionary spending; for example, it would help the Centers for Disease Control and Prevention do more testing and would assist local clinics in reaching more people at risk.

But one way or another, the drugs must be paid for, and private insurers will not foot the whole bill. Many of those affected are uninsured or covered under Medicare, Medicaid, the Veterans Affairs department, the Indian Health Service, the Ryan White H.I.V./AIDS Program or other government programs.

Mr. Trump’s budget request envisions giving the Ryan White program another $120 million next year — but simultaneously cutting Medicare and Medicaid by more than $2 trillion over 10 years.

That’s why Mr. Trump’s attacks on Medicaid and the Affordable Care Act are “so problematic,” said Jeffrey S. Crowley, a director of the White House Office of National AIDS Policy during the Obama administration. Programs like those foot the biggest bills.

Over the years, several administrations have announced plans to halt the spread of H.I.V.

In 2001, the C.D.C. said it would cut new infections in half within five years. (The rate did not budge.) In 2010, President Obama laid out his strategy, updating it in 2015.

The Obama administration did not estimate the strategy’s cost, Mr. Crowley said.

But an analysis of it in 2017 by experts at Massachusetts General Hospital concluded that the effort would require an additional $120 billion over 20 years, and that new infections would be cut by only 40 percent during that time.

By contrast, Mr. Trump’s plan envisions cutting infections by 90 percent in half that time, noted Dr. Rochelle P. Walensky, the lead author of the Mass General analysis. Mr. Trump’s plan would use PrEP to protect the uninfected, while Mr. Obama’s plan envisioned using only condoms.

Because those medications are so expensive, Dr. Walensky estimated that the total additional cost of Mr. Trump’s plan could easily reach $250 billion over a decade.

When antiretroviral triple therapy was adopted in 1996, it cost about $20,000 a year. Since then, the Food and Drug Administration has approved 30 antiretroviral drugs and a dozen one-pill combinations.

But the price has only gone up. A typical treatment regimen is now as much as $50,000 a year. Truvada, the only pill now approved for H.I.V. prevention, is $20,000 a year.

At those prices, the drug bill alone for 2.1 million people would be $75 billion a year.

The next biggest item, Dr. Walensky said, would be laboratory testing. Finding most of the 1.1 million infected people in the American population of 325 million would require tens of millions of H.I.V. tests.

They cost only $10 each, “but the manpower costs are not trivial,” she said. And various lab tests would cost about $325 per person per year.

Doctor’s bills would also mount. Relatively healthy H.I.V. patients cost about $3,600 a year in medical expenses; sick patients needing hospitalization cost $40,000, on average.

“Adherence” costs — paying case managers and counselors to track reluctant patients and keep them on their pills, which can even include personally escorting them to medical visits — add about $400 a year per patient.

“That’s ballpark,” Dr. Walensky said. “It’s kind of a squirrelly figure.”

A representative for the Department of Health and Human Services shown a summary of Dr. Walensky’s cost calculations declined to comment on it.

Deep cuts in drug prices “would be a huge win in controlling the epidemic,” Dr. Walensky said, because those savings would cover the counseling, testing, doctor’s visits and other costs.

The actual costs of making H.I.V. medications are far lower than their retail prices might suggest.

Triple-therapy drug cocktails considered state-of-the-art here as recently as two years ago are now available as generics from India for as little as $72 a year. (American taxpayers buy at those prices for patients in Africa through the President’s Emergency Plan for AIDS Relief.)

Generic versions of Truvada are as little as $50.

Even when the sky-high costs in the United States can be covered by one program or another, the paperwork baffles patients. Many, feeling overwhelmed, just drift off and never start on medication.

“Every glitch is a chance for the health system to fail,” Mr. Crowley said.

Only about a tenth of all Americans who should be on PrEP are on it. In a recent poll of gay men in California, 87 percent said they would take PrEP if it were free; almost 60 percent believed they could not afford it.

Clinicians treating H.I.V. patients are frustrated.

Dr. Leandro Mena, medical director of Open Arms Healthcare, a Mississippi clinic focused on reaching gay black men in the rural South, argued that “the U.S. should buy the license for PrEP and give it free to every person who needs it.”

Legally, the government does not need to buy the license. By law, it can simply take patent licenses away, as it can driving or hunting licenses. Various federal statutes allow officials to do so in return for paying royalties or, sometimes, while paying nothing.

That threat can be wielded to pressure a drug company to slash prices, said James P. Love, an expert on patients and director of Knowledge Ecology International, an advocacy group focusing on intellectual property.

In 1917, the government exercised this authority against the Wright Brothers to force their company to lower the price of airplanes for the Army and Navy. Today, however, the federal government almost never uses that power.

In 2001, during the anthrax scare that followed the World Trade Center attacks, Tommy G. Thompson, the secretary of health and human services, pressured Bayer A.G., which held the patent on Cipro, an antidote to inhaled anthrax, to sharply cut prices.

Mr. Thompson threatened to seek congressional permission to import generic ciprofloxacin for the government stockpile. (Alex M. Azar II, the current secretary of health and human services, was the department’s general counsel at the time.)

Additionally, government has “march-in rights” under the 1980 Bayh-Dole Act, Mr. Love said, because it paid for much of the original research on Truvada’s component drugs.

Those rights allow officials to “march in” and reassign the patent to other manufacturers without compensation if the medicine is needed for government purposes. Behind the scenes, the pharmaceutical lobby is fighting to cancel march-in rights.

At the lobby’s request, Mr. Love said, the National Institute of Standards and Technology has proposed limiting march-in rights only to “declared national emergencies” — which would not include using them just because the prices were too high.

Donald G. McNeil Jr. is a science reporter covering epidemics and diseases of the world’s poor. He joined The Times in 1976, and has reported from 60 countries. 

Source: Read Full Article