Featured Health Business Daily Story, July 10, 2015

Harvoni Eight-Week Regimen Can Help Cut Costs Without Sacrificing Outcomes

Reprinted from SPECIALTY PHARMACY NEWS, a monthly newsletter designed to help health plans, PBMs, providers and employers contain costs and improve outcomes related to high-cost specialty products. Sign up for an $84 two-month trial subscription today.

By Angela Maas, Managing Editor
June 2015Volume 12Issue 6

When Gilead Sciences, Inc.’s hepatitis C drug Harvoni (ledipasvir/sofosbuvir) came onto the market last fall, its impressive clinical trial data were almost lost in the uproar over its price — $1,125 per pill per day. The drug is indicated for genotype 1 patients, which is the most common hepatitis C infection in the U.S., and its label allows for treatment regimens of eight, 12 and 24 weeks based on certain patient characteristics. And while the 12-week course — and its $94,500 price tag — is the most common regimen, some early data are showing that almost one-quarter of patients on Harvoni are qualifying for the shorter — and less expensive — eight-week regimen.

For treatment-naïve patients either with or without cirrhosis, treatment with Harvoni is indicated for 12 weeks. However, the drug’s label notes that an eight-week treatment duration “can be considered in treatment-naïve patients without cirrhosis who have pre-treatment HCV [i.e., hepatitis C virus] RNA less than 6 million IU/mL.” In the ION-3 trial, which enrolled treatment-naïve patients without cirrhosis, 202 out of 215 patients, or 94%, on the eight-week course achieved sustained virologic response — which essentially means they were cured — while 208 out of 216 patients, or 96%, achieved SVR on 12 weeks of treatment. Among the trial participants who had an initial viral load of less than 6 million IU/mL, 119 out of 123, or 97%, achieved SVR on the shorter course, while 126 out of 131, or 96%, on the 12-week treatment achieved SVR.

Eight-Week Course Works for Some

At specialty pharmacy Burmans, among 1,093 genotype 1a and 1b patients who have completed treatment over the last six months, 385, or 26%, “have a clinical profile which may qualify them for 8 weeks of therapy; that is, they are treatment naïve, with an initial viral load of less than 6 million and noncirrhotic,” explains Paul Urick, president of Managed Markets & Industry Relations at Burmans. He tells SPN that “of the patients who have this clinical profile where eight-week treatment may be appropriate at the discretion of the physician, 74% of genotype 1a or 1b patients were treated and completed Harvoni using an eight-week regimen at Burmans. While only about one in four patients may qualify for eight-week treatment regimens using real-world data and according to the Harvoni label, Burmans has had three out of four of these patients reach a cure with eight-week treatment regimens.”

According to Urick, “We know that not all physicians will be willing to prescribe eight weeks of treatment at all times, especially since each patient may have extenuating circumstances beyond prior treatment status and cirrhotic status, among other factors....It’s at physicians’ discretion as to how long they want to treat patients,” he says. “Further, we understand that the ION-3 trial does show 5% relapse rate and 94% SVR [for the eight-week regimen] versus only 1% relapse rate and a 96% SVR in 12-week treatment cohorts. Our pharmacists work with doctors on each patient to shorten therapy where possible to eight weeks....We have found that education is necessary since eight-week treatment was slow to be considered when Harvoni first came to market.”

Urick notes that “Burmans has been working hard to identify patients who may receive eight weeks of treatment in order to produce best clinical outcomes while saving patients and health insurers money. Each eight-week treatment cycle would cost $63,000 on a Wholesale Acquisition Cost [i.e., WAC] basis and save 33% per patient, or $31,500, versus 12-week treatment cycles.”

“This is a great opportunity to make a difference to patients,” and it’s great for payers as well, he says.

Applying those costs to Burmans’ data, for the 74% who completed an eight-week course of Harvoni among the 385 people who were eligible:

  • If those people had been on a 12-week regimen, the WAC would have been $26,923,050.

  • But the WAC for these patients on an eight-week regimen actually totaled $17,948,700.

  • The patients who completed an eight-week regimen saved $8,974,350 in Harvoni costs alone.

At BioPlus Specialty Pharmacy, 20% of patients undergoing treatment with Harvoni over both the last 12 months and in 2015 were on an eight-week course, with 98% of those patients achieving SVR. “We have a dedicated clinical team that monitors patients after their last dose” to help with scheduling a follow-up visit and making sure they keep that visit, explains Elvin Montanez, Pharm.D., chief operations officer at BioPlus.

The company has what it refers to as “interventional savings” — based on guidelines from the American Association for the Study of Liver Diseases (AASLD), the company collaborates with prescribers, payers and patients to make sure patients are on the appropriate length regimen. Based on the company’s interventions, its savings over the last 12 months “have been in the millions of dollars....Savings are eight figures.” The effort, he says, “is a collaboration. It’s not a pharmacy changing a prescription, but us working with a prescriber on appropriate regimens of Harvoni.”

Firms Take Varied Approaches

At Avella Specialty Pharmacy, “less than 5% of our claims are for eight weeks,” says Eric Sredzinski, Pharm.D., executive vice president, Clinical Affairs and Quality Assurance, Pharmacy Program Director, AIDS Drug Assistance Program. “Some payers are driving eight weeks for appropriate candidates.”

Across Prime Therapeutics LLC’s commercial and Medicare members, 22% of the people who have completed Harvoni treatment did so through an eight-week regimen, Steve Johnson, the company’s senior health outcomes director, tells SPN.

At Prime, “The majority of our members seeking a hepatitis C drug regimen go through utilization management such as prior authorization, so appropriate length of therapy is established and managed via the system,” Kirsten Tiberg, vice president, Specialty Clinical Program Development, tells SPN. “For those member referrals that are not subject to prior authorization, our pharmacists at Prime Therapeutics Specialty Pharmacy review up front for appropriate length of therapy, reaching out to prescribers with questions or clarifications. Once that patient begins therapy, Prime monitors for refills and arranges for shipment based on the number of expected fills. This helps ensure they are getting and completing their treatment in the appropriate time frames to best support positive treatment outcomes.”

Burmans has a “very comprehensive program for new referrals,” explains Urick. “As soon as a doctor decides a patient will go on treatment, we do a full work-up” that includes initial viral load, liver function, kidney function and blood status, among other things. Any other relevant factors such as co-infection with HIV or hepatitis B are also determined at that time. Patient care coordinators, who are usually nurses or pharmacists, contact patients and physicians and “write up a plan” for treatment that includes patient education on aspects such as how to take the drugs, what side effects to expect and when lab dates should occur. “This is a critical part of the process,” he contends.

The company developed a Web-based software program known as HealthTrac, which contains lab data and other factors in order to “track whether patients are clearing the virus through treatment,” says Urick.

Criteria for Regimen Are Clear

BioPlus’ Montanez notes that the “FDA and Gilead Sciences were very specific as to the eligible criteria” for the shortened regimen. The AASLD “guidelines are not very strong on eight weeks, but the FDA did approve” Harvoni for this regimen.

Montanez says that “prior authorization has often given us a tremendous amount of information about patients,” including the three qualifying criteria for an eight-week course.

BioPlus has “two years’ worth of data going back initially to Sovaldi” (sofosbuvir), which is one of the active ingredients in Harvoni. The company shares those data with prescribers, plans and PBMs to demonstrate that Harvoni “is very effective in patients who” are on an eight-week regimen.

“AASLD is very clear in how to use the new agents,” and BioPlus has incorporated those guidelines in its HCV Treatment Path app to help providers stay up to date. “We want to put tools in prescribers’ hands,” he says. The specialty pharmacy also works with health plans “to create plan-specific guidelines, which are built into a live dashboard,” Montanez explains to SPN. “Plans can log in and see real-world results in real time.” The information helps with plan design, he says. “Plans may use the information to advocate treating a patient earlier rather than later.” Many insurers have had strict guidelines around which members were candidates for Harvoni, often requiring a Metavir score of F3 or F4, meaning that extensive fibrosis is present. “But you’re starting to see this barrier come down,” he says. “Eight weeks is very effective if you catch the disease early....This is a strategy that mitigates some of the costs the disease has by treating it earlier.” A question for plans is “Would you treat a patient at F2 with a viral load less than 6 million?” he asks. “With a 98% success rate, why wouldn’t you?”

Determining SVR Rate Is Critical

At Prime, says Tiberg, in order “to complement prescription fill activity,” the PBM collects SVR rates among members who have completed therapy “to understand the outcome of the treatment. We are also working on a retrospective review of claims to match the number of fills on the referrals compared to actual use.”

The SVR rate is measured between 12 and 24 weeks following the final dose of Harvoni. This means specialty pharmacies will need to continue managing patients during this time even though they aren’t taking a drug. “We have to commit to maintaining follow-up with the patient until SVR is measured and reported,” contends Montanez. “It’s worthy to note that this is an additional investment that specialty pharmacies must make to monitor patients,” particularly since “they are no longer making any money...because there’s no drug being taken. We are extending care to measuring outcomes. Specialty pharmacies have talked for years about adherence and compliance,” he points out. But in order to know these rates, “you need to know the outcome” of treatment. “Did we get there?”

Burmans “sees patients all the way through therapy and a cure,” says Urick. “It’s the only way to tell we’ve eradicated the virus.” The specialty pharmacy also monitors patients “to make sure there isn’t a relapse.” Having all these data is valuable, and not only for patient outcomes. “If providers are not getting labs done all the time, we need to do a better job together monitoring and tracking outcomes.”

At Burmans, “health insurers work with us very closely,” Urick says. And that collaboration, not just with plans but all stakeholders, will be particularly important as more therapies are expected to come onto the U.S. market. “We expect to see two more hepatitis C drugs in August, from AbbVie and Bristol-Myers Squibb,” he says. And Merck also could see approval for its hepatitis C therapy by the end of the year. These treatments will expand options for other genotypes, he notes. “This is an exciting area.”

© 2015 by Atlantic Information Services, Inc. All Rights Reserved.

At The AIS Marketplace — Specialty Pharmacy Trends and Strategies covers the most relevant topics in the specialty pharmacy arena, with details on the latest trends in: hepatitis C management; the medical benefit and site-of-care strategies; cost-control tactics such as formulary exclusions and copayments; oncology management; biosimilars; designing commercial health plans’ specialty benefits; the specialty pharmacy pipeline and other new products; and more. Click here for more information and to order the 2015 edition today!

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