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Baby Boomer Screening, Game-Changing Drugs Change the Landscape for Hepatitis C Treatment

Mary K. Caffrey
AJMC Panel Reviews Treatment, Cost Impacts of Emerging Shift to All-Oral Regimens With High Cure Rates
As Nezam H. Afdahl, MD, sees it, treatment of hepatitis C virus (HCV) is at a moment of “revolution,” one on par with the mid-1990s wave of antiretroviral combinations that converted human immunodeficiency virus (HIV) from a death sentence to a chronic illness. Now, if only providers, payers, and pharmacy managers can agree on who needs the breakthrough treatments, and how to pay for them.

Afdahl, associate professor of medicine, Harvard Medical School, and chief of hepatology, Beth Israel Deaconess Medical Center, was among the participants on a panel discussion convened by The American Journal of Managed Care on how changes in HCV treatment, coupled with a call to screen an entire generation of adults for the disease, promises to upend both care management and balance sheets, with important implications for the nation’s Medicare program.

Joining Afdahl were Steven Miller, MD, chief medical officer of ExpressScripts, and David Winston, MD, section head of gastroenterology and hepatology, Cigna HealthCare of Arizona. Leading the discussion was AJMC co-editor in-chief A. Mark Fendrick, MD, of the University of Michigan and a practicing primary care physician (PCP), an important perspective for this discussion, as new all-oral treatment regimens hold promise of putting at least some HCV treatment back in the hands of PCPs.

Last year, the US Preventive Services Task Force (USPSTF) recommended that all adults born between 1946 and 1964—the Baby Boomers—have a one-time antibody test for HCV. An  estimated 3.2 million people in the United States have the disease, but most do not know they do, and the Baby Boomer generation is the most at risk. Under the Affordable Care Act, the USPSTF recommendation means the screening itself will not require a copayment for this group. (Fendrick noted that ironically, high-risk patients outside this generation will still have to pay for screening.)

A baffling and debilitating liver disease, HCV gained steam in the early 1980s, before blood products were routinely screened for its presence. Other risk factors included the use of injectable drugs. Many who contracted HCV in this era did so unwittingly, whether they were patients who needed blood transfusions or nurses who were stuck with a needle on the job. Given the age of the targeted screening population, there are enormous health and financial implications of the USPSTF action, which Fendrick referenced when he noted that screening Baby Boomers now will put most treatment costs on the doorsteps of commercial payers, rather than “the great payer,” Medicare.

With HCV treatment moving from “chronic care” to “cure,” screening Baby Boomers now, before most of them retire, means that those found to be carrying the virus have the opportunity not only to avoid becoming more ill, but also to pay for their cures while many of them are still employed, rather than when they retire and rely largely on Medicare.

Costs and Benefits of All-Oral Therapy

The arrival of oral agents such as sofosbuvir and simeprevir has changed treatment of HCV on multiple fronts, Afdahl, Winston, and Miller agreed. According to Miller, treatment regimens centered on 48- or 52-week courses of injectable interferon, with multiple side effects, were so onerous that neither health plans nor patients were clamoring for screening.

That’s all changed, and there’s good news and bad news. The good news, according to Afdahl, is that new all-oral regimens are producing cure rates of 94% to 99%. He notes, these are cure rates—not better management of a chronic condition. Some regimens are as simple as a single pill a day. “The conversation of how to get this to our patients is more than important,” Afdahl said.

Miller agreed. “These new agents are adding tremendous value, if you look at both the tolerability of the drugs and the cure rates,” he said. The lack of side effects means adherence rates “are much greater than what we have seen historically.” The downside is that the cost, in the short run at least, could be very, very high. Miller said health plans are bracing themselves for the combined effects of the screening recommendation and therapeutic regimens that can cost $100,000. If it costs a health plan $10 per covered life to treat HCV today, that number could jump to $45 by 2015, he said, although more competition among different agents could help drive down costs.

Afdahl said, however, that the proper way to evaluate the cost of the new oral agents is on a “cost per cure” basis, as the long-term costs associated with HCV–including the possibility of a liver transplant–would be eliminated for patients who succeed on the new therapies. Winston agreed that the near-term cost of widespread screening and funding therapies had to weigh against the long-term costs for patients whose HCV progresses due to a lack of diagnosis. Such a patient may end up being treated for a very expensive condition such as cirrhosis of the liver.

Depending on how far the disease has progressed, patients may decide not to be treated right away and instead to just be monitored, he said. But the patient would still have the knowledge, and the opportunity, to make lifestyle changes to slow the progression, such as avoiding alcohol. “A patient needs to know what he has and what the prognosis is,” Winston said.

Who Should Provide Care, and When?

According to Winston, the decision by USPSTF to recommend screening for all Baby Boomers is rooted in a simple fact: primary care physicians were not doing a good job of identifying patients at risk for HCV and sending them for testing.

And, even after the recommendation, payers have plenty of work to do to get PCPs educated about the need for screening, he said. “Primary (care doctors) don’t like to order expensive tests, and they still need to screen for risk factors,” for those patients who are not Baby Boomers, Winston said.

Once widespread screening takes hold, it has been estimated that 1 million new HCV positive patients will be identified, and they will require different levels of care. Which brings up the question: with the new oral agents, who should provide the care? Can a PCP suffice?

Afdahl and Winston were enthusiastic about the role PCPs could play in HCV care with the emergence of oral agents. “I actually think this is the appropriate thing to do, and the most cost-effective.”

At ExpressScripts, Miller said, it is “crucial” that a hepatologist be involved on the front end of care. The hepatologist can decide what therapies are appropriate, how much of them, and, most importantly, for how long. It may be appropriate to send the patient back to the PCP during the for monitoring, he said.

Miller said this approach is especially important in the early history of the new oral therapies, until providers, payers, and pharmacy managers gain more experience with treatment and administration of what are very expensive drugs. Fendrick, as a PCP himself, seemed to agree with this suggestion, given the “rapid amount of innovation in this fairly broad population.”

Given the cost, Fendrick asked whether all HCV patients would be eligible for new therapies, or just those who have reached a certain level of progression with their disease?

Afdahl said the leap forward that the new therapies represent, particularly with regard to side effects, means that they should not be withheld for this reason. “I hate to think we are putting patients on less effective, less safe treatment because of cost,” he said.

Winston agreed. “We’re dealing with a progressive disease. We don’t want to deny treatment that might prevent more severe disease in the future.”

He and Miller agreed that proper staging and management would be essential. Oncology will provide a model for administration; Miller said pharmacy managers will likely employ strategies such as prior approvals and additional testing to ensure that the right treatment has been selected. Split fills will be used to gauge how well a patient tolerates a new drug to avoid waste. “We can’t afford waste when it’s this expensive,” Miller said.

Coverage and cost-sharing will vary, Winston and Miller agreed. Healthy, technology-driven companies will see the value and likely provide better coverage than companies that are struggling, Miller said. With HCV a problem not just in the United States but worldwide, his hope is that competition among pharmaceutical companies will bring even more therapies into the market and drive down costs.

All 3 panelists agreed that the promise of the new treatments is enormous. “This is one of those moments in time when a revolution is taking place in terms of a disease state,” Afdahl said. Added Winston, “This will be the first virus we can cure, and we will cure 95% of it. Somehow, we have to figure out a way to pay for it.”

“It would be a real shame to have these great cures that aren’t available because of the price,” Miller said.

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