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.
By Angela Maas, Managing Editor
February 2012Volume 9 Issue 2
When the FDA approved Incivek (telaprevir) and Victrelis (boceprevir) for the treatment of hepatitis C last May, many in the industry hailed them as game-changers. Not only are Merck & Co., Inc.’s Victrelis and Vertex Pharmaceuticals Inc.’s Incivek the first oral hepatitis C therapies and the first protease inhibitors approved for the condition (SPN 5/11, p. 1), but new data just released echo the clinical trials data that indicate the drugs also show much more promise than the previous regimen of pegylated interferon and ribavirin did of actually clearing the virus.
The drugs could cut the current 48-week treatment time down to 24 weeks for certain patients if they achieve an early viral response. However, both drugs are used with pegylated interferon and ribavirin to create a triple therapy that is fairly complicated (SPN 9/11, p. 1). People taking Incivek stop that treatment after the initial 12 weeks and continue the regimen only with pegylated interferon and ribavirin, while people on Victrelis do not take it for the initial four weeks of treatment.
Patient adherence to the rigid treatment regimen is critical to the drugs’ success, and many people are expected to clear the virus, meaning they are essentially cured. Compliance with the regimen also can have a huge impact on health plans’ bottom lines. Merck set Victrelis’ weekly price at $1,100, or $26,400 to $48,400 for a course of treatment. Vertex gave Incivek a price tag of $49,200 for a 12-week regimen. Those prices mean that treatment costs for the condition have basically doubled.
Steve Burman, CEO of Burman’s Medical Supplies and Specialty Pharmacy and president of Burman’s Pharmacy, points to a study that shows each patient in which an early viral response is identified “can save the health system a minimum of $16,200 via shortened duration of treatment. With approximately 400,000 naïve/relapsed patients in the U.S., that represents the potential of reducing the cost burden to the health system by over $4 billion. Additional saving opportunities exist when you consider identifying those less-fortunate patients by applying the FDA futility rules,” which apply when patients are not responding, and the FDA recommends halting the therapy.
With patients who were among the first to be dosed recently hitting the 24-week mark in their regimens, Burman has shared exclusive data with SPN on what his specialty pharmacy has seen so far among about 700 people it has treated with Incivek and Victrelis.
Among the people taking Incivek, “50% of referrals were for patients who were naïve” to previous hepatitis C treatment, which is exactly what Vertex had estimated, he notes. Nineteen percent were relapsers, 17% were partial responders to prior therapy, and the rest were nonresponders.
Among those taking Victrelis, “63% of the patients were naïve,” with the remainder of the patients equally divided among the other three demographic groups.
Within the naïve patient population on Victrelis, “66% achieved an early viral response; therefore, they have the opportunity for response-guided therapy,” meaning the shortened duration of treatment.
Among a sample of 77 patients taking Incivek, 75% of the naïve patients were eligible for response-guided therapy, a percentage that is “actually a little bit better than controlled studies,” he says. And 91% of prior relapsers were eligible for response-guided therapy, which is “pretty much what’s expected. Relapsers have a really great chance of clearing the virus. The only thing we can do now is compare ourselves to the clinical trials data.”
With Incivek, “if people were partial or nonresponders to previous therapy, they are not eligible for response-guided therapy and instead need to go for 48 weeks of treatment.” However, says Burman, “there are some patients who are partial responders who qualify for response-guided therapy with Victrelis.”
People treated for hepatitis C with the previous two-drug regimen have always been at risk of stopping treatment because of the dreadful flu-like symptoms they cause. Adherence is even more at risk with the addition of Incivek and Victrelis, though, which bring additional side effects.
Among those people who discontinued therapy, 30% of them discontinued Incivek due to not responding to the drug, while 44% of those patients halted therapy because they were “unable to tolerate the side effects.”
In addition, “twice as many discontinued from Victrelis due to severe anemia than Incivek,” says Burman, adding that “this is what we expected.”
“We haven’t seen any problems with patient compliance on Victrelis,” which “was an industry concern because it’s a complicated regimen,” he tells SPN.
In an interesting twist, the drugs’ rigid regimens may work in favor of patient compliance. People need to go in for lab work four weeks after starting therapy. Burman’s keeps track of the date patients start their therapy — which often may not be the same day they receive their medications — through direct communication with patients. They also have certified counselors on staff who are experts on drug and alcohol recovery for patients with a history of abuse to help them stay adherent. Then through calls, emails or text messages, the company makes sure patients come back for their four-week labs on schedule.
Following the lab results, “at four weeks, at eight weeks, they’ll have a good idea of if they will clear the virus.” Bolstered with positive results, these patients “are motivated to finish therapy.”
With clinical trials data available for only the approved regimens, some of Burman’s patients have detoured from those paths slightly but are still on the triple therapy, so he’s curious to see their final outcomes.
For example, “even though we consulted with all of the patients before they started the regimen, there were a few patients who skipped the four-week lead-in with Victrelis and started right away, but their physicians kept them on the regimen,” he says. Burman says he thinks there were two patients who did this, both naïve to prior therapy. “One was negative for the virus after four weeks,” and he is unsure of the other patient’s status.
The specialty pharmacy also had “one patient who basically had cleared the virus, and he had to go in for emergency surgery that was unrelated to the hepatitis C, which meant he had to go off the medications for one week. His doctor started him back up [on Victrelis], so it will be interesting to see what happens.”
As far as side effects of the drugs, “we have slightly more anemia with Victrelis, which was expected,” Burman says. “In most of these cases, we’ve seen physicians use ribavirin dose reductions to treat the anemia.” Ultimately, though, his specialty pharmacy has seen “a little more anemia but not as many side effects with Victrelis.”
Among people taking Incivek, “a very low percentage — less than 1% of patients — were discontinued because of a rash, although we have seen a rash on quite a few of these patients.”
One troubling trend that Burman has noticed is that “about 5% of our patients are getting triple therapy from two pharmacies.” He says he’s been told by larger PBMs that “You fill the ribavirin and interferon, and we’ll fill Incivek” — which can be $17,000 for each fill, he notes.
This kind of situation, though, can cause a “continuity of care issue,” he contends. “It doesn’t seem to be cost-effective,…and it’s disruptive to the patient.”
Burman explains that “about 25% to 30% of patients we set up and trained switched to mail order after one or two months of the six-month therapy.” But within that “complicated” six-month treatment, “there’s no room for error.”
However, some patients almost have had their adherence impacted through no fault of their own, says Burman. He tells SPN that he’s gotten calls from patients who are receiving their drugs from other PBMs through mail order but haven’t gotten their next dose as scheduled, so they’re trying to find a pharmacy that can help. Because patients cannot miss a dose, his company has driven medications to patients an hour or so away to make sure they stay compliant.
Burman expects to have final outcomes for initial patients in May or June. “The first batch of patients just finished therapy. We need to wait six months to retest them, and if they’ve still cleared the virus, we’ll consider them cured. It’s looking good for a lot of patients.…This is a new lease on life for some of these people.”
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