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When pre-exposure prophylaxisbetter known as PrEPhit the market in 2012, it was quickly recognized as a highly effective method for preventing HIV infections. So why isnt the life-saving medication free and accessible for all?
After someshort-lived handwringing that the drug wouldencourage gay men to have condomless sex, PrEP rapidly found a place in public health arsenals around the world. The medication is free or costs a few dollars a month in countries like France, New Zealand, and Kenya, but in the United States, that kind of easy access is elusive. In the worst-case scenario,if a PrEP userhad no insurance, no Medicaid, and lived in, say, rural Indiana (among many other places), they could be on the hook for a little under $2,000 a month (or $64 per pill), plus doctors fees for the prescription.
The group predominantly responsible for that price tag is Gilead Sciences, a pharmaceutical giantthat recorded over $22 billion in total revenue in 2019. Gilead has exclusive rights to produce and sell Truvada and Descovythe only approved forms of PrEP in the United Statesand it has the freedom to set prices wherever it likes.
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According to James Krellenstein, co-founder of the advocacy group PrEP4All, PrEPs lofty price tag means that a sizable chunk of government spending on HIV prevention goes directly to the company that sets the price, instead ofother prevention strategies, like community outreach.
All of the resources dont go to addressing [other] barriersthey go to pay off a company like Gilead, Krellenstein told Rewire.News.
Even then, government spending on PrEP is patchy. The most straightforward way to get free PrEP is to be on Medicaid, but low-income, uninsured adults dont meet the eligibility criteria in many states. But some municipalities like New York state and the cities of Atlanta and San Francisco do fund programs to make PrEP freefor lower-income people.
The United States Preventative Service Taskforce (USPSTF), an independent panel of experts in prevention and evidence-based medicine, recommended in 2019 that PrEP be covered fully by all private insurance plans. While the recommendation isnt a legal requirement, the Affordable Care Act (ACA) requires that most private insurance plans, as well as states with expanded Medicaid as part of the ACA, cover the full cost of any preventative service given an A or B rating by the task force. Starting January 2021, these insurance plans will be required to cover PrEP, as well as all lab work and clinic visits, with no co-pays or deductibles, according to the recommendation. (By the way, none of this helpspeople who are uninsured.)
For now, theres private insurance and its myriad co-pays and deductibles. Those left with a bill after insurance kicks in have one more option: asking Gilead for help. The company has a program that covers a chunk of out-of-pocket costs for PrEP ifinsurance already covers it to some degree.
According to Krellenstein, this isnt a particularly philanthropic move from Gileadrather, its a discount on a product that they priced in the first place.
A lot of people rely on that co-pay program, but at the end of the day, it doesnt get around the fact that even with the co-pay program theyre making $10,000 a year on a drug that costs $80 [to make], Krellenstein said, making a rough estimate on the manufacturing cost.
It doesnt seem that this mishmash of corporate and public coverage works: The Center for Disease Control and Prevention (CDC) suggests that out of 1.2 million people in the United States in the high-risk category for contracting HIV, only around 200,000 take PrEP. Plus, infection rates have declined by less than 10 percent since PrEP was approved in 2012. HIV/AIDS is an ongoing, very active epidemic, Krellenstein said.
Meanwhile, countries like Australia have closer to half of their high-risk population on PrEP. And its not because Australia is willing to spend more public moneythey have agenericversionon the market, along witha robust public system that can bargain prices down.
In the United States, Gileads Truvada patent runs out later this year, but only one genericis expected to surface in September, so only a modest price drop should be expected. Gilead is also encouraging PrEP users to switch from Truvada to Descovy, which is billed as safer (but is also patent-protected for longer) to protect its market.
While Gileads nefarious pricing is an obvious and convenient boogeyman in this case, advocates say the federal government also shoulders ashare of the blame.
The U.S. government may have had the ability to force down Gileads high prices, but didnt act on it until 2019, when it filed a series of lawsuits alleging that Gilead infringed on CDC researchers patents in developing Truvada and Descovy; Gilead has in turn claimed that the CDC infringed on its patents. While the status quo still stands, initial hearings have come down on the governments side, prompting advocates to question why the CDC didnt act earlier.
These patents were the CDCs domain they chose to do nothing about it even when they knew about these massive problems with access to the medication, Krellenstein said.
Not only that, aTrump administration program that aims to supply free PrEP to 200,000 people enrolled just 891 people since it began in December.
While the government secured the drug supply for the campaign, it didnt do the necessary outreach, particularly into Black communities where HIV infection rates are higher and PrEP use is lower, said Matthew Rose, director of U.S. policy and advocacy at Health GAP (Global Access Project), an international organization dedicated to ensuring that all people with HIV have access to affordable, life-saving medicines.
Preventative medicine has had a low uptake in these communities, he said. Some of this is due to medical mistrust and racism. It can be hard to get a provider, people may be reluctant to talk to a provider the government has to work to build the trust within those communities.
But even if the government had a flawless outreach program, 200,000 more people with access to PrEP still wouldnt be enough, Rose said. Between Gileads dominance and the high price of medical services, the health-care system simply isnt cut out for free PrEP.
Weve got to get hold of the insurance companies and the drug companiestheres just not enough money and coverage to go around to get people to live their best health outcomes, Rose said.
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