February 11, 2015
When a doctor wants to prescribe a medication to a patient that may deviate from the patient's insurance's formulary, the process includes an amount of paperwork so daunting that it may ultimately overwhelm the doctor, clinicians warn.
"The environment for prescribing, now that we finally have truly effective and almost completely safe medications, has become terrible," said Daniel Fierer, M.D., a leading HCV physician-researcher and associate professor of medicine at the Icahn School of Medicine at Mount Sinai Hospital. "It's become incredibly onerous to prescribe, including being unable to prescribe for many patients due to not clinically-indicated but presumably cost-driven attempts to save money by denying treatment to people who are not the sickest."
According to ACT UP NY's Annette Gaudino, the genesis of the restrictive nature of HCV cure access goes back to guidelines set forth by the American Association for the Study of Liver Diseases (AASLD). The guidelines were meant to prioritize treatment for the sickest people: those with Stage 3 and Stage 4 liver disease and coinfections. However, with the exorbitant pricing of the newer HCV drugs set to bankrupt state Medicaid programs, many insurance companies limited access to these drugs to people who had Stage 3 and Stage 4 liver disease, Gaudino said.
Fierer cited a specific case that backed up Gaudino's assertion. "It's only Medicare, actually, that ends up covering it, sometimes with a single application," he said. "But others, after a month of letter writing, got completely denied, saying an HIV-infected person with Stage 2 fibrosis is not sick enough."
One time, after a fourth appeal for a patient in need of treatment, Fierer tried peer-to-peer contact with the insurance company. "The peer just said, 'Send in your written report.' There was absolutely no discussion. She said, 'I'm just here to tell you that the answer is no; but you can send in a letter.'"
"It was astonishing to me that you can say an HIV-infected person with Stage 2 fibrosis is not good enough," Fierer said.
Meanwhile, the repeated attempts to secure coverage for their patients' HCV treatment have taken up an increasingly large amount of time and energy, Fierer added. "The only people who are not personally overwhelmed as physicians are ones who have a crew of navigators and people who can do it. It's overwhelmed my office practice and both of my [Mount] Sinai practices and, anecdotally, others around me: the paperwork, the automatic denials, the requirements from every different decision maker, having different criteria, almost non-consistent with any possible clinical care."
If doctors get into their careers to help heal the sick, then the ability to do that job is the hardest it's ever been, according to Fierer. "It is frustrating for me. It's much more work than it ever has been," he said. "They have successfully, for the first time ever, put up enough barriers."
With lines of bureaucratic red tape appearing to increase between people with HCV and the drugs that could cure them, TAG's Tracy Swan thinks this might be creating a mentality that any treatment is better than no treatment.
"With all the news coverage about how expensive the drugs are and how no one is getting them, I think it's sort of grinding people down to make them feel that they're lucky to get anything, instead of really thinking with their medical provider, 'What's the best treatment for me?'" she said.
In addition, HCV affects some of society's most marginalized populations, who may have more of a need to fine-tune treatment. According to the CDC and the New York City Department of Health and Mental Hygiene, HCV is most frequently associated with injection drug users and baby boomers, and is also highly prevalent in black communities. Occurrences of HCV are also especially high in areas of poverty and with a lack of access to quality education.
The Racial and Ethnic Approaches to Community Health across the US Risk Factor Survey (REACH US RFS) showed that blacks, Latinos, Asians and American Indians had the highest HCV infection rates (9.2%, 8.3%, 6.8% and 6.4%, respectively). The study also found that a large percentage of those surveyed were not tested for HCV, meaning that actual HCV prevalence in these communities is likely to be much higher than what is reported.
"We're talking about a lot of ex-prisoners, current prisoners, very poor people," said Gaudino.
Coinfections and contraindications -- drug-to-drug interactions or other medical considerations in a person's life that mean he or she cannot be prescribed a certain drug -- are more likely to be present among these people, experts say. And that means that restrictions on which drug can be used may have a bigger impact on whether someone is able to be treated or cured.
Other people who might be ill-served by prescription barriers are women on birth control or who are pregnant. According to Viekira Pak's prescribing guide, the drug regimen cannot be used with ethinyl estradiol-containing products, which are among the most common forms of birth control. In addition, most people who are prescribed Viekira Pak will need to take it with another drug called ribavirin -- but ribavirin is known to have the potential to cause fetal death or fetal abnormalities.
About 25% of people living with HIV in the U.S. are also living with HCV. Viekira Pak is contraindicated with many popular HIV medications, including rilpivirine (Edurant), lopinavir/ritonavir (Kaletra), ritonavir (Norvir), darunavir (Prezista), atazanavir (Reyataz) and efavirenz (Sustiva, Stocrin). Harvoni also has a restrictive list of contraindicative HIV medications, including lopinavir/ritonavir and tenofovir (Viread) (part of Atripla and Truvada). For people living with HIV/HCV coinfection, having to navigate an insurance bureaucracy may not be helpful to their health -- especially if they're only being considered for treatment because of their advanced liver disease.
Both Fierer and Swan expressed reservations about how well populations prescribed Viekira Pak would be able to tolerate ribavirin, as well. Most side effects from early HCV treatment regimens -- ribavirin along with interferon -- were assumed to be due to the interferon. But Fierer said that personal experience has changed his opinion. "In the year that I've been prescribing sofosbuvir, I found that a lot of people had a lot of pretty bad side effects from the ribavirin -- more than is typically reported -- and now I'm rethinking how a proportion of the side effects came from ribavirin."
Those assigned Viekira Pak may be challenged by the extra pill burden, as well. "[Viekira Pak's] got a few more moving parts -- the twice a day; the ribavirin in it. It may end up having a little bit worse efficacy than in clinical trials, compared to the decrement that we'll see from Harvoni," Fierer added.
Compounded with price and drug interactions, alcohol and drug use may be a limiting factor for those wishing to access treatment. Often, liver disease is a consequence of alcohol and drug abuse, meaning that those with damaged livers who may be prime for HCV treatment may be the first to be refused.
For Gaudino of ACT UP NY, this sends a devastating signal to populations that may already struggle with issues of self worth. "You're going to tell me that you have a drug that will save my life. But you're not going to give it to me until I become sober," said Gaudino. She added, "What would you do? I would drink. I would go use drugs."
HCV infection is a deadly disease, and it often affects those who are not in the best health to begin with. Yet the picture that advocates and clinicians paint is one in which people with liver disease must wait to be treated while piles of forms and still-steep drug prices continue to block access to a cure that, paradoxically, should be easier to achieve than ever thanks to the newest generation of drugs.
Somewhere, below the mounds of paperwork, beyond the PBM deals and behind insurance company drug formularies, these questions lie: What is the value of a human life? How can we best cure what ails us?
Gaudino believes the answer is unequivocal: "Treat to the label. Unless there is a medical contraindication, everyone who has hepatitis C who wants access to these drugs should get access to these drugs, regardless of where they are in their disease. Because it is a cure. And no one should have to wait to get sick to get cured."
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