Treating hepatitis C means expanded role for primary care

April 24, 2014

What screening recommendations and the arrival of new-but expensive-treatments means for primary care practices

New hepatitis C treatments, along with recommendations that all Baby Boomers be screened for the disease, are expected to fill up the schedules for physicians who specialize in treating this challenging condition. As a result, primary care physicians (PCPs) are going to start seeing more hepatitis C patients in their offices, experts say. 

The new drugs are a welcome development for physicians who have struggled to treat hepatitis C, but they come with hefty price tags. Deciding when and how to use them will require a sophisticated decision-making rubric that PCPs will need to be able to understand and manage.

Steven D. Pearson, MD, MSc, president of the Institute for Clinical and Economic Review in Boston, Massachusetts, predicts PCPs will see a big wave of pent-up hepatitis C inquiries for a few years but thinks it will even out with time. “If we do a good enough job screening and treating for this now, it will level out,” he says.

Although current treatment options are complex, future improvements may simplify the regimens, making it easier for PCPs to manage them on their own, says Rena Fox, MD, a professor of medicine at University of California, San Francisco, with a special interest in hepatitis, and medical editor of the hepatitis C website for the U.S. Department of Veterans Affairs.

Next: New CDC testing recommendations

 

Testing recommendations

In 2013, the U.S. Preventive Services Task Force (USPSTF) issued a recommendation that all patients born between 1945 and 1965 be tested for hepatitis C, regardless of whether they have any known risk factors. The Centers for Disease Control and Prevention made the initial recommendation in 2012.

According to a USPSTF article in the September 2013 Annals of Internal Medicine, three-quarters of U.S. hepatitis C patients are Baby Boomers, with a peak prevalence of 4.3% in people aged 40 to 49 years from 1999 to 2002. The disease’s general prevalence in the United States is 1.6%.

Albert L. Siu, MD, MSPH, co-vice chair of the USPSTF, says some patients are hesitant to admit they engaged in past high-risk behavior such as intravenous drug use, which is the reason for the blanket recommendation.

“We would miss a lot of people if we just used our judgment to decide who to test,” he says. “People may not recall using intravenous drugs just once 30 or 40 years ago or understand that puts them at high risk. They just don’t see themselves that way.”

Until this recommendation, patients were typically screened only if they had risk factors such as blood transfusions before 1992, or a history of injectable drug use. If the recommended screening of this population is fully implemented, many patients will be surprised to learn they have hepatitis because it rarely has noticeable symptoms, Sui says.

Fox does not think most PCPs have fully adopted the screening recommendation yet. “It’s probably the minority that is actually screening their patients, only because there are so many tasks for a primary care physician that it may not be fully incorporated into their usual practice yet,” she says.

Testing considerations

Fox stresses that a positive antibody test does not necessarily mean the patient has chronic hepatitis C. A hepatitis C RNA test is needed to diagnose chronic infection.

 “Don’t stop after just the initial screening test,” she says. “About 25% of patients who have a positive antibody test will be negative for the RNA test and not actually have chronic hepatitis C. They were most likely exposed to hepatitis C but cleared it spontaneously.”

Next: New options for treating hepatitis C

 

She says patients who are confirmed as being positive for hepatitis C RNA should undergo hepatitis C virus genotype testing, as well as testing to look for evidence of viral co-infections such as HIV or hepatitis B. Physicians also should assess the patients’ liver function and vaccinate them against hepatitis A and B if they are not already immune, she says. Finally, evaluate if the patient is a candidate for anti-viral treatments.

New treatments

The new treatments are very expensive and not right for everyone, which means some patients will have to be told they cannot or should not have them-at least right away. [See sidebar on the history of hepatitis C treatment options.]

One of the new drugs, sofosbuvir (Sovaldi), costs $1,000 per pill, making a 12-week course $84,000. Some patients may require a 24-week course, doubling that total to $168,000. Another new option, simeprevir (Olysio), costs  about $800 per pill. Simeprevir regimens are for 24 to 48 weeks. Those costs may be in addition to the traditional drug regimen used with hepatitis C, which may include injectable interferon and oral ribavirin.

The drugs’ manufacturers defend the costs, saying that the medications can avoid the need for costly treatments later, including liver transplants.

Because only about 20% of hepatitis C patients progress to developing cirrhosis, Fox notes that some cost analyses have modeled that the upfront cost of treating the hepatitis C population as a whole at this price would outweigh the cost savings of avoiding future cases of liver cancer or liver transplants. But models also show that treatment limited to those patients who have developed advanced liver disease would result in substantial future savings.

She notes that many other drugs are in the pipeline but cautions that they might not come with lower price tags, at least at first.

“We don’t know if increased competition would lower prices, or if new drugs might cost just as much,” she says.

Treat or refer out?

Fox, who is a PCP as well as a specialist in hepatitis C, says that currently, since there are many complex decision points about which patients should be treated and how, it may be best for PCPs to refer patients to a hepatitis specialist.

“My hope, and the hope of most specialists, is that as the treatments become more standardized and less individualized, nonspecialists will be treating hepatitis C on their own,” she says. This will be good for patients as it will increase their access to care, “however, we anticipate that payers will restrict these drugs to experienced physicians for now.”

Pearson agrees, comparing the learning curve with these treatments to the one physicians saw when drugs to treat HIV/AIDS were first emerging. “New drugs and new combinations were being introduced regularly and it was hard for primary care doctors to keep up,” he says.

“There will be an awkward phase where some primary care doctors will want to refer most or all of their patients whom they screen and are positive to a specialist. Over time, though, they will learn and the drug combinations will become more stable and more of the care of these patients will shift into primary care,” he predicts.

For now, Pearson recommends PCPs talk to colleagues in their network or community who are experienced in the treatment of hepatitis C and start to design a coordinated care plan for these patients.

Next: The importance of communicating with patients

 

Payers’ response

Payers seem to be treading cautiously as they get requests to pay for these new drugs. Pearson says many are developing formal policies about coverage, and until those are complete requests are being considered individually. Patients with more extreme liver fibrosis likely will be given stronger consideration than those without liver problems, he says.

“We don’t need to jump on every positive test and begin treatment. It’s a tough decision because you never really know how fast the liver will deteriorate,” he says “It’s also a new situation, in which we will tell a lot of  people they have a serious infection and we could treat it now but we may recommend waiting for the time being. That’s not an easy conversation to have. No one wants to feel like we are not treating because of the cost because that’s not the only reason, but it is part of the conversation.

“If we take 100 patients with hepatitis C, only about 30% will end up with serious liver problems,” Pearson continues. “Maybe 5% would need a liver transplant or die from liver problems, so we will have to treat a lot of patients but because we don’t know ahead of time who will need it and who won’t.”

Patient communication

Good doctor-patient communication about the screenings and treatment decisions will be very important. Pearson recommends telling patients who resist being tested that the CDC says 1-2% of the U.S. population is infected and probably less than half of them know it, he adds.

Siu says patients should be told that the screening is voluntary, but they also need to understand the high incidence rates in their age range mean it makes sense.

Fox encourages PCPs to discuss the subject in a non-judgmental way. “The issue is not how they got the infection. The issue is how best to treat them now,” she says.

Pearson says communication about adherence to the regimen is also important once patients begin treatment. “If we are going to give patients these expensive drugs, we of course want them to actually take them,” he says.

He predicts that the task of making them fully aware of the importance of taking the full regimen will end up on the shoulders of PCPs long term.

“They will need to communicate to patients and get them to fully commit to following through,” he says.