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A drug doesn’t do much good if people don’t take it.
That has apparently become the situation with Truvada, the highly effective medication used in the PrEP treatment that helps people avoid contracting HIV.
Gilead Sciences, the makers of Truvada, has come under fire for increasing the price of their product by 45 percent since it was approved to prevent HIV infection six years ago.
Critics say these price hikes are putting the drug beyond the reach of many who need it.
Truvada’s list price is currently almost $2,000 for a 30-day supply.
From 2012 to 2014, about 3,200 people filled prescriptions for Truvada in those first two years after its approval.
That compares with the nearly 40,000 people a year in the United States who contract HIV.
Although there may be many reasons for the lack of prescriptions, the increasing cost of Truvada can be included as a significant factor.
“If we don’t make it possible for those that need it to have access to it, we will continue to have new infections of a completely preventable virus,” said Jaasiel Chapman, clinical research community educator at the University of Cincinnati.
Truvada works well
Truvada is actually two medicines: emtricitabine and tenofovir.
It works by blocking a certain enzyme that HIV needs to reproduce.
The drug been used for more than a decade to suppress HIV in people who have already been infected.
In 2012, it became the only drug approved by the Food and Drug Administration (FDA) to prevent healthy people from contracting HIV through sexual intercourse.
PrEP is recommended for people with a high risk of HIV infection.
This generally applies to gay or bisexual men who have had sex without a condom or been diagnosed with a sexually transmitted disease (STD) in the past six months. It also includes intravenous drug users who share needles, and heterosexual men and women who have sex with high-risk partners without condoms.
Recent research shows that taking Truvada PrEP as instructed can reduce the risk of contracting HIV from unprotected sex by more than 90 percent, and the risk of contracting HIV from injection drug use by more than 70 percent.
Copay coupons are offered by drug manufacturers to offset the cost for certain prescription drugs.
Patients covered by private health insurance are eligible for copay coupons from Gilead through the Gilead Advancing Access program.
For patients who don’t qualify, organizations such as the Patient Advocate Foundation Co-Pay Relief may help.
According to Chapman, there are also multiple studies that are currently ongoing that allow people access to PrEP at no cost.
“One such study, HPTN 083, is enrolling MSM (men who have sex with men) and transgender women who have sex with men. Individuals enrolled in this study are able to access PrEP for up to five years free of charge,” Chapman said.
Paying for PrEP
Without assistance, PrEP can become unaffordable for many people.
Brandon Brown, MPH, PhD, assistant professor and HIV expert at the University of California Riverside, told Healthline that “Paying for PrEP out of pocket could amount to more than half of the annual income for millions of Americans.”
Rising prices have prompted private insurance plans to shift a growing percentage of the cost onto patients.
More insurers are refusing to honor manufacturers’ copay coupons, saying that they steer patients toward pricier medications as they try to keep costs down.
When that happens, a patient’s out-of-pocket cost can skyrocket. This may result in patients stopping PrEP treatment.
“This is a huge issue. The increasing price of any medication lowers the accessibility to populations with less money and privilege,” said Brown.
Gilead company officials say they are trying to help solve the problem.
“We recognize that many people who are at high risk for HIV infection still face challenges in accessing Truvada for PrEP, and we are in regular dialogue with public health officials, advocates and physicians to better understand and, where possible, help to address these challenges,” Ryan McKeel, a spokesperson for Gilead, told Kaiser Health News.
Publicly funded programs that help patients access PrEP have limited resources that are strained by Gilead’s price rises.
“If these programs sustain coverage of Truvada with its increasing price, then coverage for other programs must be decreased, and other programs might have a higher priority,” said Brown.
Chapman warns “If we look at the South, where HIV disproportionately affects black MSM, we’ve found that limited resources compounded with price increases have made it almost impossible for the most at risk to access PrEP.”
No generics in the United States
Generic versions of brand name drugs are typically less expensive and PrEP is no exception.
Mylan’s Ricovir EM generic PrEP can be bought for as little as one-tenth the cost of Gilead’s Truvada.
Just not in the United States.
While the FDA approved generic versions for Truvada in 2017, the agency’s approvals for generic drugs do not specify when a generic version can be brought to market.
The FDA approval only states that they’re satisfied with the terms of a legal settlement reached between Gilead and Teva, the manufacturer approved to produce a generic version.
But it’s not unusual for a generic drug manufacturer to delay bringing a competitor to market until after the brand name company’s patent on the drug expires.
The Federal Trade Commission (FTC) has previously prosecuted other companies for entering into pay-for-delay agreements.
Brown thinks this could be the case with Truvada.
“There may be some confidential agreements between the manufacturer of Truvada and the manufacturer of generic PrEP, which include delaying the release of this new product,” he said.
For now, Truvada is the only PrEP option available in the United States.
This means the people who need it remain at the mercy of Gilead’s price increases and an overburdened healthcare system that’s strained by the rising cost of PrEP while trying to significantly reduce the rate of new infections.
“Increasing the cost of any medication lowers access for less affluent and marginalized populations, who may need it most,” said Brown. “We need a public outcry, and while this has already begun, we need to do more.”