The Impact of ART's High Cost

As the rollout of new antiretroviral therapy (ART) drugs for HIV patients continues, the cost of these drugs for patients in the United States presents a forbidding obstacle for some. A research letter in a recent issue of JAMA Internal Medicine highlights this issue and discusses ways that the health care community can tackle it.

According to the authors, who work at the Medical Practice Evaluation Center at Massachusetts General Hospital in Boston, Harvard University Center for AIDS Research, Harvard Medical School and the National Alliance of State and Territorial AIDS Directors in Washington DC, prices for ART are higher in the United States than in any other developed nation, even as rates of viral suppression are the lowest at 54%.

In 2018, the average wholesale price for a yearly supply of initial ART regimens appropriate for most people with HIV ranged from roughly $36,000 to $48,000, up from $24,970 to $35,160 in 2012. This represents a 34% increase during those 6 years, far outpacing inflation.

For people in certain clinical situations, such as those with comorbidities or coinfections, the costs of the recommended ART regimens were lower but the increases over time even steeper—from an annual mean of $25,930 in 2012 to $39,670 in 2018, or a rise of 53%.

The reasons for the high cost of HIV drugs are complex, said Rochelle P. Walensky, MD, MPH, a Harvard Medical School professor and infectious disease physician at Massachusetts General Hospital, and an author of the letter. Only recently have first-line ART recommendations for patients included generic HIV drugs. This traditional reliance on branded drugs has provided drug manufacturers with little incentive to cut prices. But even the availability of generics is not an automatic panacea. “Now that there are some drugs that are generically available, current patents have limited their co-formulation into single-table regimens, which has allowed the current branded regimens--which are easier to take as a single tablet--to keep their prices high,” Walensky told Contagion®.

There’s no one-size-fits-all remedy for escalating drug prices. “For patients with private insurance, many companies are using strategies to try to limit formularies or utilization as these costs have increased, sometimes with incentives built in for patients to use less expensive options,” said Walensky. Patients who have Medicare or Medicaid or who utilize the government’s AIDS Drug Assistance Program (ADAP), part of the Ryan White CARE Act, will pay less—but at taxpayer expense. “[However], for patients without insurance who live in states without Medicaid expansion or robust ADAP programs, options for financial support to pay for these drugs are further limited,” Walensky noted.

While precise numbers are not available regarding how many HIV patients do not use ART at all or do not take it consistently due to medication costs, “there is a clear association between drug affordability and adherence, in many diseases,” Walensky said. “If physicians work to prescribe more generics, thereby driving more competition to decrease drug costs, I believe that will move branded prices down.”

The letter by Walensky and her colleagues asserts that ART accounted for $22.5 billion in therapeutic spending in the United States in 2018. In order to meet the “Ending the HIV Epidemic” goals put forth by the Department of Health and Human Services, which include a 90% reduction in new HIV infections within the next decade, the country will have to spend more than $35 billion on ART. Reining in runaway drug costs so more patients have access to medication is a crucial component of this initiative, the investigators say.